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

Primary Purpose

Rheumatic Fever

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Streptococcus pyogenes vaccine (50 µg)
Streptococcus pyogenes vaccine (100 µg)
Streptococcus pyogenes vaccine (200 µg)
Placebo
Sponsored by
Butantan Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rheumatic Fever focused on measuring vaccine, peptide, Streptococcus pyogenes

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Low-dose vaccine

    Mid-dose vaccine

    High-dose vaccine

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Solicited and unsolicited adverse reactions
    Frequency of solicited and unsolicited adverse reactions
    Immune response to vaccine
    Rate of seroconversion for vaccine epitopes

    Secondary Outcome Measures

    Full Information

    First Posted
    June 24, 2019
    Last Updated
    February 2, 2021
    Sponsor
    Butantan Institute
    Collaborators
    InCor - Instituto do Coração - HCFMUSP.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03998592
    Brief Title
    Clinical Trial to Assess Safety and Immunogenicity of a Synthetic Vaccine Against Streptococcus Pyogenes
    Official Title
    Phase I Clinical Trial for Assessment of Safety and Immunogenicity of a Synthetic Vaccine Against Streptococcus Pyogenes in Healthy Volunteers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Agreement between interested partied ended
    Study Start Date
    May 2021 (Anticipated)
    Primary Completion Date
    March 2022 (Anticipated)
    Study Completion Date
    October 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Butantan Institute
    Collaborators
    InCor - Instituto do Coração - HCFMUSP.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatic Fever
    Keywords
    vaccine, peptide, Streptococcus pyogenes

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Low-dose vaccine
    Arm Type
    Experimental
    Arm Title
    Mid-dose vaccine
    Arm Type
    Experimental
    Arm Title
    High-dose vaccine
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Biological
    Intervention Name(s)
    Streptococcus pyogenes vaccine (50 µg)
    Intervention Description
    Vaccine containing 50 µg of StreptInCor synthetic peptide and Aluminium Hydroxide as adjuvant
    Intervention Type
    Biological
    Intervention Name(s)
    Streptococcus pyogenes vaccine (100 µg)
    Intervention Description
    Vaccine containing 100 µg of StreptInCor synthetic peptide and Aluminium Hydroxide as adjuvant
    Intervention Type
    Biological
    Intervention Name(s)
    Streptococcus pyogenes vaccine (200 µg)
    Intervention Description
    Vaccine containing 200 µg of StreptInCor synthetic peptide and Aluminium Hydroxide as adjuvant
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo without active component
    Primary Outcome Measure Information:
    Title
    Solicited and unsolicited adverse reactions
    Description
    Frequency of solicited and unsolicited adverse reactions
    Time Frame
    Six months after last dose
    Title
    Immune response to vaccine
    Description
    Rate of seroconversion for vaccine epitopes
    Time Frame
    Six months after last dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Luiza Guilherme, PhD
    Organizational Affiliation
    InCor Heart Institute
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Roney O Sampaio, MD, PhD
    Organizational Affiliation
    InCor Heart Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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