First UK COVID-19 vaccine study for pregnant women launches in Newcastle
- Approximately 235 UK participants will be recruited to the study
- Every volunteer will receive the Pfizer-BioNTech COVID-19 vaccine during the study
- Participants will be recruited to eleven sites, covering Newcastle, Leeds, London, Oxford, Gillingham, Edinburgh and Southampton
The first COVID-19 vaccine study in the UK recruiting pregnant women has been launched across several National Institute for Health Research sites, including The Royal Victoria Infirmary in Newcastle. 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.
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 Ken Hodson, Principal Investigator of the study at the RVI, Newcastle said:
“This study will help us to better understand both the safety and immunogenicity of the Pfizer-BioNTech vaccine for pregnant women and infants. If you are over 18, between 24-34 weeks pregnant and have a single uncomplicated pregnancy I invite you to contact us by calling 0191 9177485.”
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.”
Ends
For NIHR media enquiries please contact Alex Rodger, Communications Officer: alexandra.rodger@nihr.ac.uk or 07708509467.
Dr Ken Hodson, Principal Investigator for the study at Newcastle, will be available for media interviews on Monday 17th May, between 9am and 12 noon or Tuesday 18th May between 9am-12 noon.
For media requests with Pfizer, please contact EUpress@Pfizer.com – this mailbox is monitored 24/7
Note to editors
The COVID-19 Vacc Maternal Immunisation study is fully funded by Pfizer
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
Questions About the Study
What is the purpose of this study?
In this study the Sponsor will analyse the investigational vaccine is safe to give to pregnant women and their unborn baby and the amounts of antibodies they produce. They will also see if the investigational vaccine works to prevent COVID-19 in women given the vaccine while pregnant. Every woman in the study will be given the COVID-19 investigational vaccine either while they are pregnant or shortly after giving birth.
How long will my baby and I be in the study?
The length of time you are in the study will depend if you are given the investigational COVID-19 vaccine while you are pregnant or shortly after your baby is born. You will be in the study for about 7-10 months but the duration will depend on when your baby is born and whether you received placebo injection or the COVID-19 investigational vaccine at the beginning of the study.
Your baby will be in the study for up to approximately 6 months. Your baby will have a clinic visit at the study site when he/she is about 6 months old.
Will I be paid for taking part in this study?
You will not receive any payment for taking part in this study. However, for each visit you/ your baby complete, you will be reimbursed by the study site to cover reasonable expenses (for example, parking, meals, travel) that you have as a result of taking part in this study.
What will happen to my baby or my personal information?
Medical records collected during this study will be stored by the study team at your study site and reviewed to verify that clinical trial procedures and/or data are correct.
The people and organisations contracted by the Sponsor to provide these services must keep your/your baby personal information private, and they will not share with the Sponsor any information that can directly identify you.
Your/your baby personal information will be collected, used, and shared (called “processing”) in compliance with applicable privacy laws. You will also be provided a separate Privacy Supplement that describes how your information will be processed and your privacy rights.
What if I join this study and then change my mind?
If you agree that you and your unborn baby will take part and then change your mind for any reason, you are free to stop at any time. Your decision will not affect your, or your baby’s regular medical care or any benefits to which you or your baby are entitled. Tell the study doctor if you are thinking about stopping or decide to stop so that you can end participation in the study in the safest way.
While you are taking part, the study team will tell you in a timely manner if new information is learned during the study that could change your mind about continuing in this study. If you decide to withdraw from the study, or if you decide that you will withdraw your baby from the study you may be asked to continue to participate in the study procedures even though you would no longer receive the study vaccine.
What will happen during this study?
All women who take part will need to visit the study site for 4 planned visits before their baby is born and then 2 more visits after the baby is born. Visits that occur before
delivery of your baby include:
- screening and your first study injection visit (these could take place on the same day),
- your second study injection visit, which is about 3 weeks after the first injection,
- 2-week follow-up visit,
- 1-month follow-up visit,
A study visit should occur on the day of baby is born, or shortly after for blood sampling and recording some information.
After your baby is born you will have a phone call about a week after your baby is born to see how you and your baby are, and a clinic visit about 1-month after you gave birth. At this visit you will be told if you were given the placebo injection while you were pregnant or the investigational COVID-19 vaccine. If you were given the investigational COVID-19 vaccine while you were pregnant you will only need to come back to the clinic for 1 more planned visit. This will be when your baby is around 6 months old.
If you were given the placebo injection while you were pregnant you will be given your first investigational COVID-19 vaccine injection about 1 month after your baby is born.
You will need to come back to the clinic about 3 weeks later to receive your second investigational COVID-19 vaccine injection. You will have a follow-up telephone call about 1 month after your second vaccination. This follow-up call will be the end of the study for you. Your baby will continue to be followed up until they are 6 months old. Every baby will need to have a clinic visit when they are about 6 months old.
The study team will tell you when you and your baby need to come for your visits. Extra visits or contacts may also be necessary if you, or your baby develop any signs or symptom of COVID-19 illness during the study, or if you have any severe symptoms after your vaccinations that you are given while you are pregnant. Before any study procedures begin, or before you begin preparing for the study, you will be asked to read and sign this participant information sheet and consent document.
After signing this consent document, the study doctor will check if you, and your unborn baby, meet all the requirements to take part in this study. If you, or your baby, do not meet the requirements, you will not be able to take part in the study and the study doctor will explain why this is the case.
About the National Institute for Health Research
The National Institute for Health Research (NIHR) is the nation's largest funder of health and care research. The NIHR:
- Funds, supports and delivers high quality research that benefits the NHS, public health and social care
- Engages and involves patients, carers and the public in order to improve the reach, quality and impact of research
- Attracts, trains and supports the best researchers to tackle the complex health and care challenges of the future
- Invests in world-class infrastructure and a skilled delivery workforce to translate discoveries into improved treatments and services
- Partners with other public funders, charities and industry to maximise the value of research to patients and the economy
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
