What is this trial aiming to find out?
The Preg-CoV trial aims to identify the best interval to be used between doses of COVID-19 vaccines for protecting pregnant women against COVID-19.
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.
The trial design
The trial will compare vaccines that are currently being used for the UK vaccination programme, as well as new vaccines as they are approved. Low-risk pregnant women aged 18-45 years-old and between 13-34 weeks gestation can be considered for enrolment onto the study.
Once successfully enrolled, participants will be randomised to receive two doses of a COVID-19 vaccine (or only one dose if the participant has already received their first dose) in a short-time interval (4-6 weeks) or a long-time interval (8-12 weeks). For some participants this means they will receive their second dose after delivery.
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 be followed up until one year after delivery.
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 between 4 and 12 weeks of age. Participants will be asked to complete a symptom diary and any significant medical events will be investigated. For a sub-group of participants breastmilk samples will also be collected.
Results of the trial will be disseminated in peer-reviewed scientific journals, internal reports, conference presentations and online publications.
To find out more please visit vaccine.ac.uk/research/preg-cov-trial/ , or email firstname.lastname@example.org and if you are interested in taking part, please complete our pre-screening questionnaire PREG-COV Royal Cornwall Hospital, Truro | Trials – Oxford Vaccine Group