Leeds women could be part of UK's first Covid-19 Vaccine trial for pregnant women

Pregnant women in Leeds could be part of the UK's first Covid 19 vaccine study.

Leeds Teaching Hospitals trust is one of 11 areas around the country taking part - with over 2 hundred participants set to be recruited.

The first COVID-19 vaccine study in the UK recruiting pregnant women has been launched across several National Institute for Health Research sites, including Leeds Teaching Hospitals NHS Trust. 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.

Kate Robinson, Senior Research Midwife at Leeds Teaching Hospitals NHS Trust said: "It is great that this important COVID-19 vaccine research study for pregnant women is taking place at Leeds Teaching Hospitals NHS Trust. Since the pandemic began, the midwifery research team at the Trust have taken enquiries from pregnant women looking to participate in COVID-19 vaccine research studies.

“It’s important that pregnant women can benefit from high quality COVID-19 vaccine research. We know many pregnant women have received COVID-19 vaccinations with no safety concerns reported. This study will provide further evidence and contribute to greater understanding of the safety and efficacy of COVID-19 vaccinations for pregnant women and their babies."

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.”

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 to take part in the study who are around 30+ weeks. This is because those who receive placebo will only get the active vaccine 1 month after delivery and the study team want to ensure they don’t wait long to be offered the active vaccine.

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.