Pregnant women in the West Midlands needed for COVID-19 vaccine booster study

Pregnant women across the West Midlands are being urged to step forward to take part in an ongoing national COVID-19 vaccine study, joining hundreds of other volunteers to help discover the most effective use of booster vaccines during pregnancy.

The Preg-CoV study, running at The Shrewsbury and Telford Hospital NHS Trust, currently has around 300 pregnant women taking part nationally. It aims to determine the best vaccine schedules and doses to protect women and their babies against COVID-19.

• Preg-CoV compares different doses of approved booster vaccines in pregnant women 

• It will provide robust data that could shape national and international guidelines 
• Participants are closely monitored and will have a 24 hour phone line to their study team

The study, led by researchers at St George’s, University of London, compares vaccines currently being used for the UK vaccination programme (Pfizer/BioNTech and Moderna) as well as new vaccines as they are approved for use, such as Novavax.

Mandy Carnahan, Lead Research Nurse at the Princess Royal Hospital (PRH) in Telford said: “Our patients have really appreciated the chance to contribute to Covid research. They have been on board with the vaccination programme and we are pleased to offer them the opportunity to take part in this study to improve the safety of themselves and their babies.”

Pictured is Ronnie Wolf Evans with his Preg-CoV bear and certificate from PRH. He and his mum Lucy were very happy to take part in the study. 

 The National Institute for Health and Care Research (NIHR) supported study will also provide vital clinical trial data on the immune response to booster vaccination with different doses of vaccines (full dose Pfizer, half dose Pfizer, half dose Moderna) as well as the immune response to different intervals between doses given in pregnancy. Participants may also be eligible to choose to receive their COVID-19 booster dose alongside the routine whooping cough vaccine.

The current UK guidance is that COVID-19 vaccination should be offered to pregnant women at the same time as the rest of the population. COVID-19 vaccines are safe and effective for pregnant women, and there is a clinical consensus that it is the best way to protect pregnant women and their babies from COVID-19.

Data from UK (.PDF) Health Security Agency (UKHSA) showed that around 59% of pregnant women have received the first dose of the life-saving COVID-19 jab by the time they deliver their babies (.PDF) and around 50% have received their second dose. However, further pregnancy-specific research will provide more data around the most effective vaccines, the best gap between vaccine doses for pregnant women and the optimal dose of a booster vaccine in pregnancy.

Hundreds more participants are needed to help provide further findings key to protecting more women and shaping future vaccine guidelines. The study launched in August 2021, and will involve around 700 pregnant women in total, across NIHR-supported sites across England. Volunteers will be closely monitored by health professionals throughout their pregnancy and following the birth of their babies.

Chief Investigator and Professor of Paediatric Infectious Diseases at St George’s, University of London, Professor Paul Heath said: 

“More than 300,000 pregnant women have now been vaccinated with COVID-19 vaccines in the UK, the USA and elsewhere, with no major safety concerns reported. But we do not yet know the optimal schedule to use or the optimal booster dose to use for pregnant women and their babies and this is what we are addressing in this study. 

“We are delighted that around 300 pregnant women have joined the study so far, but we need even more pregnant women across the country to participate. Not only will they receive special monitoring and support around their vaccines, but they will help shape future guidelines and protect pregnant women in the future. It is a really worthwhile, helpful thing to do.”

Pregnant women in the study will receive monitoring and additional support through study visits, compared to those who receive their vaccine outside of the study. They will also be provided a 24-hour phone line should they have any questions for the trial team and an electronic diary to record any symptoms. They will also be reimbursed for travel to their study appointments.

The study will collect blood samples from participants, with a cord blood sample taken after delivery for some participants. For all participants, a baby blood sample will be taken between 4 and 12 weeks of age. Breastmilk samples will also be collected for a sub-group of participants.

Once enrolled, participants who have already received two  or three doses of COVID-19 vaccine in the community will be eligible to receive a 3rd or 4th booster dose in the study. If they are also due their pertussis (whooping cough) vaccine booster they can have it at the same time, if they wish. 

All participants and their babies will be followed up until one year after delivery.

The study is seeking low-risk, pregnant women who are carrying a single baby, are aged 18-45 years-old and are between 13-36 weeks gestation.

If you are interested in the study, or know someone who could be eligible, you can find out more by visiting the study’s website.

ENDS

Notes to Editors

• The Preg-CoV study is supported by the National Institute for Health and Care Research (NIHR) and backed by £7.5 million of government funding from the UK Vaccines Taskforce
• No safety concerns relating to COVID-19 vaccination of pregnant women have been found in published studies to date. The rate of vaccine side-effects appears to be similar in pregnant and non-pregnant populations. 
• UKHSA publish figures for vaccine uptake in pregnant women every 4 weeks in its weekly surveillance reports. The latest figures were published on 12 May 2022.
• Following 160,000 pregnant women being vaccinated in the US and no safety concerns being raised, the Pfizer/BioNTech and Moderna vaccines were recommended by the independent experts at the Joint Committee on Vaccination and Immunisation (JCVI) for pregnant women in the UK. 

Why pregnant women are still needed for COVID-19 vaccine studies

Ongoing global studies have found that pregnant women are more likely to develop severe COVID-19 disease compared to non-pregnant women of the same age. Pregnant women who develop COVID-19 symptoms are two to three times more likely to have their baby early. Pregnant women with COVID-19 also have a higher mortality rate than pregnant women without COVID-19. Pregnant women can and should get vaccinated now. It is the best way to protect them and their baby. However, further pregnancy-specific research is needed on COVID-19 vaccines to work out how to optimise that protection.

What's next?
If you would like to find out more, please read the Study Information Booklet and if you are interested in taking part, please complete our pre-screening questionnaire.

Approximately two in three pregnant women with COVID-19 will have no symptoms, and those pregnant women who do have symptoms will usually have mild symptoms. However, a small number of pregnant women can become unwell with COVID-19, with the risk of severe illness being greater in the third trimester. Compared to non-pregnant women with COVID-19, pregnant women with COVID-19 have higher rates of intensive care unit admission and compared to pregnant women without COVID-19, pregnant women have overall worse maternal outcomes.

The studies have also found that women from black, Asian and minority ethnic backgrounds are more likely than other women to be admitted to hospital for COVID-19. Other risk factors that increase the chances of pregnant women developing severe COVID-19 disease and requiring hospital admission are being aged 35 years and over, having a body mass index (BMI) of 25 or more and having health conditions such as high blood pressure and diabetes. The risk of developing severe illness with COVID19 in pregnancy has also been shown to be increased in women living in areas or households with increased socioeconomic deprivation.

By performing this trial, we aim to gather further specific data on the safety of COVID-19 vaccines in pregnant women and their babies, to add to the already clear data that the vaccine is safe in pregnant women. We will also compare the immune responses to different COVID-19 vaccines, to different doses of booster vaccines and when given other routine vaccines.

What vaccines are being used in this trial?

Currently, the COVID-19 vaccines that are to be studied in this trial are:
o Pfizer/BioNTech BNT162b2 – referred to as Pfizer
o COVID-19 Vaccine Moderna –referred to as Moderna
o Novavax NNVXCoV2373 – referred to as Novavax (will ONLY be used in trial when it is used in the UK)
o AstraZeneca ChAdOx1 nCOV-19 – referred to as AstraZeneca (will ONLY be use for participants who have received one dose of the vaccine already (pre-trial) and are in Cohort