First UK COVID-19 vaccine study for pregnant women launches in Southampton
The first COVID-19 vaccine study in the UK recruiting pregnant women has been launched across several National Institute for Health Research (NIHR) sites, including University Hospital Southampton.
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 salt water 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. The study is looking for women who are around 30 weeks pregnant to take part. This is to ensure that pregnant women who receive the placebo as part of the study will not have to wait long to be offered the active vaccine after their 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."
Professor Nigel Simpson, Consultant Obstetrician and Gynaecologist at Leeds Teaching Hospital and NIHR Specialty Lead for Reproductive Health, said:
“Catching COVID-19 in pregnancy can have serious consequences for mothers and their babies. In the future we are likely to continue living with and needing to vaccinate against COVID-19 and its variants. This important study 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 be through the national rollout, is something we hope will attract potential volunteers to this important study.”