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

NCT03998592 | Withdrawn Phase 1 DMC

• 1 other identifier: EGA-01-IB
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

vaccine; peptide; Streptococcus pyogenes

Outcome Measures

Primary Outcomes (2)

• Solicited and unsolicited adverse reactions

  Frequency of solicited and unsolicited adverse reactions

  Six months after last dose

• Immune response to vaccine

  Rate of seroconversion for vaccine epitopes

  Six months after last dose

Study Arms (4)

Low-dose vaccine

EXPERIMENTAL

Biological: Streptococcus pyogenes vaccine (50 µg)

Mid-dose vaccine

EXPERIMENTAL

Biological: Streptococcus pyogenes vaccine (100 µg)

High-dose vaccine

EXPERIMENTAL

Biological: Streptococcus pyogenes vaccine (200 µg)

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Streptococcus pyogenes vaccine (50 µg) BIOLOGICAL

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

Low-dose vaccine

Streptococcus pyogenes vaccine (100 µg) BIOLOGICAL

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

Mid-dose vaccine

Streptococcus pyogenes vaccine (200 µg) BIOLOGICAL

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

High-dose vaccine

Placebo OTHER

Placebo without active component

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers, both sex, aging 18 to 45 years;
• Availability for all procedures during the study period;
• Provide free informed consent to join the study

You may not qualify if:

• Diagnosis of concomitant infections or diseases that might affect immunity, including active HIV infection, hepatitis B, hepatitis C, diabetes mellitus, neoplasias, and autoimmune diseases;
• Previous or current diagnosis or family antecedent of rheumatic fever, chorea, obsessive-compulsive disorder or glomerulonephritis;
• Previous or current diagnosis of cardiac disease;
• Severe asma or Chronic obstructive pulmonary disease (COPD);
• Abnormal neurological clinical assessment, particularly chorea;
• Use of treatments that might affect the immunity in the last four weeks, including immunomodulators, corticosteroids (only systemic use equal or longer than two weeks), or antineoplastic agents;
• Use of treatments that might affect heart valves in the latest four weeks, including fenfluramine e dexfenfluramine;
• Kidney failure determined by creatinine clearance lower than 45 ml/min/1,73m²;
• History of intolerance or allergy to any component of investigational products, including antigen or adjuvant;
• Presence of abnormalities in heart valves or heart anatomy defined by echocardiogram;
• Electrocardiogram disturbances;
• Presence of cross-reactive antibodies against human tissues (heart, kidney, cartilage, brain) in screening tests;
• Evidence or suspicion of recent infection due to S. pyogenes assessed by clinical symptoms and negative rapid test for Streptococcus;
• Pregnancy, breastfeeding mother or intention to became pregnant during the study period;
• Any other condition that might affect the study process according to the investigators.

Sponsors & Collaborators

• Butantan Institute: lead
• InCor - Instituto do Coração - HCFMUSP.: collaborator

MeSH Terms

Conditions

Rheumatic Fever

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Luiza Guilherme, PhD

  InCor Heart Institute

  STUDY CHAIR

• Roney O Sampaio, MD, PhD

  InCor Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 26, 2019
• Study Start: May 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: October 1, 2023
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share