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Clinical Trial to Assess Safety and Immunogenicity of a Synthetic Vaccine Against Streptococcus Pyogenes

NCT03998592 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2021-02-04

No results posted yet for this study

Summary

This is a double-blind, randomized, placebo-controlled phase I clinical trial with dose-escalation of a synthetic vaccine against Streptococcus pyogenes. The active component of this vaccine candidate is a synthetic polypeptide named StreptInCor designed to elicit humoral and cell-mediated immune responses. The vaccine will be formulated with Aluminium hydroxide in three different doses of StreptInCor (50 µg, 100µg, 200 µg). The proposed vaccination schedule is three doses (0, 1, 6 months). The doses will be escalated for the next group after safety review.

Conditions

  • Rheumatic Fever

Interventions

BIOLOGICAL

Streptococcus pyogenes vaccine (50 µg)

Vaccine containing 50 µg of StreptInCor synthetic peptide and Aluminium Hydroxide as adjuvant

BIOLOGICAL

Streptococcus pyogenes vaccine (100 µg)

Vaccine containing 100 µg of StreptInCor synthetic peptide and Aluminium Hydroxide as adjuvant

BIOLOGICAL

Streptococcus pyogenes vaccine (200 µg)

Vaccine containing 200 µg of StreptInCor synthetic peptide and Aluminium Hydroxide as adjuvant

OTHER

Placebo

Placebo without active component

Sponsors & Collaborators

  • InCor - Instituto do Coração - HCFMUSP.

    collaborator UNKNOWN

  • Butantan Institute

    lead OTHER_GOV

Principal Investigators

  • Luiza Guilherme, PhD · InCor Heart Institute

  • Roney O Sampaio, MD, PhD · InCor Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-31
Primary Completion
2022-03-31
Completion
2023-10-31

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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 NCT03998592 on ClinicalTrials.gov