Clinical trials: completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
- Lead sponsor (exact) National Institute of Allergy and Infectious Diseases (NIAID)
- Status Completed
- Has posted results yes
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)
Tuberculosis
Tuberculosis Treatment Shortening Trial
Tuberculosis (TB) is a serious infection that can affect the lungs and other parts of the body. The usual way to treat TB is to take 4 medicines by mouth every day for 2 months, then take 2 of the same medicines for 4 more…
- Trial name
- NCT00130247
- Testing
- Ethambutol, Isoniazid, Pyrazinamide
- Where
- 3 sites in Brazil, Philippines and 1 more
- Volunteers
- 394 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis, Multidrug-Resistant, Tuberculosis
Linezolid Dosing Strategies in Drug-Resistant TB
The purpose of the study was to evaluate the efficacy (how well the medicines work) and tolerability (whether participants stop treatment because of side effects from a drug) of an anti-TB treatment regimen that compared two…
- Conditions
- Tuberculosis, Multidrug-Resistant, Tuberculosis, Tuberculosis, Pulmonary
- Trial name
- NCT05007821
- Testing
- Linezolid 600 mg, Linezolid 1200 mg (QD), Linezolid 1200 mg (TIW)
- Where
- 13 sites in Botswana, Brazil and 5 more
- Volunteers
- 138 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Cytomegalovirus Infections, HIV Infections
Trial to Evaluate the Safety and Immunogenicity of a Modified Vaccinia Ankara (MVA)-Based Anti-Cytomegalovirus (CMV) Vaccine (Triplex®)
A5355 was a randomized, placebo-controlled study conducted at US sites to evaluate the safety and immunogenicity of two injections of the study drug Modified Vaccinia Ankara (MVA)-based anti-Cytomegalovirus (CMV) Vaccine…
- Conditions
- Cytomegalovirus Infections, HIV Infections, Vaccine
- Trial name
- NCT05099965
- Testing
- CMV-MVA Triplex
- Where
- 12 sites in United States
- Volunteers
- 94 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Malaria
L9LS MAb in Malian Infants
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of L9LS in infants in Mali and to evaluate the impact of L9LS on subsequent R21/Matrix-MTM vaccine immunogenicity.
- Trial name
- NCT06461026
- Testing
- L9LS, R21/Matrix-MTM
- Where
- 3 sites in Mali
- Volunteers
- 327 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Heart Transplant
Tocilizumab in Cardiac Transplantation
The purpose of this research study is to see if a study drug called Tocilizumab will, when given with standard anti-rejection medicines, lead to better heart transplantation outcomes at 1 year after the transplant.
- Trial name
- NCT03644667
- Testing
- tocilizumab, Standard of Care Triple IS
- Where
- 20 sites in United States
- Volunteers
- 385 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Kidney Transplant, Kidney Transplant Recipient
Rituximab in Renal Allograft Recipients Who Develop Early De Novo Anti-HLA Alloantibodies
The purpose of this study is to determine whether treatment with rituximab (anti-CD20, Rituxan®, MabThera®) in individuals who develop new anti-HLA antibodies after renal (kidney) transplant will promote longer-term survival of…
- Conditions
- Kidney Transplant, Kidney Transplant Recipient, Graft Function/Survival, de Novo HLA Antibodies Development
- Trial name
- NCT00307125
- Testing
- Rituximab plus immunosuppression
- Where
- 17 sites in United States
- Volunteers
- 757 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Kidney Transplant
Effects of Inhibiting Early Inflammation in Kidney Transplant Patients
During transplant surgery, there is a period of time when a donated kidney is removed from a donor's body and stored until the time of the transplant surgery.
- Trial name
- NCT02495077
- Testing
- Infliximab, Methylprednisolone, Mycophenolate Mofetil
- Where
- 15 sites in United States, Canada
- Volunteers
- 290 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Kidney Transplant, Adult Living Donor Kidney Transplant Recipients
Treg Therapy in Subclinical Inflammation in Kidney Transplantation
The purpose of this study is: To see if polyTregs can reduce inflammation in a transplanted kidney. To find out what effects, good or bad, polyTregs will have in the kidney recipient.
- Conditions
- Kidney Transplant, Adult Living Donor Kidney Transplant Recipients, Renal Transplant, Living Kidney Donor
- Trial name
- TASK (NCT02711826)
- Testing
- Polyclonal Regulatory T Cells, Everolimus, Tacrolimus
- Where
- 6 sites in United States
- Volunteers
- 32 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Living-Donor Kidney Transplant, Kidney Transplant Recipients
Treg Modulation With CD28 and IL-6 Receptor Antagonists
The purpose of this study is to evaluate the safety of using lulizumab pegol with tocilizumab, belatacept, and everolimus in kidney transplant recipients.
- Trial name
- NCT04066114
- Testing
- lulizumab pegol, antithymocyte globulin (rabbit), methylprednisolone
- Where
- 7 sites in United States
- Volunteers
- 24 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Peanut Allergy, Multi-food Allergy
Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants
This study is a multi-center, randomized, double-blind, placebo-controlled study in participants 1 to less than 56 years of age who are allergic to peanut and at least two other foods (including milk, egg, wheat, cashew…
- Trial name
- OUtMATCH (NCT03881696)
- Testing
- Omalizumab, Multi-Allergen Oral Immunotherapy
- Where
- 10 sites in United States
- Volunteers
- 458 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Human Metapneumovirus, Human Parainfluenza Virus Type 3
Study of the Infectivity, Safety and Immunogenicity of Two Recombinant, Live-Attenuated, B/HPIV3 Vectored Vaccines Expressing the Fusion Glycoprotein of HMPV Delivered by Nasal Spray to HPIV3-Seropositive Children 24 to <60 Months of Age
HPIV3 and HMPV are viruses that can cause breathing problems in children. The goal of this clinical trial is to look at the safety of 2 experimental HPIV3/HMPV vaccines in HPIV3-seropositive children ≥ 24 months to < 60 months of…
- Trial name
- NCT06546423
- Testing
- B/HPIV3/HMPV-PreF-A vaccine, B/HPIV3/HMPV-F-B365 vaccine
- Where
- 4 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE
The purpose of this study was to compare the efficacy, safety, and durability of two different strategies to treat participants with a history of sub-optimal adherence and control of their HIV infection: long-acting (LA)…
- Trial name
- NCT03635788
- Testing
- Standard of Care (SOC) Oral ART, Oral RPV, Oral CAB
- Where
- 33 sites in United States, Puerto Rico
- Volunteers
- 456 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Urethritis
NGU: Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole)
This study will look at the safety, effectiveness, and tolerability of combination medications for the initial treatment of non-gonococcal urethritis (NGU). NGU is inflammation of the tube that carries urine from the bladder.
- Trial name
- NCT00322465
- Testing
- Doxycycline, Tinidazole, Azithromycin
- Where
- 4 sites in United States
- Volunteers
- 305 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
EBV, Epstein-Barr Virus Infection
Safety and Immunogenicity of an Epstein-Barr Virus (EBV) gp350-Ferritin Nanoparticle Vaccine in Healthy Adults
Background: Epstein-Barr virus (EBV) causes most cases of infectious mononucleosis (mono). Up to 1 in 10 people who get mono can have fatigue that lasts more than 6 months. One out of 100 people can have severe complications.
- Conditions
- EBV, Epstein-Barr Virus Infection, Infectious Mononucleosis
- Trial name
- NCT04645147
- Testing
- EBV gp350-Ferritin Vaccine
- Where
- United States
- Volunteers
- 83 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Immunisation, Shigella Infection
Phase 2 Shigella Vaccine and Challenge
This is a trial to evaluate the safety, reactogenicity, immunogenicity and efficacy of a 10^6 cfu dose of an oral live-attenuated S.
- Trial name
- NCT04242264
- Testing
- Shigella sonnei strain 53G, WRSs2
- Where
- 2 sites in United States
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Chlamydial Infection
Treatment Failure of Chlamydial Infection in Males and Females in Youth Correctional Facilities
Chlamydia is a common infection among youth and can be given from one person to another during sex. Many people who have chlamydia have no signs of infection at all, but can pass the infection to anyone they have sex with.
- Trial name
- NCT00980148
- Testing
- Azithromycin, Doxycycline
- Where
- 2 sites in United States
- Volunteers
- 567 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Evaluating the Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants
The purpose of this study was to compare the virologic efficacy and safety of three antiretroviral (ARV) regimens, dolutegravir plus emtricitabine/tenofovir alafenamide, dolutegravir plus emtricitabine/tenofovir disoproxil…
- Trial name
- VESTED (NCT03048422)
- Testing
- Dolutegravir, Emtricitabine/tenofovir alafenamide, Emtricitabine/tenofovir disoproxil fumarate
- Where
- 21 sites in United States, Botswana and 7 more
- Volunteers
- 643 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Safety and Immunogenicity of Clade C ALVAC and gp120 HIV Vaccine
The purpose of this study is to evaluate the safety and immune response to an HIV clade C vaccine and to an MF59- or alum-adjuvanted clade C Env protein in healthy, HIV-uninfected adults.
- Trial name
- HVTN107 (NCT03284710)
- Testing
- ALVAC-HIV (vCP2438), Bivalent Subtype C gp120/MF59, Bivalent Subtype C gp120 admixed with Al(OH)3 Suspension
- Where
- 6 sites in Mozambique, South Africa and 1 more
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Safety and Virologic Effect of a Human Monoclonal Antibody (VRC01) Administered Intravenously to Adults During Early Acute HIV Infection
This study will evaluate the safety and virologic effect of an experimental human monoclonal antibody (mAb), VRC-HIVMAB060-00-AB (VRC01), alone or in combination with antiretroviral therapy (ART), in adults during early acute HIV…
- Trial name
- NCT02591420
- Testing
- VRC01, Antiretroviral therapy (ART) (regimen will vary within countries and by patient)
- Where
- 5 sites in Kenya, Tanzania and 2 more
- Volunteers
- 24 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)