Mums-to-be wanted for vaccine study
Pregnant women from West Lothian are being sought to take part in a Covid-19 vaccine study.
The initiative is open to people living in the NHS Lothian area.
The phase 2/3 study aims to further understand the safety, tolerability and immunogenicity of the Pfizer-BioNTech 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 vaccines at the same time as the rest of the UK population, based on 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.
The role of this placebo controlled study is to provide more robust information on vaccine immune response in pregnancy, as well as safety reporting and the potential transfer of antibodies to infants.
Each participant 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 across the UK and take place at the Western General Hospital in Edinburgh for participants from NHS Lothian.
The study has been running in the US since February.
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.
Volunteers need to visit their site four times before their baby is born and two follow up appointments after the birth.
Participants for the study will be identified via obstetricians and midwives at the hospitals involved, with the study doctor determining whether each pregnant woman and their unborn baby would be suitable.
Participation is 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.”
Dr Sarah Stock, consultant obstetrician and specialist in maternal and fetal medicine at the Royal Infirmary of Edinburgh, added: “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, continued:“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, 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.”