Booster Dose of SARS-CoV-2 Vaccine with Adjuvant [COVID-19]
Research type
Research Study
Full title
Immunogenicity and Safety of SARS-CoV-2 Recombinant Protein Vaccines with AS03 Adjuvant in Adults 18 Years of Age and Older as a Primary Series and Immunogenicity and Safety of a Booster Dose of SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (two Monovalent and one Bivalent)
IRAS ID
302236
Contact name
Adam Finn
Contact email
Sponsor organisation
Sanofi Pasteur Inc.
Eudract number
2020-003370-41
Duration of Study in the UK
1 years, 3 months, 3 days
Research summary
COVID-19 is a contagious disease that has quickly infected many people all over the world and continues to be a major public health concern. There are currently several vaccines that have been shown to protect against COVID-19 that have been approved/authorised and are being given to people in many countries. However, further vaccines must be developed to meet global demand and emerging virus variants [i.e. type of coronavirus]. This study investigates a new COVID-19 vaccine called SARS-CoV-2 AS03 Adjuvanted Recombinant Protein Vaccine. It consists of a virus “spike” protein used in other authorised COVID-19 vaccines and an adjuvant, AS03. Adjuvants are ingredients added to help a vaccine work better by increasing the immune response. This COVID-19 study vaccine is either monovalent (contains the spike protein antigen from 1 variant) or bivalent (contains the spike protein antigen from 2 variants). The trial has been set-up to determine which vaccine dose provides the desired safety profile and immune response. Additionally, the study will determine if the vaccines are safe and can stimulate similar immune responses between the different variants that cause COVID-19 after 2 primary injections or 1 booster injection, and if a booster injection can increase and broaden the immune response against these variants. A total of 5412 participants, 18 years of age and older are planned to take part in the study in United States, Honduras, and other parts of the world. In the UK, participants will receive a single booster vaccine. Blood samples and nasal swabs will be collected from each participant and blood sample for cellular mediated immunity and saliva samples from randomly selected participants. Participants will be involved in the study for 12 months.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
21/EM/0201
Date of REC Opinion
24 Aug 2021
REC opinion
Further Information Favourable Opinion