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

Rheumatic Fever Clinical Trial

Official title:

Phase I Clinical Trial for Assessment of Safety and Immunogenicity of a Synthetic Vaccine Against Streptococcus Pyogenes in Healthy Volunteers

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03998592
• Other study ID #: EGA-01-IB
• Status: Withdrawn
• Phase: Phase 1
• Start date: May 2021
• Est. completion date: October 2023

Study information

• Verified date: February 2021
• Source: Butantan Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2023
• Est. primary completion date: March 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Rheumatic Fever

Intervention

Biological:
• Streptococcus pyogenes vaccine (50 µg)
Vaccine containing 50 µg of StreptInCor synthetic peptide and Aluminium Hydroxide as adjuvant
• Streptococcus pyogenes vaccine (100 µg)
Vaccine containing 100 µg of StreptInCor synthetic peptide and Aluminium Hydroxide as adjuvant
• Streptococcus pyogenes vaccine (200 µg)
Vaccine containing 200 µg of StreptInCor synthetic peptide and Aluminium Hydroxide as adjuvant

Other:
• Placebo
Placebo without active component

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Butantan Institute	InCor - Instituto do Coração - HCFMUSP.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Solicited and unsolicited adverse reactions	Frequency of solicited and unsolicited adverse reactions	Six months after last dose
Primary	Immune response to vaccine	Rate of seroconversion for vaccine epitopes	Six months after last dose