First COVID-19 vaccine study for pregnant women launches in the UK
17th May 2021
The first COVID-19 vaccine study in the UK recruiting pregnant women has been launched and will be open in NHS Lothian
The phase 2/3 study aims to further understand the safety, tolerability and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine in healthy pregnant women, with approximately 235 volunteers involved throughout the UK.
Following updated guidance from the Joint Committee on Vaccination and Immunisation (JCVI) released in April, pregnant women 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 has been collected, in which over 100,000 pregnant women have been vaccinated (mainly with mRNA vaccines including Pfizer-BioNTech), without any safety concerns raised.
The role of this placebo-controlled study (COVID-19 Vacc Maternal Immunisation) is 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.
Recruitment will begin this week at the UK sites involved. The study has already been running in the US since February 2021. Research participants will be required to answer 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 need to visit their site for four planned visits before their baby is born and then two more follow-up appointments after the baby is born.
Participants for the study will be identified via obstetricians and midwives at the hospital sites involved, with the study doctor determining whether each pregnant woman and their unborn baby would be suitable. Participation in the study is completely voluntary and participants can leave the study at any time.
Dr Chrissie Jones, Associate Professor in Paediatric Infectious Diseases at University of Southampton, and Chief Investigator for the study said: "While we have a large amount of real-world data which tells us that it's safe for pregnant women to receive approved COVID-19 vaccines, the data gathered from a controlled research study like this is important because it will give us more information about the vaccine immune response in pregnant women, including the transfer of maternal antibodies to infants.
"All women taking part in the study will receive two doses of the approved Pfizer-BioNTech vaccine, as well as additional monitoring and support from their local research team."
Dr Sarah Stock, Consultant Obstetrician and Subspecialist in Maternal and Fetal Medicine at the Royal Infirmary of Edinburgh, said: "Catching COVID-19 in pregnancy can have serious consequences for mothers and their babies. This is an important study as it will not only help us understand how best to protect the mothers and babies of today, but also how we can prepare to protect those in the future."
Professor Andrew Ustianowski, National Clinical Lead for the UK NIHR COVID Vaccine Research Programme, said: "We want to ensure we provide the data to guide the best way of protecting and vaccinating our entire population. This includes pregnant women and I am excited that this study is commencing as there are important questions still to be answered.
"The extra monitoring involved being a participant in this study, along with the possibility of some pregnant women receiving a licensed and effective COVID vaccine before they would through the national rollout, is something we hope will attract potential volunteers to this important study."
Study volunteers will be recruited across 11 sites in the trial, including:
- Royal Victoria Hospital - Newcastle Hospitals Foundation Trust
- St James’ University Hospital - The Leeds Teaching Hospitals NHS Trust
- St Thomas’ Hospital- Guy’s and St Thomas’ NHS Foundation Trust
- St Mary’s Hospital - Imperial College Healthcare NHS Trust
- University College London Hospitals NHS Foundation Trust
- King’s College Hospital NHS Foundation Trust
- St George’s University Hospital Foundation Trust
- John Radcliffe Hospital - Oxford University Hospitals NHS Trust
- Medway Maritime Hospital - Medway NHS Foundation Trust
- Western General Hospital - NHS Lothian
- Southampton General Hospital - University Hospital Southampton NHS Foundation Trust