Clinical trials: Controlled Human Malaria Infection
Malaria
Trial to Evaluate L9LS in Healthy Adults
Background: Malaria is a parasitic disease carried by mosquitoes in tropical areas. There is no vaccine to prevent malaria infection. If not treated right away, it can become serious or deadly.
- Trial name
- VRC 614 (NCT05019729)
- Testing
- VRC-MALMAB0114-00-AB, Plasmodium falciparum (P. falciparum) sporozoite challenge
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Malaria
Trial to Evaluate CIS43LS in Healthy Adults
Background: People get malaria when they are bitten by an infected mosquito. Malaria can be serious and sometimes deadly. Although there are medicines to treat malaria, there is no vaccine that fully prevents infection.
- Trial name
- NCT04206332
- Testing
- VRC-MALMAB0100-00-AB, Plasmodium falciparum (P. falciparum) sporozoite challenge
- Where
- 2 sites in United States
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Plasmodium Falciparum Infection, Malaria
L9LS MAb in Malian Adults
The purpose of this study is to evaluate the safety and tolerability of a one time SC administration of L9LS in healthy adults in Mali, as well as its protective efficacy against naturally occurring Plasmodium falciparum (Pf)…
- Trial name
- NCT05816330
- Testing
- L9LS (VRC-MALMAB0114-00-AB)
- Where
- 3 sites in Mali
- Volunteers
- 490 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Plasmodium Falciparum, Malaria
DSM265 Chemoprophylaxis of Plasmodium Falciparum Malaria
Study to evaluate the efficacy of DSM265 as a causal prophylactic in a standardized and validated Human Challenge model using direct venous inoculation of aseptic, purified, cryopreserved, vialed Plasmodium falciparum sporozoites.
- Trial name
- NCT02450578
- Testing
- DSM265 400mg, Plasmodium falciparum sporozoite challenge, Malarone
- Where
- Germany
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Healthy
First-in-Human Trial of Single Ascending Dose, Multiple Ascending Dose and Malaria Challenge Model in Healthy Participants
The primary purpose of this study was to investigate the safety and tolerability of M5717 and to characterize the Pharmacokinetics (PK) /Pharmacodynamic relationship between M5717 PK and parasite clearance in healthy participants…
- Trial name
- NCT03261401
- Testing
- M5717
- Where
- Australia
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Malaria,Falciparum, Gametocytes
Controlled Human Malaria Infection Model for Evaluation of Transmission-blocking Interventions - Study 2
This is a single-center, open label study. The primary aim of this project is to develop a controlled human malaria infection transmission model ("CHMI-trans") or "challenge model" to evaluate the capacity of vaccines, biologics…
- Conditions
- Malaria,Falciparum, Gametocytes, Controlled Human Malaria Infection, Transmission
- Trial name
- CHMI-trans2 (NCT03454048)
- Testing
- Piperaquine (low dose), Piperaquine (high dose), Sulfadoxine pyrimethamine
- Where
- Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Malaria,Falciparum, Plasmodium Falciparum
Safety and Protective Efficacy of Pb(PfCS@UIS4)
In the underlying study, a genetically modified P. berghei parasite is used. P. berghei is one of the four Plasmodium species that causes malaria in rodents. The hypothesis is that immunization of humans with P.
- Conditions
- Malaria,Falciparum, Plasmodium Falciparum, Plasmodium Berghei, Controlled Human Malaria Infection (CHMI)
- Trial name
- PbVac (NCT03138096)
- Testing
- Pb(PfCS@UIS4)-infected mosquitoes, Challenge infection P. falciparum
- Where
- 2 sites in Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Malaria,Falciparum, Controlled Human Malaria Infection
Safety and Efficacy of NF135 CPS Immunization
This is an open label, randomized, controlled clinical trial. The primary aim of this project is to determine the safety and tolerability of NF135.C10 sporozoite immunization under chemoprophylaxis against homologous and…
- Conditions
- Malaria,Falciparum, Controlled Human Malaria Infection, Immunization; Infection
- Trial name
- CPS135 (NCT03813108)
- Testing
- CPS-immunization, malaria challenge infection, P. falciparum NF135.C10, malaria challenge infection, P. falciparum NF54
- Where
- Netherlands
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Malaria, Malaria,Falciparum
A Phase 1 Trial of PfSPZ Vaccine in Healthy Adults to Determine Safety, Tolerability and Efficacy Against Heterologous CHMI
USSPZV7 is a randomized, phase 1, double-blind, placebo-controlled trial of Sanaria® PfSPZ Vaccine administered on Days 1, 8 and 29 by direct venous inoculation (DVI) to assess safety, tolerability, immunogenicity, and vaccine…
- Trial name
- NCT05604521
- Testing
- PfSPZ Vaccine, PfSPZ Challenge (7G8), Normal Saline
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Malaria
A Clinical Trial to Evaluate the Safety, Efficacy and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria
This was a randomized, dose-escalation Phase I/IIa study to evaluate safety, tolerability, immunogenicity and efficacy of an investigational RNA-based vaccine (BNT165e) for prevention of P.
- Trial name
- NCT06069544
- Testing
- BNT165c, BNT165d
- Where
- 5 sites in United States
- Volunteers
- 163 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Malaria,Falciparum
Evaluate the Infectivity Equivalence of Current and New Lots of Plasmodium Falciparum Strain NF54
Objectives: Primary: To characterize the infectivity of the new lot of Plasmodium falciparum strain 3D7 within the standard WRAIR CHMI model as compared to the current lot (historical data) Secondary: To assess safety of the new…
- Trial name
- NCT03882528
- Testing
- Plasmodium falciparum malaria parasite
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Malaria
Safety, Tolerability, Pharmacokinetics and Protective Efficacy of MAM01 in Healthy Adults
This is a First-in-Human (FiH), randomized, two-part, dose-escalation trial of MAM01 monoclonal antibody (mAb) targeting the Plasmodium falciparum (Pf) Circumsporozoite Protein (CSP).
- Trial name
- NCT05891236
- Testing
- MAM01 1.5 mg/kg, MAM01 5 mg/kg, MAM01 10 mg/kg
- Where
- United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Gates Medical Research Institute
Malaria
Efficacy, Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine Evaluating Different Dose Schedules in a Sporozoite Challenge Model in Healthy Malaria-naïve Adults
This study is designed to evaluate efficacy, immunogenicity and safety of various dose schedules of GSK Biologicals' candidate malaria vaccines RTS,S/AS01B (adult formulation) and RTS,S/AS01E (pediatric formulation) in healthy…
- Trial name
- NCT03162614
- Testing
- RTS,S/AS01E, RTS,S/AS01B, Sporozoite-infected mosquitoes challenge.
- Where
- United States
- Volunteers
- 154 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
Safety, Tolerability and Chemoprotective Activity of P218 in PfSPZ Challenge Model
This was a single centre, randomised, double-blind, placebo-controlled Phase Ib study, to evaluate the safety, tolerability and chemoprotective activity of P218 in a controlled P. falciparum sporozoite infection model.
- Trial name
- NCT03707041
- Testing
- P218 (1000 mg) Oral Capsules, P218 (100 mg) Oral Capsules, PfSPZ Challenge
- Where
- Belgium
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Malaria, Plasmodium Falciparum
Optimisation of Controlled Human Malaria Infection Using Sporozoites Administered by Needle and Syringe
This is an open label, human pilot study to optimise controlled human malaria infection (CHMI) administered by Plasmodium falciparum sporozoites (PfSPZ. Volunteers will be inoculated with PfSPZ Challenge.
- Trial name
- NCT01465048
- Testing
- Plasmodium falciparum sporozoites 2sites, Plasmodium falciparum sporozoites 1 site, Plasmodium falciparum sporozoites 1site
- Where
- United Kingdom
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Malaria, Vivax
VAC069: A Study of Blood-stage Controlled Human P. Vivax Infection
This is a clinical study to assess the safety and feasibility of Plasmodium vivax (P. vivax) controlled blood-stage human malaria infection (CHMI), by inoculation using a newly created source of P. vivax malaria-infected blood.
- Trial name
- NCT03797989
- Testing
- P. vivax infected inoculum (parasitised red blood cells)
- Where
- United Kingdom
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Plasmodium Falciparum Infection, Malaria
Anti-malaria MAb in Kenyan Children
The purpose of this study is to evaluate the safety and tolerability of one-time subcutaneous (SC) administration of monoclonal antibody (MAb) L9LS in healthy Kenyan children aged 5 months to 10 years, as well as the protective…
- Trial name
- NCT05400655
- Testing
- L9LS
- Where
- Kenya
- Volunteers
- 912 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)