Clinical trials: sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
- Lead sponsor (exact) National Institute of Allergy and Infectious Diseases (NIAID)
- Has posted results yes
Plasmodium Falciparum Infection
Pharmacokinetic Study of IV Artesunate to Treat Children With Severe Malaria
This clinical study is a phase 4, single-site, open-label pharmacokinetic (PK) study of IV artesunate in up to 100 Ugandan children 6 months-14 years of age who are diagnosed with severe malaria according to standardized World…
- Trial name
- NCT05750459
- Testing
- Artesunate
- Where
- Uganda
- Volunteers
- 90 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Campylobacter Infection
Safety and Immunogenicity of CJCV2 With and Without ALFQ
This is a randomized, double-blind, dose-escalating, outpatient trial in a total of approximately 60 subjects, assigned to 3 cohorts (20 subjects per cohort).
- Trial name
- NCT05500417
- Testing
- ALFQ, CJCV2
- Where
- United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)
COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders
This is a randomized, multi-site, adaptive, open-label clinical trial comparing the immune response to different additional doses of COVID-19 vaccine in participants with autoimmune disease requiring IS medications.
- Conditions
- Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Pemphigus Vulgaris, Multiple Sclerosis (MS)
- Trial name
- NCT05000216
- Testing
- Moderna mRNA-1273, BNT162b2, Ad26.COV2.S
- Where
- 29 sites in United States
- Volunteers
- 258 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Atopic Dermatitis
Longitudinal Endotyping Of Atopic Dermatitis Through Transcriptomic Skin Analysis
This is a multi-center, longitudinal study which will characterize the gene expression profiles and transcriptomic endotypes that underlie mild and moderate-severe Atopic dermatitis (AD) and will determine changes in these…
- Trial name
- LEADS (NCT05436535)
- Testing
- Dupilumab, Vanicream- Dupilumab-naïve, Triamcinolone Acetonide
- Where
- 10 sites in United States
- Volunteers
- 433 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV
A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1
The purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics (PK) of dolutegravir (DTG) in infants born to mothers living with HIV-1.
- Trial name
- NCT05406583
- Testing
- Dolutegravir 0.5 mg/kg liquid suspension (starts at 0-5 days of life), Dolutegravir 5 mg Dispersible Tablets (single doses), Dolutegravir 5 mg Dispersible Tablets (chronic dose)
- Where
- 15 sites in United States, South Africa and 1 more
- Volunteers
- 96 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
COVID-19
Phase 1 Study on Bioavailability, Food Effect, and Drug-Drug Interaction of ALG-097558 Tablets in Healthy Volunteers
The aim of this multi-part Phase 1 study is to evaluate the drug-drug interaction (DDI) potential of ALG-097558 via co-administration with a P-gp substrate (dabigatran) and a CYP3A4 inhibitor/P-gp inhibitor (itraconazole).
- Trial name
- NCT06945276
- Testing
- ALG-097558, Dabigatran, Itraconazole
- Where
- United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Systemic Lupus Erythematosus, SLE
JBT-101 in Systemic Lupus Erythematosus (SLE)
The objective of this study is to evaluate the efficacy, safety, and tolerability of JBT-101 (also known as lenabasum) in systemic lupus erythematosus (SLE).
- Conditions
- Systemic Lupus Erythematosus, SLE, Lupus
- Trial name
- NCT03093402
- Testing
- JBT-101
- Where
- 16 sites in United States
- Volunteers
- 109 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Diffuse Cutaneous Systemic Sclerosis, Scleroderma
Brentuximab Vedotin for Systemic Sclerosis
There is significant unmet need for effective treatment options for Diffuse Cutaneous Systemic Sclerosis (dcSSc). The present study will be a dose-escalation safety trial of brentuximab vedotin, a drug-antibody conjugate approved…
- Conditions
- Diffuse Cutaneous Systemic Sclerosis, Scleroderma, dcSSc
- Trial name
- BRAVOS (NCT03222492)
- Testing
- Brentuximab Vedotin
- Where
- 8 sites in United States
- Volunteers
- 17 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Pivotal Phase 2b/3 ALVAC/Bivalent gp120/MF59 HIV Vaccine Prevention Safety and Efficacy Study in South Africa
This study will evaluate the preventive vaccine efficacy, safety, and tolerability of ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59 in HIV-seronegative South African adults over 24 months and potentially up to 36 months…
- Trial name
- HVTN702 (NCT02968849)
- Testing
- ALVAC-HIV (vCP2438), Bivalent Subtype C gp120/MF59
- Where
- 14 sites in South Africa
- Volunteers
- 5,404 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Evaluating the Safety and Immunogenicity of EnvSeq-1 and CH505 M5 gp120 Envs Adjuvanted With GLA-SE in Healthy, HIV-Uninfected Adults
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of EnvSeq-1 and CH505 M5 gp120 Envs adjuvanted with GLA-SE in healthy, HIV-uninfected adults.
- Trial name
- NCT03220724
- Testing
- CH505TF, CH505w53, CH505w78
- Where
- 8 sites in United States
- Volunteers
- 117 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infection
Dual bNAb Treatment in Children
The purpose of this study is to evaluate the impact of two broadly neutralizing antibodies, VRC01LS and 10-1074, on the maintenance of HIV suppression in a cohort of early-treated children in Botswana.
- Trial name
- NCT03707977
- Testing
- ART, VRC01LS, 10-1074
- Where
- 2 sites in Botswana
- Volunteers
- 30 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Enterovirus Infection
Phase 1, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of an Enterovirus D68-specific Monoclonal Antibody in Healthy Adults
This is a Phase 1, randomized, placebo-controlled, double-blinded study to assess the safety and pharmacokinetics of single IV administrations of EV68-228-N in healthy adult volunteers.
- Trial name
- NCT06444048
- Testing
- EV68-228-N
- Where
- 2 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Allergic Rhinoconjunctivitis, Grass Pollen Allergy
Grass Pollen Immunotherapy Plus Dupilumab for Tolerance Induction
The primary objective of this study is to assess whether the combination of grass allergen sublingual immunotherapy (SLIT) and dupilumab for 2 years is more effective than double placebo in suppressing the nasal allergen…
- Trial name
- GRADUATE (NCT04502966)
- Testing
- Dupixent®, Grazax®
- Where
- United Kingdom
- Volunteers
- 199 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Kidney Transplant Recipients, Liver Transplant Recipients
COVID Protection After Transplant-Immunosuppression Reduction
This study will enroll individuals who have: Completed primary series of mRNA COVID-19 vaccine, and An antibody response ≤ 2500 U/mL measured at least 30 days after the last dose of vaccine.
- Trial name
- CPAT-ISR (NCT05077254)
- Testing
- Pfizer-BioNTech COVID-19 Vaccine 2023-2024, Moderna COVID-19 Vaccine 2023-2024, SOC IS Regimen
- Where
- 15 sites in United States
- Volunteers
- 48 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV
A Clinical Trial to Evaluate Safety, Tolerability, and Immunogenicity of Adjuvanted HIV-1 Fusion Peptide Conjugate Vaccine Alone or in Prime-Boost Regimens With Adjuvanted HIV-1 Envelope Trimer 4571 and HIV-1 Trimer 6931 Vaccines in Healthy Adults
This is an open-label, dose-escalation study to examine the safety, tolerability, and immunogenicity of adjuvanted Fusion Peptide Vaccine alone or in prime-boost regimens with adjuvanted Trimer 4571 and Trimer 6931 vaccines in…
- Trial name
- NCT05470400
- Testing
- FP conjugate vaccine (25 mcg), FP conjugate vaccine (200 mcg), Trimer 6931 (100 mcg)
- Where
- 6 sites in United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Vitiligo
Evaluation of AMG 714 for Vitiligo
This study is designed to evaluate the efficacy of AMG 714 for the treatment of adult participants with vitiligo.
- Trial name
- REVEAL (NCT04338581)
- Testing
- AMG 714, nbUVB phototherapy
- Where
- 7 sites in United States
- Volunteers
- 60 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Monkeypox
Trial to Evaluate the Immunogenicity of Dose Reduction Strategies of the MVA-BN Monkeypox Vaccine
This study is a Phase 2 randomized, open-label, non-placebo controlled, multi-site clinical trial that will evaluate two intradermal (ID) regimens for Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine compared to the…
- Trial name
- NCT05512949
- Testing
- JYNNEOS
- Where
- 8 sites in United States
- Volunteers
- 229 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Evaluating the Safety and Immunogenicity of Stabilized CH505 TF chTrimer in Healthy, HIV-uninfected Adult Participants.
This is an open-label Phase 1 study to examine the safety and immunogenicity of the CH505 TF chTrimer vaccine with 3M-052-AF +/- Alum adjuvant in healthy adults.
- Trial name
- NCT04915768
- Testing
- CH505 TF chTrimer, 3M-05-AF, Aluminum hydroxide suspension
- Where
- 3 sites in United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV I Infection
Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy
Transgender women (TW) are a key population and priority for HIV treatment. More research is needed to develop evidence-based clinical guidance when it comes to choosing antiretroviral treatment (ART) regimens for TW on…
- Trial name
- GETITRIgHT (NCT06005610)
- Testing
- Estradiol
- Where
- 18 sites in United States, Mexico and 2 more
- Volunteers
- 93 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Monkeypox
A Phase 2 Randomized Multisite Trial to Inform Public Health Strategies Involving the Use of MVA-BN Vaccine for Mpox
This study is a Phase 2 open-label, non-placebo controlled, multi-site clinical trial that will evaluate the standard SC regimen in adolescents ages 12 through 17 years, inclusive, and compared to the standard subcutaneous…
- Trial name
- NCT05740982
- Testing
- JYNNEOS
- Where
- 18 sites in United States, Puerto Rico
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)