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

NCT04993209 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2023-08-21

No results posted yet for this study

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.

Conditions

  • Coronavirus Infections
  • Healthy

Interventions

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

Sponsors & Collaborators

  • Butantan Institute

    lead OTHER_GOV

Principal Investigators

  • Fernanda Castro Boulos, MD,PhD · Butantan Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-09
Primary Completion
2021-12-10
Completion
2022-11-04

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04993209 on ClinicalTrials.gov