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
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
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, 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
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.
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.
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 (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
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
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, Healthy Participants
A Study of Oral E1018 in Healthy Adult Participants
The primary purpose of the study is to evaluate the safety and tolerability of single ascending oral doses of E1018 in healthy adult participants and to evaluate the pharmacokinetics (PK) of E1018 in plasma and urine after single…
- Trial name
- NCT06854042
- Testing
- E1018
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
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 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
Safety, Tolerability and Immunogenicity of PfSPZ Vaccine in an Age De-escalation Trial in Equatorial Guinea.
This trial will evaluate the safety, tolerability, and immunogenicity of PfSPZ Vaccine in healthy Equatoguinean adults, adolescents, children and infants who receive doses of 0.9x10^6, 1.8x10^6 or 2.7x10^6 PfSPZ Vaccine via…
- Trial name
- NCT02859350
- Testing
- PfSPZ Vaccine, PfSPZ Challenge (for CHMI), Normal Saline
- Where
- Equatorial Guinea
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Malaria
Experimental Human Malaria Infection by PfSPZ
The study is a single center, varied dose, open label study. A maximum of eighteen volunteers will be exposed to live NF54 P. falciparum sporozoites (PfSPZ Challenge) by intradermal injection.
- Trial name
- NCT01086917
- Testing
- PfSPZ Challenge
- Where
- Netherlands
- Volunteers
- 18 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
Optimization of Controlled Human Malarial Infection by Injection of P. 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) by injection.
- Trial name
- NCT01771848
- Testing
- PfSPZ Challenge
- Where
- 2 sites in Spain
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.