NCT04577066 is a Phase 1, PHASE2 clinical trial of GA2 in Plasmodium Falciparum Malaria, sponsored by Leiden University Medical Center.

Who is sponsoring NCT04577066?

NCT04577066 is sponsored by Leiden University Medical Center.

What drugs are being tested in NCT04577066?

Interventions in NCT04577066: GA2, GA1, Placebo.

What condition does NCT04577066 study?

NCT04577066 studies Plasmodium Falciparum Malaria.

Is NCT04577066 still recruiting?

NCT04577066 is currently completed. Last updated 13 January 2023.

Last reviewed 2023-01-13 · How we verify

NCT04577066

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Preliminary Protective Efficacy of Genetically Attenuated GA2 Parasites.

Completed Phase 1, PHASE2 Last updated 13 January 2023

What this trial tests

Phase 1, PHASE2 trial testing GA2 in Plasmodium Falciparum Malaria in 43 participants. Completed in 22 December 2022.

Timeline

27 September 2021

Primary endpoint
30 May 2022

22 December 2022

Quick facts

Lead sponsor	Leiden University Medical Center
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	43
Start date	27 September 2021
Primary completion	30 May 2022
Estimated completion	22 December 2022
Sites	1 location across Netherlands

Drugs / interventions tested

GA2 — full drug profile →
GA1
Placebo

Conditions studied

Plasmodium Falciparum Malaria — all drugs for Plasmodium Falciparum Malaria →

Sponsor

Leiden University Medical Center

Who can join

Adults 18 to 35, any sex, with Plasmodium Falciparum Malaria. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will consist of two phases and be aimed at assessing the safety and tolerability of the new genetically attenuated GA2 malaria parasite (Phase 1) and its preliminary protective efficacy against controlled human malaria infection (Phase 2) in healthy Dutch volunteers.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Safety and Efficacy of Immunization with a Late-Liver-Stage Attenuated Malaria Parasite.
Lamers OAC, Franke-Fayard BMD, Koopman JPR, Roozen GVT, et al · · 2024 · cited 33× · PMID 39565990 · DOI 10.1056/nejmoa2313892
Five decades of clinical assessment of whole-sporozoite malaria vaccines.
Nunes-Cabaço H, Moita D, Prudêncio M. · · 2022 · cited 30× · PMID 36159849 · DOI 10.3389/fimmu.2022.977472
Correlative humoral and cellular immunity to genetically attenuated malaria parasites in humans.
Colstrup E, Nakajima R, Krol JMM, Lamers OAC, et al · · 2025 · cited 6× · PMID 40487438 · DOI 10.1016/j.isci.2025.112589
Whole sporozoite immunization with Plasmodium falciparum strain NF135 in a randomized trial.
van der Boor SC, Alkema M, van Gemert GJ, Teelen K, et al · · 2023 · cited 5× · PMID 37024868 · DOI 10.1186/s12916-023-02788-9

Verify or expand the search:

Other recruiting trials for Plasmodium Falciparum Malaria

Currently open trials in the same condition.

NCT06068530 — Mass Vaccine and Drug Administration, Bangladesh · Phase 4 · recruiting

Other Leiden University Medical Center trials

Trials by the same sponsor.

NCT07312565 — Occurrence of Abdominal Aortic Aneurysms in Patients With Aneurysmal Subarachnoid Hemorrhage · not yet recruiting
NCT07090343 — Semaglutide in Patients Undergoing Transcatether Aortic Valve Replacement · Phase 3 · not yet recruiting
NCT07498738 — Making Diabetes Care Fit for Young Adults Living With Type 1 Diabetes: Observations, Reflections and Expert Opinions · NA · not yet recruiting
NCT06545292 — Microsampling for Therapeutic Drug Monitoring of Oral Oncolytics in Oncology Patients · NA · recruiting
NCT07021495 — SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY) · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04577066 (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 Leiden University Medical Center
Last refreshed: 13 January 2023

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/NCT04577066.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing