The National Institute for Health Research (NIHR) has launched the UK’s first Covid-19 vaccine study for pregnant women and will begin recruiting participants this week.
The study aims to improve the understanding of safety, tolerability, and immunogenicity of the Pfizer/BioNTech vaccine in people who are pregnant, the NIHR announced yesterday (17 May).
It said that recruitment will begin at 11 NHS sites, covering Newcastle, Leeds, London, Oxford, Gillingham, Edinburgh and Southampton, with investigators looking to involve 235 volunteers.
Participants in the trial, which is fully funded by Pfizer, will receive either two doses of the vaccine or a placebo 21 days apart.
The study is looking for people who are around 30 weeks pregnant to take part to ensure those who receive the placebo will not need to wait long to be offered the vaccine, the NIHR said.
Volunteers will need to visit their study site four times before their baby is born, followed by two appointments after they have given birth. Participants will be unblinded one month after the study, with those who received a placebo being offered a vaccine.
The study comes after NHS England instructed practices without an alternative to the AstraZeneca vaccine to cancel first dose appointments for people who are pregnant last month, after JCVI advised that it is ‘preferable’ for pregnant women in the UK to be offered the Pfizer or Moderna vaccines where available.
Real-world data from the United States shows that more than 100,000 pregnant women have been vaccinated, mainly with mRNA vaccines including Pfizer and Moderna, without any safety concerns being raised, the NIHR said.
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.’
Study volunteers will be recruited across 11 sites, 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.
- Southampton General Hospital – University Hospital Southampton NHS Foundation Trust.
- Western General Hospital – NHS Lothian.