NCT06293339

Durability of Protection After Single Immunisation With GA2 Sporozoites (CoGA-Rechallenge)

Durability of Protection After Single Immunisation With Genetically Attenuated Plasmodium Falciparum ∆mei2 (GA2) Sporozoites - a Follow-up, Controlled Human Malaria Rechallenge Study

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

This study will assess the durability of protection of a single immunisation with the Genetically Attenuated Parasite 2 (GA2) against controlled human malaria infection by rechallenging previously immunised and protected participants from the CoGA study (NCT05468606)

Detailed description

This will be a non-randomised, open-label, controlled human malaria infection study that will consist of two study arms: the rechallenge group and infection controls. The rechallenge group consists of study participants from the CoGA study (phase I) who received single immunisation with GA2 and were protected during subsequent CHMI, while infection controls are newly recruited, malaria-naïve study participants. All participants will undergo CHMI through the bites of 5 mosquitos infected with wild-type 3D7 sporozoites. From day 6 to 21 after CHMI, participants will be followed daily on an out-patient basis to determine parasite loads detected by a quantitative polymerase chain reaction (qPCR). As soon as parasitaemia is detected (cut-off \>100p/mL), or at the latest 28 days after CHMI, participants will be treated with a curative regimen of antimalarials.

Conditions

• Malaria,Falciparum

Interventions

Type	Name	Description
BIOLOGICAL	CHMI with 3D7 malaria	Controlled human malaria infection with 3D7 malaria through mosquito bites

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-07-01
• Completion: 2025-09-30
• First posted: 2024-03-05
• Last updated: 2024-12-27