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

NCT05441410 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-12-06

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Sanaria Inc.

    collaborator INDUSTRY

  • University of Oxford

    collaborator OTHER

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Sabine Bélard, Dr. · University Hospital Tuebingen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2026-06-30
Completion
2026-06-30

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Entities

Diseases

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 NCT05441410 on ClinicalTrials.gov