New malaria vaccine trial aims to protect women and their future babies
NCT ID NCT06080243
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests the R21/Matrix-M1 malaria vaccine in 330 healthy women aged 18–35 in Mali who may become pregnant. Participants receive two or three doses of the vaccine or a placebo, and are followed for two years to check safety, immune response, and protection against malaria. Pregnant women and their babies are also monitored for safety and infection.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- R21/Matrix-M1 malaria vaccine
- What this could lead to
- If successful, this vaccine could help protect women of childbearing age from malaria, reducing infection and improving maternal and child health in malaria-endemic regions.
- What could go wrong
- This is a phase II trial with only 330 participants, so results may not apply to larger populations. The vaccine may not provide lasting protection or could have side effects not yet seen.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 330 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 35 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Healthy females of childbearing potential aged ≥ 18 and ≤ 35 years * Able and willing (in the Investigator's opinion) to comply with all study requirements. * Agreement to release medical and other information concerning contra-indications for participation in the study, and to be attended by a study clinician for physical examination and any other clinical investigations. * Provide written informed consent. * Available for the duration of the study * Must be willing to use reliable contraception (defined as: pharmacologic contraceptives \[parental delivery\] or pre-existing intrauterine or implantable device) from 21 days prior to study day 1 to 28 days after third vaccination and 21 days prior to the booster vaccination to 28 days after the booster vaccination. * Report being interested in becoming pregnant within the next 1 year. Exclusion Criteria: * Pregnancy at the time of enrollment, as determined by a positive urine or serum human chorionic gonadotropin (β-hCG) test. * Biologically unable to become pregnant secondary to: surgical sterilization, premature ovarian insufficiency (defined as no menses for ≥12 months without an alternative medical cause). * Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and comply with the study protocol. * Hemoglobin (Hgb), WBC, absolute neutrophils, and platelets outside the local laboratory-defined limits of normal and ≥ Grade 2 (participants may be included at the investigator's discretion for 'not clinically significant' abnormal values). * Alanine transaminase (ALT) or creatinine (Cr) level above the local laboratory-defined upper limit of normal and ≥ Grade 2 (participants may be included at the investigator's discretion for 'not clinically significant' abnormal values). * Infected with human immunodeficiency virus (HIV). * Known or documented sickle cell disease by history or lab test at screening (Note: known sickle cell trait is NOT exclusionary). * Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and/or laboratory studies including urinalysis. * Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment or during the trial follow up period. * Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * History of hereditary angioedema acquired angioedema, or idiopathic angioedema. * History of a severe allergic reaction (Grade 2 or higher or per PI discretion) or anaphylaxis following administration of a vaccine. * Severe asthma (defined as asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past two years, or that has required the use of oral or parenteral corticosteroids at any time during the past two years). * Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, or autoimmune thrombocytopenia. * Any confirmed or suspected immunosuppressive or immunodeficient state, including asplenia; recurrent, severe infections and chronic (more than 14 days) systemically active immunosuppressant medication within the past 6 months. * Use of chronic (≥14 days) oral or IV corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone ≥20 mg/day) or immunosuppressive drugs within 30 days of vaccination. * Receipt of a live vaccine within the past 28 days or a killed vaccine within the past 14 days prior to Vaccination #1 and every subsequent vaccination day. * Receipt of immunoglobulins and/or blood products within the past six months. * Previous receipt of an investigational malaria vaccine in the last five years. * Other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of a participant participating in the trial, interfere with the evaluation of the study objectives, or would render the participant unable to comply with the protocol.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Koumantou Study Clinic
Bougouni, Sikasso, Mali
More trials for these conditions
Other studies related to the condition(s) this trial covers.