Evidence map›Paper›PMID 39020446›Full record

ArticleTrials2024

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

David W J Griffin, Michael Dymock, Germaine Wong, C Orla Morrissey, Sharon R Lewin, Allen C Cheng, Kirsten Howard, Julie A Marsh, Kanta Subbarao, Michelle Hagenauer and 4 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05556720 (Bringing Optimised COVID-19 Vaccine Schedules To ImmunoCompromised Populations), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05556720 phase3active not recruitingnot on this map

Bringing Optimised COVID-19 Vaccine Schedules To ImmunoCompromised Populations (BOOST-IC): an Adaptive Randomised Controlled Clinical Trial

TypeinterventionalSponsorMonash UniversityRan2022 to 2026Enrolled960ConditionsHIV, Organ Transplantation, Lymphoma, Non-Hodgkin, Chronic Lymphocytic LeukemiaArmsPfizer Bivalent COVID-19 Vaccine, Moderna Bivalent mRNA vaccine
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

David W J GriffinDepartment of Infectious Diseases, Alfred Hospital and School of Translational Medicine, Monash University, Melbourne, Australia. d.griffin@alfred.org.au.ORCID http://orcid.org/0000-0001-9249-1780
Michael DymockWesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Perth, Australia.
Germaine WongCentre for Kidney Research, The Children's Hospital at Westmead, Westmead, NSW, Australia.
C Orla MorrisseyDepartment of Infectious Diseases, Alfred Hospital and School of Translational Medicine, Monash University, Melbourne, Australia.
Sharon R LewinDepartment of Infectious Diseases, Alfred Hospital and School of Translational Medicine, Monash University, Melbourne, Australia.
Allen C ChengDepartment of Infectious Diseases, Monash Medical Centre, Melbourne, Australia.
Kirsten HowardSydney School of Public Health, Faculty of Medicine & Health, University of Sydney, Sydney, NSW, Australia.
Julie A MarshWesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Perth, Australia.
Kanta SubbaraoWHO Collaborating Centre for Reference and Research On Influenza at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.
Michelle HagenauerDepartment of Infectious Diseases, Alfred Hospital and School of Translational Medicine, Monash University, Melbourne, Australia.
Janine RoneyDepartment of Infectious Diseases, Alfred Hospital and School of Translational Medicine, Monash University, Melbourne, Australia.
Anthony CunninghamWestmead Institute for Medical Research, University of Sydney, Sydney, NSW, Australia.
Tom SnellingSydney School of Public Health, Faculty of Medicine & Health, University of Sydney, Sydney, NSW, Australia.
James H McMahonDepartment of Infectious Diseases, Alfred Hospital and School of Translational Medicine, Monash University, Melbourne, Australia.

Funding

National Health and Medical Research Council MRF2014921
6 · The paper itself

Abstract

backgroundImmunocompromised 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.

methodsBringing 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 registrationClinicalTrials.gov NCT05556720. Registered on 23rd August 2022.

Indexed as

COVID-19COVID-19 VaccinesImmunization ScheduleImmunocompromised HostSARS-CoV-2AdultAustraliaHumansImmunization, SecondaryImmunogenicity, VaccineRandomized Controlled Trials as TopicTime FactorsCOVID-19 VaccinesChronic lymphocytic leukaemiaCOVID-19HIVImmunisationmRNA vaccineMultiple myelomaNon-Hodgkin lymphomaRCTSolid organ transplantation

Identifiers

PMID39020446
PMCPMC11253462

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.