Safety and efficacy of BCG re-vaccination in relation to COVID-19 morbidity in healthcare workers: A double-blind, randomised, controlled, phase 3 trial

Morbidity and mortality attributable to COVID-19 is devastating global health systems and economies. Bacillus Calmette Guérin (BCG) vaccination has been in use for many decades to prevent severe forms of tuberculosis in children. Studies have also shown a combination of improved long-term innate or trained immunity (through epigenetic reprogramming of myeloid cells) and adaptive responses after BCG vaccination, which leads to non-specific protective effects in adults. Observational studies have shown that countries with routine BCG vaccination programs have significantly less reported cases and deaths of COVID-19, but such studies are prone to significant bias and need confirmation. To date, in the absence of direct evidence, WHO does not recommend BCG for the prevention of COVID-19. This project aims to investigate in a timely manner whether and why BCG-revaccination can reduce infection rate and/or disease severity in health care workers during the SARS-CoV-2 outbreak in South Africa...., This dataset was collected in a clinical randomised control trial under the TASK008-BCG CORONA protocol. The trial was conducted in South Africa. This trial was registered with ClinicalTrials.gov, NCT04379336., , # **Data from: Safety and efficacy of BCG re-vaccination in relation to COVID-19 morbidity in healthcare workers: A double-blind, randomised, controlled, phase 3 trial**

The TASK008-BCG CORONA SDTM datasets contains all the study data collected under the TASK008-BCG CORONA protocol. The data is in the raw format of information captured onto the electronic Case Report Forms from the source documentation.

**Description of the data and file structure**

The TASK008-BCG CORONA SDTM datasets contain the study data in the CDISC SDTM format. The following CDISC SDTM domains were reported in the datasets:

AE - Adverse Events

CM - Concomitant Medication

DM - Demographics

DS - Disposition

EX - Exposure

IE - Inclusion and Exclusion Criteria

LB - Laboratory Findings

MH - Medical History

SV - Subject Visits

VS - Vital Signs

File Formats: The datasets are in both .CSV and .sas7bdat (include 1 SAS formats. catalogue) Below is the structure of each domain

| **AE (Adverse Events) Domain** ...