. 2024 Jul 17;25(1):485.

doi: 10.1186/s13063-024-08315-2.

Bringing optimised COVID-19 vaccine schedules to immunocompromised populations (BOOST-IC): study protocol for an adaptive randomised controlled clinical trial

David W J Griffin¹, Michael Dymock², Germaine Wong^{3

4

5}, C Orla Morrissey⁶, Sharon R Lewin^{6

7

8}, Allen C Cheng^{9

10}, Kirsten Howard^{5

11}, Julie A Marsh^{2

12}, Kanta Subbarao^{13

14}, Michelle Hagenauer⁶, Janine Roney⁶, Anthony Cunningham¹⁵, Tom Snelling⁵, James H McMahon^{6

9}

Affiliations

¹ Department of Infectious Diseases, Alfred Hospital and School of Translational Medicine, Monash University, Melbourne, Australia. d.griffin@alfred.org.au.
² Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Perth, Australia.
³ Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, NSW, Australia.
⁴ Department of Renal Medicine, Westmead Hospital, Westmead, NSW, Australia.
⁵ Sydney School of Public Health, Faculty of Medicine & Health, University of Sydney, Sydney, NSW, Australia.
⁶ Department of Infectious Diseases, Alfred Hospital and School of Translational Medicine, Monash University, Melbourne, Australia.
⁷ Department of Infectious Diseases, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.
⁸ Victorian Infectious Diseases Service, Royal Melbourne Hospital, at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.
⁹ Department of Infectious Diseases, Monash Medical Centre, Melbourne, Australia.
¹⁰ Monash University School of Clinical Sciences at Monash Health, Clayton, Australia.
¹¹ Menzies Centre for Health Policy and Economics, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
¹² Centre for Child Health Research, School of Medicine, The University of Western Australia, Perth, Australia.
¹³ WHO Collaborating Centre for Reference and Research On Influenza at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.
¹⁴ Department of Microbiology and Immunology, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.
¹⁵ Westmead Institute for Medical Research, University of Sydney, Sydney, NSW, Australia.

PMID: 39020446
PMCID: PMC11253462
DOI: 10.1186/s13063-024-08315-2

Bringing optimised COVID-19 vaccine schedules to immunocompromised populations (BOOST-IC): study protocol for an adaptive randomised controlled clinical trial

David W J Griffin et al. Trials. 2024.

. 2024 Jul 17;25(1):485.

doi: 10.1186/s13063-024-08315-2.

Authors

Affiliations

¹ Department of Infectious Diseases, Alfred Hospital and School of Translational Medicine, Monash University, Melbourne, Australia. d.griffin@alfred.org.au.
² Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Perth, Australia.
³ Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, NSW, Australia.
⁴ Department of Renal Medicine, Westmead Hospital, Westmead, NSW, Australia.
⁵ Sydney School of Public Health, Faculty of Medicine & Health, University of Sydney, Sydney, NSW, Australia.
⁶ Department of Infectious Diseases, Alfred Hospital and School of Translational Medicine, Monash University, Melbourne, Australia.
⁷ Department of Infectious Diseases, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.
⁸ Victorian Infectious Diseases Service, Royal Melbourne Hospital, at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.
⁹ Department of Infectious Diseases, Monash Medical Centre, Melbourne, Australia.
¹⁰ Monash University School of Clinical Sciences at Monash Health, Clayton, Australia.
¹¹ Menzies Centre for Health Policy and Economics, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
¹² Centre for Child Health Research, School of Medicine, The University of Western Australia, Perth, Australia.
¹³ WHO Collaborating Centre for Reference and Research On Influenza at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.
¹⁴ Department of Microbiology and Immunology, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.
¹⁵ Westmead Institute for Medical Research, University of Sydney, Sydney, NSW, Australia.

PMID: 39020446
PMCID: PMC11253462
DOI: 10.1186/s13063-024-08315-2

Abstract

Background: Immunocompromised hosts (ICH) experience more breakthrough infections and worse clinical outcomes following infection with COVID-19 than immunocompetent people. Prophylactic monoclonal antibody therapies can be challenging to access, and escape variants emerge rapidly. Immunity conferred through vaccination remains a central prevention strategy for COVID-19. COVID-19 vaccines do not elicit optimal immunity in ICH but boosting, through additional doses of vaccine improves humoral and cellular immune responses. This trial aims to assess the immunogenicity and safety of different COVID-19 vaccine booster strategies against SARS-CoV-2 for ICH in Australia.

Methods: Bringing optimised COVID-19 vaccine schedules to immunocompromised populations (BOOST-IC) is an adaptive randomised trial of one or two additional doses of COVID-19 vaccines 3 months apart in people living with HIV, solid organ transplant (SOT) recipients, or those who have haematological malignancies (chronic lymphocytic leukaemia, non-Hodgkin lymphoma or multiple myeloma). Key eligibility criteria include having received 3 to 7 doses of Australian Therapeutic Goods Administration (TGA)-approved COVID-19 vaccines at least 3 months earlier, and having not received SARS-CoV-2-specific monoclonal antibodies in the 3 months prior to receiving the study vaccine. The primary outcome is the geometric mean concentration of anti-spike SARS-CoV-2 immunoglobulin G (IgG) 28 days after the final dose of the study vaccine. Key secondary outcomes include anti-spike SARS-CoV-2 IgG titres and the proportion of people seroconverting 6 and 12 months after study vaccines, local and systemic reactions in the 7 days after vaccination, adverse events of special interest, COVID-19 infection, mortality and quality of life.

Discussion: This study will enhance the understanding of COVID-19 vaccine responses in ICH, and enable the development of safe, and optimised vaccine schedules in people with HIV, SOT, or haematological malignancy.

Trial registration: ClinicalTrials.gov NCT05556720. Registered on 23rd August 2022.

Keywords: COVID-19; Chronic lymphocytic leukaemia; HIV; Immunisation; Multiple myeloma; Non-Hodgkin lymphoma; RCT; Solid organ transplantation; mRNA vaccine.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

**Fig. 1**
Trial design if a) one COVID-19 vaccine is included in the trial, b) if two COVID-19 vaccines are included in the trial, and c) if three COVID-19 vaccines are included in the trial

See this image and copyright information in PMC

References

1. Weerasuria M, Ko C, Ehm A, O'Bryan J, McMahon J, Woolley I, et al. The impact of the COVID-19 pandemic on people living with HIV in Victoria, Australia. AIDS Res Hum Retroviruses. 2021;37(4):322–328. doi: 10.1089/aid.2021.0007. - DOI - PubMed
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1. Yamanaga S, Shimata K, Ohfuji S, Yoshikawa M, Natori Y, Hibi T, Yuzawa K, Egawa H. Japan Society for Transplantation COVID-19 Registry Study Group. Excess mortality in COVID-19-affected solid organ transplant recipients across the pandemic. Am J Transplant[Internet]. 2024. [Cited 2024 April 10]. Available from: https://www.amjtransplant.org/article/S1600-6135(24)00212-0/fulltext. 10.1016/j.ajt.2024.03.016. Epub ahead of print. - PubMed

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Bringing optimised COVID-19 vaccine schedules to immunocompromised populations (BOOST-IC): study protocol for an adaptive randomised controlled clinical trial

Affiliations

Bringing optimised COVID-19 vaccine schedules to immunocompromised populations (BOOST-IC): study protocol for an adaptive randomised controlled clinical trial

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Substances

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Medical

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