A randomised, phase II UK multi-centre study to determine reactogenicity and immunogenicity of booster vaccination against SARS-CoV-2 (COV-BOOST)

Project summary:

We are studying combinations of seven different COVID-19 vaccines compared to a control group who receive a vaccine against the meningococcal bacteria which causes meningitis and sepsis (Men ACWY). There will be 2886 participants.

Participants will be allocated, at random, (rather like a flip of a coin) to receive one dose of one of the seven study vaccines, or the control vaccine (MenACWY).

Four of the vaccines are currently approved by the MHRA for NHS use to prevent COVID-19, 2 are under review for approval by the MHRA and 1 is still in clinical trials.

Between 4 and 6 routine blood tests will be taken over the course of a year to look at the immune responses to the vaccine depending on the group participants are in. They may also be asked for a nasal fluid sample and a saliva sample at each visit.  If participants were to test positive for the virus causing COVID-19 we may ask them to attend for an extra visit.

Participants will need to complete an online diary for up to 28 days following vaccination.

The trial will take one year to complete per participant (from the time the first dose of vaccine is given).

Funders

National Institute for Health Research (NIHR), Vaccine Task Force

Leader researcher:

Professor Saul Faust

Lead institution:

University Hospital Southampton NHS Foundation Trust

Vaccine type:

AstraZeneca
Janssen
Moderna
Novavax
Pfizer
Valneva

Recruitment for clinical trial open:

No