Safety and Immunogenicity of an Intranasal SARS-CoV-2 Vaccine (BBV154) for COVID-19

Summary

The study is designed to evaluate the safety, reactogenicity, and immunogenicity of three groups of healthy volunteers who receive either intranasal single dose (vaccine on Day 0 and placebo on Day 28) or two-dose (vaccine on Day 0 and 28) of BBV154 vaccine or Placebo (on Day 0 and day 28). A total of 175 subjects will be enrolled in 2:2:1 ratio and will be conducted in a double-blinded manner. To assess the safety of the vaccine, each participant will record symptoms in a diary card for 7 days after each dose. Safety and laboratory tests and physical exams will also be performed. Blood samples and saliva samples be collected to assess the immune response from the vaccine. An interim report based on the safety and immunogenicity of the vaccine (BBV154) will be notified to the Central Drugs Standard Control Organization (CDSCO), India, for further progressing the clinical development of the vaccine. This unblinded interim report will contain a detailed analysis of the data based on the primary and secondary objectives of all visits through Day 42 (Immunogenicity \& Safety).

Timeline

Start

2021-03-01

Primary completion

2021-06-25

Completion

2021-11-30

Publications

• Background Hassan AO, Kafai NM, Dmitriev IP, Fox JM, Smith BK, Harvey IB, Chen RE, Winkler ES, Wessel AW, Case JB, Kashentseva E, McCune BT, Bailey AL, Zhao H, VanBlargan LA, Dai YN, Ma M, Adams LJ, Shrihari S, Danis JE, Gralinski LE, Hou YJ, Schafer A, Kim AS, Keeler SP, Weiskopf D, Baric RS, Holtzman MJ, Fremont DH, Curiel DT, Diamond MS. A Single-Dose Intranasal ChAd Vaccine Protects Upper and Lower Respiratory Tracts against SARS-CoV-2. Cell. 2020 Oct 1;183(1):169-184.e13. doi: 10.1016/j.cell.2020.08.026. Epub 2020 Aug 19.

Drugs

Indications