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

NCT04509947 | Completed Phase 1

• 2 other identifiers: CR108871VAC31518COV1002
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to assess the safety and reactogenicity of Ad26.COV2.S administered intramuscularly (IM) at 2-dose levels, as 2-dose schedule in healthy participants aged greater than or equal to 20 to less than or equal to 55 years and greater than or equal to 65 years in good health with or without stable underlying conditions.

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

• Number of Participants with Solicited Local Adverse Events (AEs) for 7 days after First Vaccination

  Solicited local AEs are pre-defined local (at the injection site) AEs for which participants are specifically questioned and which are noted by participants in their diary for 7 days post first vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, swelling and induration at the vaccination site. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.

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

• Number of Participants with Solicited Local AEs for 7 days after Second Vaccination

  Solicited local AEs are pre-defined local (at the injection site) AEs for which participants are specifically questioned and which are noted by participants in their diary for 7 days post second vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, swelling and induration at the vaccination site. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.

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

• Number of Participants with Solicited Systemic AEs for 7 days after First Vaccination

  Participants will be instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events include fatigue, headache, nausea and myalgia.

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

• Number of Participants with Solicited Systemic AEs for 7 days after Second Vaccination

  Participants will be instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events include fatigue, headache, nausea and myalgia.

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

• Number of Participants with Unsolicited AEs for 28 days after First Vaccination

  Number of participants with unsolicited AEs for 28 days after first vaccination will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned.

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

• Number of Participants with Unsolicited AEs for 28 days after Second Vaccination

  Number of participants with unsolicited AEs for 28 days after second vaccination will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned.

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

• Number of Participants with Serious Adverse Events (SAEs)

  SAE is an adverse event 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.

  Up to 12 months

Secondary Outcomes (2)

• Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Neutralization as measured by Virus Neutralization Assay (VNA)

  Up to 12 months

• SARS-CoV-2-Binding Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)

  Up to 12 months

Study Arms (3)

Ad26.COV2.S: High Dose

EXPERIMENTAL

Participants (healthy adults aged greater than or equal to (\>=) 20 to less than or equal to (\<=) 55 years \[cohort 1\] and \>= 65 years \[cohort 2\]) will receive intramuscular (IM) injection of Ad26.COV2.S at high dose, as 2-dose schedule on Day 1 and Day 57.

Biological: Ad26.COV2.S

Ad26.COV2.S: Low Dose

EXPERIMENTAL

Participants (healthy adults aged \>= 20 to \<= 55 years \[cohort 1\] and \>= 65 years \[cohort 2\]) will receive IM injection of Ad26.COV2.S at low dose, as 2-dose schedule on Day 1 and Day 57.

Biological: Ad26.COV2.S

Placebo

PLACEBO COMPARATOR

Participants (healthy adults aged \>= 20 to \<= 55 years \[cohort 1\] and \>= 65 years \[cohort 2\]) will receive IM injection of placebo on Day 1 and Day 57.

Biological: Placebo

Interventions

Ad26.COV2.S BIOLOGICAL

Ad26.COV2.S will be administered as IM injection at 2-dose (high and low) levels.

Also known as: JNJ-78436735, Ad26COVS1

Ad26.COV2.S: High Dose; Ad26.COV2.S: Low Dose

Placebo BIOLOGICAL

Placebo will be administered as IM injection.

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must have a body mass index (BMI) less than (\<) 40.0 kilograms per meter square (kg/m\^2)
• Contraceptive (birth control) use by women should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies. Before randomization, participants who were born female must be either (a) not of childbearing potential; (b) of childbearing potential and practicing a highly effective method of contraception (failure rate of less than (\<) 1 percent (%) per year when used consistently and correctly) and agrees to remain on such a method of contraception from signing the informed consent until 3 months after the last dose of study vaccine. Use of hormonal contraception should start at least 28 days before the first administration of study vaccine. The investigators should evaluate the potential for contraceptive method failure (example, noncompliance, recently initiated) in relationship to the first vaccination. Highly effective methods for this study include: (1) hormonal contraception: (i) combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal); (ii) progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable); (2) intrauterine device (IUD); (3) intrauterine hormone-releasing system (IUS); (4) bilateral tubal occlusion/litigation procedure; (5) vasectomized partner (the vasectomized partner should be the sole partner for that participant; (6) sexual abstinence. Applicable to Cohort 2 only: Before randomization, a woman must be (a) postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause) or permanently sterile; and (b) not intending to conceive by any method.
• All female participants of childbearing potential must: have a negative highly sensitive urine or serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening; have a negative highly sensitive urine beta-hCG pregnancy test immediately prior to each study vaccine administration
• A male participant must agree not to donate sperm for the purpose of reproduction for a minimum 28 days after receiving the dose of study vaccine
• Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine

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 investigators 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 previously received a coronavirus vaccine
• Participant has a positive molecular test result for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection, confirmed by polymerase chain reaction (PCR) at screening
• Participant currently working in an occupation with a high risk of exposure to SARS-CoV-2 (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 Pharmaceutical K.K.: lead

Study Sites (3)

Souseikai Hakata Clinic

Fukuoka, 812-0025, Japan

Location

SOUSEIKAI PS Clinic

Fukuoka, 812-0025, Japan

Location

Souseikai Fukuoka Mirai Hospital

Fukuoka, 813-0017, Japan

Location

Related Publications (1)

• Tsuchiya Y, Tamura H, Fujii K, Numaguchi H, Toyoizumi K, Liu T, Le Gars M, Cardenas V, Eto T. Safety, reactogenicity, and immunogenicity of Ad26.COV2.S: Results of a phase 1, randomized, double-blind, placebo-controlled COVID-19 vaccine trial in Japan. Vaccine. 2023 Feb 24;41(9):1602-1610. doi: 10.1016/j.vaccine.2023.01.006. Epub 2023 Jan 5.

  PMID: 36732164 DERIVED

MeSH Terms

Interventions

Ad26COVS1

Intervention Hierarchy (Ancestors)

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

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 12, 2020
• Study Start: August 11, 2020
• Primary Completion: February 22, 2021
• Study Completion: November 16, 2021
• Last Updated: November 24, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share

Locations

JP (3)