68 Results
U.S. Clinical Trial Evaluating Antiviral for Monkeypox Begins
September 9, 2022
A Phase 3 clinical trial evaluating the antiviral tecovirimat, also known as TPOXX, is now enrolling adults and children with monkeypox infection in the United States. Study investigators aim to enroll more than 500 people from clinical research sites nationwide. Interested volunteers can visit the ACTG website (clinical trial A5418) for more information. The NIAID-funded Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG) is leading the study, which may later expand to international sites. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at NIH is supporting several sites, including through the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT).
Statement—Large Clinical Trial Will Test Combination Monoclonal Antibody Therapy for Mild/Moderate COVID-19
January 5, 2021
A NIAID-supported clinical trial has begun to evaluate a combination investigational monoclonal antibody therapy for people with mild to moderate COVID-19.
Statement—Janssen Investigational COVID-19 Vaccine—Interim Analysis
January 29, 2021
NIH reports that an investigational COVID-19 vaccine by Janssen Pharmaceuticals appears to be safe and effective at preventing COVID-19 in adults.
Investigational Three-Month TB Regimen Is Safe but Ineffective, NIH Study Finds
July 5, 2023
The first clinical trial of a three-month tuberculosis (TB) treatment regimen is closing enrollment because of a high rate of unfavorable outcomes with the investigational course of treatment. Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG) 5362, also known as the CLO-FAST trial, sought to evaluate the safety and efficacy of a three-month clofazimine- and high-dose rifapentine-containing regimen. An interim data analysis showed that participants taking the investigational regimen experienced ongoing or recurring TB at rates above thresholds set in the study protocol.
Monkeypox Treatment Trial Begins in the Democratic Republic of the Congo
October 12, 2022
A clinical trial to evaluate the antiviral drug tecovirimat, also known as TPOXX, in adults and children with monkeypox has begun in the Democratic Republic of the Congo (DRC). The trial will evaluate the drug’s safety and its ability to mitigate monkeypox symptoms and prevent serious outcomes, including death. NIAID and the DRC’s National Institute for Biomedical Research (INRB) are co-leading the trial as part of the government-to-government PALM partnership. Collaborating institutions include the U.S. Centers for Disease Control and Prevention (CDC), the Institute of Tropical Medicine Antwerp, the aid organization Alliance for International Medical Action (ALIMA) and the World Health Organization (WHO).
Statement—Four Potential COVID-19 Therapeutics Enter Phase 2/3 Testing in NIH ACTIV-2 Trial
February 12, 2021
Enrollment has begun to test additional investigational drugs in the NIH Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program.
Statement—Large NIH Clinical Trial Will Test Polyclonal Antibody Therapeutic for COVID-19
April 21, 2021
A Phase 2/3 trial to evaluate a new fully-human polyclonal antibody therapeutic targeted to SARS-CoV-2, called SAB-185, has begun enrolling non-hospitalized people with mild or moderate cases of COVID-19. The trial, ACTIV-2, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The therapeutic was developed by SAB Biotherapeutics, Inc. (Sioux Falls, South Dakota).
World TB Day 2023 – ‘Yes! We Can End TB!’
March 24, 2023
Each year, on March 24, the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, joins people and organizations from around the globe in marking World Tuberculosis Day. On this day, more than 140 years ago, Dr. Robert Koch announced his discovery that most human tuberculosis (TB) is caused by the bacterium Mycobacterium tuberculosis (Mtb). Although our scientific insight into this disease has grown over the past century, TB is still one of the deadliest infectious diseases on the planet. Today, NIAID joins the world in a message of hope: “Yes!
NIH Selects Dr. Jeanne Marrazzo as Director of the National Institute of Allergy and Infectious Diseases
August 2, 2023
Lawrence A. Tabak, D.D.S., Ph.D., acting director for the National Institutes of Health (NIH), has named Jeanne M. Marrazzo, M.D., as director of NIH’s National Institute of Allergy and Infectious Diseases (NIAID).
NIH Researchers Uncover New Details on Rare Immune Disease
May 3, 2023
In an 11-year study, researchers at the National Institutes of Health have further characterized idiopathic CD4 lymphocytopenia (ICL), a rare immune deficiency that leaves people vulnerable to infectious diseases, autoimmune diseases and cancers. Researchers observed that people with the most severe cases of ICL had the highest risk of acquiring or developing several of the diseases associated with this immune deficiency. This study, published in the New England Journal of Medicine, was led by Irini Sereti M.D., M.H.S. and Andrea Lisco, M.D., Ph.D.
Emergency Department Screening More Than Doubles Detection of Syphilis Cases
September 10, 2024
Providing optional syphilis tests to most people seeking care at a large emergency department led to a dramatic increase in syphilis screening and diagnosis, according to study of nearly 300,000 emergency department encounters in Chicago. Most people diagnosed had no symptoms, which suggests that symptom-based testing strategies alone could miss opportunities to diagnose and treat people with syphilis.
Intranasal Influenza Vaccine Spurs Strong Immune Response in Phase 1 Study
February 3, 2021
An experimental influenza vaccine was safe and produced a durable immune response when tested in a Phase 1 study, NIH reports.
Findings Suggest COVID-19 Rebound Not Caused by Impaired Immune Response
October 6, 2022
Findings from a small study of eight patients published in Clinical Infectious Diseases suggest that COVID-19 rebound is likely not caused by impaired immune responses. The study, led by scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, aimed to define the clinical course and the immunologic and virologic characteristics of COVID-19 rebound in patients who have taken nirmatrelvir/ritonavir (Paxlovid), an antiviral therapeutic developed by Pfizer, Inc.
Leadership Transition at the NIAID Vaccine Research Center
February 16, 2022
Dr. Fauci expresses gratitude to John R. Mascola, M.D., as he announces his retirement as Director of the Dale and Betty Bumpers Vaccine Research Center at the National Institute of Allergy and Infectious Diseases.
Existing Drug Shows Promise as Treatment for Rare Genetic Disorder
May 30, 2024
A drug approved to treat certain autoimmune diseases and cancers successfully alleviated symptoms of a rare genetic syndrome called autoimmune polyendocrine syndrome type 1 (APS-1).
Tecovirimat Is Safe but Ineffective as Treatment for Clade II Mpox
March 12, 2025
Monotherapy with the antiviral drug tecovirimat was safe but ineffective as an mpox treatment in an international clinical trial.
NIH Launches Trial to Study Allergic Reactions to COVID-19 mRNA Vaccine
March 9, 2022
Researchers from the National Institute of Allergy and Infectious Diseases (NIAID) are conducting a clinical trial designed to help understand rare but potentially serious systemic allergic reactions to COVID-19 mRNA vaccines.
NIH Study Finds Tecovirimat Was Safe but Did Not Improve Mpox Resolution or Pain
December 10, 2024
Tecovirimat was safe but did not reduce the time to lesion resolution or reduce pain among adults with mild to moderate clade II mpox and a low risk of severe disease in an international study.
