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NCT02773979
PfSPZ Challenge in Healthy Malaria-Naïve Adults in the United States
Phase 1 trial testing Chloroquine in Plasmodium Falciparum Infection in 28 participants. Completed in 22 January 2018.
22 January 2018
Quick facts
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 28 |
| Start date | 12 September 2016 |
| Primary completion | 22 January 2018 |
| Estimated completion | 22 January 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Chloroquine (CHLOROQUINE) — full drug profile →
- PfSPZ (NF54) Challenge — full drug profile →
- Placebo
Conditions studied
- Plasmodium Falciparum Infection — all drugs for Plasmodium Falciparum Infection →
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Who can join
Adults 18 to 45, any sex, with Plasmodium Falciparum Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase I trial of the replication-intact PfSPZ Challenge vaccine given under CQ cover will enroll 28 healthy volunteers to receive PfSPZ or placebo, as well as suppressive doses of chloroquine (CQ)on varying schedules. 10 weeks post 3rd immunization subjects will be subjected to controlled human malarial infection. The primary objective of this study is to evaluate the safety and tolerability of escalating doses of Sanaria PfSPZ Challenge administered by DVI on varying schedules to healthy malaria-naïve adults taking suppressive doses of CQ (PfSPZ-CVac).
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
PfSPZ-CVac efficacy against malaria increases from 0% to 75% when administered in the absence of erythrocyte stage parasitemia: A randomized, placebo-controlled trial with controlled human malaria infection.
Murphy SC, Deye GA, Sim BKL, Galbiati S, et al · · 2021 · cited 51× · PMID 34048504 · DOI 10.1371/journal.ppat.1009594 -
Sporozoite immunization: innovative translational science to support the fight against malaria.
Richie TL, Church LWP, Murshedkar T, Billingsley PF, et al · · 2023 · cited 44× · PMID 37571809 · DOI 10.1080/14760584.2023.2245890 -
Immune responses to malaria pre-erythrocytic stages: Implications for vaccine development.
Abuga KM, Jones-Warner W, Hafalla JCR. · · 2021 · cited 14× · PMID 32981095 · DOI 10.1111/pim.12795 -
<i>Plasmodium</i> 18S Ribosomal RNA Biomarker Clearance After Food and Drug Administration-Approved Antimalarial Treatment in Controlled Human Malaria Infection Trials.
Chavtur C, Staubus WJ, Ho M, Hergott DEB, et al · · 2023 · cited 2× · PMID 37265668 · DOI 10.1093/ofid/ofad202
Verify or expand the search:
- PubMed search for NCT02773979
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02773979 (US National Library of Medicine, public domain)
- 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: 27 December 2019
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/NCT02773979.
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