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Tests treatment safety and results for Group A Streptococcal Infection
Official title A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-A1 in Healthy Young Adults
ClinicalTrials.gov ID: NCT07616934
What this study is testing
What is VAX-A1 Low?
VAX-A1 Low is an investigational medicine, being studied as a potential treatment for group a streptococcal infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase 1, first-in-human, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability, and immunogenicity of VAX-A1 in healthy adults 18-40 years of age.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40. Healthy volunteers may be eligible.
You may be able to join if
- Individuals 18-40 years of age (inclusive) at the time of randomization into the study
- Able and willing to complete the informed consent process
- Available for clinical follow-up through the last study visit at 6 months post-Dose 2
- Willing to have blood samples collected, stored indefinitely, and be used for research purposes
- Able to provide proof of identity to the satisfaction of the study staff completing the enrollment process
You likely can't join if
- History of any clinically important cardiac, rheumatologic, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary...
- History of invasive GAS infection (such as toxic shock syndrome, necrotizing fasciitis, bloodstream infection, pleural empyema, meningitis) or...
- Known or suspected autoimmune disease, collagen vascular disease, or impairment/alteration of immune function (e.g., congenital or acquired...
- Previous or existing diagnosis of human immunodeficiency virus, Hepatitis B virus, or Hepatitis C virus, or a positive serologic test at Screening
- History of malignancy or neoplasm, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
- Bleeding disorder diagnosed by a physician (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) resulting in...
See the full eligibility criteria
Who can join
- Individuals 18-40 years of age (inclusive) at the time of randomization into the study
- Able and willing to complete the informed consent process
- Available for clinical follow-up through the last study visit at 6 months post-Dose 2
- Willing to have blood samples collected, stored indefinitely, and be used for research purposes
- Able to provide proof of identity to the satisfaction of the study staff completing the enrollment process
- Healthy, as defined by absence of clinically significant medical condition, either acute or chronic, as determined by medical history, vital signs, physical examination, screening laboratory test results, TTE and ECG...
- For applicable individuals, postmenopausal (as confirmed by follicle-stimulating hormone [FSH] level at Screening) for at least 1 year, or surgically sterile for at least 6 months prior to dosing
- Individuals of childbearing potential must be not pregnant and not lactating, must have negative urine and serum pregnancy tests at Screening and a negative urine pregnancy test immediately prior to randomization, and...
- Able to access and use a smartphone, tablet, computer, or other device connected to Wi-Fi or cellular network for completion of an eDiary
What rules you out
- History of any clinically important cardiac, rheumatologic, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other disease as determined...
- History of invasive GAS infection (such as toxic shock syndrome, necrotizing fasciitis, bloodstream infection, pleural empyema, meningitis) or poststreptococcal immune mediated disease (such as RHD, ARF, or APSGN)
- Known or suspected autoimmune disease, collagen vascular disease, or impairment/alteration of immune function (e.g., congenital or acquired immunodeficiency)
- Previous or existing diagnosis of human immunodeficiency virus, Hepatitis B virus, or Hepatitis C virus, or a positive serologic test at Screening
- History of malignancy or neoplasm, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
- Bleeding disorder diagnosed by a physician (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) resulting in clinically significant bruising or bleeding difficulties with IM...
- History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis to any previous vaccination
- Oral temperature \>38.0°C (\>100.4°F) or acute illness within 3 days prior to study vaccination (subject may be rescreened)
- Confirmed elevated BP at Screening, defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg measured seated after ≥5 minutes rest and confirmed by repeat measurement
- Physical examination indicating any clinically significant medical condition or inadequate venous access
- Any Grade ≥2 abnormal safety laboratory test at Screening
- Abnormal ESR, or CRP or C3 levels at Screening
- Confirmed microscopic hematuria (\>10 RBC/mm³) on UA at Screening. If a potential confounder is present, a repeat UA may be performed during the Screening window; exclusion applies to confirmed microscopic hematuria on...
- Evidence of antecedent/recent GAS infection based on anti-DNase B titer ≥ the laboratory reported upper limit of normal (ULN) for the assay used at Screening. Participants with anti-DNase B titer ≥0.8×ULN and \<ULN at...
- Positive GAS rapid NAAT at Screening or Day 1
- Any finding based on comprehensive TTE at Screening indicative of possible cardiac pathology, including valvular abnormalities defined as mild stenosis or regurgitation.
- Any finding on ECG that is indicative of possible cardiac pathology, including a prolonged PR interval or conduction abnormality
- Receipt of any investigational product within 30 days prior to enrollment into the study, currently participating in another study that includes receipt of an investigational product or procedure, or having plans to...
- Planned or actual administration of any licensed vaccine within 30 days before or after receipt of study vaccine, or within 14 days before or after receipt of study vaccine in the case of influenza and COVID-19...
- Received blood or blood product (including intravenous immunoglobulin) within 6 months of enrollment into the study
- Receipt of any immunosuppressive therapy, including systemic steroids at a dosage equivalent to ≥0.5 mg/kg/day of prednisone, chronic use of inhaled or nebulized high potency corticosteroids, or use of intra-articular...
- Body mass index (BMI) ≥32 kg/m2 or ≤18 kg/m2
- History of alcohol or drug abuse in the 5 years prior to enrollment, or any history of intravenous drug abuse
- Any medical, psychiatric, or social condition that in the judgment of the Investigator may interfere with the study objectives, impair a participant's ability to give informed consent, pose a risk to the participant, or...
- Employee of, or first degree relative of any person employed by the Sponsor, the contract research organization (CRO), the Investigator, study site personnel, or site
The study team makes the final eligibility decision.
Where it's taking place
- Adelaide, South Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Adelaide, South Australia, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.