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NCT02780154
PfSPZ Challenge in Non-immune Adults in Baltimore, USA
Phase 1 trial testing PfSPZ (7G8) Challenge in Plasmodium Falciparum Infection in 30 participants. Completed in 15 December 2016.
15 December 2016
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 | 30 |
| Start date | 25 August 2016 |
| Primary completion | 15 December 2016 |
| Estimated completion | 15 December 2016 |
| Sites | 1 location across United States |
Drugs / interventions tested
- PfSPZ (7G8) Challenge — full drug profile →
- PfSPZ (NF54) Challenge — full drug profile →
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 is a single center, randomized and controlled human study to optimize controlled human malaria infection (CHMI) administered by direct venous inoculation (DVI). 36 healthy adults aged between 18 and 45 years, will be randomized to one of five groups and will be inoculated with PfSPZ Challenge DVI. Participation duration is estimated to be 2 months, while the study duration is planned to be 4 months. The primary objective of this study is to assess the safety and reactogenicity of PfSPZ Challenge administered by DVI using 7G8 and NF54 P. falciparum strains.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Dose-Dependent Infectivity of Aseptic, Purified, Cryopreserved Plasmodium falciparum 7G8 Sporozoites in Malaria-Naive Adults.
Laurens MB, Berry AA, Travassos MA, Strauss K, et al · · 2019 · cited 26× · PMID 31419294 · DOI 10.1093/infdis/jiz410 -
The Controlled Human Malaria Infection Experience at the University of Maryland.
Friedman-Klabanoff DJ, Laurens MB, Berry AA, Travassos MA, et al · · 2019 · cited 18× · PMID 30675854 · DOI 10.4269/ajtmh.18-0476 -
Immunoprofiles associated with controlled human malaria infection and naturally acquired immunity identify a shared IgA pre-erythrocytic immunoproteome.
Berry AA, Obiero JM, Travassos MA, Ouattara A, et al · · 2021 · cited 6× · PMID 34518543 · DOI 10.1038/s41541-021-00363-y -
Controlled human malaria infection with NF54 and 7G8 strains elicit differential antibody responses to Plasmodium falciparum peptides.
Friedman-Klabanoff DJ, Jensen TL, Lyke KE, Laurens MB, et al · · 2025 · PMID 41030440 · DOI 10.3389/fimmu.2025.1641280
Verify or expand the search:
- PubMed search for NCT02780154
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of PfSPZ (7G8) Challenge
Trials testing the same drug.
- NCT06735209 — First-in-Human PfSPZ-LARC2 Vaccination/CHMI · Phase 1 · active not recruiting
Other National Institute of Allergy and Infectious Diseases (NIAID) trials
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 NCT02780154 (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: 28 January 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/NCT02780154.
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