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Clinical Trial of the COVID-19 Vaccine (Recombinant, Inactivated) in Brazil — ADAPTCOV  

Healthy Clinical Trial

Official title:
Double-blind, Randomized, With an Active Control Vaccine, Phase I Clinical Trial for Evaluation of Safety and Immunogenicity of a Recombinant Inactivated COVID-19 Vaccine in Adults in Brazil - ADAPTCOV

Clinical Trial Summary

NDV-HXP-S is an inactivated COVID-19 vectored-vaccine virus using the Newcastle Disease Virus as basis and expressing S protein from SARS-CoV-2 stabilized in pre-fusion form with Hexapro technology. This vaccine was successfully tested in non-clinical study with a good safety profile and eliciting neutralizing antibodies against SARS-CoV-2. Clinical testing is conducted by an international consortium including three different manufacturers. Butantan, in Brazil, is one of them.

Clinical Trial Description

The present protocol aims, to respond to several regulatory requirements to advance the clinical development of the product through a dose-escalation, controlled, randomized, adult clinical trial. The results of the Phase I (former Stage A), allow us to base the decision to evaluate the safety and immunogenicity of three doses of HDV-HXP-S (1μg, 3μg or 10μg). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04993209
Study type Interventional
Source Butantan Institute
Contact
Status Completed
Phase Phase 1
Start date July 9, 2021
Completion date November 4, 2022
View Details
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