People with HIV should participate in tuberculosis vaccine trials, new recommendations say
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Experts say that people with HIV should be included in clinical trials for new tuberculosis vaccine candidates in the pipeline, according to newly written recommendations published in The Lancet HIV.
Recent WHO data show that TB leads to 1.5 million deaths in 2020, with nearly 10 million people developing TB that same year — 8% of whom were also infected with HIV. These data mean that almost 800,000 diagnosed cases that caused roughly 214,000 deaths were among people with HIV.
Further data showed that people living with HIV have a 15- to 21-fold greater likelihood of developing TB and dying from it, which researchers say is likely due to HIV-associated immunosuppression and lower vaccine efficacy 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,” James G. Kublin, MD, executive director of the HIV Vaccine Trials Network (HVTN) based out of the Fred Hutchinson Cancer Center, said in a press release. “Yet, many questions remain unanswered about developing an effective TB vaccine for this group.”
To best address the gaps in developing TB vaccines for people with HIV, a series of symposia was held that posed six questions to international experts: What is the use case or rationale for developing TB vaccines? What is the landscape of TB vaccines? Which vaccine candidates should be prioritized? What are the TB vaccine trial design considerations? What is the role of immunological correlates of protection? What are the gaps in preclinical models for studying TB vaccines?
Kublin and other members of the HVTN panel convened by the DAIDS Cross-Network TB Vaccine Working Group, worked collaboratively with other expert groups to develop strategic recommendations based on these questions to ensure people with HIV have access to safe and effective vaccines that are available to the general population.
Based on these goals and the questions posed, the researchers recommend that trials include people with HIV, with careful consideration of safety, immunogenicity and efficacy specific to people with HIV. They added that for people with HIV regardless of age, subunit protein or adjuvanted TB vaccines and inactivated mycobacterial vaccines should be prioritized, followed by nonreplicating viral-vectored vaccines.
Additionally, as live-attenuated vaccines are being developed for infants, the researchers say it will be important to know the safety, immunogenicity, and efficacy of these vaccines in infants with HIV on ART. Building further on this, they wrote that the evaluation of immunogenicity and safety of novel live-attenuated vaccines early in development is encouraged and that novel vaccine platforms such as messenger RNA and DNA should be prioritized for evaluation among people with HIV, including infants and children.
The experts also recommend that all people with HIV involved in the TB vaccine trials be on ART and should have either completed a course of TB preventive treatment (TPT) before enrolment or be offered TPT during the study.
Finally, they recommend that correlates of protection and other immunogenicity endpoints identified in people without HIV should be applied to and evaluated in people with HIV with immune-bridging studies.
“It is critical that persons living with HIV across the lifespan be included in TB vaccine trials,” Amita Gupta, MD, MHS, FIDSA, director of the Division of Infectious Diseases at Johns Hopkins School of Medicine and vice-chair of the IMPAACT TB Scientific Committee, said in a press release. “Data for children, adolescents and pregnant women are much needed but are often slow to be generated. The goals of TB elimination require novel TB vaccines, and we must focus on these populations who are at especially high risk for TB disease after exposure.”
References:
- Miner MD, et al. Lancet HIV. 2022;doi:10.1016/S2352-3018(22)00255-7.
- The NIH/DAIDS Cross-Network (ACTG/HVTN/IMPAACT) TB Vaccine Working Group calls for people living with HIV to be included in tuberculosis vaccine development. https://www.eurekalert.org/news-releases/967579. Published Oct. 11, 2022. Accessed Oct. 12, 2022.
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