COV-COMPARE Immunogenicity of vaccine VLA2001 (Valneva) compared to AZD1222 (AstraZeneca)

Project summary:

This is a multicentre, randomised, observer-blind, active-controlled, superiority study to compare the immunogenicity of VLA2001 (Valneva) to AZD1222 (AstraZeneca).

Approximately 4000 participants will be recruited in the study. About 3000 participants aged 30 years and above will be randomized in a 2:1 ratio to receive 2 intramuscular recommended doses of either VLA2001 (n=3000) or AZD1222 (n=1000). In addition, approximately 1000 subjects aged 18-29 years will participate in this study in a non-randomized, open-label fashion to receive VLA2001. The 2 doses of vaccination for both vaccines will be administered 28 days apart, on Days 1 and 29. All visits will be conducted at the clinical site on an outpatient basis.

As an extension of this study, adolescents aged 12-17 years are being recruited to a phase 3 trial to test the Valneva vaccine compared to a placebo. Participation involves up to 8 visits over the course of 12 months. Study participants will be compensated for their time and participation.

Funders

Valneva Austria GmbH,  Pharm-Olam International (UK) Ltd

Leader researcher:

Professor Adam Finn and Dr Jolanta Bernatoniene

Lead institution:

University Hospitals for Bristol and Weston NHS Foundation Trust

Vaccine type:

Valneva

Recruitment for clinical trial open:

Yes

Website:

Find out how to get involved in the COV-COMPARE study