Phase 1 N=78 Randomized Double-blind Prevention

Study of the Transmission-Blocking Vaccine Pfs230D1-EPA/Matrix-M Against Malaria in Adults in Mali

Malaria,Falciparum

Bottom Line

View on ClinicalTrials.gov: NCT05135273 ↗

Enrolled (actual)

Serious AEs

1.3%

Results posted

May 2024

Primary outcome: Primary: Number of Local and Systemic Adverse Events (AEs) to Assess the Safety of the Study Drug — 34; 24; 23; 16 Adverse Events

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Pfs230D1-EPA/Matrix-M Vaccine (Biological); Verorab Rabies Vaccine (Biological)
Age: Adult · 18+ yrs
Sex: All
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion: Feb 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Local and Systemic Adverse Events (AEs) to Assess the Safety of the Study Drug	34; 24; 23; 16; 45; 60	—
PRIMARY Number of Local and Systemic Serious Adverse Events (SAEs) to Assess the Safety of the Study Drug	1; 0; 0; 0; 0; 0	—

Summary

Background: Researchers are trying to develop a vaccine that will safely reduce the spread of malaria in the community by preventing mosquitos from carrying malaria from person to person. Objective: To assess in African adults the safety of and immune response to the administration of Pfs230D1-EPA/Matrix-M vaccine as compared to the rabies vaccine control. Eligibility: Healthy adults (18 to 50 years of age) who reside in Sotuba and surrounding villages in Mali Design: Participants will be screened with: * Medical history * Physical exam * Blood, urine, and heart tests * Malaria comprehension exam Participants will be randomly assigned to get either the experimental vaccine or the approved rabies vaccine. They will not know which they are getting. Participants will get 3 doses of the study or comparator vaccine via injection in the upper arm. This occurs at the first visit, 1 month, and 2 months later. Participants will have up to 23 scheduled visits over 14 to 16 months. Each visit includes a physical exam, and blood will be collected at most visits. Participants will be followed up to 1 year after the final vaccination. If participants develop an injection site rash or reaction, photographs may be taken of the site.

Eligibility Criteria

INCLUSION CRITERIA

All of the following criteria must be fulfilled for a volunteer to participate in this trial:

Age: > 18 years old and 10 mg/day) or immunosuppressive drugs within 30 days of Study Day 0.
Allergy to latex or neomycin.
Receipt of:
Live vaccine within 4 weeks prior to enrollment or a killed vaccine within 2 weeks prior to enrollment.
Immunoglobulins and/or blood products within the past 6 months.
Investigational malaria vaccine in the last 2 years.
Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a subject participating in the trial, interfere with the evaluation of the study objectives, or would render the subject unable to comply with the protocol.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05135273). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.