A Parallel-Group, Phase III, multi-stage, modified double-blind, multi-armed study to assess the efficacy, safety, and immunogenicity of two SARS-CoV – 2 Adjuvanted Recombinant Protein Vaccines (monovalent and bivalent) for prevention against COVID- 19 in adults 18 years of age and older’’ is being conducted from September 2021 in collaboration with International Vaccine Institute and Sanofi Pasteur. The purpose of this Phase III study is to assess the efficacy, safety, and immunogenicity of two CoV preS dTM – AS03 vaccines (monovalent and bivalent) in adults 18 years of age and older in a multi-stage approach. Study Details include:
Study Duration: 365 days post-last injection (i.e. approximately 386 days total) for each participant.
Treatment Duration: 2 injections of either CoV2 preS dTM-AS03 monovalent (D614) vaccine (stage I), Cov2 preS dTM – AS03 bivalent (D614+ B.1.351) vaccine (Stage II), or Placebo was administered 21 days apart.
Visit Frequency: 8 visits
A total of approximately 368 subjects were screened and 280 subjects were enrolled in stage I (Dhulikhel Hospital) whereas, 526 subjects were screened and 450 were enrolled in Stage II (Dolakha Hospital). Follow-up visits are ongoing for both stages.
Due to the current epidemiological situation, amendments have been made to the protocol. The purpose of these amendments is to assess the efficacy, safety, and immunogenicity of two CoV2 preS dTM- As03 vaccines (monovalent and bivalent) as part of primary series vaccinations in multi-stage approach, as well as a booster injection of a CoV2 preS dTM- AS03 vaccine, in adults 18 years’ age and older. Based on the interim/final efficacy analysis, primary series followed by a booster dose will be offered to initial placebo recipients and a booster will be offered to initial vaccine recipients to participants. For the participants who do not consent to continue in the unblinded Crossover/ Booster part of the study, all the study procedures will be stopped and participants will be discontinued from the study.
NHRC team visited both Dhulikhel Hospital Kathmandu University Hospital and Dolakha Hospital Dhulikhel Hospital on 18 to 21 November, 2021 for Inspection of the clinical trial sites. Auditor from Sanofi Pasteur, Ms. Saba Siddique visited Dhulikhel Hospital Kathmandu University Hospital and Dolakha Hospital Dhulikhel Hospital on January 20 to 26 2022. During her visit she observed the VAT00008 Clinical Trial Sites, interacted with some site team members and conducted audit of trial sites.