Phase III Pivotal comparative clinical trial of intranasal (iNCOVACC) and intramuscular COVID 19 vaccine (Covaxin®)

One of the most preferable characteristics for a COVID-19 vaccine candidate is the ability to reduce transmission and infection of SARS-CoV-2, in addition to disease prevention. Unlike intramuscular vaccines, intranasal COVID-19 vaccines may offer this by generating mucosal immunity. In this open-la...

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Bibliographic Details
Published in:	npj vaccines Vol. 8; no. 1; p. 125
Main Authors:	Singh, Chandramani, Verma, Savita, Reddy, Prabhakar, Diamond, Michael S., Curiel, David T., Patel, Chintan, Jain, Manish Kumar, Redkar, Sagar Vivek, Bhate, Amit Suresh, Gundappa, Vivek, Konatham, Rambabu, Toppo, Leelabati, Joshi, Aniket Chandrakant, Kushwaha, Jitendra Singh, Singh, Ajit Pratap, Bawankule, Shilpa, Ella, Raches, Prasad, Sai, Ganneru, Brunda, Chiteti, Siddharth Reddy, Kataram, Sreenivas, Vadrevu, Krishna Mohan
Format:	Journal Article
Language:	English
Published:	London Nature Publishing Group UK 18-08-2023 Nature Publishing Group Nature Portfolio
Subjects:	692/308/575 692/699/255/2514 Antibodies Biomedical and Life Sciences Biomedicine Clinical trials COVID-19 COVID-19 vaccines Disease transmission Drug dosages Hospitals Infections Infectious Diseases Medical Microbiology Neutralization Pandemics Proteins Public Health Severe acute respiratory syndrome coronavirus 2 Vaccine Vaccines Virology
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Summary:	One of the most preferable characteristics for a COVID-19 vaccine candidate is the ability to reduce transmission and infection of SARS-CoV-2, in addition to disease prevention. Unlike intramuscular vaccines, intranasal COVID-19 vaccines may offer this by generating mucosal immunity. In this open-label, randomised, multicentre, phase 3 clinical trial (CTRI/2022/02/40065; ClinicalTrials.gov: NCT05522335), healthy adults were randomised to receive two doses, 28 days apart, of either intranasal adenoviral vectored SARS-CoV-2 vaccine (BBV154) or licensed intramuscular vaccine, Covaxin ® . Between April 16 and June 4, 2022, we enrolled 3160 subjects of whom, 2971 received 2 doses of BBV154 and 161 received Covaxin. On Day 42, 14 days after the second dose, BBV154 induced significant serum neutralization antibody titers against the ancestral (Wuhan) virus, which met the pre-defined superiority criterion for BBV154 over Covaxin ® . Further, both vaccines showed cross protection against Omicron BA.5 variant. Salivary IgA titers were found to be higher in BBV154. In addition, extensive evaluation of T cell immunity revealed comparable responses in both cohorts due to prior infection. However, BBV154 showed significantly more ancestral specific IgA-secreting plasmablasts, post vaccination, whereas Covaxin recipients showed significant Omicron specific IgA-secreting plasmablasts only at day 42. Both vaccines were well tolerated. Overall reported solicited reactions were 6.9% and 25.5% and unsolicited reactions were 1.2% and 3.1% in BBV154 and Covaxin ® participants respectively.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	2059-0105 2059-0105
DOI:	10.1038/s41541-023-00717-8