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Safety and Preliminary Protective Efficacy of Genetically Attenuated GA2 Parasites.

NCT04577066 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2023-01-13

No results posted yet for this study

Summary

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.

Conditions

  • Plasmodium Falciparum Malaria

Interventions

OTHER

GA2

15 volunteers will receive 50 GA2-infected mosquito bites. The GA2 parasite is a new genetically attenuated Plasmodium falciparum parasite, which arrests development in the liver and should not be able to cause malaria in humans.

OTHER

GA1

10 volunteers will receive 50 GA1-infected mosquito bites. The GA1 parasite is a genetically attenuated Plasmodium falciparum parasite, which arrests development in the liver and is not able to cause malaria in humans.

OTHER

Placebo

5 volunteers will receive 50 uninfected mosquito bites.

Sponsors & Collaborators

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Meta Roestenberg, MD, PhD, Prof. · Leiden University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-27
Primary Completion
2022-05-30
Completion
2022-12-22

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04577066 on ClinicalTrials.gov