A Study to Evaluate Tolerability, Safety and Immunogenicity of MVX01 Pneumococcal Vaccine (NCT06337643) | Clinical Trial Compass
UnknownPhase 1
A Study to Evaluate Tolerability, Safety and Immunogenicity of MVX01 Pneumococcal Vaccine
United States75 participantsStarted 2023-03-07
Plain-language summary
The objectives of this first-in-human study is to evaluate the tolerability, safety, and immunogenicity of MVX01, a pneumococcal vaccine candidate, at four dose levels.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant must be male or non-pregnant, non-lactating female ≥ 18 to ≤ 50 years of age for Cohorts 1 to 4 and ≥ 60 to ≤ 75 years of age for Cohort 5, at the time of signing the informed consent.
* Body mass index within the range 18 to 32 kg/m2 (inclusive) for Cohorts 1-4. Body mass index within the range 18 to 35 kg/m2 (inclusive) for Cohort 5.
* Participants who are free of clinically significant acute or chronic health conditions in the opinion of the Investigator.
* Have provided written informed consent prior to screening procedures.
* Participant's screening laboratory test results must be either within the normal range or deemed as not clinically significant by the Investigator.
* Venous access considered adequate for collection of safety laboratory samples and immunogenicity samples.
* Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. In addition, women of childbearing potential must agree to avoid heterosexual activity for a period of 14 days prior to the administration of study intervention.
Exclusion Criteria:
* Positive screening test suggesting a current infection due to human immunodeficiency virus, hepatitis C virus, or hepatitis B virus infection.
* Symptoms of active respiratory illness at the time of the first dose of study intervention or close contact with a known SARS-CoV-2 positive patient within 10 days of first…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of immediate reactogenicity adverse events
Timeframe: Up to 30 minutes after each dose
2
Incidence of solicited reactogenicity events
Timeframe: Up to 7 days after each dose
3
Incidence of adverse events (AEs)
Timeframe: Up to study day 61
4
Incidence of Serious Adverse Events (SAEs) and New-Onset Chronic Illness (NOCI)
Timeframe: Up to study day 224
5
Changes in safety laboratory results compared to baseline
Timeframe: Up to study day 61
6
Changes in vital signs compared to baseline
Timeframe: Up to study day 61
7
Geometric Mean Titer (GMT) post immunization of Anti-pneumolysin (PLY) and anti-choline binding protein A (CbpA)
Timeframe: Up to study day 224
Trial details
NCT IDNCT06337643
SponsorMatrivax Research and Development Corporation