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New treatment option for Malaria (Plasmodium Falciparum)
Official title PfSPZ-LARC2 Vaccine in Women of Child-bearing Potential (WOCBP) in Mali
ClinicalTrials.gov ID: NCT07675785
What this study is testing
What is PfSPZ-LARC2 Vaccine?
PfSPZ-LARC2 Vaccine is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for malaria (plasmodium falciparum).
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
- A randomized double blind, placebo-controlled study to assess the safety, tolerability, immunogenicity, and protective efficacy of 1, 6, 29-day PfSPZ-LARC2 Vaccine regimen given at a dose of 2 x10\^5 PfSPZ or placebo in healthy WOCBP, who are on pregnancy prevention during vaccination, but report plans to become pregnant in the near future. Participants will be randomized into two arms.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
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 38, women only. Healthy volunteers may be eligible.
You may be able to join if
- Females of childbearing potential aged ≥ 18 and ≤ 38 years
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
- In good general health and without clinically significant medical history
- Willing to have blood samples stored for future research
- Available for the duration of the study
You likely can't join if
- Pregnancy at the time of enrollment/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...
- Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and comply...
- Hemoglobin (Hgb), WBC, absolute neutrophils, and platelets outside the local laboratorydefined limits of normal and ≥ Grade 2 (participants may be...
- Alanine transaminase (ALT) or creatinine (Cr) level above the local laboratory-defined upper limit of normal and ≥ Grade 2 (participants may be...
- Infected with human immunodeficiency virus (HIV)
See the full eligibility criteria
- Females of childbearing potential aged ≥ 18 and ≤ 38 years
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
- In good general health and without clinically significant medical history
- Willing to have blood samples stored for future research
- 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 first vaccination (study day 1) to 28...
- Willingness to undergo HIV testing
- Report being interested in becoming pregnant within the next 1 year
- Pregnancy at the time of enrollment/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 laboratorydefined limits of normal and ≥ Grade 2 (participants may be included at the investigator's discretion for 'not clinically...
- 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'...
- Infected with human immunodeficiency virus (HIV)
- Known or documented sickle cell disease by history (Note: known sickle cell trait is NOT exclusionary)
- Clinically significant abnormal electrocardiogram (ECG) such as abnormal QTc.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and/or laboratory studies...
- History of receiving any investigational product within the past 30 days
- Participation or planned participation in a clinical trial with an investigational product prior to completion of the follow-up visit 28 days following last vaccination OR planned participation in an investigational...
- Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
- History of a severe allergic reaction (Grade 2 or higher or per PI discretion) or anaphylaxis
- 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...
- 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
- Known immunodeficiency syndrome
- Known seizure disorder or history of seizures (exclusion: simple febrile seizure during childhood) or history of migraine headaches
- Laboratory evidence of hepatitis B or C
- Known asplenia or functional asplenia
- 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 four weeks or a killed vaccine within the past two weeks 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 ten years
- Known allergies or other contraindications against use of artemether/lumefantrine
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Bamako, Mali
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 female, 18 years to 38 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bamako, Mali. 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.