Testing a malaria vaccine in healthy women planning to become pregnant in Mali

A Phase II Randomised, Controlled Trial to Evaluate the Safety, Immunogenicity and Efficacy of the R21/Matrix-M1 Malaria Vaccine in Healthy African Women of Childbearing Potential in Mali

This study is testing a malaria vaccine in healthy women who plan to become pregnant in Mali to see if it is safe and effective.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 330 (estimated)
• Ages: 18 Years to 35 Years
• Sex: Female
• Sponsor: University of Oxford (Academic / other)
• Drugs / interventions: prednisone
• Locations: 1 site (Bougouni, Sikasso Region)
• Trial ID: NCT06080243 on ClinicalTrials.gov

What this trial studies

This clinical trial is a double-blind, randomized study assessing the safety, immunogenicity, and efficacy of the R21/Matrix-M1 malaria vaccine in healthy women of childbearing potential in Mali. Participants aged 18 to 35 will be randomly assigned to receive either the vaccine or a placebo in three different groups. The study will evaluate the participants over a 12-month period, with follow-up assessments during the malaria transmission season. Additionally, non-pregnant participants will receive a booster dose in the second year to further assess the vaccine's efficacy.

Who should consider this trial

Good fit: Ideal candidates are healthy women of childbearing potential aged 18 to 35 who are interested in becoming pregnant within the next year.

Not a fit: Patients who are currently pregnant or unable to comply with the study's contraceptive requirements will not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could provide effective protection against malaria for women planning to become pregnant.

How similar studies have performed: Other studies have shown promise in malaria vaccine development, but this specific approach is novel in targeting women of childbearing potential.

Eligibility criteria

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 or any subsequent vaccination, 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.

Where this trial is running

Bougouni, Sikasso Region

• Koumantou Study Clinic — Bougouni, Sikasso Region, Mali (Recruiting)

Study contacts

• Study coordinator: Adrian Hill, MD

Conditions Healthy Women of Child Bearing Potential