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Updated May 2026 · ClinicalTrials.gov

National Institute of Allergy and Infectious Diseases (NIAID)

28 clinical trials · 28 recruiting · NIH

National Institute of Allergy and Infectious Diseases (NIAID) has 28 clinical trials registered on ClinicalTrials.gov, with 28 actively recruiting participants. The trials listed below cover 20 conditions across the phases listed in the sidebar. Always discuss any specific trial with your physician before contacting a study site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About National Institute of Allergy and Infectious Diseases (NIAID)\'s Trial Portfolio

National Institute of Allergy and Infectious Diseases (NIAID) is a federal-government sponsor. Government-funded trials, including those from the National Institutes of Health, are typically focused on public-health priorities, rare-disease research, and questions where commercial sponsors have less incentive to fund. They are also among the most rigorously documented trials on ClinicalTrials.gov.

28 of National Institute of Allergy and Infectious Diseases (NIAID)'s 28 registered trials are currently recruiting — roughly 100% of the portfolio. A high recruiting share usually points to an active research pipeline with multiple programs at the enrollment stage.

National Institute of Allergy and Infectious Diseases (NIAID)'s research footprint spans Malaria (8 trials), Influenza (7), and COVID-19 (4) as the top three conditions. The full condition list, sorted by trial count, is in the sidebar.

is the largest single phase in National Institute of Allergy and Infectious Diseases (NIAID)'s portfolio at 50% of registered trials. The full phase breakdown appears in the sidebar.

Trials by National Institute of Allergy and Infectious Diseases (NIAID)

RECRUITINGPhase 4NCT05285891

Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis

This study is a prospective, multi-center, randomized, double blinded, placebo-controlled study of OCR treatment-discontinuation in patients with early RMS. All eligible...

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)Enrolling: 12312 locations
Multiple Sclerosis
RECRUITINGPhase 2NCT07108387

Tocilizumab Discontinuation Versus Dose Reduction for Patients With Well-Controlled Giant Cell Arteritis

This is a multi-center, randomized, open label study that will assess the efficacy and safety of ACTEMRA(R) or one of its FDA-approved biosimilars Tocilizumab (TCZ) maintenance...

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)Enrolling: 787 locations
Giant Cell Arteritis (GCA)
RECRUITINGNCT07051902

Microbiome and Atopy in Mali

This study is about allergic diseases in people living in Mali. Allergic diseases can cause health problems like asthma or skin rashes. In this study, the investigators will look...

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)Enrolling: 2882 locations
Atopic Disease
RECRUITINGPhase 1NCT07536308

A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and...

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...

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)Enrolling: 805 locations
COVID-19
RECRUITINGPhase 1NCT05586230

Study of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children With Rifampicin-Resistant...

The purpose of the study is to evaluate the pharmacokinetics (PK), safety, tolerability, and acceptability of a single dose of pretomanid, added to an optimized background...

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)Enrolling: 726 locations
TuberculosisRifampicin Resistant Tuberculosis
RECRUITINGPhase 2NCT05383742

Trial of a Six-Month Regimen of High-Dose Rifampicin, High-Dose Isoniazid, Linezolid, and Pyrazinamide Versus a...

The purpose of this study is to compare a 6-month regimen of high-dose rifampicin (RIF), high-dose isoniazid (INH), linezolid (LZD), and pyrazinamide (PZA) versus the World Health...

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)Enrolling: 33018 locations
Tuberculous Meningitis
RECRUITINGNCT01212003

Training Protocol on the Natural History of Tuberculosis

Background: \- Tuberculosis (TB) is an infectious disease that affects numerous people worldwide. Researchers are interested in actively recruiting individuals with TB for...

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)Enrolling: 1501 location
Mycobacterium InfectionsTuberculosis, Multidrug-ResistantLatent Tuberculosis+2
RECRUITINGNCT00001281

Studies of the Pathogenesis of HIV Infection in Human Peripheral Blood Cells and/or Body Fluids in People Living With...

We are studying virologic and/or immunologic parameters of HIV infection and other infectious or non-infectious immune deficiency diseases in order to better understand the...

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)Enrolling: 24192 locations
HIVImmunodeficienciesInfectious Diseases
RECRUITINGPhase 1 / Phase 2NCT07040319

Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in Women With Hepatitis C...

This is a Phase I/II, multi-site, open-label, single arm study to describe the pharmacokinetics (PK) and safety of glecaprevir/pibrentasvir (GLE/PIB) initiated during pregnancy in...

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)Enrolling: 3010 locations
Hepatitis C
RECRUITINGNCT01306084

Viral Infections in Healthy and Immunocompromised Hosts

Background: \- Viral infections are an important cause of illness and death in hospitalized patients as well as outpatients. New strains of viruses may appear and infect both...

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)Enrolling: 10001 location
Anogenital HerpesCOVID-19Herpes Labialis
RECRUITINGPhase 1NCT06607003

Induced Blood-Stage Malaria in Healthy Malaria-Naive Adults to Assess the Safety and Infectivity of Plasmodium Vivax...

Background: Malaria is a disease caused by parasites transmitted to people by mosquitoes. Around the world, there were 241 million cases and 627,000 deaths from malaria in 2020....

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)Enrolling: 3001 location
Malaria
RECRUITINGPhase 2NCT07060508

L9LS in Women of Childbearing Potential in Mali

Safety and Efficacy of L9LS, a Human Monoclonal Antibody Against Plasmodium falciparum, in a Randomized, Double-Blind, Placebo-Controlled Trial of Women of Childbearing Potential...

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)Enrolling: 2903 locations
Malaria
RECRUITINGNCT01168271

Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early...

Malaria caused by Plasmodium falciparum continues to be a global problem with devastating consequences. A greater understanding of the immunologic and parasitologic factors...

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)Enrolling: 150002 locations
Malaria
RECRUITINGNCT02471378

Laboratory Evaluation of Pregnancy Malaria Vaccine Candidates/In-vitro Testing of Pregnancy Malaria Vaccine Candidates

Background: \- Malaria is a disease that affects many people in African countries. It is caused by germs that are spread by mosquito bites. It can be fatal if not diagnosed and...

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)Enrolling: 74761 location
Malaria
RECRUITINGNCT06468319

Pregnancy Registry in Mali

This registry will assess pregnancy outcomes through demographic surveillance and prospective data collection at a health facility in Kalifabougou, Mali.

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)Enrolling: 95001 location
MalariaPregnancy Related
RECRUITINGNCT02639299

Screening of Healthy Volunteers for Investigational Antimalarial Drugs, Malaria Vaccines, and Controlled Human Malaria...

Background: Malaria is a serious infection caused by a parasite. People get malaria when an infected mosquito bites them. Malaria can cause major health and social problems in...

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)Enrolling: 15001 location
Malaria
RECRUITINGNCT03937817

Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants

Background: Blood disorders like sickle cell disease and malaria affect many people around the world. Researchers want to learn more about blood disorders. To do this, they need...

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)Enrolling: 3001 location
Alpha and Beta ThalassemiaSickle Cell DiseaseMalaria+1
RECRUITINGNCT00001645

Evaluation, Treatment and Monitoring of Patients With a Known or Suspected Parasitic Infection

The purpose of this study is to evaluate, treat and follow patients with parasitic infections. People with a known or suspected parasitic infection who are at least 1 year old...

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)Enrolling: 8001 location
MalariaIntestinal WormsGI Protozoa+2
RECRUITINGNCT04772170

Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies

Background: Respiratory viruses circulate throughout the year and around the globe. Wearable and sensor devices, like smartwatches, may be able to help monitor infectious...

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)Enrolling: 10001 location
InfluenzaRespiratory VirusCoronavirus
RECRUITINGPhase 2NCT07215858

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. Current vaccines...

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)Enrolling: 1292 locations
InfluenzaHuman
RECRUITINGNCT01386424

Screening for LID Clinical Studies Unit Healthy Volunteer Protocols

Background: * The Laboratory of Infectious Diseases (LID) Clinical Studies Unit (CSU) enrolls healthy volunteers into clinical studies to study infectious diseases. * Viruses can...

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)Enrolling: 50001 location
ZikaInfluenza
RECRUITINGPhase 1NCT07111078

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...

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)Enrolling: 561 location
Influenza PreventionPandemic Influenza Prevention
RECRUITINGPhase 1NCT07169318

First-in-Human Study of VNT-101: Safety, Tolerability, and Pharmacokinetics

A randomized, double-blind, placebo-controlled Phase 1 study conducted at a single center with approximately 78 healthy adults aged 18-59 years. Part 1 Single Ascending Dose (SAD)...

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)Enrolling: 781 location
Influenza
RECRUITINGNCT04794829

Natural History of Systemic and Nasal Mucosal Immunity to Influenza and SARS-CoV-2 in Adults After Vaccination

Background: Influenza (flu) vaccinations are required for all NIH staff members who have direct contact with patients. COVID-19 vaccines are recommended for persons 6 months of...

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)Enrolling: 1501 location
InfluenzaCOVID-19
RECRUITINGPhase 1NCT07110532

pH1N1 Blinded Challenge Study

This protocol describes a clinical trial to develop and validate a Controlled Human Infection Model (CHIM) for influenza A/Arkansas/08/2020 (pH1N1). The study is designed to...

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)Enrolling: 902 locations
Influenza
RECRUITINGPhase 1NCT06863142

Evaluating the Dose, Safety, Tolerability, and Immunogenicity of Mosaic Hexavalent Influenza Vaccine...

Background: Vaccines help the body learn to fight infections. Some vaccines are combined with adjuvants, which are added substances that make vaccines work better. FluMos-v2 is...

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)Enrolling: 451 location
Influenza PreventionSeasonal Influenza
RECRUITINGNCT05266222

Respiratory Virus Sampling and Repository

Background: Respiratory viruses, like the flu or COVID-19, cause significant illness and death worldwide. Researchers want to collect samples from people with respiratory virus...

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)Enrolling: 200002 locations
InfluenzaCOVID-19
RECRUITINGPhase 1NCT06974877

Repeat PET/CT Imaging in People With CAPS and Anakinra-Induced Amyloidosis Using an Amyloid-Reactive Peptide to Measure...

Background: Anakinra is a drug used to treat people with certain diseases that affect their immune systems. Sometimes anakinra can cause proteins under the skin to clump...

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)Enrolling: 301 location
Cryopyrin-Associated Periodic SyndromesAmyloidosis

How to Approach a Trial Listing

Each trial card above links to a dedicated page with the official ClinicalTrials.gov data plus a plain-English translation of the eligibility criteria. We translate technical terminology (ECOG performance status, hepatic function values, exclusionary lab thresholds) into language that a patient or caregiver can understand, but the original clinical text and the live ClinicalTrials.gov record always govern any actual eligibility decision.

Before contacting a trial site, write down questions for your treating physician using the framework on our 25 Questions guide. Discuss whether the trial fits your treatment plan, what the time commitment looks like, and whether your insurance will cover the standard-of-care portions. Trials are not a substitute for a treatment plan — they are an addition that needs medical guidance to evaluate.

Authoritative Resources

Verify any trial registration directly on ClinicalTrials.gov. For background on the FDA approval pathway that Phase 3 trials feed into, see the FDA drug approval process. For cancer-specific trial guidance, the National Cancer Institute publishes patient-oriented overviews. For global trial registrations beyond the U.S., the WHO ICTRP aggregates registries from around the world.

Frequently Asked Questions

How many clinical trials does National Institute of Allergy and Infectious Diseases (NIAID) have on ClinicalTrials.gov?

National Institute of Allergy and Infectious Diseases (NIAID) has 28 clinical trials registered on the federal ClinicalTrials.gov registry, of which 28 are actively recruiting participants right now. These counts come directly from the ClinicalTrials.gov API and are updated as the registry changes.

What conditions does National Institute of Allergy and Infectious Diseases (NIAID) study?

National Institute of Allergy and Infectious Diseases (NIAID)'s registered trials cover 20 conditions on ClinicalTrials.gov, led by Malaria (8 trials), Influenza (7 trials), COVID-19 (4 trials), Tuberculosis (2 trials), Influenza Prevention (2 trials). The complete condition list appears in the sidebar of this page; each condition links to a page listing every recruiting trial in that area, regardless of sponsor.

How do I join a National Institute of Allergy and Infectious Diseases (NIAID) clinical trial?

Joining a clinical trial is a medical decision that should always involve your treating physician. Each trial page on this site includes the eligibility criteria translated into plain English alongside the official clinical text, plus the contact information that the sponsor has registered with ClinicalTrials.gov. Bring the trial information to your doctor before reaching out — they can review the full inclusion and exclusion criteria against your medical history and help you decide whether to pursue screening.

What does the trial phase mean?

Phase 1 trials test safety and dosing in small groups (often 20–80 healthy volunteers or patients). Phase 2 trials evaluate efficacy and side effects in larger groups (100–300 patients with the target condition). Phase 3 trials confirm efficacy and monitor safety in the largest groups (300–3,000+ patients) and form the basis of an FDA approval submission. Phase 4 studies happen after a treatment is approved, monitoring long-term safety and effectiveness in real-world use. Some trials register without a phase — common for device, behavioral, or observational studies.

Where does this trial data come from?

All trial data is pulled directly from the ClinicalTrials.gov API v2, the official federal trial registry maintained by the National Library of Medicine at NIH. Under FDAAA 801, most U.S. drug and device trials are required to register, making ClinicalTrials.gov the most comprehensive source. Sponsors are responsible for keeping their listings current; trial status can shift between data refreshes.

How This Sponsor Page Is Built

Every count on this page is derived directly from ClinicalTrials.gov API v2 records. Trial counts include all trials currently registered to this sponsor; the recruiting count reflects trials with status "Recruiting" or equivalent. Plain-English eligibility translations on each linked trial page preserve the original clinical text alongside an accessible version. Read the full methodology for the data pipeline and limitations.

Source: ClinicalTrials.gov API v2, maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · 28 trials tracked for National Institute of Allergy and Infectious Diseases (NIAID).

this entity is one of the data points covered by this site’s U.S. clinical trials and research registries dataset. The detail above comes directly from the NIH ClinicalTrials.gov registry; the context that follows situates the headline numbers against the broader distribution across active and historical clinical trials.

Every number on this page links back to the NIH ClinicalTrials.gov registry; the methodology page describes the inputs, refresh cadence, and known limitations of the underlying data product.

For readers using this page as a decision input, the related-entity pages elsewhere on the site provide the comparison set. The most useful comparison for this entity is typically a peer within active and historical clinical trials with similar size, similar exposure, or similar geography — not the national-level summary alone.