Preg-CoV Trial

Open to recruitment

Why are we doing this study?

Ongoing global studies so far 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. For these reasons, the current UK guidance on immunisation is that COVID-19 vaccination should be offered to pregnant women at the same time as the rest of the population. However, further pregnancy-specific research is needed on COVID-19 vaccines.

What is this trial aiming to find out?

The trial will compare vaccines that are currently being used for the UK vaccination programme, as well as new vaccines as they are approved.Pregnant women who are due to receive any COVID-19 vaccine in pregnancy (either their first, second or booster dose) may be eligible for the study.

Participants will receive one or two COVID-19 vaccines depending on what vaccines have already been received. For participants who are due both their first and second doses, they will receive two COVID-19 vaccines at either 4-6 week interval or at 8-12 week interval.

For participants who are due their second or booster COVID vaccine, they will receive a single dose as part of the study.

The study also includes an observational cohort, following women who have received all their COVID-19 vaccines before joining the trial, if their most recent vaccine was given during pregnancy.

The majority of participants will be blinded to the vaccine they receive. Some participants will also be blinded to the interval between doses by incorporating the pertussis (whooping cough) vaccine into the trial schedule.

Participants will receive additional monitoring compared to pregnant women who receive their vaccine outside of the study. Participants will be provided with a 24-hour phone line should they have any questions for the study team and an electronic diary to record any symptoms following vaccination. There will be a minimum of seven routine study visits and participants will be followed up until one year after their baby’s birth. The majority of visits will happen at hospital and participants will be reimbursed for travel to their study appointments.

Blood samples will be taken from participants throughout the study. For some participants, a cord blood sample will be taken after delivery. For all participants, a baby blood sample will be taken when babies are between 4-12 weeks old. For a sub-group of participants breastmilk samples will also be collected.

Dissemination

Results of the trial will be disseminated in peer-reviewed scientific journals, internal reports, conference presentations and online publications.

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. Once sites are opened, you will be contacted and given a local information sheet.

Location

Download Participant Information Sheet

Complete prescreen questionnaire

Birmingham Heartlands Hospital

Queen Charlotte’s and Chelsea Hospital

Liverpool Women’s Hospital

Leeds General Hospital

Milton Keynes University Hospital

Princess Royal Hospital, Telford

Royal Free Hospital, London

Royal Cornwall Hospital, Truro

Royal Preston Hospital

St George’s Hospital, London

St Mary’s Hospital, Manchester

St Michael’s Hospital, Bristol

Southampton General Hospital