Phase III Study of BBV154 Intranasal Vaccine in Healthy Volunteers
Summary
Group 1 (BBV154): In this group, 3000 participants will be recruited, randomized in 1:1:1 ratio receive 3 consecutive lots (Lot 1: 1000, Lot 2: 1000, Lot 3: 1000) of the BBV154 vaccine (0.5 mL each dose) on day 0 and day 28 via intranasal route. Group 2 (COVAXIN®): In this group, 160 participants will be recruited and administered with COVAXIN® vaccine on day 0 and on day 28 via intramuscular route. A total sample size of 3160 healthy volunteer's age's ≥18 years will be recruited in this study. BBV154-Subjects- Part 1 ( Immunogenicity Group)- First 640 Subjects BBV154-Subjects- Part 2 ( Safety Group)- (Remaining 2520 subjects) Visit 1: Baseline (Day 0) Visit 2 (Day 28+2) Visit 3 (Day 42 ± 7 days) Visit 4 (Day 90 ± 7 days) and Visit 5 (Day 180± 7 days)
Timeline
- Start
- 2022-04-16
- Primary completion
- 2022-07-19
- Completion
- 2023-02-28
Publications
- Singh C, Verma S, Reddy P, Diamond MS, Curiel DT, Patel C, Jain MK, Redkar SV, Bhate AS, Gundappa V, Konatham R, Toppo L, Joshi AC, Kushwaha JS, Singh AP, Bawankule S, Ella R, Prasad S, Ganneru B, Chiteti SR, Kataram S, Vadrevu KM. Phase III Pivotal comparative clinical trial of intranasal (iNCOVACC) and intramuscular COVID 19 vaccine (Covaxin(R)). NPJ Vaccines. 2023 Aug 18;8(1):125. doi: 10.1038/s41541-023-00717-8.
- Nakahashi-Ouchida R, Fujihashi K, Kurashima Y, Yuki Y, Kiyono H. Nasal vaccines: solutions for respiratory infectious diseases. Trends Mol Med. 2023 Feb;29(2):124-140. doi: 10.1016/j.molmed.2022.10.009. Epub 2022 Nov 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | BBV-152 ANTIGEN ADJUVATED WITH ALGEL-IMDG | Vaccine | 0.5 ml | Intramuscular |
| Comparator | BBV154 | Vaccine | 0.5 ml | Intranasal |