The Sanofi and GSK adjuvanted recombinant COVID-19 vaccine candidate has been evaluated in a phase 2, randomized, modified double-blind, multi center, dose-finding study (VAT00002)1, conducted in adults 18 years of age and older to evaluate its safety, reactogenicity, and immunogenicity.
During the first stage of the study, 3 different antigen doses (effective doses of 5 µg, 10 µg, and 15 µg of CoV2 preS dTM monovalent D614 antigen) with a full dose of AS03 adjuvant were evaluated as a primary vaccination series of 2 injections administered 21 days apart.
In the published interim results2, the candidate achieved strong rates of neutralizing antibody responses with 95% to 100% seroconversion following the second injection in all age groups (18 to 95 years old) and across all doses, with no safety concerns. Overall, the vaccine candidate elicited neutralizing antibody levels that were comparable to those generated by natural infection, with higher levels observed in younger adults (18 to 59 years old). Based on these results, the companies initiated a global Phase 3 study (VAT00008)3, evaluating 10µg of antigen as primo-vaccination.
In the specific group of previously infected participants (non-naïve), one dose of the candidate vaccine induced higher neutralizing antibody titres than after two doses in naïve participants, suggesting a strong booster effect.
To further evaluate the booster effect of the candidate vaccine, this phase 2 was amended (phase 2/3) to add cohorts of participants previously primed with authorized vaccines1.
The booster vaccine candidate containing the initial strain (D614) induces robust immune responses and is showing a favorable safety profile in multiple settings. In participants who had received a primary series of an already authorized mRNA or adenovirus vaccine, the candidate booster vaccine induced a significant increase in neutralizing antibodies of 18- to 30-fold across vaccine platforms and age groups. When the candidate vaccine was used as a two-dose primary series followed by a booster dose, neutralizing antibodies increased 84- to 153-fold compared to pre-boost levels. Final analysis of the global booster trial confirms universal ability to boost neutralizing antibodies across vaccine platforms (mRNA, adenovirus) with a favorable safety profile4. Full study results will be published later this year.
To address the emergence of variant strains of concern, Sanofi is developing monovalent and bivalent vaccine formulations containing the original Wuhan strain (D614) and/or the Beta (B.1.351) variant first identified in South Africa. The clinical trial continues to evaluate the booster effect of those vaccines candidates.
For more information on the phase 2 booster clinical trial per country, please refer to the following contact list:
Recruitments are completed
Recruitments are completed
Recruitments are completed
Recruitments are completed
Our phase 2 booster study (NCT04762680)
In the original phase 2 cohort:
Participants received 2 injections 21 days apart of one of the 3 different doses of CoV2 preS dTM antigen with fixed dose of AS03 adjuvant.
In the supplemental booster and variant-priming cohorts:
Volunteers in previously vaccinated groups will receive either a single booster dose of Monovalent (D614) AS03 vaccine or Bivalent (D614 + B.1.351)-AS03 or a single dose of Monovalent (B.1.351) with or without AS03 adjuvant. No placebo control will be given in this study.
An additional cohort of SARS-CoV-2-naïve, unvaccinated adults who are 18-55 years of age, will receive 2 doses of Monovalent (D614)-AS03 or Monovalent (B.1.351)-AS03 or Bivalent (D614 + B.1.351)-AS03 vaccine candidate as a primary vaccination series.
Primary objectives and endpoints
- To assess the safety profile of the vaccine candidate among all participants in each age group and in each study intervention group.
- To assess the neutralizing antibody profile after primary series vaccination in SARS-CoV-2-naïve adults.
- To demonstrate that a booster dose of monovalent or bivalent SARS-CoV-2 vaccine given to adults previously vaccinated with an authorized/approved COVID-19 vaccine induces an immune response that is non-inferior to the response induced by a two-dose priming series with the monovalent vaccine, and superior to that observed immediately before booster.
- To demonstrate that two doses of monovalent (B.1.351)-AS03 or bivalent (D614 + B.1.351)-AS03 SARS-CoV-2 vaccine induce an immune response that is non inferior to the response induced by monovalent (D614)-AS03 vaccine.
For Original Phase 2 Cohort, the number of participants who were positive for SARS-Cov-2 (as shown by rapid serodiagnostic test upon enrollment) were capped at approximately 20% of the study population to ensure there is a sufficient number of SARS-CoV-2 naïve participants in the study.
Participants with medical conditions that put them at high risk for COVID-19 will also be included.
Aged 18 years old or older
Able to attend all scheduled visits and to comply with all study procedures
Does not intend to receive an authorized/approved COVID-19 vaccine from inclusion to the study to 3 weeks after the vaccination
- Aged 18 years or older
- Women are eligible if not pregnant nor breastfeeding
- Able to attend all scheduled visits and to comply with all study procedures
- Original cohort: Willingness to have a SARS-CoV-2 rapid serodiagnostic test performed at the time of enrollment to detect presence of SARS-CoV-2 antibodies.
- Does not intend to receive an authorized/approved COVID-19 vaccine from the time of first vaccination in this study to 3 weeks after the second vaccination, despite encouragement by the investigator to receive available authorized vaccine(s).
- Booster arms: Participants who have received a complete primary vaccination series with an authorized/conditionally approved mRNA COVID-19 vaccine (mRNA-1273 [Moderna] or BNT162b2 [Pfizer/BioNTech]) or adenovirus-vectored COVID-19 vaccine (ChAdOx1 nCoV-19 [Oxford University/AstraZeneca] or Ad26.CoV2.S [J&J/Janssen]), with the last dose administered a minimum of 4 months prior to inclusion but not longer than 10 months prior to inclusion.
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances
- Receipt of any vaccine in the 30 days preceding or on the day of the first study vaccination or planned receipt of any vaccine between the first study vaccination and in the 30 days following the second study vaccination.
- Except for influenza vaccination which may be received at any time in relation to study intervention.
- Original Phase II Cohort and Supplemental priming cohorts: Prior administration of a coronavirus vaccine (severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2], SARS-CoV, Middle East Respiratory Syndrome [MERS-CoV])
How does the Trial Work?
- Before study enrollment, blood samples are obtained to ascertain evidence of SARS-CoV-2 antibodies using a SARS-CoV-2 rapid serodiagnostic tests done at the site.
- At the enrollment visit, all participants have a single bilateral nasopharyngeal swab collected.
- Blood samples are collected at different timepoints during the trial to be able to assess the strength of the immune response after vaccination.
- After the first vaccine injection, all participants are monitored by trial staff on a regular basis (or more frequently in a SARS-CoV-2 infection or suspected COVID-19) during the entire trial.
- The duration of study is approximately 365 days post-booster injection and after the second injection for primo-vaccinated.
- If an approved/authorized vaccine is available in the country/region where the study is conducted, investigators inform participants who have not yet received an authorized/approved vaccine at the time of informed consent. Participants are encouraged to obtain the approved/authorized vaccine if applicable to them. Recruitment of eligible participants into one of the study cohorts evaluating priming vaccines is proceed only if, despite encouragement, the candidate participant expresses no intention to seek an authorized or approved vaccine at least until completion of the key follow-up timepoints.
- Study of Recombinant Protein Vaccines With Adjuvant as a Primary Series and as a Booster Dose against
COVID-19 in Adults 10 Years of Age and Older. Available at:
- Sridhar S, et al. Lancet Infect Dis 2022;S1473-3099(21)00764-7.
- Study of Monovalent and Bivalent Recombinant Protein Vaccines Against COVID-19 in Adults 18 Years of Age and Older (VAT00008). Available at: https://clinicaltrials.gov/ct2/show/NCT04904549
- Sanofi and GSK initiate global Phase 3 clinical efficacy study of COVID-19 vaccine candidate.
MAT-GLB-2103505 V3.0 – March 2022