Trials / Completed
CompletedNCT04993209
Clinical Trial of the COVID-19 Vaccine (Recombinant, Inactivated) in Brazil
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 320 (actual)
- Sponsor
- Butantan Institute · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Detailed 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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | NDV-HXP-S 1μg | NDV-HXP-S 1μg 0.5mL 2 doses intramuscular (deltoid) 28 days apart |
| BIOLOGICAL | NDV-HXP-S 3μg | NDV-HXP-S 3μg 0.5mL 2 doses intramuscular (deltoid) 28 days apart |
| BIOLOGICAL | NDV-HXP-S 10μg | NDV-HXP-S 10μg 0.5mL 2 doses intramuscular (deltoid) 28 days apart |
| OTHER | Adsorbed inactivated COVID-19 vaccine (CoronaVac) | Adsorbed inactivated COVID-19 vaccine 600 SU/0.5 mL 2 doses intramuscular (deltoid) 28 days apart |
Timeline
- Start date
- 2021-07-09
- Primary completion
- 2021-12-10
- Completion
- 2022-11-04
- First posted
- 2021-08-06
- Last updated
- 2023-08-21
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT04993209. Inclusion in this directory is not an endorsement.