SARS-CoV-2 post-vaccine surveillance studies in Australian children and adults with cancer: SerOzNET Quality of Life, Toxicity and Vaccine Beliefs Substudy Statistical Analysis Plan

Abstract

COVID-19 disease is associated with higher morbidity and mortality in cancer patients. SerOzNET is a prospective cohort study of adults and children with cancer undergoing routine SARS-CoV-2 vaccination in Australia. Peripheral blood was collected and processed at multiple points (one pre-vaccination and five or more post-vaccination) to address the primary aim of the study to assess the serological and immunological responses to vaccination. A secondary aim of the study was to document patient response to vaccination using qualitative measures, including patient-reported outcomes, vaccine hesitancy survey and post-hoc toxicity recording (body, et al.,2022). This statistical analysis plan describes the analysis of the data collected to address this aim. We will refer to this as the SerOzNET QoL Substudy.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Protocols

https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-021-07019-1

Funding Statement

This study was partially funded by Cancer Australia, Victorian Cancer Agency and The Leukaemia Foundation (Australia)

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Monash Human Research and Ethics Committee gave ethical approval for this work.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors.

留言 (0)

沒有登入
gif