Effect of heterologous intranasal iNCOVACC^® vaccination as a booster to two-dose intramuscular Covid-19 vaccination series: a randomized phase 3 clinical trial.

ABSTRACT:

Background

Due to waning immunity and emerging variants, protection following primary intramuscular Covid-19 vaccinations is decreasing, so health agencies have been proposing heterologous booster vaccinations. Here, we report immunogenicity and safety evaluation of heterologous booster vaccination with an intranasal, adenovirus vectored SARS-CoV-2 vaccine (BBV154) in healthy adults, who were previously primed with two doses of either Covaxin® or Covishield™. We compare results with use of a homologous booster vaccination combination.

Methods

This was a randomized, open-label phase 3 trial conducted to evaluate immunogenicity and safety of a booster dose of intranasal BBV154 vaccine or intramuscular EUA approved Covid-19 vacines in India. Healthy participants of ≥18 years ag

SUBMITTER: Akula VR 

PROVIDER: S-EPMC12019531 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature