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NIH Launches Clinical Trial of Three mRNA HIV Vaccines

March 14, 2022

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has launched a Phase 1 clinical trial evaluating three experimental HIV vaccines based on a messenger RNA (mRNA) platform—a technology used in several approved COVID-19 vaccines. NIAID is sponsoring the study, called HVTN 302, and the NIAID-funded HIV Vaccine Trials Network (HVTN), based at Fred Hutchinson Cancer Research Center in Seattle, is conducting the trial.

NIH Experts Call for Accelerated Research to Address Concurrent HIV and COVID-19 Pandemics

April 8, 2021

The COVID-19 pandemic is affecting people with or at risk for HIV both indirectly, by interfering with HIV treatment and prevention services, and directly, by threatening individual health. An effective response to these dual pandemics requires unprecedented collaboration to accelerate basic and clinical research, as well as implementation science to expeditiously introduce evidence-based strategies into real-world settings. This message comes from a review article co-authored by Anthony S.

NIH Statement on HIV Vaccine Awareness Day 2023

May 18, 2023

Today marks the 26th observance of HIV Vaccine Awareness Day. The National Institutes of Health applauds the efforts of the collaborative global community of scientists, advocates, study participants, study staff, and funders enabling unprecedented levels of innovation and adaptation in the pursuit of a highly effective HIV vaccine.

NIH Research Identifies Opportunities to Improve Future HIV Vaccine Candidates

December 14, 2023

An effective HIV vaccine may need to prompt strong responses from immune cells called CD8+ T cells to protect people from acquiring HIV, according to a new study from researchers at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and colleagues. The study findings, appearing in Science, draw comparisons between the immune system activity of past HIV vaccine study participants and people with HIV who naturally keep the virus from replicating even in the absence of antiretroviral therapy (ART).

Combination Anti-HIV Antibody Infusions Suppress Virus for Prolonged Period

June 1, 2022

Individuals with HIV who began taking antiretroviral therapy (ART) in the early stages of infection achieved a lengthy period of HIV suppression without ART after receiving two broadly neutralizing anti-HIV antibodies (bNAbs), according to a small study published today in the journal Nature. The findings suggest that combination bNAb therapy might offer a future alternative to daily ART for people living with HIV.

Experimental mRNA HIV Vaccine Safe, Shows Promise in Animals

December 9, 2021

An experimental HIV vaccine based on mRNA—the same platform technology used in two highly effective COVID-19 vaccines—shows promise in mice and non-human primates, according to scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Their results, published in Nature Medicine, show that the novel vaccine was safe and prompted desired antibody and cellular immune responses against an HIV-like virus.

HIV Vaccine Candidate Does Not Sufficiently Protect Women Against HIV Infection

August 31, 2021

An investigational HIV vaccine tested in the “Imbokodo” clinical trial conducted in sub-Saharan Africa posed no safety concerns but did not provide sufficient protection against HIV infection, according to a primary analysis of the study data. The Phase 2b proof-of-concept study, which began in November 2017, enrolled 2,637 women ages 18 to 35 years from five countries.

Antibody Infusions Prevent Acquisition of Some HIV Strains, NIH Studies Find

January 26, 2021

NIH finds that an investigational anti-HIV antibody prevented acquisition of some HIV strains, but did not significantly reduce overall acquisition.

NIH Researchers Identify How Two People Controlled HIV After Stopping Treatment

October 28, 2021

Research led by scientists at the National Institutes of Health has identified two distinct ways that people with HIV can control the virus for an extended period after stopping antiretroviral therapy (ART) under medical supervision. This information could inform efforts to develop new tools to help people with HIV put the virus into remission without taking lifelong medication, which can have long-term side-effects. 

An Isolated Viral Load Test May Generate False Positive Results for People Using Long-Acting PrEP

July 23, 2024

A single laboratory-based HIV viral load test used by U.S. clinicians who provide people with long-acting, injectable cabotegravir (CAB-LA) HIV pre-exposure prophylaxis (PrEP) did not reliably detect HIV in a multi-country study. In the study, a single positive viral load test was frequently found to be a false positive result. However, a second viral load test with a new blood sample was able to distinguish true positive results from false positive results for all participants whose initial viral load test was positive.

Kidney Transplantation Between Donors and Recipients with HIV Is Safe

October 16, 2024

Kidney transplantation from deceased donors with HIV to recipients with HIV was safe and comparable to kidney transplantation from donors without HIV.

Experimental HIV Vaccine Regimen Safe but Ineffective, NIH Study Finds

January 18, 2023

An investigational HIV vaccine regimen tested among men who have sex with men (MSM) and transgender people was safe but did not provide protection against HIV acquisition, an independent data and safety monitoring board (DSMB) has determined. The HPX3002/HVTN 706, or “Mosaico,” Phase 3 clinical trial began in 2019 and involved 3,900 volunteers ages 18 to 60 years in Europe, North America and South America.

NIH-Developed HIV Antibodies Protect Animals in Proof-of-Concept Study

January 17, 2024

Three different HIV antibodies each independently protected monkeys from acquiring simian-HIV (SHIV) in a placebo-controlled proof-of-concept study intended to inform development of a preventive HIV vaccine for people. The antibodies—a human broadly neutralizing antibody and two antibodies isolated from previously vaccinated monkeys—target the fusion peptide, a site on an HIV surface protein that helps the virus fuse with and enter cells.

Statement—NIH Celebrates FDA Approval of Long-Acting Injectable Drug for HIV Prevention

December 21, 2021

Yesterday the U.S. Food and Drug Administration announced its first approval of a long-acting HIV prevention medication. Developed by ViiV Healthcare, the medicine is long-acting cabotegravir injected once every two months. FDA has approved the medicine for use by adults and adolescents weighing at least 35 kilograms who are at risk of sexually acquiring HIV. This milestone marks a vital expansion of biomedical HIV prevention options available to people in the United States.

Statement: Long-Acting HIV Treatment Demonstrates Efficacy in People with Challenges Taking Daily Medicine as Prescribed

February 21, 2024

Long-acting antiretroviral therapy (ART) with cabotegravir and rilpivirine was superior in suppressing HIV replication compared to daily oral ART in people who had been unable to maintain viral suppression through an oral daily regimen, according to interim data from a randomized trial. Upon review of these findings, an independent Data and Safety Monitoring Board (DSMB) recommended halting randomization and inviting all eligible study participants to take long-acting ART.

NIH Statement on Preliminary Efficacy Results of Twice-Yearly Lenacapavir for HIV Prevention in Cisgender Women

June 26, 2024

The injectable antiretroviral drug lenacapavir was safe and 100% effective as long-acting HIV pre-exposure prophylaxis (PrEP) among cisgender women in a Phase 3 clinical trial, according to top-line findings released by Gilead Sciences, Inc., the study sponsor. Lenacapavir is administered every six months, making it the most durable HIV prevention method to have shown efficacy in this population.

NIH Clinical Trial of Tuberculous Meningitis Drug Regimen Begins

December 7, 2023

A trial of a new drug regimen to treat tuberculous meningitis (TBM) has started enrolling adults and adolescents in several countries where tuberculosis (TB) is prevalent. The trial will include 330 participants aged 15 years and older who have or are likely to have TBM based on signs and symptoms, including people living with and without HIV. Because pregnant women are eligible to enroll in this study with appropriate consent, a small number of pregnant women are expected to be included.

NIAID Selects Sarah Read as Principal Deputy Director

October 2, 2024

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has named Sarah W. Read, M.D., MHS, as the principal deputy director for the institute.

NIAID Pandemic Preparedness Plan Targets ‘Prototype’ and Priority Pathogens

February 2, 2022

As the global COVID-19 pandemic continues into its third year, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is focusing on preparing for a range of other viral threats that could cause a public health emergency. For decades, NIAID has launched major research responses and developed medical countermeasures to combat multiple emerging infectious diseases, including HIV/AIDS, SARS-CoV-1, Middle East respiratory syndrome coronavirus (MERS-CoV), Ebola virus, Zika virus, and SARS-CoV-2. 

NIH Experts Review Monkeypox Challenges

August 24, 2022

Lessons learned from the public health responses to the HIV and COVID-19 pandemics should help guide the response to the current outbreak of monkeypox, National Institutes of Health experts write in an editorial published today in the New England Journal of Medicine. Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), and H.

World TB Day 2022—Invest to End TB. Save Lives

March 24, 2022

Today marks the 140th anniversary of the announcement by Dr. Robert Koch that tuberculosis (TB) is caused by the bacterium Mycobacterium tuberculosis. World TB Day is a reminder that this ancient disease remains a relentless killer. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, affirms its commitment to the 2022 World TB Day theme, Invest to End TB. Save Lives, by supporting and conducting wide-ranging research aimed at reducing the health and economic impacts of TB.

World TB Day 2024 – Yes! We Can End TB!

March 22, 2024

In observance of World Tuberculosis Day (Sunday, March 24), NIAID joins our partners in reaffirming our commitment to ending the tuberculosis (TB) pandemic while honoring the lives lost to TB disease.

Dr. Fauci Reflects on the Perpetual Challenge of Infectious Diseases

November 28, 2022

Once considered a potentially static field of medicine, the discipline of studying infectious diseases has proven to be dynamic as emerging and reemerging infectious diseases present continuous challenges, Anthony S. Fauci, M.D., writes in a perspective in The New England Journal of Medicine. In the piece, Dr. Fauci, who since 1984 has directed the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, reflects on his career responding to infectious disease threats. Dr.

Statement by Anthony S. Fauci, M.D.

August 22, 2022

I am announcing today that I will be stepping down from the positions of Director of the National Institute of Allergy and Infectious Diseases (NIAID) and Chief of the NIAID Laboratory of Immunoregulation, as well as the position of Chief Medical Advisor to President Joe Biden. I will be leaving these positions in December of this year to pursue the next chapter of my career.

NIAID Appoints Ted Pierson as New Vaccine Research Center Director

April 25, 2023

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has named Theodore (Ted) C. Pierson, Ph.D., as the new director of its Dale and Betty Bumpers Vaccine Research Center (VRC) in Bethesda, MD.