Clinical trials: Controlled Human Malaria Infection
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
Controlled Human Malaria Infection by Intradermal Injection of Plasmodium Falciparum Sporozoites in Tanzanian Adults
The proposed trial will evaluate whether relatively non immune populations in endemic countries can be effectively infected with aseptic, purified, cryopreserved sporozoites (PfSPZ Challenge) given intradermally.
- Trial name
- NCT01540903
- Testing
- PfSPZ Challenge, Saline
- Where
- Tanzania
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Malaria
Controlled Human Malaria Infection in Semi-Immune Kenyan Adults. (CHMI-SIKA)
The investigators wish to understand how resistance to malaria develops and how this affects the growth rate of malaria in individuals who have past exposure to malaria.
- Trial name
- CHMI-SIKA (NCT02739763)
- Testing
- Plasmodium falciparum sporozoite (PfSPZ)
- Where
- 2 sites in Kenya
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Malaria
A Clinical Trial of the PfSPZ Vaccine Administered by Direct Venous Inoculation in Healthy Malaria-Naïve Adults: Heterologous vs. Homologous Controlled Human Malaria Infection and Reduction in Number of Doses
This is an open-label evaluation of the safety, tolerability immunogenicity and efficacy of the PfSPZ Vaccine administered by Direct Venous Inoculation (DVI) in healthy, malaria-naïve subjects.
- Trial name
- NCT02215707
- Testing
- PfSPZ Vaccine
- Where
- United States
- Volunteers
- 67 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.
Plasmodium Vivax Infection
Vivax Malaria Human Infection Studies in Thailand
This study is a human challenge study to assess the feasibility and safety of controlled human malaria infection (via P. vivax sporozites) in healthy volunteers, and to develop a bank of P.
- Trial name
- MIST1 (NCT04083508)
- Testing
- Mosquito bites
- Where
- Thailand
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- University of Oxford
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
Study of Controlled Human Malaria Infections to Evaluate Protection After Intravenous or Intramuscular Administration of PfSPZ Vaccine in Malaria-Naive Adults
Background: People bitten by mosquitoes carrying weakened malaria parasites could fight off the disease if later exposed to normal malaria parasites.
- Trial name
- NCT02015091
- Testing
- PfSPZ Vaccine
- Where
- 2 sites in United States
- Volunteers
- 141 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Plasmodium Falciparum Infection
A Systems Biology Approach to Malaria Immunity
This is a phase I study that will assess the acquisition of immunity to Pf malaria over the course of 5 sequential Controlled Human Malaria Infections (CHMI) over 2-4 years, in 10 healthy adult participants.
- Trial name
- NCT03014258
- Testing
- NF54 P. falciparum malaria challenge
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Malaria
Evaluation of Reactive Focal Mass Drug Administration (rfMDA) +/- Reactive Focal Vector Control (RAVC) in Namibia
This is a cluster randomised controlled trial with factorial study design comparing the impact of reactive community-based malaria interventions: 1) presumptive treatment (or rfMDA, reactive focal mass drug administration) versus…
- Trial name
- NCT02610400
- Testing
- RACD, RAVC, rfMDA
- Where
- Namibia
- Volunteers
- 9,845 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
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,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
Controlled Human Malaria Infection, Induced Blood Stage Malaria Infection
In-vivo Transmission Model in Semi-immune Adults
Controlled human malaria infection (CHMI) has revolutionized the development of malaria vaccines. It involves the administration of either known numbers of sporozoites or infected erythrocytes to healthy human volunteers under a…
- Conditions
- Controlled Human Malaria Infection, Induced Blood Stage Malaria Infection, Malaria Transmission, Malaria Challenge
- Trial name
- NCT06172686
- Testing
- Piperaquine tablets , which will be administered orally as a single dose of 480mg (320mg+160mg)., Doxycycline (100mg tablets strength as Doxycycline Hyclate) will also be administered orally and will be given as 1 tablet (100mg) Once daily for 7 days.
- Where
- Tanzania
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Ifakara Health Institute
Malaria (Plasmodium Falciparum)
Challenge Trial of PfSPZ-LARC2 Vaccine in Burkina Faso
This is a randomized, double-blind, placebo-controlled, Phase 1 trial of Plasmodium falciparum (Pf) late liver stage-arresting replication-competent (LARC) sporozoite (SPZ) malaria vaccine (Sanaria® PfSPZ-LARC2 Vaccine)…
- Trial name
- BFSPZL3 (NCT07730177)
- Testing
- PfSPZ-LARC2 Vaccine, PfSPZ Challenge, Normal Saline
- Where
- Burkina Faso
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Malaria,Falciparum
To Assess the Safety, Immunogenicity and Efficacy of VLPM01 in Healthy, Malaria-Naïve Volunteers
This study is a proof-of-concept, first in human, Phase I, single center study designed to evaluate the safety, tolerability, immunogenicity and experimental efficacy of VLPM01 in healthy, malaria-naïve adult volunteers.
- Trial name
- NCT03867331
- Testing
- 5 microgram VLPM01, 15 microgram VLPM01, 30 microgram VLPM01
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- VLP Therapeutics
Malaria
First-in-Human PfSPZ-LARC2 Vaccination/CHMI
This randomized, double-blind, placebo-controlled, Phase 1 trial will enroll up to 22 malaria-naïve, adult participants to test safety, tolerability, immunogenicity, and efficacy of the genetically attenuated Plasmodium…
- Trial name
- NCT06735209
- Testing
- PfSPZ Vaccine, PfSPZ (7G8) Challenge, Sodium Chloride, 0.9%
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Malaria, Plasmodium Falciparum
A Study of Blood-stage Controlled Human Plasmodium Falciparum Malaria Infection in Tanzania
This will be a single-centre, open label trial to determine the safety and feasibility of CHMI model using Plasmodium falciparum-infected cryopreserved erythrocytes administered to healthy Tanzanian adults with varying prior…
- Trial name
- NCT04788862
- Testing
- P. falciparum infected erythrocytes
- Where
- Tanzania
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- University of Oxford
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
Malaria
Safety and Protective Efficacy of Genetically Attenuated PfSPZ-GA1 Vaccine in Healthy Dutch Volunteers
This is a first-in-human, randomized clinical trial of PfSPZ-GA1 Vaccine (genetically attenuated PfSPZ) in healthy malaria-naïve adult volunteers. This Phase 1 trial is divided into two stages, Stage A and B.
- Trial name
- NCT03163121
- Testing
- PfSPZ-GA1 Vaccine, PfSPZ Vaccine, Normal Saline
- Where
- 2 sites in Netherlands
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
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