Milton Keynes joins COVID-19 study into vaccine intervals in pregnancy
The country’s largest clinical study investigating the best gap between first and second COVID-19 vaccine doses for pregnant women is to launch in Milton Keynes.
The NIHR-supported Preg-CoV study will open at Milton Keynes University Hospital on Monday 20 September and plans to recruit 20 participants.
The study will provide vital clinical trial data on the immune response to vaccination at different dose intervals, either four to six weeks or eight to 12 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.
Pregnant women are more likely to develop severe COVID-19 or die from the disease, but are excluded from clinical trials with new vaccines. This means there is currently very limited clinical trial data on the immune response and side effects caused by the vaccines for these women.
The trial will involve 600 pregnant women across 14 NIHR-supported sites, with either the Pfizer/BioNTech or the Moderna vaccine.
Both vaccines are recommended by the Joint Committee on Vaccination and Immunisation (JCVI) for pregnant women in the UK. Over 62,000 pregnant women in England have now been vaccinated.
Data from NHS England and the University of Oxford shows no pregnant women who have had both doses of a vaccine have been admitted to hospital with COVID-19. Only three have been admitted after having their first dose, meaning 99% of those admitted to hospital have not received a jab.
Participants must be aged 18 to 44, be generally healthy and between 13 and 34 weeks pregnant on the day of vaccination. They will receive two doses of a COVID-19 vaccine (or one dose if they’ve already had their first) at either the shorter interval of four to six weeks, or the longer interval of eight to 12 weeks.
They will be scheduled to attend nine visits in total and will be required to complete an electronic diary between visits on any symptoms. They will also be given a 24-hour mobile number so they can contact one of the trial team at any time if they have concerns.
Scientists will analyse blood samples and one blood sample from newborn babies, alongside samples from breastmilk. They will use the samples to help understand more about how the vaccines are protecting both pregnant women and potentially also their babies from COVID-19, with initial results expected by the end of the year.
Ghaly Hanna, an obstetrics and gynaecology consultant at Milton Keynes University Hospital, said: “Current evidence indicates that it is safe for pregnant women to received approved COVID-19 vaccines, but we would like to know more about why this is the case and, in particular, when vaccinations should be administered, and this trial will provide us with more data in this regard.
“Given that pregnant women are at an increased risk of serious COVID-19 symptoms, this study represents an important chance to obtain more information to help us to protect pregnant women and their babies.”
For more information visit https://vaccine.ac.uk/research/preg-cov-trial/
