Clinical trials: sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
HIV
Phase 1 Study of CH505 HIV Vaccine Nanoparticles and mRNA Boosters in Healthy Adults
This Phase 1 study will evaluate the safety, tolerability, and immune responses of investigational CH505 HIV vaccine regimens in adults in overall good health without HIV.
- Trial name
- NCT07757802
- Testing
- DV901-NP, DV902-NP, CH505 TF mRNA-gp160
- Where
- 8 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
WHIM, Warts
Base-Edited Hematopoietic Stem/Progenitor Cell Gene Therapy for Treatment of CXCR4-WHIM
Background: Warts, hypogammaglobulinemia, infections and myelokathexis syndrome (WHIMs) is a rare disorder that affects the immune system. People with WHIMs can have severe infections all over their body.
- Conditions
- WHIM, Warts, Hypogammaglobulinemia, Immunodeficiency
- Trial name
- NCT07775313
- Testing
- Busulfan, Palifermin, Plerixafor
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy Volunteer, Malaria
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Background: Malaria is a serious disease caused by parasites spread by mosquitoes. To better diagnose and treat malaria, researchers need to learn more about where the parasites go when they enter a person's body.
- Trial name
- NCT07859800
- Testing
- 18F-fluorodeoxyglucose-positron emission tomography/computed tomography scan
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Anosmia, Chronic Obstructive Pulmonary Disease
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Background: Exposure to smoke increases the risk of many diseases. People can be exposed to dangerous levels of smoke during wildfires. Also, smoke from fires that burn manmade materials may contain toxic chemicals.
- Conditions
- Anosmia, Chronic Obstructive Pulmonary Disease, Hyposmia, Chronic Rhinosinusitis
- Trial name
- NCT07867184
- Where
- United States
- Volunteers
- 350 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Lyme Disease
A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations
This study will determine whether patients who have been infected with the Lyme bacteria, Borrelia burgdorferi, and treated with antibiotics still have the bacteria alive inside them and whether it is causing their symptoms.
- Trial name
- NCT00001539
- Where
- United States
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
X-linked Severe Combined Immunodeficiency (XSCID)
Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID)
This is a Phase I/II non-randomized clinical trial of ex vivo hematopoietic stem cell (HSC) gene transfer treatment for X-linked severe combined immunodeficiency (XSCID, also known as SCID-X1) using a self-inactivating lentiviral…
- Trial name
- NCT01306019
- Testing
- Ex vivo culture and transduction of the patient's autologous CD34+ HSC with lentivirus vector VSV-G pseudotyped CL20- 4i-EF1alpha-hgammac-OPT vector, Busulfan, Palifermin
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Peanut Allergy
Efficacy of Tezepelumab in Peanut Oral Immunotherapy
The proposed study is a proof-of-concept Phase 2, double-blind, randomized placebo-controlled clinical trial evaluating the safety and efficacy of tezepelumab and peanut Oral Immunotherapy (OIT) for the treatment of peanut…
- Trial name
- ZENITH (NCT07015996)
- Testing
- Tezepelumab, Peanut Oral Immunotherapy (OIT)
- Where
- 10 sites in United States
- Volunteers
- 62 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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)
Mycobacterium Infections
Study of Mycobacterial Infections
This study will examine the symptoms, course of disease and treatment of non-tuberculous mycobacterial (NTM) infections, as well as the genetics involved in these infections.
- Trial name
- NCT00018044
- Testing
- Clofazimine
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy Volunteers
Sample Collection From Healthy Volunteers for Assay Optimization
Background: The Laboratory of Immune System Biology (LISB) works with other labs at the National Institutes of Health. They study how parts of living things come together to make a whole.
- Trial name
- NCT03538600
- Where
- United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Gonorrhoea
Mucosal Immunity Against Neisseria Gonorrhoeae After 4CMenB Vaccination
This is a Phase 2 mechanistic clinical trial to assess the systemic and mucosal immunogenicity of the multicomponent meningococcal serogroup B vaccine (4CMenB or Bexsero (R)) (group 1, 40 subjects) against Neisseria gonorrhoeae…
- Trial name
- NCT04722003
- Testing
- Meningococcal Group B Vaccine
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Autoimmune Disorders
Daratumumab in Primary Antiphospholipid Syndrome
The purpose of this study is to see if the study medication, daratumumab, is safe to treat individuals with Anti-Phospholipid Syndrome (APS).
- Trial name
- DARE-APS (NCT05671757)
- Testing
- Daratumumab
- Where
- 8 sites in United States
- Volunteers
- 22 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Multiple Sclerosis
Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)
Background: In people with multiple sclerosis (MS), brain and cerebrospinal fluid (CSF) biomarkers indicate inflammation or disease. Researchers want to see if 4 drugs given alone or combined affect MS biomarkers.
- Trial name
- NCT03109288
- Testing
- Cilostazol, Leucovorin, Pirfenidone
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV
PREVAIL VIII: A CoHOrt Clinical, Viral, and ImmuNOlogic Monitoring Study of People Living With Retroviral Infection in Liberia (HONOR)
Background: There are many people living with human immunodeficiency virus (HIV) infection in Liberia. Most experts consider HIV an epidemic there.
- Trial name
- NCT03733093
- Where
- 4 sites in Liberia
- Volunteers
- 1,377 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Relapsing Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis
Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)
This is a multi-center prospective rater-masked (blinded) randomized controlled trial of 156 participants, comparing the treatment strategy of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) to the treatment strategy…
- Conditions
- Relapsing Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis
- Trial name
- BEAT-MS (NCT04047628)
- Testing
- Autologous Hematopoietic Stem Cell Transplantation, Best Available Therapy (BAT)
- Where
- 23 sites in United States
- Volunteers
- 156 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV/AIDS, Tuberculosis
Prevent TB: Choice Architecture for TPT Delivery
Background: Clinical guidelines and policies often fail to achieve high levels of delivery of intended clinical interventions. The difference in what the investigators know works and what is actually delivered at the clinic-level…
- Trial name
- NCT04466488
- Testing
- Choice Architecture
- Where
- South Africa
- Volunteers
- 50,798 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
HIV Infections
Testing a Barbershop-based HIV Prevention Initiative Among Men
To test community-based approaches to engage heterosexual men at risk for HIV and specifically to assess the feasibility and acceptability of a barbershop based HIV prevention program.
- Trial name
- TRIM (NCT06148584)
- Testing
- General, status-neutral HIV education, HIV self-test kits, Information about where to receive HIV prevention services
- Where
- Uganda
- Volunteers
- 271 people, healthy volunteers welcome
- Sponsor
- HIV Prevention Trials Network
Influenza Prevention, Pandemic Influenza Prevention
Quadrivalent Influenza HA Stem Vaccine VRC-FLUMOS0122-00-VP (SteMos1) With and Without ALFQ Adjuvant in Healthy Adults
Background: Influenza (flu) is a contagious respiratory illness caused by viruses. Flu symptoms can range from mild to severe, and the illness can be fatal. Vaccines help the body learn to prevent or fight infections such as flu.
- Trial name
- NCT07111078
- Testing
- VRC-FLUMOS0122-00-VP, ALFQ
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Sexually Transmitted Infection (STI), Gonorrhea
A Clinical Study to Assess the Efficacy of Weekly Doxycycline Prophylaxis to Reduce Bacterial Sexually Transmitted Infections (STI) in Young African Women
This study is for people who may get sexually transmitted infections (STIs). Approximately 580 African adolescent and young adult women ages 13-34 in Africa will be included in this study.
- Conditions
- Sexually Transmitted Infection (STI), Gonorrhea, Syphilis, Chlamydia
- Trial name
- NCT07884240
- Testing
- Doxycycline hyclate, Standard of Care for STI prevention
- Where
- 4 sites in Botswana, Eswatini and 2 more
- Volunteers
- 580 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Background: Most people with tuberculosis (TB) feel better after starting treatment. But for some people, the opposite happens. They may feel better at first, but then suddenly get worse. This is a paradoxical reaction.
- Trial name
- NCT04052022
- Where
- 3 sites in United States, Mexico
- Volunteers
- 140 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)