Pregnant women in the south are being invited to help discover the most effective use of booster vaccines during pregnancy.
The Preg-CoV study, running at University Hospital Southampton NHS Foundation Trust, currently has around 300 pregnant women taking part nationally. It aims to determine the best vaccine schedules and doses to protect women and their babies against COVID-19.
The study compares vaccines currently being used for the UK vaccination programme (Pfizer/BioNTech and Moderna) as well as new vaccines as they are approved for use, such as Novavax.
The research is also assessing the immune response to different doses and intervals between vaccines during pregnancy. Participants may also be eligible to choose to receive their COVID-19 booster dose alongside the routine whooping cough vaccine.
Protecting women and their babies
The current UK guidance is that COVID-19 vaccination should be offered to pregnant women at the same time as the rest of the population. Dr Chrissie Jones, local investigator for the study, said: “COVID-19 vaccination in pregnancy has been shown to be safe in hundreds of thousands of women and to protect them against severe infection. Now we need to understand the very best ways to protect women and their infants with booster doses. This study will give us important information about the spacing of vaccines in pregnancy and whether a half dose of the booster is as good as the full dose of booster."
Shaping future guidelines
The study launched in August 2021, and will involve around 700 pregnant women in total, in sites across England. It is supported by the National Institute for Health and Care Research (NIHR).
Pregnant women in the study will receive monitoring and additional support through study visits, compared to those who receive their vaccine outside of the study. They will also be provided a 24-hour phone line should they have any questions for the trial team and an electronic diary to record any symptoms. They will also be reimbursed for travel to their study appointments.
Professor Paul Heath, Chief Investigator and Professor of Paediatric Infectious Diseases at St George’s, University of London, said: “We are delighted that around 300 pregnant women have joined the study so far, but we need even more pregnant women across the country to participate. Not only will they receive special monitoring and support around their vaccines, but they will help shape future guidelines and protect pregnant women in the future. It is a really worthwhile, helpful thing to do.”
Take part in the study
The study is seeking low-risk, pregnant women who are carrying a single baby, are aged 18-45 years-old and are between 13-36 weeks gestation.
The trial will collect blood samples from participants, with a cord blood sample taken after delivery for some participants. For all participants, a baby blood sample will be taken between 4 and 12 weeks of age. Breastmilk samples will also be collected for a sub-group of participants.
Once enrolled, participants who have already received two or three doses of COVID-19 vaccine in the community will be eligible to receive a 3rd or 4th booster dose in the study. If they are also due their pertussis (whooping cough) vaccine booster they can have it at the same time, if they wish.
All participants and their babies will be followed up until one year after delivery. If you are interested in the study, or know someone who could be eligible, you can find out more by visiting the study’s website.