A Study of Ad26.COV2.S in Adults (COVID-19)

NCT04436276 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: CR1088282020-001483-28VAC31518COV1001
• Study Type: interventional
• Target: 1,085
• Locations: 2 countries
• Sites: 12

Brief Summary

The purpose of the study is to assess the safety, reactogenicity, and immunogenicity of Ad26.COV2.S at 2 dose levels, administered intramuscularly (IM) as a single-dose or 2-dose schedule, with a single booster vaccination administered in one cohort in healthy adults aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 years and in adults aged \>= 65 years in good health with or without stable underlying conditions. The purpose of the study is also to assess the safety and reactogenicity of Ad26.COV2.S administered as ad hoc booster vaccination in healthy adults aged \>= 18 to \<= 55 years and in adults \>= 65 years in good health with or without stable underlying conditions.

Conditions

Covid-19 Prevention

Keywords

COVID-19; Ad26COVS1; Ad26.COV2.S; SARS CoV 2; Vaccine

Outcome Measures

Primary Outcomes (46)

• Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen

  Number of participants with solicited local AEs for 7 days after vaccination 1 in Cohorts 1a and 1b were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

  7 days post-vaccination 1 on Day 1 (Day 8)

• Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen

  Number of participants with solicited local AEs for 7 days after vaccination 2 in Cohorts 1a and 1b were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

  7 days after vaccination 2 on Day 57 (Day 64)

• Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination

  Number of participants with solicited local AEs for 7 days after ad hoc booster vaccination in Cohorts 1a and 1b were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

  7 days after ad hoc booster vaccination (Day 488 up to Day 604)

• Cohorts 2a and 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen

  Number of participants with solicited local AEs for 7 days after vaccination 1 in Cohorts 2a and 2b were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

  7 days after Vaccination 1 on Day 1 (Day 8)

• Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 1

  Number of participants with solicited local AEs for 7 days after booster vaccination 1 in Cohort 2a were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

  7 days after booster vaccination 1 on Day 183 (Day 190)

• Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 2

  Number of participants with solicited local AEs for 7 days after booster vaccination 2 in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

  7 days after booster vaccination 2 on Day 366 (Day 373)

• Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination

  Number of participants with solicited local AEs for 7 days after ad hoc booster vaccination in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

  7 days after ad hoc booster vaccination (Day 384 up to Day 451)

• Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen

  Number of participants with solicited local AEs for 7 days after Vaccination 2 in Cohort 2b were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

  7 days after Vaccination 2 on Day 57 (Day 64)

• Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 1

  Number of participants with solicited local AEs for 7 days after booster vaccination 1 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

  7 days after booster vaccination 1 on Day 239 (Day 246)

• Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 2

  Number of participants with solicited local AEs for 7 days after booster Vaccination 2 in Cohort 2b were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

  7 days after booster vaccination 2 on Day 422 (Day 429)

• Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination

  Number of participants with solicited local AEs for 7 days after ad hoc booster vaccination in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

  7 days after ad hoc booster vaccination (Day 369 up to Day 412)

• Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen

  Number of participants with solicited systemic AEs for 7 days after vaccination 1 in Cohorts 1a and 1b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

  7 days after vaccination 1 on Day 1 (Day 8)

• Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen

  Number of participants with solicited systemic AEs for 7 days after vaccination 2 in Cohorts 1a and 1b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

  7 days after Vaccination 2 on Day 57 (Day 64)

• Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination

  Number of participants with solicited systemic AEs for 7 days after ad hoc booster vaccination in Cohorts 1a and 1b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post Ad Hoc Booster Vaccination (day of Ad hoc booster vaccination and the subsequent 7 days).

  7 days after ad hoc booster vaccination (Day 488 up to Day 604)

• Cohorts 2a and 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen

  Number of participants with solicited systemic AEs for 7 days after vaccination 1 in Cohorts 2a and 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

  7 days after Vaccination 1 on Day 1 (Day 8)

• Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 1

  Number of participants with solicited systemic AEs for 7 days post booster vaccination 1 in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

  7 days after booster vaccination 1 on Day 183 (Day 190)

• Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 2

  Number of participants with solicited systemic AEs for 7 days after booster vaccination 2 in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

  7 days after booster vaccination 2 on Day 366 (Day 373)

• Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination

  Number of participants with solicited systemic AEs for 7 days after ad hoc booster vaccination in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post adhoc booster vaccination (day of ad hoc booster vaccination and the subsequent 7 days).

  7 days after ad hoc booster vaccination (Day 384 up to Day 451)

• Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen

  Number of participants with solicited systemic AEs for 7 days after vaccination 2 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

  7 days after Vaccination 2 on Day 57 (Day 64)

• Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 1

  Number of participants with solicited systemic AEs for 7 days after booster vaccination 1 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

  7 days after booster vaccination 1 on Day 239 (Day 246)

• Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 2

  Number of participants with solicited systemic AEs for 7 days after booster vaccination 2 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

  7 days after booster vaccination 2 on Day 422 (Day 429)

• Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination

  Number of participants with solicited systemic AEs for 7 days after ad hoc booster vaccination in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post ad hoc booster vaccination (day of ad hoc booster vaccination and the subsequent 7 days).

  7 days after ad hoc booster vaccination (Day 369 up to Day 412)

• Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen

  Number of participants with solicited local AEs for 7 days after vaccination 1 in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site).

  7 days after vaccination 1 on Day 1 (Day 8)

• Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen

  Number of participants with solicited systemic AEs for 7 days after vaccination 1 in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

  7 days post-vaccination 1 on Day 1 (Day 8)

• Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen

  Number of participants with solicited local AEs for 7 days after vaccination 2 in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site).

  7 days post-vaccination 2 on Day 57 (Day 64)

• Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen

  Number of participants with solicited systemic AEs for 7 days after vaccination 2 in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

  7 after post-vaccination 2 on Day 57 (Day 64)

• Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination

  Number of participants with solicited local AEs for 7 days after ad hoc booster vaccination in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site).

  7 days after ad hoc booster vaccination (Day 456 up to Day 711)

• Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination

  Number of participants with solicited systemic AEs for 7 days after ad hoc booster vaccination in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post ad hoc booster vaccination (day of ad hoc booster vaccination and the subsequent 7 days).

  7 days after ad hoc booster vaccination (Day 456 up to Day 711)

• Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen

  Number of participants with unsolicited AEs after vaccination 1 in Cohorts 1a and 1b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

  28 days after vaccination 1 on Day 1 (Day 29)

• Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen

  Number of participants with unsolicited AEs after vaccination 2 in Cohorts 1a and 1b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

  28 days after vaccination 2 on Day 57 (Day 85)

• Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination

  Number of participants with unsolicited AEs after ad hoc booster vaccination in Cohorts 1a and 1b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

  28 days after ad hoc booster vaccination (Day 488 up to Day 625)

• Cohorts 2a and 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen

  Number of participants with unsolicited AEs after vaccination 1 in Cohorts 2a and 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

  28 days after Vaccination 1 on Day 1 (Day 29)

• Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 1

  Number of participants with unsolicited AEs after booster 1 vaccination in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

  28 days after booster vaccination 1 on Day 183 (Day 211)

• Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 2

  Number of participants with unsolicited AEs after booster vaccination 2 in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

  28 days after booster vaccination 2 on Day 366 (Day 394)

• Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination

  Number of participants with unsolicited AEs after ad hoc booster vaccination in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

  28 days after ad hoc booster vaccination (Day 384 up to Day 472)

• Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen

  Number of participants with unsolicited AEs after vaccination 1 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

  28 days after Vaccination 2 on Day 57 (Day 85)

• Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 1

  Number of participants with unsolicited AEs 28 days after booster vaccination 1 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

  28 days after booster vaccination 1 on Day 239 (Day 267)

• Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 2

  Number of participants with unsolicited AEs 28 days after booster vaccination 2 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

  28 days after booster vaccination 2 on Day 422 (Day 450)

• Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination

  Number of participants with unsolicited AEs 28 days after ad hoc booster vaccination in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

  28 days after ad hoc booster vaccination (Day 369 up to Day 433)

• Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen

  Number of participants with unsolicited AEs 28 days after vaccination 1 in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

  28 days after vaccination 1 on Day 1 (Day 29)

• Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen

  Number of participants with unsolicited AEs 28 days after vaccination 2 in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

  28 days after vaccination 2 on Day 57 (Day 85)

• Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination

  Number of participants with unsolicited AEs 28 days after ad hoc booster vaccination in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

  28 days after ad hoc booster vaccination (Day 456 up to Day 732)

• Cohorts 1a and 1b and Cohort 3: Number of Participants With Serious Adverse Events (SAEs)

  An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.

  Day 1 up to 2 years after Vaccination 2 on Day 57 (Day 787)

• Cohorts 2a and 2b: Number of Participants With Serious Adverse Events (SAEs)

  An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.

  Day 1 up to 6 months post primary regimen (up to Day 183 for Cohort 2a; up to Day 239 for Cohort 2b)

• Cohorts 1a, 1b and 3: Number of Participants With Adverse Events of Special Interest (AESIs)

  Number of participants with AESIs was reported. AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, was considered to be an AESI in this study. A suspected TTS case was defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/microliter.

  Day 1 up to 2 years after Vaccination 2 on Day 57 (Day 787)

• Cohorts 2a and 2b: Number of Participants With Adverse Events of Special Interest (AESIs)

  Number of participants with AESIs was reported. AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, was considered to be an AESI in this study. A suspected TTS case was defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/microliter.

  Day 1 up to 6 months post primary regimen (up to Day 183 for Cohort 2a; up to Day 239 for Cohort 2b)

Secondary Outcomes (24)

• Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA)

  Days 29, 57, 71, 85, 239, and 422

• Cohort 1b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA)

  Days 29 and 71

• Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA)

  Days 8, 29, 183, 190, 211, 366, 373, and 394,

• Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA)

  Days 8, 29, 57, 64, 85, 239, 246, 267 and 422

• Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA)

  Days 15, 29, 87, 100, 114 and 268

Study Arms (5)

Cohort 1a

EXPERIMENTAL

Participants (healthy adults aged greater than or equal to (\>=)18 to less than or equal to (\<=) 55 years) will receive Ad26.COV2.S at 2 dose levels, as a single dose or 2 dose schedule with an 8-week interval or matching Placebo on Day 1 and Day 57. At unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen of Ad26.COV2.S vaccine, participants initially receiving placebo will be offered to receive a single dose of Ad26.COV2.S. If they choose not to receive Ad26.COV2.S they will be asked to continue to be followed in this study. All eligible participants who have previously received coronavirus disease-2019 (COVID-19) vaccination (as primary regimen or additional dose) if the last vaccination was \>=6 months ago, will be offered to receive a single ad hoc booster dose of Ad26.COV2.S. If they choose not to receive ad-hoc booster dose they will be asked to continue to be followed in this study.

Biological: Ad26.COV2.S; Biological: Placebo

Cohort 1b

EXPERIMENTAL

Participants (healthy adults aged \>=18 to \<= 55 years) will receive Ad26.COV2.S as a single vaccination in the primary regimen or matching Placebo on Day 1 and Day 57. At unblinding visit, post EUA, conditional licensure, or approval for the single dose regimen of Ad26.COV2.S vaccine, participants initially receiving placebo will be offered to receive a single dose of Ad26.COV2.S. If they choose not to receive Ad26.COV2.S they will be asked to continue to be followed in this study. All eligible participants who have previously received any COVID-19 vaccination (as primary regimen or additional dose) if the last vaccination was \>=6 months ago will be offered to receive a single ad hoc booster dose of Ad26.COV2.S. If they choose not to receive ad-hoc booster dose they will be asked to continue to be followed in this study.

Biological: Ad26.COV2.S; Biological: Placebo

Cohort 2a

EXPERIMENTAL

Participants (healthy adults aged \>=18 to \<=55 years) will receive Ad26.COV2.S as single vaccination in the primary regimen or matching Placebo on Day 1, followed by booster vaccination at 6 or 12 months with same dose or matching Placebo. At unblinding visit, post EUA, conditional licensure, or approval for the single dose regimen of Ad26.COV2.S vaccine, participants initially receiving placebo will be offered to receive a single dose of Ad26.COV2.S vaccine and who are not willing to receive single dose of Ad26.COV2.S vaccine will continue to receive booster vaccination. All eligible participants who have previously received any COVID-19 vaccination (as primary regimen or additional dose) if the last vaccination was \>= 6 months ago, will be offered to receive a single ad hoc booster dose of Ad26.COV2.S and who are not willing to receive single ad hoc booster dose of Ad26.COV2.S or are not eligible to receive the ad hoc booster dose will continue to receive booster vaccination.

Biological: Ad26.COV2.S; Biological: Placebo

Cohort 2b

EXPERIMENTAL

Participants(healthy adults aged \>=18 to \<=55 years)will receive Ad26.COV2.S in primary regimen or matching Placebo on Day 1 and 57,followed by booster vaccination at 8 or 14 months (that is, 6 or 12 months after completion of primary regimen)with same dose or matching Placebo.At unblinding visit,post EUA,conditional licensure,or approval for single dose regimen of Ad26.COV2.S vaccine,participants initially receiving placebo will be offered to receive single dose of Ad26.COV2.S vaccine and who are not willing to receive single dose of Ad26.COV2.S vaccine will continue to receive booster vaccination.All eligible participants who have previously received any COVID-19 vaccination(as primary regimen or additional dose)if last vaccination was \>= 6 months ago,will be offered to receive single ad hoc booster dose of Ad26.COV2.S and who are not willing to receive single ad hoc booster dose of Ad26.COV2.S or are not eligible for ad hoc booster dose will continue to receive booster vaccination.

Biological: Ad26.COV2.S; Biological: Placebo

Cohort 3

EXPERIMENTAL

Participants (good or stable health adults aged \>=65 years) will receive Ad26.COV2.S at 2 dose levels, as a single dose or 2 dose schedule with an 8-week interval or matching Placebo on Day 1 and Day 57. At unblinding visit, post EUA, conditional licensure, or approval for the single dose regimen of Ad26.COV2.S vaccine, participants initially receiving placebo will be offered to receive a single dose of Ad26.COV2.S. If they choose not to receive Ad26.COV2.S they will be asked to continue to be followed in this study. All eligible participants who have previously received any COVID-19 vaccination (as primary regimen or additional dose) if the last vaccination was \>=6 months ago will be offered to receive a single ad hoc booster dose of Ad26.COV2.S. If they choose not to receive ad-hoc booster dose or if they are not eligible for ad-hoc booster dose, then they will be asked to continue to be followed in this study.

Biological: Ad26.COV2.S; Biological: Placebo

Interventions

Ad26.COV2.S BIOLOGICAL

Participants will receive intramuscular (IM) injection of Ad26.COV2.S.

Also known as: JNJ-78436735, Ad26COVS1

Cohort 1a; Cohort 1b; Cohort 2a; Cohort 2b; Cohort 3

Placebo BIOLOGICAL

Participants will receive Placebo.

Cohort 1a; Cohort 1b; Cohort 2a; Cohort 2b; Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must sign an informed consent form (ICF) indicating that he or she understands the purpose, procedures, and potential risks and benefits of the study, and is willing to participate in the study
• All female participants of childbearing potential must have a negative highly sensitive urine pregnancy test at screening; and have a negative highly sensitive urine pregnancy test immediately prior to each study vaccine administration
• Participant must have a body mass index (BMI) less than or equal to (\<=) 30.0 kilograms per square meter (kg/m\^2)
• Applicable to Cohorts 1 and 2 only: Participant must be healthy, in the investigator's clinical judgment, as confirmed by medical history, physical examination, clinical laboratory assessments, and vital signs performed at screening, and must not have comorbidities related to an increased risk of severe coronavirus disease-2019 (COVID-19). Applicable to Cohort 3 only: In the investigator's clinical judgment, participant must be either in good or stable health Participants may have underlying illnesses such as hyperlipoproteinemia or hypothyroidism, as long as their symptoms and signs are medically controlled and not considered to be comorbidities related to an increased risk of severe COVID-19 (participants may have medical conditions of mild severity (according to the Toxicity Grading Scale), as long as it is stable and medically controlled as defined by no change in medication over the past 6 months (except for issues of tolerability or use of similar drug with same mechanism of action, for example, thiazides, Beta blockers, Alpha blockers at the same effective dose).

You may not qualify if:

• Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (\>=) 38.0 degree Celsius within 24 hours prior to the planned first dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor
• Participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
• Participant has a history of any neurological disorders or seizures including Guillain-Barre syndrome, with the exception of febrile seizures during childhood
• Participant has a positive diagnostic test result for SARS-CoV-2 infection confirmed by polymerase chain reaction (PCR) at screening
• Participants with comorbidities that are or might be associated with an increased risk of progression to severe COVID-19, that is, participants with moderate-to-severe asthma; chronic lung diseases such as chronic obstructive pulmonary disease (COPD) (including emphysema and chronic bronchitis), idiopathic pulmonary fibrosis and cystic fibrosis; diabetes (including type 1 or type 2); serious heart conditions, including heart failure, coronary artery disease, congenital heart disease, cardiomyopathies, and (pulmonary) hypertension or high blood pressure; obesity (BMI \>= 30 kg/m\^2); chronic liver disease, including cirrhosis; sickle cell disease; thalassemia; cerebrovascular disease; neurologic conditions (dementia); smoking end stage renal disease; organ transplantation; cancer; HIV infection and other immunodeficiencies; hepatitis B infection; and sleep apnea. Applicable to Cohort 3 only: Participants may have hypertension of mild severity (according to the Toxicity Grading Scale), as long as it is stable and medically controlled as defined by no change in medication over the past 6 months (except for issues of tolerability or use of similar drug with same mechanism of action, for example, thiazides, Beta blockers, Alpha blockers at the same effective dose)
• Applicable to Cohorts 1 and 3 only: Participant currently working in an occupation with a high risk of exposure to SARS-CoV-2 (for example, health care worker or emergency response personnel) or considered at the investigator's discretion to be at increased risk to acquire COVID-19 for any other reason

Sponsors & Collaborators

• Janssen Vaccines & Prevention B.V.: lead

Study Sites (12)

Optimal Research

San Diego, California, 92108, United States

Location

Optimal Research

Melbourne, Florida, 32934, United States

Location

Optimal Research

Peoria, Illinois, 61614, United States

Location

Optimal Research

Rockville, Maryland, 20850, United States

Location

Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company

Knoxville, Tennessee, 37923, United States

Location

Optimal Research

Austin, Texas, 78744, United States

Location

Universiteit Antwerpen - Centrum voor de Evaluatie van Vaccinaties (CEV)

Edegem, 2650, Belgium

Location

UZA-SGS

Edegem, 2650, Belgium

Location

Center for Vaccinology (CEVAC)

Ghent, 9000, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Clinical Pharmacology Unit

Merksem, 2170, Belgium

Location

Related Publications (4)

• Sadoff J, Le Gars M, Brandenburg B, Cardenas V, Shukarev G, Vaissiere N, Heerwegh D, Truyers C, de Groot AM, Jongeneelen M, Kaszas K, Tolboom J, Scheper G, Hendriks J, Ruiz-Guinazu J, Struyf F, Van Hoof J, Douoguih M, Schuitemaker H. Durable antibody responses elicited by 1 dose of Ad26.COV2.S and substantial increase after boosting: 2 randomized clinical trials. Vaccine. 2022 Jul 30;40(32):4403-4411. doi: 10.1016/j.vaccine.2022.05.047. Epub 2022 Jun 3.

  PMID: 35667914 DERIVED

• Stephenson KE, Le Gars M, Sadoff J, de Groot AM, Heerwegh D, Truyers C, Atyeo C, Loos C, Chandrashekar A, McMahan K, Tostanoski LH, Yu J, Gebre MS, Jacob-Dolan C, Li Z, Patel S, Peter L, Liu J, Borducchi EN, Nkolola JP, Souza M, Tan CS, Zash R, Julg B, Nathavitharana RR, Shapiro RL, Azim AA, Alonso CD, Jaegle K, Ansel JL, Kanjilal DG, Guiney CJ, Bradshaw C, Tyler A, Makoni T, Yanosick KE, Seaman MS, Lauffenburger DA, Alter G, Struyf F, Douoguih M, Van Hoof J, Schuitemaker H, Barouch DH. Immunogenicity of the Ad26.COV2.S Vaccine for COVID-19. JAMA. 2021 Apr 20;325(15):1535-1544. doi: 10.1001/jama.2021.3645.

  PMID: 33704352 DERIVED

• Sadoff J, Le Gars M, Shukarev G, Heerwegh D, Truyers C, de Groot AM, Stoop J, Tete S, Van Damme W, Leroux-Roels I, Berghmans PJ, Kimmel M, Van Damme P, de Hoon J, Smith W, Stephenson KE, De Rosa SC, Cohen KW, McElrath MJ, Cormier E, Scheper G, Barouch DH, Hendriks J, Struyf F, Douoguih M, Van Hoof J, Schuitemaker H. Interim Results of a Phase 1-2a Trial of Ad26.COV2.S Covid-19 Vaccine. N Engl J Med. 2021 May 13;384(19):1824-1835. doi: 10.1056/NEJMoa2034201. Epub 2021 Jan 13.

  PMID: 33440088 DERIVED

• Bos R, Rutten L, van der Lubbe JEM, Bakkers MJG, Hardenberg G, Wegmann F, Zuijdgeest D, de Wilde AH, Koornneef A, Verwilligen A, van Manen D, Kwaks T, Vogels R, Dalebout TJ, Myeni SK, Kikkert M, Snijder EJ, Li Z, Barouch DH, Vellinga J, Langedijk JPM, Zahn RC, Custers J, Schuitemaker H. Ad26 vector-based COVID-19 vaccine encoding a prefusion-stabilized SARS-CoV-2 Spike immunogen induces potent humoral and cellular immune responses. NPJ Vaccines. 2020 Sep 28;5:91. doi: 10.1038/s41541-020-00243-x. eCollection 2020.

  PMID: 33083026 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Ad26COVS1

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

COVID-19 Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Clinical Franchise Leader
• Organization: Janssen Vaccines & Prevention B.V.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Vaccines & Prevention B.V. Clinical Trial

  Janssen Vaccines & Prevention B.V.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 18, 2020
• Study Start: July 15, 2020
• Primary Completion: February 21, 2023
• Study Completion: February 21, 2023
• Last Updated: February 4, 2025
• Results First Posted: May 24, 2024

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

BE (5); US (7)