National Institute of Allergy and Infectious Diseases (NIAID)
Who can join
Adults 18 to 50, any sex, with Malaria,Falciparum. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Local and Systemic Adverse Events (AEs) to Assess the Safety of the Study DrugPrimary· Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
The analyses included only subjects who received at least one vaccination
Group
Value
95% CI
12.5 µg Dose (Arm 1a Pilot)
34
20 µg Dose (Arm 1b Pilot)
24
40 µg Dose (Arm 1c Pilot)
23
Rabies Comparator (Arm 1d Pilot)
16
12.5 µg (Arm 2a Main)
45
20 µg Dose (Arm 2b Main)
60
40 µg Dose (Arm 2c Main)
58
Rabies Comparator (Arm 2d Main)
39
Number of Local and Systemic Serious Adverse Events (SAEs) to Assess the Safety of the Study DrugPrimary· Serious Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
Group
Value
95% CI
12.5 µg Dose (Arm 1a Pilot)
1
20 µg Dose (Arm 1b Pilot)
0
40 µg Dose (Arm 1c Pilot)
0
Rabies Comparator (Arm 1d Pilot)
0
12.5 µg (Arm 2a Main)
0
20 µg Dose (Arm 2b Main)
0
40 µg Dose (Arm 2c Main)
0
Rabies Comparator (Arm 2d Main)
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06987318 — A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS)
· Phase 1
· not yet recruiting
NCT07124559 — A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of
· Phase 1, PHASE2
· not yet recruiting
NCT07342491 — Dasatinib for HIV-1 Reservoir Reduction
· Phase 1
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
Last refreshed: 6 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05135273.