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NOT YET RECRUITING
NCT05441410
PHASE1/PHASE2

Comparing Safety and Protective Efficacy of Vaccine Candidate PfSPZ-CVac and MVA ME-TRAP/ ChAd63 ME-TRAP in Adults

Sponsor: University Hospital Tuebingen

View on ClinicalTrials.gov

Summary

This is a single centre, randomized, placebo-controlled phase 1/2 study comparing two malaria vaccine candidates. The first vaccine candidate PfSPZ-CVac (Plasmodium falciparum sporozoites (PfSPZ) challenge administered with a chemoprophylactic antimalarial) will be chemoattenuated in vivo with the antimalarial Pyramax. The second vaccine candidate is prime- target vaccination with viral vectored vaccine candidate regime MVA ME-TRAP (Modified Vaccinia Ankara (MVA) multiple epitope thrombosponin-related adhesion protein (ME-TRAP)) and ChAd63 ME-TRAP (Chimpanzee adenovirus 63 (ChAd63). The safety and protective efficacy of both vaccine candidates will be to assessed by controlled human malaria infection with PfSPZ Challenge strain NF54 administered intravenously by syringe.

Official title: Comparing Safety and Protective Efficacy of the Whole Plasmodium Falciparum Sporozoite Chemoprophylaxis Vaccine Candidate PfSPZ-CVac and Prime- Target Vaccination with Viral Vectored Vaccine Candidate Regime MVA ME-TRAP/ ChAd63 ME-TRAP in Malaria-naïve, Healthy Adult Volunteers in Germany

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-06-01

Completion Date

2026-06-30

Last Updated

2024-12-06

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Pyronaridine Tetraphosphate, Artesunate Drug Combination

Combination drug for treatment of uncomplicated malaria

BIOLOGICAL

PfSPZ Challenge (NF54)

cryopreserved Plasmodium falciparum sporozoites injected by intravenous inoculation

BIOLOGICAL

MVA ME-TRAP

virally vectored subunit vaccine candidates where ME-TRAP is expressed by the non-replicating viral vector Modified Vaccinia Ankara (MVA)

BIOLOGICAL

ChAd63 ME-TRAP

virally vectored subunit vaccine candidates where ME-TRAP is expressed by the non-replicating viral vector Chimpanzee Adenovirus 63 (ChAd63)

BIOLOGICAL

Sodium chloride (NaCl) 0.9%

0.9% NaCl solution for injection