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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

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;

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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 groups in NCT03998592
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.

May 2021Oct 2023

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Rheumatic Fever trials

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.

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

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Effects of Paraffin Wax Therapy and Dry Cupping on Pain and Wrist Function in Patients With Rheumatoid Arthritis
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RecruitingObservational study
Glucocorticoid-induced Osteoporosis in Patients With Chronic Inflammatory Rheumatic Diseases or Psoriasis
Osteoporosis, Inflammatory Rheumatism
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
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ACT4RHD is an Open-label, Randomised, Adaptive Platform Trial to Evaluate Novel and Repurposed Clinical Interventions for Patients With Acute Rheumatic Fever and Carditis. ACT4RHD Seeks to Determine Whether These Interventions Reduce RHD Severity at 6 Months.
Rheumatic Fever, Rheumatic Heart Disease in Children
RecruitingObservational study
Dynamics in Bone Turnover Markers During and After Short-term Glucocorticoid Treatment in Patients With an Inflammatory Joint Disease
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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?

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?

On the ClinicalTrials.gov record for NCT03998592.

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.