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Withdrawn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
About this trial
This is an interventional prevention trial for Rheumatic Fever focused on measuring vaccine, peptide, Streptococcus pyogenes
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.
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
NCT ID
NCT03998592
First Posted
June 24, 2019
Last Updated
February 2, 2021
Sponsor
Butantan Institute
Collaborators
InCor - Instituto do Coração - HCFMUSP.
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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