UCLH first in UK to recruit to national Covid-19 vaccine study for pregnant women
University College London Hospitals NHS Foundation Trust is the first site in the UK to recruit to an international vaccine study looking at the safety, tolerability and immune response generated by the Pfizer-BioNTech Covid-19 vaccine in healthy pregnant women.
Pregnant woman are now offered approved Covid-19 vaccines at the same time as the rest of the UK population, based on their age and clinical risk group. Real-world data from the United States on over 100,000 pregnant women who have been vaccinated (mainly with mRNA vaccines including Pfizer-BioNTech), have not highlighted any safety concerns.
The Covid-19 Vacc Maternal Immunisation trial aims to provide more robust information on the vaccine immune response in pregnancy, as well as safety reporting and the potential transfer of maternal antibodies to infants.
Each participant enrolled in the study will initially receive either two doses of the vaccine or a placebo 21 days apart. All participants will be unblinded one month post pregnancy, and those who were given the placebo jab (a saltwater solution that does not contain any active ingredients) will receive the Pfizer-BioNTech COVID-19 vaccine.
Dr Eleni Nastouli, Principal Investigator of the trial at UCLH, said: “I’m excited to recruit the first UK participant at UCLH. Thanks to the marvellous Maternity Team, our CRF, Paediatric and Virology teams for making this possible! It is so important for women and their babies as the pandemic keeps evolving to produce the evidence and protect them from SARS-CoV-2.”
The study has already been running in the US since February 2021. Research participants are answering questionnaires about their health, provide blood samples, complete an e-diary and will receive extra monitoring while on the study, compared to those who receive a vaccine through the rollout.
All volunteers will visit their site for four planned visits before their baby is born and then two more follow up appointments after the baby is born.