Study of the safety of & response to a COVID-19 vaccine in pregnancy COVID-19] [UPH]
Research type
Research Study
Full title
An Open-label, Phase 2 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.COV2.S in Healthy Pregnant Participants
IRAS ID
293579
Contact name
David Wright
Contact email
Sponsor organisation
Janssen Vaccines & Prevention B.V.
Eudract number
2020-005330-14
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 12 days
Research summary
This study is being done to test a new COVID vaccine called Ad26.COV2.S. Doctors and scientists hope that this experimental vaccine could stop or reduce how seriously people are affected by COVID-19.
This study is being done in pregnant women and it aims to find out if the vaccine is safe and effective when used in pregnancy.
About 400 women who are at Week 16 to 38 of their pregnancy will take part in this study worldwide.
After consenting for the study, a participant will have tests including a nasal swab COVID test and blood test to check that she isn’t currently or hasn’t in the past been infected with the virus causing COVID-19. If she is eligible to take part in the study, she will then receive two injections of the Ad26.COV2.S vaccine with the second injection being given about 8 weeks after the first injection. Each participant will then be monitored at frequent intervals by the study team. When her baby has been born, both she and her baby will be monitored until the baby is a year old. The health of the woman and her baby will be assessed by the study team during clinic visits (eg, by physical examination, urine tests and blood tests). Each participant will also be asked to answer questions about her health and that of her baby using an electronic diary. If either the participant or her baby develops symptoms of COVID-19, the participant will immediately be contacted by the study team and monitored very closely. A thermometer and pulse oximeter will be given to a participant so that she can measure her blood oxygen levels and temperature (and those of her baby once born) if she or her baby develop symptoms of COVID-19.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
21/NW/0085
Date of REC Opinion
12 Apr 2021
REC opinion
Further Information Favourable Opinion