# Safety, Immunogenicity, and Protective Efficacy of Two Regimens of Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites (PfSPZ Vaccine) During Natural Transmission Season in Healthy African Adults in Mali

> **NCT03510481** · PHASE1 · COMPLETED · sponsor: **National Institute of Allergy and Infectious Diseases (NIAID)** · enrollment: 478 (actual)

## Conditions studied

- Malaria

## Interventions

- **BIOLOGICAL:** PfSPZ Vaccine
- **DRUG:** Normal Saline
- **DRUG:** artemether 20mg/lumefantrine 120mg (AL)

## Key facts

- **NCT ID:** NCT03510481
- **Lead sponsor:** National Institute of Allergy and Infectious Diseases (NIAID)
- **Sponsor class:** NIH
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2018-05-14
- **Primary completion:** 2019-11-23
- **Final completion:** 2020-02-13
- **Target enrollment:** 478 (ACTUAL)
- **Last updated:** 2021-08-20

## Collaborators

- [object Object]
- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03510481

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03510481, "Safety, Immunogenicity, and Protective Efficacy of Two Regimens of Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites (PfSPZ Vaccine) During Natural Transmission Season in Healthy African Adults in Mali". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT03510481. Licensed CC0.

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