Trials / Not Yet Recruiting
Not Yet RecruitingNCT05441410
Comparing Safety and Protective Efficacy of Vaccine Candidate PfSPZ-CVac and MVA ME-TRAP/ ChAd63 ME-TRAP in Adults
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
- Status
- Not Yet Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- University Hospital Tuebingen · Academic / Other
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2025-06-01
- Primary completion
- 2026-06-30
- Completion
- 2026-06-30
- First posted
- 2022-07-01
- Last updated
- 2024-12-06
Source: ClinicalTrials.gov record NCT05441410. Inclusion in this directory is not an endorsement.