COVID-19 vaccine study calls on London's pregnant women to help build upon booster dose guidance
The Preg-CoV study, running at the Royal Free London 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, led by researchers at St George’s, University of London, 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 NIHR supported study will also provide vital clinical trial data on the immune response to booster vaccination with different doses of vaccines (full dose Pfizer, half dose Pfizer, half dose Moderna) as well as the immune response to different intervals between doses given in pregnancy. Participants may also be eligible to choose to receive their COVID-19 booster dose alongside the routine whooping cough vaccine.
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. COVID-19 vaccines are safe and effective for pregnant women, and there is a clinical consensus that it is the best way to protect pregnant women and their babies from COVID-19.
Data from UK Health Security Agency (UKHSA) showed that around 59% of pregnant women have received the first dose of the life-saving COVID-19 jab by the time they deliver their babies and around 50% have received their second dose. However, further pregnancy-specific research will provide more data around the most effective vaccines, the best gap between vaccine doses for pregnant women and the optimal dose of a booster vaccine in pregnancy.
Hundreds more participants are needed to help provide further findings key to protecting more women and shaping future vaccine guidelines. The study launched in August 2021, and will involve around 700 pregnant women in total, across NIHR-supported sites across England. Volunteers will be closely monitored by health professionals throughout their pregnancy and following the birth of their babies.
Chief Investigator and Professor of Paediatric Infectious Diseases at St George’s, University of London, Professor Paul Heath said:
“More than 300,000 pregnant women have now been vaccinated with COVID-19 vaccines in the UK, the USA and elsewhere, with no major safety concerns reported. But we do not yet know the optimal schedule to use or the optimal booster dose to use for pregnant women and their babies and this is what we are addressing in this study.
“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.”
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 Lucy Chappell, Chief Scientific Adviser for the Department of Health and Social Care, NIHR Chief Executive and Professor of Obstetrics at King’s College London said:
“Nationally we have been concerned about pregnant women with COVID-19 needing intensive care unit care and hospitalisation. We understand that pregnant women have been hesitant about taking the COVID-19 vaccine. But we would really like to encourage all pregnant women and those considering pregnancy to get vaccinated so that we can see an impact in these numbers coming down.
“We have seen data on effectiveness and safety of vaccination in pregnancy coming through from around the world, following up on the hundreds of thousands of pregnant women who have received COVID-19 vaccines.
“The Preg-CoV study team is leading on this research in the UK to help us gather further information so that we can continue to provide the most accurate advice to parents and parents to be.”
"We are looking forward to the next phase in the Preg CoV trial, to help further understand COVID-19 vaccine induced immunity in women and their babies. We are so pleased to support such an important trial."
“Having just had my 20-week scan to find out the sex of my first baby, I was greeted by the lovely Emma who was asking pregnant women to take part in the covid trial.
“I became a participant in the trial as covid has affected every single person across the world and many pregnant women refuse to get the vaccine that could protect both themselves and their unborn child due to propaganda. If I could help then why wouldn’t I? Even my unborn baby was doing something good.
“I was put at ease and given all of the information that a member of the British Library would enjoy reading. Bloods were taken during my pregnancy and I was kept up to date on the trial via email. Once my child was born, I had my first visit at home from a research midwife and paediatric nurse Vanessa and Cecilia. We laughed a lot which was not part of the trial but demonstrates the assets that both women have at putting both mother and baby at ease.
“To receive such excellent support in return for a little bit of blood that will help many is something I would absolutely do again.
“If you are ever asked to help with a medical trial and all that is required is a small amount of blood, do not hesitate. The women that I have spoken with and met through this trial were incredibly grateful at each appointment and yet all I was doing was something that we should all do to help research move forward.”
The study 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 3 rd or 4 th 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.
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.
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.