Clinical trials: Controlled Human Malaria Infection
Malaria
A Study to Evaluate Antimalarial Activity and Safety of MK-7602 in Healthy Adults (MK-7602-003)
The purpose of this study is to assess the antimalarial activity, pharmacokinetics, and safety of MK-7602 in healthy adults following Plasmodium falciparum (P. falciparum) infection.
- Trial name
- NCT06294912
- Testing
- Plasmodium falciparum, MK-7602, Artemether/lumefantrine
- Where
- Australia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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
Controlled Human Malarial Infection by Intravenous Injection of Plasmodium Falciparum Sporozoites in Non-Immune Adults
The study is designed to establish the best dose to safely infect healthy individuals with Plasmodium falciparum sporozoites (PfSPZ) via intravenous (IV) injection.
- Trial name
- NCT01624961
- Testing
- PfSPZ Challenge
- Where
- Germany
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Malaria
Sequential Optimization of Dose and Schedule of PfSPZ Vaccine
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…
- Trial name
- NCT02704533
- Testing
- PfSPZ Vaccine, PfSPZ Challenge (NF54), PfSPZ Challenge (7G8)
- Where
- Germany
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Malaria, Plasmodium Falciparum Malaria
Dose Escalation, Randomized Controlled Trial to Evaluate the Safety, Immunogenicity and Efficacy of Intravenously Administered Attenuated Plasmodium Falciparum Sporozoite Vaccine (PfSPZ Vaccine) in Tanzanian Adults
This trial will evaluate whether relatively non-immune populations in endemic countries can effectively generate significant cellular and humoral immune responses that confer protection against P.
- Trial name
- NCT02132299
- Testing
- PfSPZ Vaccine, PfSPZ Challenge
- Where
- Tanzania
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
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)
Vaccine Reaction
A Trial For The Study of Falciparum Malaria Protein 014 Administered Via Intramuscular Injection in Healthy Adults
A Phase 1, open label clinical study to evaluate the safety, immunogenicity, tolerability and efficacy of Plasmodium falciparum Malaria Protein 014 (FMP014) combined with (ALF with QS-21), saponin molecule derived from the bark…
- Trial name
- NCT04296279
- Testing
- FMP014, ALFQ
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Malaria
Safety, Tolerability and Efficacy of PfSPZ Vaccine Against Heterologous CHMI in US Malaria naïve Adults
This is a randomized, double blind, placebo-controlled, single site, trial of a condensed regimen of PfSPZ Vaccine administered on Days 1, 8 and 29 by direct venous inoculation (DVI) to assess safety, tolerability, immunogenicity…
- Trial name
- NCT04966871
- Testing
- PfSPZ Vaccine, PfSPZ Challenge (7G8) for CHMI, Normal Saline
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Malaria Falciparum
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
This is a randomized, double-blind, placebo-controlled Phase 1 trial of Plasmodium falciparum (Pf) sporozoite (SPZ) late-arresting replication-competent (LARC) malaria vaccine (PfSPZ-LARC2 Vaccine) administered to healthy…
- Trial name
- LARC-Tu (NCT06862453)
- Testing
- PfSPZ-LARC2 Vaccine, PfSPZ Challenge (NF54)
- Where
- Germany
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Malaria
Screening of Healthy Volunteers for Investigational Antimalarial Drugs, Malaria Vaccines, and Controlled Human Malaria Challenge
Background: Malaria is a serious infection caused by a parasite. People get malaria when an infected mosquito bites them. Malaria can cause major health and social problems in places were malaria is common, such as Africa but can…
- Trial name
- NCT02639299
- Where
- United States
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Malaria, Falciparum
A Study to Investigate the Safety of GSK4024484 in Healthy Adult Participants
The primary purpose of the study is to characterise the safety of GSK4024484 in healthy participants within a controlled pharmacokinetic (PK) range, and the effect of food on the study intervention.
- Trial name
- NCT06171113
- Testing
- GSK4024484C
- Where
- United Kingdom
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
Phase 1 Clinical Trial With Controlled Human Malaria Infection (CHMI) to Evaluate the Safety and Efficacy of the Plasmodium Falciparum Vaccine Candidate FMP012 Administered Intramuscularly With AS01B Adjuvant System in Healthy Malaria-Naïve Adults
The proposed study is a Phase 1 study with controlled human malaria infection (CHMI) designed primarily to evaluate the safety of the FMP012 combined with AS01B adjuvant system.
- Trial name
- NCT02174978
- Testing
- FMP012 with AS01B adjuvant system, P falciparum Controlled Human Malaria Infection (CHMI)
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Malaria,Falciparum
Controlled Human Malaria Infection Transmission Model - Phase A
This is to develop a model to test the efficacy of vaccines and/or drugs designed to block transmission of malaria to mosquitoes and to identify the targets of transmission-blocking immunity to malaria.
- Trial name
- CHMI-TransMod (NCT04280692)
- Testing
- PfSPZ Challenge, Sulfadoxine-Pyrimethamine, Piperaquine
- Where
- Kenya
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Malaria
Controlled Human Malaria Infection Model for Evaluation of Transmission-Blocking Interventions - Study 1
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…
- Trial name
- CHMI-trans1 (NCT02836002)
- Testing
- Sulfadoxine-pyrimethamine (low dose), Piperaquine (low dose), Sulfadoxine-pyrimethamine (high dose)
- Where
- Netherlands
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
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)
Malaria
PfSPZ Vaccine: Dose Optimization With Heterologous Challenge in Healthy Malaria-Naïve Adults
This is an open-label evaluation of the safety, tolerability, immunogenicity and efficacy of PfSPZ Vaccine administered by direct venous inoculation (DVI) in healthy, malaria-naïve adult subjects.
- Trial name
- NCT02601716
- Testing
- PfSPZ Vaccine, CHMI (7G8), CHMI (NF135.C10)
- Where
- 2 sites in United States
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
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
Malaria, Plasmodium Falciparum
Controlled Human Malaria Infection (CHMI) After Immunization With Cryopreserved Plasmodium Falciparum Sporozoites Under Chloroquine Prophylaxis
The purpose of the study is to determine the safety and tolerability of ID administration of PfSPZ Challenge to volunteers taking chloroquine chemoprophylaxis (an approach called PfSPZ-CVac).
- Trial name
- NCT01728701
- Testing
- PfSPZ Challenge, Normal Saline (NS)
- Where
- Netherlands
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Malaria
Chloroquine (CQ) and Azithromycin (AZ) Combination for Malaria Prophylaxis
This is an open label, Phase 2 study with controlled human malaria infection (CHMI). Twenty three subjects will be enrolled into 2 groups (15 subjects in the Chloroquine-Azithromycin [CQ/AZ] Intervention Group, and 8 subjects in…
- Trial name
- NCT03278808
- Testing
- Chloroquine-Azithromycin (CQ/AZ), Chloroquine (CQ), atovaquone-proguanil (Malarone®)
- Where
- 2 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
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