Rheumatic FeverPhase 1NCT03998592
Clinical Trial to Assess Safety and Immunogenicity of a Synthetic Vaccine Against Streptococcus Pyogenes
A Phase 1 study testing Streptococcus pyogenes vaccine (50 µg), Streptococcus pyogenes vaccine (100 µg) and Streptococcus pyogenes vaccine (200 µg) in people with Rheumatic Fever, run by Butantan Institute.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatic Fever
- What is being tested?
- Streptococcus pyogenes vaccine (50 µg), Streptococcus pyogenes vaccine (100 µg) and Streptococcus pyogenes vaccine (200 µg)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2021to Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 15Show fewer
- 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.
About this study
Official title: Phase I Clinical Trial for Assessment of Safety and Immunogenicity of a Synthetic Vaccine Against Streptococcus Pyogenes in Healthy Volunteers
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
- Being tested
- Streptococcus pyogenes vaccine (50 µg), Streptococcus pyogenes vaccine (100 µg), Streptococcus pyogenes vaccine (200 µg), Placebo
- Keywords
- vaccine, peptide, Streptococcus pyogenes
- Medical subject headings
- Rheumatic Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Streptococcus pyogenes vaccine (50 µg)Biological
Vaccine containing 50 µg of StreptInCor synthetic peptide and Aluminium Hydroxide as adjuvant
Streptococcus pyogenes vaccine (100 µg)Biological
Vaccine containing 100 µg of StreptInCor synthetic peptide and Aluminium Hydroxide as adjuvant
Streptococcus pyogenes vaccine (200 µg)Biological
Vaccine containing 200 µg of StreptInCor synthetic peptide and Aluminium Hydroxide as adjuvant
PlaceboOther
Placebo without active component
| Study group | Role | What they receive |
|---|---|---|
| Low-dose vaccine | Experimental | Not described Receives: Biological: Streptococcus pyogenes vaccine (50 µg) |
| Mid-dose vaccine | Experimental | Not described Receives: Biological: Streptococcus pyogenes vaccine (100 µg) |
| High-dose vaccine | Experimental | Not described Receives: Biological: Streptococcus pyogenes vaccine (200 µg) |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Solicited and unsolicited adverse reactions
Frequency of solicited and unsolicited adverse reactions
Measured: Six months after last dose
Immune response to vaccine
Rate of seroconversion for vaccine epitopes
Measured: Six months after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study startMay 2021 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionOct 2023 (estimated)
Why it stopped: Agreement between interested partied ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butantan Institute
- Sponsor type
- Other government
- Collaborators
- InCor - Instituto do Coração - HCFMUSP.
- Responsible party
- Sponsor
- Investigators
- Luiza Guilherme, PhD, Study chair, InCor Heart InstituteRoney O Sampaio, MD, PhD, Principal investigator, InCor Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998592
- Sponsor's protocol ID
- EGA-01-IB
- Status last verified
- Feb 2021
- First submitted
- 24 Jun 2019
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial for Assessment of Safety and Immunogenicity of a Synthetic Vaccine Against Streptococcus Pyogenes in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03998592
- Acronym / sponsor ID
- EGA-01-IB
- Conditions
- Rheumatic Fever
- Keywords
- vaccine, peptide, Streptococcus pyogenes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Agreement between interested partied ended
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Butantan InstituteOther government
- Collaborators
- InCor - Instituto do Coração - HCFMUSP.
- Study start
- May 2021 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 26 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Streptococcus pyogenes vaccine (50 µg)Vaccine containing 50 µg of StreptInCor synthetic peptide and Aluminium Hydroxide as adjuvant | Biological | Low-dose vaccine |
| Streptococcus pyogenes vaccine (100 µg)Vaccine containing 100 µg of StreptInCor synthetic peptide and Aluminium Hydroxide as adjuvant | Biological | Mid-dose vaccine |
| Streptococcus pyogenes vaccine (200 µg)Vaccine containing 200 µg of StreptInCor synthetic peptide and Aluminium Hydroxide as adjuvant | Biological | High-dose vaccine |
| PlaceboPlacebo without active component | Other | Placebo |
Primary outcome
Solicited and unsolicited adverse reactions
Time frame: Six months after last dose
Frequency of solicited and unsolicited adverse reactions
Immune response to vaccine
Time frame: Six months after last dose
Rate of seroconversion for vaccine epitopes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Rheumatic Fever
Not yet recruiting
Effects of Paraffin Wax Therapy and Dry Cupping on Pain and Wrist Function in Patients With Rheumatoid Arthritis
Rheumatic Arthritis
RecruitingObservational study
Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
Heart Valve Diseases, Aortic Valve Stenosis
RecruitingObservational study
Glucocorticoid-induced Osteoporosis in Patients With Chronic Inflammatory Rheumatic Diseases or Psoriasis
Osteoporosis, Inflammatory Rheumatism
Not yet recruiting
Assessment of the Prevalence of Rheumatic Heart Disease in School Settings in Mayotte and the Acquisition of Ultrasound Sequences Guided by Artificial Intelligence
Rheumatic Heart Diseases, Scabies
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luiza Guilherme, PhD study chair
InCor Heart Institute
Roney O Sampaio, MD, PhD principal investigator
InCor Heart Institute
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Streptococcus pyogenes vaccine (50 µg), Streptococcus pyogenes vaccine (100 µg) and Streptococcus pyogenes vaccine (200 µg) in people with Rheumatic Fever, run by Butantan Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Solicited and unsolicited adverse reactions (time frame: Six months after last dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.