Malaria Clinical Trial
Official title:
Sequential Optimization of Dose and Schedule of PfSPZ Vaccine, Verified by Randomized, Controlled, Double-blind Immunization and Controlled Human Malaria Infection in Malaria-naïve, Healthy Adult Volunteers in Germany
MAVACHE is a sequential dose and schedule optimization trial of intravenous immunization with
PfSPZ Vaccine in 18 to 54 malaria-naïve, healthy adult volunteers receiving 9x10^5,
1.35x10^6, or 2.7x10^6 PfSPZ per dose and a total dose between 2.7x10^6 and 8.1x10^6 PfSPZ
followed by CHMI with 3,200 fully infectious PfSPZ (PfSPZ Challenge).
PfSPZ Challenge (7G8) to assess vaccine efficacy, safety, tolerability and infectivity of
ascending PfSPZ doses will be assessed in healthy, malaria-naïve volunteers.
The study is to take place at Institut für Tropenmedizin, Eberhard Karls Universität
Tübingen, Tübingen Germany.
The study has two phases: 1) dose optimization, and 2) regimen verification. In the first
phase groups A, B1, B2, C1, C2 and C3 will be vaccinated sequentially in a pre-specified
order, followed by homologous CHMI with 3,200 PfSPZ Challenge (NF54) three weeks after last
vaccine injection.
Dose optimization phase A: 9x10^5 PfSPZ on Days 0, 7 and 28 (n = 6) B1: 1.35x10^6 PfSPZ on
Days 0 and 7 (n = 6) B2: 1.35x10^6 PfSPZ on Days 0, 7, and 28 (n = 6) C1: 2.7x10^6 PfSPZ on
Day 0 (n = 6) C2: 2.7x10^6 PfSPZ on Day 0 and 7 (n = 6) C3: 2.7x10^6 PfSPZ on Days 0, 7 and
28 (n = 6)
In parallel to CHMI with PfSPZ Challenge (NF54) during the optimization phase, a total of
nine volunteers will receive either 800, 1,600 or 3,200 PfSPZ Challenge (7G8) (PfSPZ
Challenge (7G8) dose finding) to assess safety, tolerability and infectivity of PfSPZ
Challenge (7G8) in malaria-naïve healthy adult volunteers.
PfSPZ Challenge (7G8) dose finding/infection D1: 800 PfSPZ (n = 3) D2: 1,600 PfSPZ (n = 3)
D3: 3,200 PfSPZ (n = 3)
Subsequently, the shortest efficacious regimen (V1) and a three-dose regimen (Day 0, 7 and
28) of the highest safe dose (V2) will be selected and verified against placebo (normal
saline (NS)). Groups V1 and V2 will be vaccinated at approximately the same time and undergo
repeat CHMI three and eight weeks after the last immunization. Volunteers will either receive
PfSPZ Vaccine or NS as placebo. Allocation will be random and double blind. Repeat CHMI will
be done with PfSPZ Challenge (NF54) and PfSPZ Challenge (7G8), given in a randomized
sequence. All immunizations are given by direct venous inoculation (DVI).
Regimen verification phase V1: Shortest efficacious regimen (n = 12) against placebo (n = 6)
V2: Maximum regimen (n = 12) against placebo (n = 6) P1: Placebo for V1 group (n=6) P2
Placebo for V2 group (n=6)
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04601714 -
Baseline Cohort Malaria Morbidity Study
|
||
Withdrawn |
NCT04020653 -
A Study to Assess the Safety and Efficacy of 5-aminolevulinic Acid Hydrochloride (5-ALA HCl) and Sodium Ferrous Citrate (SFC) Added on Artemisinin-based Combination Therapy (ACT) in Adult Patients With Uncomplicated Malaria
|
Phase 2 | |
Terminated |
NCT04368910 -
Safety and Efficacy of Pyronaridine Artesunate Vs Chloroquine in Children and Adult Patients With Acute Vivax Malaria
|
Phase 3 | |
Completed |
NCT03641339 -
Defining Skin Immunity of a Bite of Key Insect Vectors in Humans
|
N/A | |
Completed |
NCT02544048 -
Markers of T Cell Suppression: Antimalarial Treatment and Vaccine Responses in Healthy Malian Adults
|
||
Completed |
NCT00527163 -
Role of Nitric Oxide in Malaria
|
||
Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
Active, not recruiting |
NCT04704674 -
Community Dynamics of Malaria Transmission in Humans and Mosquitoes in Fleh-la and Marshansue, Salala District, Bong County, Liberia
|
||
Completed |
NCT03276962 -
Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age
|
Phase 2 | |
Completed |
NCT04966871 -
Safety, Tolerability and Efficacy of PfSPZ Vaccine Against Heterologous CHMI in US Malaria naïve Adults
|
Phase 1 | |
Completed |
NCT00289185 -
Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine in Tanzanian Infants
|
Phase 2 | |
Recruiting |
NCT03937817 -
Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants
|
||
Active, not recruiting |
NCT06153862 -
Africa Ready Malaria Screening
|
N/A | |
Completed |
NCT04545905 -
Antenatal Care as a Platform for Malaria Surveillance: Utilizing Community Prevalence Measures From the New Nets Project to Validate ANC Surveillance of Malaria in Burkina Faso
|
||
Recruiting |
NCT06278181 -
Diabetes, Metabolic Syndrome and Risk of Malaria in Cameroon
|
||
Withdrawn |
NCT02793388 -
A Trial on Supervised Primaquine Use in Ethiopia
|
Phase 4 | |
Completed |
NCT02909712 -
Cardiac Safety of Dihydroartemisinin-Piperaquine Amongst Pregnant Women in Tanzania
|
Phase 2 | |
Completed |
NCT02793622 -
Prevention of Malaria in HIV-uninfected Pregnant Women and Infants
|
Phase 3 | |
Withdrawn |
NCT02793414 -
Diagnostic Utility of Volatile Organic Compounds in Human Breath for Acute Clinical Malaria in Ethiopia
|
||
Completed |
NCT02527005 -
A Comparative Study of Azithromycin and S-P as Prophylaxis in Pregnant HIV+ Patients
|
Phase 1 |