Clinical trials: Human Challenge Trial
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
Dengue
ADVP005; Dengue CVD 12000 - Dengue-1-Virus Live Virus Human Challenge (DENV-1-LVHC)
The purpose of this research study is to test the protection of volunteers previously vaccinated with Tetravalent Dengue Virus (TDEN) Purified Inactivated Vaccine (PIV) with alum and boosted with TDEN live attenuated vaccine…
- Trial name
- NCT04786457
- Testing
- Dengue 1 Live Virus Human Challenge (DENV-1-LVHC)
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
Streptococcal Pharyngitis
Stopping Strep Throat With Antibodies in Healthy Adults.
This research group has previously established a safe and reliable model of experimental human streptococcal pharyngitis (a 'strep throat' human challenge model).
- Trial name
- CHIVAS-IgG (NCT07864350)
- Testing
- Streptococcus pyogenes M1 challenge strain, Intravenous immunoglobulin (IVIG)
- Where
- Australia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Murdoch Childrens Research Institute
Celiac Disease
VTP-1000 in Adults With Celiac Disease
GLU001 is a first-in-human clinical trial to assess the safety and tolerability of VTP-1000 for adults with celiac disease. This trial will assess VTP-1000 at various dose levels compared to placebo in a single ascending dose…
- Trial name
- NCT06310291
- Testing
- VTP-1000
- Where
- 16 sites in United States
- Volunteers
- 45 people
- Sponsor
- Barinthus Biotherapeutics
Tuberculosis
Aerosol BCG Challenge Trial in Healthy UK Adults
TB041 is a clinical challenge trial primarily to evaluate the safety of BCG challenge administered by the aerosol inhaled route in healthy, BCG naive UK adults.
- Trial name
- NCT02709278
- Testing
- BCG
- Where
- 3 sites in United Kingdom
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Allergic Rhinitis
OC000459 Dose Finding Study in Hay Fever Sufferers.
The primary objective of this study is to evaluate a range of dose levels for efficacy in the control of symptoms of allergic rhinitis
- Trial name
- NCT00697281
- Testing
- OC000459
- Where
- Austria
- Volunteers
- 120 people
- Sponsor
- Oxagen Ltd
Pertussis (Whooping Cough)
Establishing a Controlled Human Infection Model of Pertactin-deficient Bordetella Pertussis
The overall goal of this study is to establish a PRN-deficient pertussis Controlled Human Infection Model (CHIM) that represents currently circulating isolates, in the context of a North American exposure (vaccination and…
- Trial name
- NCT06827470
- Testing
- Biological: Bordetella pertussis J820
- Where
- Canada
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Dalhousie University
Tuberculosis
Phase I Open Label BCG Clinical Trial Assessing TB Drugs and Vaccines
The purpose of the study is to develop a BCG challenge model for use in short term Phase I human trials capable of assessing the ability of TB drugs and/or vaccine-induced immune responses to impact in vivo mycobacterial…
- Trial name
- NCT05592223
- Testing
- BCG Vaccine USP, Isoniazid, Rifampin
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Fred Hutchinson Cancer Center
COPD Exacerbation Acute, COPD With Acute Lower Respiratory Infection
RCT of Vapendavir in Patients With COPD and Human Rhinovirus/Enterovirus Upper Respiratory Infection
Vapendavir (VPV) is a drug being developed to treat human rhinovirus (RV) infection, one virus responsible for the common cold. Vapendavir prevents the virus from entering cells and making more infectious copies of itself.
- Conditions
- COPD Exacerbation Acute, COPD With Acute Lower Respiratory Infection, Rhinovirus, Virus Diseases
- Trial name
- NCT06149494
- Testing
- Vapendavir
- Where
- United Kingdom
- Volunteers
- 52 people
- Sponsor
- Altesa Biosciences, Inc.
Healthy
Infectivity of Norovirus in Shellfish Treated With High Hydrostatic Pressure Processing-Human Challenge Study
Norwalk virus and related "Norwalk-like viruses" are the most common cause of outbreaks of stomach sickness (nausea, vomiting, diarrhea) in older children and adults in the United States.
- Trial name
- Shellfish (NCT00674336)
- Testing
- High Hydrostatic Pressure Processing
- Where
- United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Emory University
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)
Plasmodium Vivax Malaria
Clinical Trial for the Development of a Safe Malaria Challenge Model That Can be Reproduced in Humans
The purpose of this study is to demonstrate that volunteers can be safely and reproducibly infected with Plasmodium vivax (P. vivax) by the bites of experimentally infected Anopheles dirus (An. dirus) mosquitoes carrying P.
- Trial name
- Pvivax (NCT00935623)
- Testing
- Malaria Challenge
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
HIV, Hypertension
INTEGRATE-RX: Integrating Clinical Pharmacists in HIV Care to Mitigate Last-Mile Challenges and Reduce Cardiovascular Disease Burden
The risk of heart attacks and stroke is two times higher among people living with HIV (PLWH), as compared to the general population.
- Conditions
- HIV, Hypertension, Cardiovascular Disease Prevention
- Trial name
- INTEGRATE-RX (NCT07711366)
- Testing
- INTEGRATE-RX
- Where
- 2 sites in Kenya
- Volunteers
- 450 people
- Sponsor
- Temple University
Tuberculosis
ID93/GLA-SE Vaccination + BCG Challenge
The purpose of this study is to: 1. Demonstrate the safety of a novel TB vaccine (ID93/GLA-SE) when given to both BCG-vaccinated and BCG-naïve volunteers. 2.
- Trial name
- NCT06670755
- Testing
- ID93/GLA-SE, BCG Danish
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Healthy Volunteers, Dengue
Phase 1 Challenge Study Using rDEN2delta30-7169 to Evaluate Host-Pathogen Interactions in Primary, Homotypic, and Heterotypic Dengue Virus Infection
Background: Dengue is a viral disease spread by mosquitoes. Most people bitten by mosquitoes carrying dengue viruses do not get sick, but severe cases can cause shock, internal bleeding, and death.
- Conditions
- Healthy Volunteers, Dengue, Human Challenge Trial
- Trial name
- NCT07706686
- Testing
- rDEN2delta30-7169
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Streptococcus Pneumonia
PREVENTING PNEUMOcoccal Disease Through Vaccination (Study 2)
To determine the effect of PCV-13 and PPV-23 vaccination versus control on experimental pneumococcal colonisation of 2 clades of serotypes 3 and 6B at 1 month and 6 months post vaccination respectively, using the EHPC model.
- Trial name
- Pneumo 2 (NCT04974294)
- Testing
- PPV23, PCV13, Saline for injection
- Where
- United Kingdom
- Volunteers
- 516 people, healthy volunteers welcome
- Sponsor
- Liverpool School of Tropical Medicine
Dengue
An Evaluation of Repeated Oral Doses of JNJ-64281802 Against DENV-3 Challenge
The investigational study drug, JNJ-64281802, is being developed for the prevention and treatment of dengue infection. This study is hypothesizing that the highest dose of the investigational study drug is superior to receiving a…
- Trial name
- NCT05048875
- Testing
- Cohort 1 - Group 1 JNJ High Dose, Cohort 1 - Group 2 JNJ Medium Dose, Cohort 1 - Group 2 JNJ Low Dose
- Where
- 2 sites in United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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)
Healthy
Infectivity of Norovirus in Groundwater-Human Challenge Study
Norwalk virus and related "Norwalk-like viruses" are the most common cause of outbreaks of stomach sickness (nausea, vomiting, diarrhea) in older children and adults in the United States.
- Trial name
- NCT00313404
- Testing
- Safety tested norovirus inoculum
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Emory University
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.