Pregnant women in Southampton are being invited to take part in a COVID-19 vaccine study.
Preg-CoV is the UK’s largest clinical study to investigate the best gap between vaccine doses for pregnant women. The results will help shape national and international guidance around COVID-19 vaccination and pregnancy.
Recent data shows that one in five of the most critically ill COVID-19 patients are pregnant women who have not been vaccinated.
Over 84,600 pregnant women have received the first dose of the COVID-19 jab, and around 80,700 have received their second dose.
Dr Chrissie Jones, Associate Professor in Paediatric Infectious Diseases at University of Southampton and local investigator for the study, said:
“We are inviting women who are pregnant and have not yet had any COVID-19 vaccines, as well as those that have already had one or two doses of a COVID-19 vaccine, to take part in the Preg-CoV study.
“We now have lots of ‘real-world’ data to show that these vaccines are safe and effective, now we are investigating the best timing of COVID-19 vaccines in pregnancy to ensure that women have the best protection from these vaccines for themselves and their babies.”
Identifying the best dosage interval
The research will compare vaccines that are currently being used for the UK vaccination programme (Pfizer/BioNTech and Moderna) as well as new vaccines as they are approved.
It will provide vital clinical trial data on the immune response to vaccination at different dose intervals - either four to six weeks or eight to 10 weeks. This data will help determine the best dosage interval and tell us more about how the vaccine works to protect pregnant mothers and their babies against COVID-19.
The Preg-CoV study will involve 600 pregnant women, across 14 NIHR-supported sites. Once successfully enrolled, most volunteers will be randomised to receive two doses of an approved COVID-19 vaccine with either a short-time interval (4-6 weeks) or a long-time interval (8-10 weeks) between doses, with the majority of volunteers blinded to which vaccine they receive.
For some volunteers, this means they will receive their second dose after delivery. Participants will receive a single dose if they have already received their first dose or if they just need a booster (3rd) dose. The study is also recruiting participants who have already had two doses of a COVID-19 vaccine in the community.
Volunteers needed in Southampton
In Wessex, the study will take place in the NIHR Southampton Clinical Research Facility (CRF).
Volunteers will need to be between 18 and 45-years-old, generally healthy and low-risk, carrying a single baby and between 13 and 34 weeks gestation.
They will be closely monitored by health professionals throughout their pregnancy and following the birth, receiving additional support through study visits compared to those who receive their vaccine outside of the study.
Volunteers will also be provided with a 24-hour phone line should they have any questions for the study team, and will be reimbursed for travel to their study appointments.