Safety, Immunogenicity, and Protective Efficacy of Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites (PfSPZ Vaccine) During Malaria Transmission Season in Healthy African Adult Women of Childbearing Potential in Mali
CompletedPhase 2Results postedLast updated 19 March 2024
What this trial tests
Phase 2 trial testing PfSPZ Vaccine in Malaria in 324 participants. Completed in 17 March 2023.
Timeline
3 July 2019
Primary endpoint 5 April 2022
17 March 2023
Quick facts
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Who can join
Under 38, any sex, with Malaria. 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 Participants With Adverse Events Within 7 Days After Each Vaccine AdministrationPrimary· 7 days after each vaccination at days 1, 8, and 29
Assess safety and tolerability of PfSPZ Vaccine primary series in healthy Malian women of child-bearing potential (WOCBP) when given at 1, 8, 29 days at two doses (9 x10\^5; 1.8 x10\^6).
Group
Value
95% CI
Arm 1
51
Arm 2
43
Arm 3
43
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 8, and 29, All-Cause Mortality monitored/assessed through year 4.
Reporting threshold: 1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Background:
Malaria is a disease spread by mosquitos. Pregnant women are highly susceptible to malaria. This can lead to poor health outcomes for pregnant women and their babies. Researchers want to test a malaria vaccine in women of child bearing potential (WOCBP) and pregnant women. This has not been done before.
Objective:
To assess the safety and tolerability of PfSPZ vaccine in healthy Malian WOCBP.
Eligibility:
Healthy women ages 18 38 who live in Ouelessebougou, Mali, and surrounding villages
Design:
Participants will be screened with:
* Physical exam
* Medical history
* Blood, urine, and heart tests
* Multiple-choice test about malaria
Participants will get 3 injections by needle into a vein of the study vaccine or a placebo. All 3 will be within 1 month. They will not know whether they receive the vaccine or placebo.
Participants will receive treatment to prevent malaria. This will be about 2 weeks before the first and third injections.
After the third injection, participants will be followed for about 1 year. They will be tested to see if the vaccine is safe and protects against malaria infection. They will have blood tests.
If participants get a rash or injection site reaction, photos of the site may be taken.
Any women who become pregnant during the trial will be followed through the end of pregnancy. Babies and their mothers will be followed through the first year of life
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05652504 — Safety Evaluation of PfSPZ Vaccine in Pregnant Women in Mali (MalVIP1)
· Phase 1
· suspended
NCT06735209 — First-in-Human PfSPZ-LARC2 Vaccination/CHMI
· Phase 1
· active not recruiting
NCT05604521 — A Phase 1 Trial of PfSPZ Vaccine in Healthy Adults to Determine Safety, Tolerability and Efficacy Against Heterologous C
· Phase 1
· terminated
NCT03503058 — Safety, Tolerability, Immunogenicity and Protective Efficacy of PfSPZ Vaccine and PfSPZ-CVac in Indonesian Adults Agains
· Phase 2
· completed
NCT04966871 — Safety, Tolerability and Efficacy of PfSPZ Vaccine Against Heterologous CHMI in US Malaria naïve Adults
· Phase 1
· completed
Other recruiting trials for Malaria
Currently open trials in the same condition.
NCT07358910 — Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
· recruiting
NCT07036159 — A Study to Assess the Safety and Immunogenicity of a Vaccine Against Malaria in Healthy Children Aged 5-60 Months
· Phase 2
· recruiting
NCT06735209 — First-in-Human PfSPZ-LARC2 Vaccination/CHMI
· Phase 1
· active not recruiting
NCT06854042 — A Study of Oral E1018 in Healthy Adult Participants
· Phase 1
· recruiting
NCT06607003 — Induced Blood-Stage Malaria in Healthy Malaria-Naive Adults to Assess the Safety and Infectivity of Plasmodium Vivax Cha
· Phase 1
· recruiting
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Trials by the same sponsor.
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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: 19 March 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/NCT03989102.