Developing tuberculosis vaccines for people with HIV: consensus statements from an international expert panel

Maurine D Miner¹, Mark Hatherill², Vidya Mave³, Glenda E Gray⁴, Sharon Nachman⁵, Sarah W Read⁶, Richard G White⁷, Anneke Hesseling⁸, Frank Cobelens⁹, Sheral Patel¹⁰, Mike Frick¹¹, Theodore Bailey¹², Robert Seder¹³, Joanne Flynn¹⁴, Jyothi Rengarajan¹⁵, Deepak Kaushal¹⁶, Willem Hanekom¹⁷, Alexander C Schmidt¹⁸, Thomas J Scriba², Elisa Nemes², Erica Andersen-Nissen¹⁹, Alan Landay²⁰, Susan E Dorman²¹, Grace Aldrovandi²², Lisa M Cranmer¹⁵, Cheryl L Day¹⁵, Alberto L Garcia-Basteiro²³, Andrew Fiore-Gartland¹, Robin Mogg²⁴, James G Kublin¹, Amita Gupta²⁵, Gavin Churchyard²⁶

Affiliations

¹ Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
² South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.
³ Johns Hopkins India, Byramjee-Jeejeebhoy Government Medical College Clinical Research Site, Pune, India.
⁴ South African Medical Research Council, Cape Town, South Africa.
⁵ Department of Pediatrics, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, USA.
⁶ Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
⁷ Department of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK.
⁸ Desmond Tutu Tuberculosis Centre, Stellenbosch University, Stellenbosch, South Africa.
⁹ Department of Global Health, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.
¹⁰ US Food and Drug Administration, Silver Spring, MD, USA.
¹¹ Treatment Action Group, New York, NY, USA.
¹² Greater Baltimore Medical Center, Baltimore, MD, USA.
¹³ Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
¹⁴ Microbiology and Molecular Genetics, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
¹⁵ Emory School of Medicine, Emory University, Atlanta, GA, USA.
¹⁶ Texas Biomedical Research Institute, San Antonio, TX, USA.
¹⁷ Africa Health Research Institute, Durban, KwaZulu-Natal, South Africa.
¹⁸ Gates Medical Research Institute, Boston, MA, USA.
¹⁹ Fred Hutchinson Cancer Research Center, Seattle, WA, USA; Cape Town HIV Vaccine Trials Network (HVTN) Immunology Laboratory, Cape Town, South Africa.
²⁰ Rush Medical Center, Chicago, IL, USA.
²¹ Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.
²² Department of Pediatrics, University of California, Los Angeles, CA, USA.
²³ ISGlobal, Hospital Clínic Universitat de Barcelona, Barcelona, Spain; Centro de investigação de Saúde de Manhiça, Maputo, Mozambique.
²⁴ Takeda Pharmaceutical Company, Cambridge, MA, USA.
²⁵ Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
²⁶ The Aurum Institute, Johannesburg, South Africa; School of Public Health, University of Witwatersrand, Johannesburg, South Africa; Department of Medicine, Vanderbilt University, Nashville, TN, USA. Electronic address: gchurchyard@auruminstitute.org.

PMID: 36240834
PMCID: PMC9667733
DOI: 10.1016/S2352-3018(22)00255-7

Review

Developing tuberculosis vaccines for people with HIV: consensus statements from an international expert panel

Maurine D Miner et al. Lancet HIV. 2022 Nov.

. 2022 Nov;9(11):e791-e800.

doi: 10.1016/S2352-3018(22)00255-7. Epub 2022 Oct 11.

Authors

Affiliations

¹ Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
² South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.
³ Johns Hopkins India, Byramjee-Jeejeebhoy Government Medical College Clinical Research Site, Pune, India.
⁴ South African Medical Research Council, Cape Town, South Africa.
⁵ Department of Pediatrics, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, USA.
⁶ Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
⁷ Department of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK.
⁸ Desmond Tutu Tuberculosis Centre, Stellenbosch University, Stellenbosch, South Africa.
⁹ Department of Global Health, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.
¹⁰ US Food and Drug Administration, Silver Spring, MD, USA.
¹¹ Treatment Action Group, New York, NY, USA.
¹² Greater Baltimore Medical Center, Baltimore, MD, USA.
¹³ Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
¹⁴ Microbiology and Molecular Genetics, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
¹⁵ Emory School of Medicine, Emory University, Atlanta, GA, USA.
¹⁶ Texas Biomedical Research Institute, San Antonio, TX, USA.
¹⁷ Africa Health Research Institute, Durban, KwaZulu-Natal, South Africa.
¹⁸ Gates Medical Research Institute, Boston, MA, USA.
¹⁹ Fred Hutchinson Cancer Research Center, Seattle, WA, USA; Cape Town HIV Vaccine Trials Network (HVTN) Immunology Laboratory, Cape Town, South Africa.
²⁰ Rush Medical Center, Chicago, IL, USA.
²¹ Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.
²² Department of Pediatrics, University of California, Los Angeles, CA, USA.
²³ ISGlobal, Hospital Clínic Universitat de Barcelona, Barcelona, Spain; Centro de investigação de Saúde de Manhiça, Maputo, Mozambique.
²⁴ Takeda Pharmaceutical Company, Cambridge, MA, USA.
²⁵ Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
²⁶ The Aurum Institute, Johannesburg, South Africa; School of Public Health, University of Witwatersrand, Johannesburg, South Africa; Department of Medicine, Vanderbilt University, Nashville, TN, USA. Electronic address: gchurchyard@auruminstitute.org.

PMID: 36240834
PMCID: PMC9667733
DOI: 10.1016/S2352-3018(22)00255-7

Erratum in

Correction to Lancet HIV 2022; 9: e791-800.
[No authors listed] [No authors listed] Lancet HIV. 2022 Dec;9(12):e822. doi: 10.1016/S2352-3018(22)00334-4. Epub 2022 Nov 10. Lancet HIV. 2022. PMID: 36372080 No abstract available.

Abstract

New tuberculosis vaccine candidates that are in the development pipeline need to be studied in people with HIV, who are at high risk of acquiring Mycobacterium tuberculosis infection and tuberculosis disease and tend to develop less robust vaccine-induced immune responses. To address the gaps in developing tuberculosis vaccines for people with HIV, a series of symposia was held that posed six framing questions to a panel of international experts: What is the use case or rationale for developing tuberculosis vaccines? What is the landscape of tuberculosis vaccines? Which vaccine candidates should be prioritised? What are the tuberculosis vaccine trial design considerations? What is the role of immunological correlates of protection? What are the gaps in preclinical models for studying tuberculosis vaccines? The international expert panel formulated consensus statements to each of the framing questions, with the intention of informing tuberculosis vaccine development and the prioritisation of clinical trials for inclusion of people with HIV.

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Conflict of interest statement

Declaration of interests We declare no competing interests.

Figures

**Figure 1.. TB vaccine pipeline in 2021.**
Ongoing trials were identified through clinicaltrials.gov, WHO International Clinical Trials Registry, and Clinical Trials Registry of India. Upcoming or planned trials were identified by references –. Figure adapted from reference .

See this image and copyright information in PMC

References

1. WHO. WHO Global TB Report 2021. https://www.who.int/teams/global-tuberculosis-programme/tb-reports/globa...; 2021.
1. Kwan CK, Ernst JD. HIV and tuberculosis: a deadly human syndemic. Clin Microbiol Rev. 2011;24(2):351–76. - PMC - PubMed
1. Bell LCK, Noursadeghi M. Pathogenesis of HIV-1 and Mycobacterium tuberculosis co-infection. Nat Rev Microbiol. 2018;16(2):80–90. - PubMed
1. Bunjun R, Soares AP, Thawer N, Muller TL, Kiravu A, Ginbot Z, et al. Dysregulation of the Immune Environment in the Airways During HIV Infection. Front Immunol. 2021;12:707355. - PMC - PubMed
1. Corleis B, Bucsan AN, Deruaz M, Vrbanac VD, Lisanti-Park AC, Gates SJ, et al. HIV-1 and SIV Infection Are Associated with Early Loss of Lung Interstitial CD4+ T Cells and Dissemination of Pulmonary Tuberculosis. Cell Rep. 2019;26(6):1409–18 e5. - PMC - PubMed

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Developing tuberculosis vaccines for people with HIV: consensus statements from an international expert panel

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Developing tuberculosis vaccines for people with HIV: consensus statements from an international expert panel

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