A Study of Ad26.COV2.S in Healthy Pregnant Participants (COVID-19)

NCT04765384 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: CR108962VAC31518COV20042020-005330-14
• Study Type: interventional
• Target: 51
• Locations: 3 countries
• Sites: 18

Brief Summary

The purpose of this study is to assess the safety and reactogenicity of Ad26.COV2.S administered intramuscularly (IM) as a 1-dose schedule at the standard dose level in adult participants during the second and/or third trimester of pregnancy and (potentially) post-partum; to assess the humoral immune response in peripheral blood of adult participants to Ad26.COV2.S administered IM as a 1-dose schedule during the second and/or third trimester of pregnancy, 28 days after vaccination.

Conditions

COVID-19 Prevention

Outcome Measures

Primary Outcomes (8)

• Number of Adult Participants With Solicited Local Adverse Events (AEs) for 7 Days Post First Vaccination

  Number of adult participants with solicited local AEs for 7 days post first vaccination was 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 AEs were used to assess the reactogenicity of the study vaccine and were pre-defined as local (at the injection site) AEs for which participants were specifically asked and which were noted by participants in their reactogenicity diary for 7 days post first vaccination (day of first vaccination and the subsequent 7 days). Solicited local AEs are injection site pain/tenderness, erythema, swelling at the vaccination site.

  From first vaccination on Day 1 up to 7 days post first vaccination (up to Day 8)

• Number of Adult Participants With Solicited Systemic AEs for 7 Days Post First Vaccination

  Number of adult participants with solicited systemic AEs for 7 days post first vaccination was 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 AEs were used to assess the reactogenicity of the study vaccine and were predefined as systemic AEs for which participants were specifically asked and which were noted by participants in their reactogenicity diary for 7 days post first vaccination. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post first vaccination (day of first vaccination and the subsequent 7 days) for the following solicited systemic AEs: fatigue, headache, nausea, myalgia.

  From first vaccination on Day 1 up to 7 days post first vaccination (up to Day 8)

• Number of Adult Participants With Unsolicited AEs for 28 Days Post First Vaccination

  Number of adult participants with unsolicited AEs for 28 days post first vaccination was 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. Unsolicited AEs were defined as AEs for which the participants were not specifically questioned in the participant's reactogenicity diary.

  From first vaccination on Day 1 up to 28 days post first vaccination (up to Day 29)

• Number of Adult Participants With Serious Adverse Events (SAEs) From First Vaccination Until End of the Study (EOS)

  Number of adult participants with SAEs from first vaccination until EOS 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. SAEs were defined as any untoward medical occurrence that at any dose results in any of the following outcomes: 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.

  From first vaccination on Day 1 until end of study (up to post-partum [PP] Day 366 [Day 15 up to Day 554])

• Number of Adult Participants With Adverse Events of Special Interest (AESIs) From First Vaccination Until EOS

  Number of adult participants with AESIs from first vaccination until EOS were reported. Thrombosis with thrombocytopenia syndrome (TTS) in adults was considered an AESI in this study. TTS is a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia.

  From first vaccination on Day 1 until end of study (up to PP Day 366 [Day 15 up to Day 554])

• Number of Adult Participants With Medically Attended Adverse Events (MAAEs) Until 6 Months Post First Vaccination

  Number of adult participants with MAAEs until 6 months post first vaccination was reported. MAAEs were defined as AEs with medically attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not considered medically attended visits. New onset of chronic diseases was collected as part of the MAAEs.

  From first vaccination on Day 1 until 6 months post first vaccination (up to Day 183)

• Number of Adult Participants With AEs Leading to Study Discontinuation

  Number of adult participants with AEs leading to study discontinuation 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. All AEs leading to discontinuation from the study (regardless of the causal relationship) were reported for all adult participants from the moment of first vaccination until completion of the participant's last study-related procedure.

  From first vaccination on Day 1 until end of study (up to PP Day 366 [Day 15 up to Day 554])

• Serological Response to Vaccination as Measured by S-Enzyme-linked Immunosorbent Assay (S-ELISA) in Adult Participants 28 Days Post First Vaccination

  Serological response to vaccination as measured by S-ELISA in adult participants 28 days post first vaccination was reported.

  28 days post first vaccination on Day 1 (at Day 29)

Secondary Outcomes (20)

• Group 4: Number of Adult Participants With Solicited Local AEs for 7 Days Post Booster Vaccination

  7 days post booster vaccination (Day 84 up to Day 371)

• Group 4: Number of Adult Participants With Solicited Systemic AEs for 7 Days Post Booster Vaccination

  7 days post booster vaccination (Day 84 up to Day 371)

• Group 4: Number of Adult Participants With Unsolicited AEs for 28 Days Post Booster Vaccination

  28 days post booster vaccination (Day 84 up to Day 392)

• Group 4: Number of Adult Participants With SAEs Post Booster Vaccination Until EOS

  From booster vaccination (Day 84 up to Day 364) until EOS (up to PP Day 366 [Day 366 up to Day 554])

• Group 4: Number of Adult Participants With AESIs Post Booster Vaccination Until EOS

  From booster vaccination (Day 84 up to Day 364) until EOS (up to PP Day 366 [Day 366 up to Day 554])

Study Arms (1)

Groups 1-4: Ad26.COV2.S (One Dose)

EXPERIMENTAL

Participants who are previously vaccinated (Group 1-3) and participants who are vaccine naïve (Group 4) will receive single dose of Ad26.COV2.S vaccine at standard dose level on Day 1. Participants from group 4 who are no longer pregnant may receive single booster dose of Ad26.COV2.S vaccine at standard dose level.

Biological: Ad26.COV2.S

Interventions

Ad26.COV2.S BIOLOGICAL

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

Also known as: JNJ-78436735, Ad26COVS1

Groups 1-4: Ad26.COV2.S (One Dose)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• If on medication for a condition, the medication dose must have been stable for at least 4 weeks preceding vaccination
• Participant must be healthy as confirmed by medical history, physical examination, vital signs, and obstetric history performed at Screening. Participant may have underlying illnesses, as long as the symptoms and signs are medically controlled
• Participant will be at second or third trimester of pregnancy, that is, Week 16 to Week 38 of gestation (inclusive), at the time of vaccination, based on ultrasound at the time of screening (or not longer than 10 days prior to vaccination if performed elsewhere)
• 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
• Participant must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
• Participant either received their last COVID-19 vaccination with an authorized/licensed COVID-19 vaccine (at least 4 months prior to first study vaccination) or is COVID 19 vaccine-naïve

You may not qualify if:

• Participants with medical or obstetric histories that put them at higher risk for maternal or fetal complications (example, chronic pregnancy-related disorders, birth defects or genetic conditions during previous pregnancy)
• Participant with abnormal pregnancy screening test (example, ultrasound fetal abnormalities, maternal blood screen)
• Participant has a history of malignancy within 2 years before screening (exceptions are squamous, basal cell carcinomas of the skin, carcinoma in situ of the cervix, or malignancy, considered cured with minimal risk of recurrence)
• Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine)
• Participant has a history of any serious, chronic, or progressive neurological disorders or seizures including Guillain-Barre syndrome, with the exception of febrile seizures during childhood
• Participant has a positive diagnostic test result (polymerase chain reaction \[PCR\] based viral ribonucleic acid \[RNA\] detection) severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection at screening or Day 1 (if more than 4 days in between)
• Participant has a history of thrombosis with thrombocytopenia syndrome (TTS), including cerebral venous sinus thrombosis (CVST), or heparin-induced thrombocytopenia (HIT)
• Participant has a history of capillary leak syndrome (CLS)

Sponsors & Collaborators

• Janssen Vaccines & Prevention B.V.: lead

Study Sites (18)

Medpharmics, LLC

Gulfport, Mississippi, 39503, United States

Location

Meridian Clinical Research, LLC

Norfolk, Nebraska, 68701, United States

Location

Medpharmics, LLC

Albuquerque, New Mexico, 87102, United States

Location

Maximos OB/GYN

League City, Texas, 77573, United States

Location

Universidade Federal De Minas Gerais - Hospital das Clínicas

Belo Horizonte, 30130-100, Brazil

Location

Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose

Criciúma, 88811-508, Brazil

Location

Associacaode Ensino de Marilia LTDA - UNIMAR - Universidade de Marilia

Marília, 17525-160, Brazil

Location

Centro de Estudos e Pesquisas em Moléstias Infecciosas - CEPCLIN

Natal, 59025-050, Brazil

Location

Hospital das Clinicas de Porto Alegre

Porto Alegre, 90035-903, Brazil

Location

NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul

Porto Alegre, 90430-001, Brazil

Location

CEMEC - Centro Multidisciplinar de Estudos Clínicos

São Bernardo do Campo, 09715-090, Brazil

Location

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base

São José do Rio Preto, 15090-000, Brazil

Location

Clinical Research College

São Paulo, 4534002, Brazil

Location

CMPC - Consultoria Médica e Pesquisa Clínica

Sorocaba, 18040-425, Brazil

Location

Ndlovu Elandsdoorn Site

Dennilton, 0485, South Africa

Location

Shandukani Research Centre

Johannesburg, 2001, South Africa

Location

Stanza Clinical Research Centre : Mamelodi

Mamelodi East, 0122, South Africa

Location

Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital

Soweto, 1864, South Africa

Location

MeSH Terms

Interventions

Ad26COVS1

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Sample size for safety and immunogenicity analyses was low. In addition, further subdivision into subgroups by baseline serostatus and by baseline gestational age led to a further decrease in vaccination group sizes, making it difficult to draw any meaningful conclusions for the subgroup analyses.

Results Point of Contact

• Title: Vice President Medical Affairs IDV
• 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 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: February 21, 2021
• Study Start: August 27, 2021
• Primary Completion: November 24, 2023
• Study Completion: November 24, 2023
• Last Updated: May 25, 2025
• Results First Posted: November 13, 2024

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

ZA (4); US (4); BR (10)