The NIH/DAIDS Crossover Network (ACTG/HVTN/IMPAAC | EurekAlert!

SEATTLE – (OCTOBER 11, 2022) – People living with HIV must be included in clinical trials of new TB vaccine candidates currently in development, say experts from an international group convened last year to fill gaps in current TB vaccine landscape tuberculosis.

Their recommendations, which appear in a new article published on October 11, 2022, in The Lancet HIVare designed to shape the future of TB vaccine development and help ensure that people living with HIV have access to safe and effective TB vaccines, such as those intended for the general population.

The panel was convened by the DAIDS Cross-Network TB Vaccine Working Group consisting of the HIV Vaccine Trials Network (HVTN), the AIDS Clinical Trials Group (ACTG) and the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT). The three networks worked in collaboration with the National Institutes of Health, the National Institute of Allergy and Infectious Diseases (NIAID) and its Division of AIDS.

Gathered at a series of symposia in January and February 2021, panel members developed consensus statements that serve as policy recommendations designed to address current TB vaccine gaps and prioritize clinical trials for people living with HIV.

“People living with HIV are at high risk for TB infection and subsequent disease and tend to develop less robust vaccine-induced immune responses,” said James G. Kublin, MD, executive director of HVTN. , based at the Fred Hutchinson Cancer Center, and co-lead author of the paper. “Yet many questions remain unanswered about developing an effective TB vaccine for this group.”

Background

Tuberculosis was responsible for 1.5 million deaths in 2020 and continues to pose a threat to global health, especially for people living in countries with a high incidence of tuberculosis. The World Health Organization estimated that nearly 10 million people developed the disease in 2020, 8% of whom were co-infected with HIV. This resulted in nearly 800,000 diagnosed cases which caused some 214,000 deaths among people living with HIV.

The paper notes that people living with HIV are 15 to 21 times more likely to develop TB and die from it than those who are not living with HIV. This is likely due to HIV-associated immunosuppression leading to a weaker immune response and lower vaccine efficacy for people living with HIV.

“TB remains the leading cause of morbidity and mortality among people living with HIV, and people with advanced HIV disease are at the highest risk of contracting TB,” said Gavin Churchyard, MBBCH, FCP (SA), FRCP (Edin), MMED, PhD, Founder and CEO of The Aurum Institute NPC, Fellow of HVTN and ACTG, and co-lead author of the paper. “Even with antiretroviral therapy (ART) lowering viral loads to undetectable levels, people living with HIV remain at significantly higher risk of TB and worse outcomes than the general population.”

Additionally, people living with HIV have always been excluded from TB vaccine trials so that developers can maximize the ability to demonstrate strong immunity and efficacy with their candidate vaccines, Kublin explained. There have also been concerns about the use of live attenuated vaccines, such as Bacillus Calmette-Guérin (BCG), in people living with HIV who are not on ART, for fear of spreading live bacteria.

It is important to note that even among people living with HIV, certain communities are often excluded from TB vaccine trials – children, adolescents and pregnant women.

“It is critical that people living with HIV throughout their lives are included in TB vaccine trials,” said Amita Gupta, MD, MHS, FIDSA, director of the Division of Infectious Diseases at Johns Hopkins School. of Medicine, vice-president of IMPAACT. Tuberculosis Scientific Committee and co-author of the study. “Data on children, adolescents and pregnant women is essential but is often slow to be generated. TB elimination goals require new TB vaccines, and we need to focus on those populations that are at particularly high risk of post-exposure TB,” Gupta added.

Gap in the new roadmap

Recently, the Amsterdam Institute for Global Health and Development, in cooperation with the European and Developing Countries Clinical Trials Partnership, produced a comprehensive roadmap with short and long-term goals for research and the development of tuberculosis vaccines.

But the roadmap had one glaring omission: it did not specifically address TB vaccines for people living with HIV.

“This surveillance served as the impetus to convene the expert panel to make strategic recommendations to close these gaps for people living with HIV and set priorities for future TB vaccines,” Kublin said.

“Our paper with the panel’s recommendations makes the case for including people living with HIV in the clinical development of TB vaccines as early as possible,” Churchyard concluded. “This will help maximize the safety and effectiveness of TB vaccines for this at-risk group while benefiting the population as a whole.”

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DOI: 10.1016/S2352-3018

Post-embargo link: https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00255-7/fulltext

About the HIV Vaccine Trials Network (HVTN)

HVTN is an international collaboration based at the Fred Hutchinson Cancer Center in Seattle to facilitate the evaluation of vaccines to prevent HIV/AIDS, as well as tuberculosis and COVID-19. It is the largest publicly funded international collaboration in the world facilitating the evaluation of vaccines to prevent HIV/AIDS. The HVTN helps advance the field of vaccinology, social and behavioral sciences, statistics and immunology, as well as tuberculosis and COVID-19 vaccines. The mission of the HVTN is to fully characterize the safety, immunogenicity, and efficacy of candidate HIV vaccines with the goal of developing a safe and effective vaccine for the prevention of HIV worldwide as quickly as possible. Funding is provided by public and private sources. The US National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) is the primary funder and sponsor of the majority of trials conducted by the HVTN. The network’s headquarters are at the Fred Hutchinson Cancer Center in Seattle, Washington.

About ACTG

Founded in 1987, the AIDS Clinical Trials Group (ACTG) was the world’s first HIV research network. The ACTG carries out innovative studies to improve the treatment of HIV and its complications, in particular tuberculosis and viral hepatitis; reduce new HIV infections and illnesses; and advancing new approaches to prevent, treat and ultimately cure HIV in adults and children. More recently, the ACTG has expanded its scope to include the evaluation of outpatient treatments for COVID-19 and monkeypox. ACTG investigators and research units in 15 countries are major resources for research, treatment, care and training/education on HIV/AIDS, tuberculosis and viral hepatitis in their communities. ACTG studies have helped establish the current paradigms for the management of these infectious diseases and have informed many treatment guidelines.

About the IMPAACT Network

The IMPAACT (International Maternal Pediatric Adolescent AIDS Clinical Trials) network is a global collaboration of investigators, institutions, community representatives and other partners organized to evaluate interventions for the prevention and treatment of HIV and complications and comorbidities associated with HIV in infants. , children and adolescents, as well as during pregnancy and postpartum through the conduct of high quality clinical trials. The network evaluates new and sustainable treatments for HIV and tuberculosis, HIV remission/cure strategies without antiretroviral treatment and strategies to treat complications and comorbidities affecting these populations of interest with or at risk of HIV. IMPAACT trials have led to changes in global HIV and TB treatment guidelines and the licensing of new antiretrovirals (ARVs) and new formulations of ARVs as well as the development of other interventions for these populations keys. The network is funded primarily by the National Institute of Allergy and Infectious Diseases (NIAID), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and the National Institute of Mental Health (NIMH).

MEDIA CONTACTS:

HVTN
sand van
[email protected]
808.206.4576

ACTG
Jenna Conley
[email protected]
215.684.9476

IMPACT NETWORK
Kyle Hayden
[email protected]
919-544-7040


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