Preg-Cov [COVID-19]
Research type
Research Study
Full title
A Phase II, randomised, single-blind, platform trial to assess safety, reactogenicity and immunogenicity of COVID-19 vaccines in pregnant women in the United Kingdom
IRAS ID
301115
Contact name
Paul T Heath
Contact email
Sponsor organisation
St. George's, University of London
Eudract number
2021-003073-60
ISRCTN Number
ISRCTN15279830
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This trial will investigate COVID-19 vaccines in pregnancy and identify the optimal interval between doses. Pregnant women are more likely to develop severe COVID-19 disease compared to non-pregnant women. Those who develop COVID-19 symptoms are two to three times more likely to have their baby early and have a higher mortality rate than pregnant women without COVID-19. For these reasons, the current UK guidance on immunisation is that COVID-19 vaccination should be offered to pregnant women at the same time as the rest of the population. However, further pregnancy-specific research is needed on COVID-19 vaccines.
The trial will compare vaccines that are currently being used in the UK vaccination programme, as well as new vaccines as they are approved. Pregnant women 18-45 years, at low risk of pregnancy complications and between 13-34 weeks gestation can be enrolled into the study. Following informed consent, participants will be randomised to receive two doses of a COVID-19 vaccine (or only one dose if the participant has received their first dose prior to the study) in a short-time interval (4-6 weeks) or a long-time interval (8-12 weeks). For some participants this means they will receive their second dose after delivery.
Participants will be blinded to the vaccine they receive and, where possible, the interval between doses. This will be done by incorporating the pertussis (whooping cough) vaccine into the trial schedule. Participants will be followed up until one year after delivery.
Blood samples will be taken from maternal participants throughout the study. A cord blood sample will be taken after delivery for some participants and one baby blood sample will be collected during the study. Participants will complete a symptom diary and any significant medical events will be investigated. For a sub-group of participants breastmilk samples will also be collected.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
21/NE/0114
Date of REC Opinion
2 Aug 2021
REC opinion
Further Information Favourable Opinion