DOI: 10.5061/dryad.7m0cfxq2r
title: 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

description: 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.  These objectives
 will be achieved with a blinded, randomised controlled trial of BCG
 revaccination versus placebo in exposed front-line staff in
 hospitals in Cape Town. Observations will include the rate
 of infection with COVID-19 as well as the occurrence of mild,
 moderate or severe ambulatory respiratory tract infections,
 hospitalisation, need for oxygen, mechanical ventilation or death.
 HIV-positive individuals will be excluded. Safety of the vaccines
 will be monitored. A secondary endpoint is the occurrence of
 latent or active tuberculosis. Initial sample size and follow-up duration
 is at least 500 workers and 52 weeks. Statistical analysis will
 be model-based and ongoing in real time with frequent interim
 analyses and optional increases of both sample size or observation time,
 based on the unforeseeable trajectory of the South African
 COVID-19 epidemic, available funds and recommendations of an
 independent data and safety monitoring board. The study will be supported
 by a novel 3D lung organoid model of SARS-CoV-2 infection system
 that can mimic the cascade of immunological events after
 SARS-CoV-2 infection to determine and analyse the contribution of cellular
 components to the impact of BCG revaccination in this study.
 Given the immediate threat of the SARS-CoV-2 epidemic the trial has been
 designed as a pragmatic study with highly feasible endpoints that
 can be continuously measured. This allows for the most
 rapid identification of a beneficial outcome that would lead to
 immediate dissemination of the results, vaccination of the
 control group and outreach to the health authorities to consider BCG
 vaccination for all qualifying health care workers.
description: 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.
description: # **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** | | | | | | | |
 :----------------------------- | ----------------- | -------- | ------- |
 ---------- | ------------ |
 ------------------------------------------------------------------- | |
 **#** | **Variable** | **Type** | **Len** | **Format** | **Informat** |
 **Label** | | **1** | STUDYID | Char | 18 |   |   |  Study ID | | **2** |
 TRTGRP | Char | 200 | $GROUPS. |   | Treatment Group | | **3** | USUBJID |
 Char | 7 | $7. | $7. | Unique Participant ID | | **4** | AESPID | Num | 8
 | BEST12. | BEST32. | AE Sponsor ID | | **5** | AECAT | Char | 5 | $5. |
 $5. | AE Category | | **6** | AEPT | Char | 41 | $41. | $41. | AE MedDRA
 Preferred Term | | **7** | AEPTCD | Num | 8 | BEST12. | BEST32. | AE
 MedDRA Preferred Term Code | | **8** | AEHLGT | Char | 86 | $86. | $86. |
 AE MedDRA High Level Group Term | | **9** | AEHLGTCD | Num | 8 | BEST12. |
 BEST32. | AE MedDRA High Level Group Term Code | | **10** | AEHLT | Char |
 70 | $70. | $70. | AE MedDRA High Level Term | | **11** | AEHLTCD | Num |
 8 | BEST12. | BEST32. | AE MedDRA High Level Term Code | | **12** | AELLT
 | Char | 79 | $79. | $79. | AE MedDRA Lower Level Term | | **13** |
 AELLTCD | Num | 8 | BEST12. | BEST32. | AE MedDRA Lower Level Term Code |
 | 14 | AESTDTC | Num | 8 | YYMMDD10. | YYMMDD10. | Anonymised AE Start
 Date (Number of Days after Study Day 1) | | 15 | AEENDTC | Num | 8 |
 YYMMDD10. | YYMMDD10. | Anonymised AE End Date (Number of Days after Study
 Day 1) | | **16** | AEENDTFU | Num | 8 | YYMMDD10. | YYMMDD10. |
 Anonymised AE End Follow Up Date (Number of Days after Study Day 1) | |
 **17** | AEOUT | Char | 500 | $9. | $9. | AE Outcome | | **18** | AEOUTFU
 | Char | 500 | $9. | $9. | AE Outcome Follow Up | | **10** | AEONGO | Char
 | 3 | $3. | $3. | AE Ongoing? | | 20 | AESEV | Num | 8 | BEST12. | BEST32.
 | AE Severity | | 21 | AEHS | Num | 8 | BEST12. | BEST32. | AE Highest
 Score | | 22 | AEHSFU | Num | 8 | BEST12. | BEST32. | AE Highest Score
 Follow Up | | 23 | AESER | Char | 3 | $3. | $3. | AE Seriousness | | 24 |
 AESERCRIT | Char | 28 | $28. | $28. | AE Seriousness Criteria | | 25 |
 AEDEATH | Char | 29 | $29. | $29. | AE Death | | 26 | AEREL | Char | 16 |
 $16. | $16. | AE Relationship to IP | | 27 | AEREPDT | Num | 8 | YYMMDD10.
 | YYMMDD10. | Anonymised AE Report Date (Number of Days after Study Day 1)
 | | 28 | AEFUDT1 | Num | 8 | YYMMDD10. | YYMMDD10. | Anonymised AE Follow
 Up Date 1 (Number of Days after Study Day 1) | | 29 | AEFUDT2 | Num | 8 |
 YYMMDD10. | YYMMDD10. | Anonymised AE Follow Up Date 2 (Number of Days
 after Study Day 1) | | 30 | AEFUDT3 | Num | 8 | YYMMDD10. | YYMMDD10. |
 Anonymised AE Follow Up Date 3 (Number of Days after Study Day 1) | | 31 |
 OnsetHS | Char | 3 | $3. | $3. | Onset Highest Score | | 32 | AEWK1HS |
 Char | 3 | $3. | $3. | AE Week 1 Highest Score | | 33 | AEWK2HS | Char | 3
 | $3. | $3. | AE Week 2 Highest Score | | 34 | AEWK3HS | Num | 8 | BEST12.
 | BEST32. | AE Week 3 Highest Score | | 35 | AEWK4HS | Num | 8 | BEST12. |
 BEST32. | AE Week 4 Highest Score | | 36 | AEWK5HS | Num | 8 | BEST12. |
 BEST32. | AE Week 5 Highest Score | | 37 | AEWK6HS | Num | 8 | BEST12. |
 BEST32. | AE Week 6 Highest Score | | 38 | AEWK7HS | Num | 8 | BEST12. |
 BEST32. | AE Week 7 Highest Score | | 39 | AEWK8HS | Num | 8 | BEST12. |
 BEST32. | AE Week 8 Highest Score | | 40 | AEWK9HS | Num | 8 | BEST12. |
 BEST32. | AE Week 9 Highest Score | | 41 | AEWK10HS | Num | 8 | BEST12. |
 BEST32. | AE Week 10 Highest Score | | 42 | AEWK11HS | Num | 8 | BEST12. |
 BEST32. | AE Week 11 Highest Score | | 43 | AEWK12HS | Num | 8 | BEST12. |
 BEST32. | AE Week 12 Highest Score | | 44 | AE\_ISR\_LYMPH | Char | 3 |
 $3. | $3. | AE\_ISR\_LYMPH | | 45 | AE\_ISR\_PAIN | Char | 3 | $3. | $3. |
 AE Injection Side Reaction Pain | | 46 | AE\_ISR\_RED | Char | 3 | $3. |
 $3. | AE Injection Side Reaction Redness | | 47 | AE\_ISR\_SWELLING | Char
 | 3 | $3. | $3. | AE Injection Side Reaction Swelling | | 48 | AE\_ISR\_CM
 | Char | 3 | $3. | $3. | AE Injection Side Reaction Concomitant Medication
 | | 49 | AE\_ISR\_ULCER | Char | 3 | $3. | $3. | AE Injection Side
 Reaction Ulcer | | 50 | AESOC | Char | 69 | $69. | $69. | AE MedDRA System
 Organic Class | | 51 | AESOCCD | Num | 8 | BEST12. | BEST32. | AE MedDRA
 System Organic Class Code |   | **CM (Concomitant Medication) Domain** | |
 | | | | | | :------------------------------------- | ------------ |
 -------- | ------- | ---------- | ------------ |
 ------------------------------------------------------------------------------- | | **#** | **Variable** | **Type** | **Len** | **Format** | **Informat** | **Label** | | **1** | STUDYID | Char | 18 |   |   |  Study ID | | **2** | TRTGRP | Char | 200 | $GROUPS. |   | Treatment Group | | **3** | USUBJID | Char | 7 | $7. | $7. | Unique Participant ID | | **4** | VISITNAM | Char | 200 |   |   | Visit Name | | **5** | CMSPID | Char | 1 |   |   | Concomitant Medication Sponsor ID | | **6** | CMCAT | Char | 200 |   |   | Concomitant Medication Category | | **7** | CMTEST | Char | 112 |   |   | Concomitant Medication Test Question | | **8** | CMORRES | Char | 1000 |   |   | Concomitant Medication Test Question Response | | **9** | CMTRT | Char | 200 | $200. | $11. | Concomitant Medication Treatment | | **10** | CMSTDT | Num | 8 | YYMMDD10. | YYMMDD10. | Anonymised Concomitant Medication Start Date (Number of Days after Study Day 1) | | **11** | CMENDT | Num | 8 | YYMMDD10. |   | Anonymised Concomitant Medication End Date (Number of Days after Study Day 1) | | **12** | CMSTATUS | Char | 16 | $16. | $16. | Concomitant Medication Status |   | **DM (Demography) Domain** | | | | | | | | :------------------------- | ---------------- | -------- | ------- | ---------- | ------------ | --------------------------------------------------------------- | | **#** | **Variable** | **Type** | **Len** | **Format** | **Informat** | **Label** | | **1** | STUDYID | Char | 18 |   |   |  Study ID | | **2** | TRTGRP | Char | 200 | $GROUPS. |   | Treatment Group | | **3** | USUBJID | Char | 7 | $7. | $7. | Unique Participant ID | | **4** | VISITNAM | Char | 21 |   |   | Visit Name | | **5** | SEX | Char | 6 | $6. | $6. | Sex for Stratification | | **6** | Age | Num | 8 | 5. |   | Anonymised Age (Categorised per Age Range) | | **7** | RACE | Char | 9 | $9. | $9. | Race for Stratification | | **8** | education | Char | 8 | $8. | $8. | Highest Level of education? | | **9** | work\_hours | Char | 12 | $12. | $12. | Working Hours per Week (Including Overtime) | | **10** | patients\_seen | Char | 13 | $13. | $13. | Number of Patients Seen /Interacting With per Day | | **11** | expect\_interact | Char | 3 | $3. | $3. | Expected to Interact with Known COVID-19 Patients in Your Work? |   | **DS (Disposition) Domain** | | | | | | | | :-------------------------- | ------------ | -------- | ------- | ---------- | ------------ | -------------------------------------------------------------- | | **#** | **Variable** | **Type** | **Len** | **Format** | **Informat** | **Label** | | **1** | STUDYID | Char | 18 |   |   |  Study ID | | **2** | TRTGRP | Char | 200 | $GROUPS. |   | Treatment Group | | **3** | USUBJID | Char | 7 | $7. | $7. | Unique Participant ID | | **4** | VISITNAM | Char | 200 |   |   | Visit Name | | **5** | DSSPID | Char | 1 |   |   | Disposition Sponsor ID | | **6** | DSTERM | Char | 200 |   |   | Disposition Term | | **7** | DSCAT | Char | 200 |   |   | Disposition Category | | **8** | DSYN | Char | 3 | $3. | $3. | Disposition Yes/No | | **9** | DSDT | Num | 8 | YYMMDDD10. | YYMMDD10. | Anonymised Disposition Date (Number of Days after Study Day 1) | | **10** | DSTM | Num | 8 | TOD5. |   | Disposition Time | | **11** | DSREAS | Char | 200 | $554. | $554. | Disposition Reason | | **12** | DSTEST | Char | 200 |   |   | Disposition Test Question | | **13** | DSORRES | Char | 1000 |   |   | Disposition Test Response |   | **EX (Exposure) Domain** | | | | | | | | :----------------------- | ------------ | -------- | ------- | ---------- | ------------ | ---------------------- | | **#** | **Variable** | **Type** | **Len** | **Format** | **Informat** | **Label** | | **1** | STUDYID | Char | 18 |   |   | Study ID | | **2** | TRTGRP | Char | 200 | $GROUPS. |   | Treatment Group | | **3** | USUBJID | Char | 7 | $7. | $7. | Unique Participant ID | | **4** | VISITNAM | Char | 200 |   |   | Visit Name | | **5** | EXDRUG | Char | 200 |   |   | Exposure Drug | | **6** | EXFORM | Char | 17 |   |   | Exposure Form | | **7** | EXROUTE | Char | 13 |   |   | Exposure Route | | **8** | EXDOSE | Char | 3 |   |   | Exposure Dose | | **9** | EXDOSEU | Char | 2 |   |   | Exposure Dose Unit | | **10** | EXFREQ | Char | 4 |   |   | Exposure Frequency | | **11** | EXTEST | Char | 72 |   |   | Exposure Test Question | | **12** | EXORRES | Char | 119 |   |   | Exposure Test Response |   | **IE (Inclusion/Exclusion Criteria) Domain** | | | | | | | | :------------------------------------------- | ------------ | -------- | ------- | ---------- | ------------ | -------------------------------------------- | | **#** | **Variable** | **Type** | **Len** | **Format** | **Informat** | **Label** | | **1** | STUDYID | Char | 18 |   |   | Study ID | | **2** | TRTGRP | Char | 200 | $GROUPS. |   | Treatment Group | | **3** | USUBJID | Char | 7 | $7. | $7. | Unique Participant ID | | **4** | VISITNAM | Char | 21 |   |   | Visit Name | | **5** | IECAT | Char | 200 |   |   | Inclusion/Exclusion Criteria: | | **6** | IETESTCD | Char | 9 |   |   | Inclusion/Exclusion Criteria Test Code | | **7** | IETEST | Char | 1000 |   |   | Inclusion/Exclusion Criteria Test Question: | | **8** | IEORRES | Char | 3 |   |   | Inclusion/Exclusion Criteria Met? | | **9** | IESTRESC | Char | 3 |   |   | All Inclusion and No Exclusion Criteria Met? |   | **LB (Laboratory Findings) Domain** | | | | | | | | :---------------------------------- | ------------ | -------- | ------- | ---------- | ------------ | ------------------------ | | **#** | **Variable** | **Type** | **Len** | **Format** | **Informat** | **Label** | | **1** | STUDYID | Char | 18 |   |   | Study ID | | **2** | TRTGRP | Char | 200 | $GROUPS. |   | Treatment Group | | **3** | USUBJID | Char | 7 | $7. | $7. | Unique Participant ID | | **4** | VISITNAM | Char | 200 |   |   | Visit Name | | **5** | LBCAT | Char | 200 |   |   | Laboratory Category | | **6** | LBSCAT | Char | 200 |   |   | Laboratory Sub Category | | **7** | LBTEST | Char | 200 |   |   | Laboratory Test Question | | **8** | LBYN | Char | 3 | $3. | $3. | Laboratory Yes/No | | **9** | LBORRES | Char | 200 | $8. | $8. | Laboratory Test Response |   | **MH (Medical History) Domain** | | | | | | | | :------------------------------ | ------------ | -------- | ------- | ---------- | ------------ | -------------------------------------- | | **#** | **Variable** | **Type** | **Len** | **Format** | **Informat** | **Label** | | **1** | STUDYID | Char | 18 |   |   | Study ID | | **2** | TRTGRP | Char | 200 | $GROUPS. |   | Treatment Group | | **3** | USUBJID | Char | 7 | $7. | $7. | Unique Participant ID | | **4** | VISITNAM | Char | 200 |   |   | Visit Name | | **5** | MHSPID | Char | 1 |   |   | Medical History Sponsor ID | | **6** | MHCAT | Char | 15 |   |   | Medical History Category | | **7** | MHSCAT | Char | 200 |   |   | Medical History Sub-Category | | **8** | MHTEST | Char | 200 |   |   | Medical History Test Question | | **9** | MHORRES | Char | 1000 | $200. | $3. | Medical History Test Response | | **10** | MHTERM | Char | 200 |   |   | Medical History Term | | **11** | MHDECOD | Char | 200 | $53. | $53. | Medical History Standard Term | | **12** | MHONGO | Char | 3 | $3. | $3. | Medical History Ongoing? | | **13** | MHCM | Char | 3 | $3. | $3. | Medical History Concomitant Medication |   | **SV (Subject Visit) Domain** | | | | | | | | :---------------------------- | ------------ | -------- | ------- | ---------- | ------------ | -------------------------------------------------------- | | **#** | **Variable** | **Type** | **Len** | **Format** | **Informat** | **Label** | | **1** | STUDYID | Char | 18 |   |   | Study ID | | **2** | TRTGRP | Char | 200 | $GROUPS. |   | Treatment Group | | **3** | USUBJID | Char | 7 | $7. | $7. | Unique Participant ID | | **4** | VISITNUM | Num | 8 | BEST12. | BEST32. | Visit Week Number | | **5** | VISITNAM | Char | 200 |   |   | Visit Name | | **6** | SVCAT | Char | 200 |   |   | Hospital Admission, Study Visit or Follow Up | | **7** | SVDT | Num | 8 | YYMMDDD10. | YYMMDD10. | Anonymised Visit Date (Number of Days after Study Day 1) | | **8** | HAYN | Char | 3 |   |   | Subject Admitted to Hospital |   | **VS (Vital Signs) Domain** | | | | | | | | :-------------------------- | ------------ | -------- | ------- | ---------- | ------------ | ------------------------------ | | **#** | **Variable** | **Type** | **Len** | **Format** | **Informat** | **Label** | | **1** | STUDYID | Char | 18 |   |   | Study ID | | **2** | TRTGRP | Char | 200 | $GROUPS. |   | Treatment Group | | **3** | USUBJID | Char | 7 | $7. | $7. | Unique Participant ID | | **4** | VISITNAM | Char | 200 |   |   | Visit Name | | **5** | VSTEST | Char | 40 |   |   | Vital Signs Test Question | | **6** | VSORRES | Char | 170 |   |   | Vital Signs Test Response | | **7** | VSORRESU | Char | 200 |   |   | Vital Signs Test Response Unit |  **Sharing/Access information** More information regarding the TASK008-BCG CORONA study can be found at the following links: [https://clinicaltrials.gov/study/NCT04379336](https://clinicaltrials.gov/study/NCT04379336) Published results from the analysis of the TASK008-BCG CORONA SDTM datasets can be found in the following address on the DMJ: [https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(22)00144-4/fulltext](https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370\(22\)00144-4/fulltext) **Code/Software** The TASK008-BCG CORONA SDTM datasets was generated using SAS 9.4.