Clinical trials: sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Atopy, Primary Immunodeficiency
NIAID Centralized Sequencing Protocol
Background: Genetic testing called "sequencing" helps researchers look at DNA. Genes are made of DNA and are the instructions for our bodies to function. We all have thousands of genes.
- Conditions
- Atopy, Primary Immunodeficiency, Autoimmunity, Autoinflammation
- Trial name
- NCT03206099
- Where
- 2 sites in United States
- Volunteers
- 20,000 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy Volunteer Samples
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Background: The HIV research program is part of the National Institute of Allergy and Infectious Diseases. The program aims to learn more about HIV. It also aims to improve the health of people with HIV and create HIV vaccines.
- Trial name
- NCT03895645
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Highly Sensitized Prospective Kidney Transplant Recipients
Daratumumab and Belatacept for Desensitization
Some kidney transplant candidates have a very low chance of getting a kidney transplant because their immune systems are "highly sensitized" to most kidney donors.
- Trial name
- ATTAIN (NCT04827979)
- Testing
- daratumumab, belatacept, Bone marrow aspiration
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Group A Streptococcal Infection
CandyCollect Strep Throat Testing
This study will enroll children ages 5-17 who test positive for Group A Streptococcus (GAS) at a single clinic visit lasting approximately 30-60 minutes.
- Trial name
- NCT05175196
- Testing
- CandyCollect, Lollipop Swab
- Where
- United States
- Volunteers
- 210 people
- Sponsor
- University of Wisconsin, Madison
Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), Alopecia Areata
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
Background: Autoimmune polyendocrinopathy candidiasis ectodermal dystrophy (APECED) is a problem of the immune system. In people with APECED, the immune system makes a mistake and attacks the body.
- Trial name
- NCT05398809
- Testing
- Ruxolitinib
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Malaria, Cerebral
DON in Pediatric Cerebral Malaria
The goal of this clinical trial is to evaluate the safety of a single intravenous dose of DON in healthy adults, adults with uncomplicated malaria, and children 12 months-14 years old with clinically defined Cerebral Malaria.
- Trial name
- NCT05478720
- Testing
- 6-diazo-5-oxo-L-norleucine (DON)
- Where
- 2 sites in Malawi
- Volunteers
- 152 people
- Sponsor
- Douglas Postels, MD, MS
Kidney Transplant
Advancing Transplantation Outcomes in Children
This is a pediatric kidney transplant study comparing the safety and efficacy of an immunosuppressive regimen of belatacept and sirolimus to tacrolimus and Mycophenolate Mofetil (MMF).
- Trial name
- ADVANTage (NCT06055608)
- Testing
- Sirolimus, Belatacept, Mycophenolate Mofetil
- Where
- 21 sites in United States, Canada
- Volunteers
- 200 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Background: Infections in the lower respiratory tract (lungs) are the leading cause of death from infectious disease worldwide. This was true even before the COVID-19 pandemic. Respiratory viruses are still a major health threat.
- Trial name
- NCT06120244
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
RSV Infection
Real-World Effectiveness of Perinatal RSV Immunoprophylaxis
The purpose of this study is to continue evaluating how well the RSV vaccines work as they are currently being used in routine clinical practice.
- Trial name
- NCT06172660
- Testing
- Nirsevimab
- Where
- United States
- Volunteers
- 3,750 people
- Sponsor
- Yale University
Staphylococcal Infections
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Background: Staphylococcus aureus (S.aureus) are bacteria that can make people sick. Sometimes, an S. aureus infection can develop inside the spine; these infections can lead to paralysis and death. Researchers do not know how S.
- Trial name
- NCT06479837
- Where
- 2 sites in United States
- Volunteers
- 500 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tenofovir
CROSSOVER STUDY OF ON-DEMAND PREP FORMULATIONS COMPARING RECTAL AND ORAL TENOFOVIR
This is a Phase 2, multi-site, two-period, open label randomized crossover (Period 1 and 2) study. Participants are randomized 1:1 to one of two 8-week on-demand product sequences - TFV douche then oral F/TDF or oral F/TDF then…
- Trial name
- NCT06560684
- Testing
- Oral F/TDF Pills, TFV rectal douche
- Where
- 8 sites in United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Influenza Prevention, Seasonal Influenza
Evaluating the Dose, Safety, Tolerability, and Immunogenicity of Mosaic Hexavalent Influenza Vaccine VRCFLUMOS0116-00-VP (FluMos-v2) With and Without ALFQ Adjuvant in Healthy Adults
Background: Vaccines help the body learn to fight infections. Some vaccines are combined with adjuvants, which are added substances that make vaccines work better.
- Trial name
- NCT06863142
- Testing
- VRC-FLUMOS0116-00-VP, ALFQ
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Kidney Transplant Rejection
Treatment of Antibody-Mediated Rejection (ABMR) With CarBel
The purpose of this study is to evaluate the safety of carfilzomib and belatacept, administered with steroids and maintenance immunosuppression, in kidney transplant recipients with donor-specific antibody (DSA)-associated graft…
- Trial name
- CarBel (NCT06918990)
- Testing
- Carfilzomib, Belatacept
- Where
- 11 sites in United States
- Volunteers
- 25 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Dysphagia, Eosinophilic Esophagitis
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Background: Eosinophilic esophagitis (EoE) is a disease that causes inflammation in the esophagus. The esophagus is the tube that moves food from the mouth to the stomach.
- Trial name
- NCT07027826
- Testing
- Esophageal string test
- Where
- 3 sites in United States, Mali
- Volunteers
- 70 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Influenza, Human
BPL-1357 Against H1N1 Influenza Virus Challenge
Background: Influenza (flu) infections are a serious global health threat. Each year, between 3 and 5 million people get the flu, and up to 500,000 die from it.
- Trial name
- NCT07215858
- Testing
- BPL-1357 IM, BPL-1357 IN
- Where
- 2 sites in United States
- Volunteers
- 129 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Background: Autosomal dominant hyper-IgE syndrome (HIES), also called Job syndrome, is a genetic disorder that affects the immune system.
- Conditions
- Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome, HIES, Lupus
- Trial name
- NCT07262983
- Testing
- baricitinib
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Allergy
Study of Oral Food Challenge Biomarkers (SAFER)
This is a multi-center, mechanistic study. It is designed to learn more about signs in the body, called biomarkers, that might show if someone will have a reaction to peanut during a feeding test.
- Trial name
- SAFER (NCT07279467)
- Testing
- Oral Food Challenge (OFC): Peanut Protein
- Where
- 10 sites in United States
- Volunteers
- 500 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
COVID-19
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
This phase 1 randomized, open-label, dose-escalation clinical trial evaluates the safety and immunogenicity of OCU500, a ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine, in healthy adults aged 18-64 who previously completed a…
- Trial name
- NCT07536308
- Testing
- OCU500
- Where
- 6 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Background: Trisomy 8 mosaicism is a genetic disorder that can increase inflammation in the body. Symptoms include fevers; sores or ulcers in the mouth, digestive tract, or genital area; skin rashes; problems in organs or…
- Conditions
- Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease, Mucosal Ulcerations
- Trial name
- NCT07683104
- Where
- United States
- Volunteers
- 750 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Influenza
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
This is a Phase 1, randomized, controlled, dose-ranging clinical trial to assess the safety and immunogenicity of novel influenza A Group 1 and influenza A Group 2 mRNA chimeric hemagglutinin (HA) vaccine candidates given as…
- Trial name
- NCT07703514
- Testing
- cH15/3, cH4/3, cH5/1N1
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)