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

Completed · Phase 2

Conditions studied: COVID-19 Prevention

In brief

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.

Key facts

Study ID: NCT04765384
Run by: Janssen Vaccines & Prevention B.V.
People needed: 51
Starts: 2021-08-27
Expected to finish: 2023-11-24
Last updated by the study team: 2025-05-25

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

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)

Where it is running

Medpharmics, LLC — Gulfport, Mississippi, United States
Meridian Clinical Research, LLC — Norfolk, Nebraska, United States
Medpharmics, LLC — Albuquerque, New Mexico, United States
Maximos OB/GYN — League City, Texas, United States
Universidade Federal De Minas Gerais - Hospital das Clínicas — Belo Horizonte, Brazil
Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose — Criciúma, Brazil
Associacaode Ensino de Marilia LTDA - UNIMAR - Universidade de Marilia — Marília, Brazil
Centro de Estudos e Pesquisas em Moléstias Infecciosas - CEPCLIN — Natal, Brazil
Hospital das Clinicas de Porto Alegre — Porto Alegre, Brazil
NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul — Porto Alegre, Brazil
CEMEC - Centro Multidisciplinar de Estudos Clínicos — São Bernardo do Campo, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base — São José do Rio Preto, Brazil
Clinical Research College — São Paulo, Brazil
CMPC - Consultoria Médica e Pesquisa Clínica — Sorocaba, Brazil
Ndlovu Elandsdoorn Site — Dennilton, South Africa
Shandukani Research Centre — Johannesburg, South Africa
Stanza Clinical Research Centre : Mamelodi — Mamelodi East, South Africa
Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital — Soweto, South Africa

Full record on ClinicalTrials.gov

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