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

Phase 1

Completed

• Conditions: Healthy; Coronavirus Infections

• Registration Number: NCT04993209
• Lead Sponsor: Butantan Institute

Brief 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).

Study Timeline

• Study Start: 2021-07-09
• Study First Submitted: 2021-08-03
• Study First Submitted QC: 2021-08-04
• Study First Posted: 2021-08-06
• Primary Completion: 2021-12-10
• Study Completion: 2022-11-04
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-17
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety: Adverse reactions.	7 days after each vaccination.	Number and intensity of solicited local and systemic adverse reactions.
Safety: Laboratory evaluations	7 days after each vaccination.	Number, severity and summary of clinically significant changes of hematological (hemoglobin \[g/dL\], white blood cells \[cells/mm³\] and platelets \[count per mm³\]) and biochemical evaluations (creatinine \[mg/dL\], AST \[U/L\], ALT \[U/L\], and total bilirubin \[mg/dL\]) since the baseline within 7 days after each vaccination.
Immunogenicity: Neutralization GMT SARS-CoV-2 pseudovirus.	42(+7) days after the first dose.	Neutralization GMT against SARS-CoV-2 pseudovirus (beta and gamma strains)
Immunogenicity: Percentage of seroconversion.	42(+7) days after the first dose.	Percentage of positive SARS-CoV-2 pseudovirus neutralization assay in a participant with a baseline negative result (Wuhan strain).

Secondary Outcome Measures

Name	Time	Method
Immunogenicity: Levels of antibodies.	At baseline, 28 days after the first vaccination, and 14 days after the second vaccination, and 3, 6, 9, and 12 months after first vaccination.	Levels of antibodies against SARS-CoV-2 Nucleocapsid protein and RBD
Safety: serious and medically-attended adverse reactions.	Throughout the entire study period.	Number, intensity, and relatedness of serious adverse reactions
Safety: events of special interest.	Throughout the entire study period.	Number, intensity, and relatedness of events of special interest.
Safety: all unsolicited adverse reactions.	28 days after each vaccination.	Number, intensity, and relatedness of all unsolicited adverse reactions.
Exploratory Endpoints: Neutralization GMT of SARS-CoV-2 pseudovirus.	at 3 months, 6 months, 9 months, and 12 months after first vaccination in subjects.	Neutralization GMT against SARS-CoV-2 pseudovirus at 3 months, 6 months, 9 months, and 12 months after first vaccination in subjects.
Exploratory Endpoints - COVID-19 cases.	14 days after first and second vaccination.	Number and intensity of COVID-19 cases diagnosed.
Exploratory Endpoints: Levels of antibodies.	At baseline, 28 days after the first vaccination, and 14 days after the second vaccination, and 3 months, 6 months, 9 months, and 12 months after first vaccination.	Levels of antibodies against SARS-CoV-2 Nucleocapsid protein and RBD.
Immunogenicity: Neutralization GMT of SARS-CoV-2 pseudovirus.	28 days after the first vaccination, and 14 days after the second vaccination.	Neutralization GMT against SARS-CoV-2 pseudovirus per age group

Trial Locations

Locations (1)

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo; 🇧🇷 Ribeirão Preto, São Paulo, Brazil