Sanaria PfSPZ Challenge With Pyrimethamine or Chloroquine Chemoprophylaxis Vaccination (PfSPZ-CVac Approach): A Randomized Double Blind Placebo Controlled Phase I/II Trial to Determine Safety and Protective Efficacy Against Natural Plasmodium Falcipa...
CompletedPhase 1, PHASE2Results postedLast updated 12 July 2022
What this trial tests
Phase 1, PHASE2 trial testing Chloroquine Phosphate in Malaria in 252 participants. Completed in 10 February 2021.
Timeline
23 May 2019
Primary endpoint 10 February 2021
10 February 2021
Quick facts
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Who can join
Adults 18 to 50, 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 Positive Sensitive Blood Smear (sBS)Primary· 7 -12 days post-inoculation
Count of participants with positive sensitive blood smear (sBS) occurring after PfSPZ-CVac immunization starting on day 7 post DVI. Only pilot phase arms (Arms 1a, 2a) were analyzed for this outcome measure. Arms 5a and 6a were not performed, as no patent parasitemia was observed in either Arms 1a or 2a, per the protocol.
Group
Value
95% CI
1a - Pilot/Safety: Dosing Interval on Days: 1
0
2a - Pilot/Safety: Dosing Interval on Days: 1
0
Number of Participants With Local and Systemic Grade 3 Adverse Events (AEs) and Serious Adverse Events (SAEs)Primary· From day of inoculation to 14 days post-inoculation
Count of participants with local and systemic grade 3 signs or symptoms lasting more than 48 hours despite adequate management and serious adverse events (SAEs) occurring after PfSPZ-CVac DVI. Only arm 3a was analyzed for this outcome measure, per the protocol objectives.
Group
Value
95% CI
3a - Pilot/Safety: Dosing Interval on Days: 1
0
Number of Participants With Local and Systemic Adverse Events (AEs) and Serious Adverse Events (SAEs)Primary· For the main phase: from the day of inoculation to approximately 6 months post-3rd inoculation. For the booster phase: from the time of inoculation to approximately 6 months post-booster inoculation
Count of participants with local and systemic adverse events (AEs) and serious adverse events (SAEs) occurring after PfSPZ-CVac immunization. This outcome measure applies to main phase arms 1b, 2b, 4a, and 4b. Arms 5b and 6b were not performed as patent parasitemia with the higher dose of PfSPZ was not observed in the pilot phase (Arms 1a, 2a).
Group
Value
95% CI
1b - Safety/Efficacy: Dosing Interval on Days: 1, 29, 57
88
2b - Safety/Efficacy: Dosing Interval on Days: 1, 29, 57
Time frame: One month for pilot phase; eight months for main phase; seven months for booster phase.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
1a - Pilot/Safety: Dosing Interval on Days: 1
Serious: 0/4 (0%)
Deaths: 0/4
1b - Safety/Efficacy: Dosing Interval on Days: 1, 29, 57
Serious: 1/90 (1%)
Deaths: 1/90
2a - Pilot/Safety: Dosing Interval on Days: 1
Serious: 0/4 (0%)
Deaths: 0/4
2b - Safety/Efficacy: Dosing Interval on Days: 1, 29, 57
Background:
Malaria remains a major global health problem. Malaria is spread by the bite of mosquitos. Africa is the region of the world where most people get malaria. Sanaria PfSPZ Challenge is a malaria vaccine. Researchers want to see if the vaccine combined with partner drugs can help protect against malaria.
Objective:
To test if injections with 3 monthly doses of Sanaria PfSPZ Challenge, combined with either pyrimethamine (PYR) or chloroquine as a partner drug, is safe, tolerable, and effective.
Eligibility:
Healthy people ages 18-50 years who live in Bancoumana, Mali, or nearby
Design:
Participants will be screened with the Malaria Comprehension Exam to check their understanding of the study. They will have a medical history. They will have a physical exam. They will have blood tests, urine tests, and heart tests.
Participants will join either the pilot study or the main study.
Participants will be assigned to groups. Depending on their group, they will get at least one injection of either a placebo or the vaccine. They may have up to 3 vaccines, 4 weeks apart. The injection will be into a vein with a needle.
Participants will also take pyrimethamine or chloroquine by mouth. They will also take standard doses of antimalarial drugs by mouth.
Participants will have blood tests throughout the study.
Participants may develop a rash or injection site reaction. If this happens, photos of the site may be taken.
Participants will be observed for infection for many days after the injections.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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
Other National Institute of Allergy and Infectious Diseases (NIAID) trials
Trials by the same sponsor.
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NCT07124559 — A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of
· Phase 1, PHASE2
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NCT07342491 — Dasatinib for HIV-1 Reservoir Reduction
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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: 12 July 2022
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/NCT03952650.