Trial Outcomes & Findings for BCG Vaccine for Health Care Workers as Defense Against COVID 19 (NCT NCT04348370)
NCT ID: NCT04348370
Last Updated: 2024-10-08
Results Overview
The primary outcome measure is development of COVID19 infection. This will be reported as the number of individuals receiving the intervention who are PCR-positive or seroconvert, defined as number of new cases during the 6 month time period
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
659 participants
Primary outcome timeframe
6 months
Results posted on
2024-10-08
Participant Flow
Participant milestones
| Measure |
BCG Group
FDA-approved BCG Tice strain, procured from Merck, will be used. The vaccine will be reconstituted according to the package insert. In brief, a vial containing \~1x10\^8 CFU of lyophilized BCG will be reconstituted in 50 mL of saline. A single dose will consist of 0.1 mL (\~2x10\^5 CFU) will be administered by slow intradermal injection using a 25 gauge/ 0.5 mm syringe in the deltoid area.
BCG Vaccine: BCG vaccine will be administered by research nurses. Participants and investigators will be blinded.
|
Placebo Group
A single dose will consist of 0.1 mL saline
Placebo Vaccine: Placebo vaccine will be administered by research nurses. Participants and investigators will be blinded.
|
|---|---|---|
|
Overall Study
STARTED
|
334
|
325
|
|
Overall Study
COMPLETED
|
263
|
266
|
|
Overall Study
NOT COMPLETED
|
71
|
59
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BCG Vaccine for Health Care Workers as Defense Against COVID 19
Baseline characteristics by cohort
| Measure |
BCG Group
n=334 Participants
FDA-approved BCG Tice strain, procured from Merck, will be used. The vaccine will be reconstituted according to the package insert. In brief, a vial containing \~1x10\^8 CFU of lyophilized BCG will be reconstituted in 50 mL of saline. A single dose will consist of 0.1 mL (\~2x10\^5 CFU) will be administered by slow intradermal injection using a 25 gauge/ 0.5 mm syringe in the deltoid area.
BCG Vaccine: BCG vaccine will be administered by research nurses. Participants and investigators will be blinded.
|
Placebo Group
n=325 Participants
A single dose will consist of 0.1 mL saline
Placebo Vaccine: Placebo vaccine will be administered by research nurses. Participants and investigators will be blinded.
|
Total
n=659 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.01 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
46.6 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
46.81 years
STANDARD_DEVIATION 12.37 • n=5 Participants
|
|
Sex: Female, Male
Female
|
215 Participants
n=5 Participants
|
222 Participants
n=7 Participants
|
437 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
119 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
43 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
291 Participants
n=5 Participants
|
266 Participants
n=7 Participants
|
557 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
37 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
276 Participants
n=5 Participants
|
266 Participants
n=7 Participants
|
542 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
334 participants
n=5 Participants
|
325 participants
n=7 Participants
|
659 participants
n=5 Participants
|
|
Prior BCG
|
28 participants
n=5 Participants
|
35 participants
n=7 Participants
|
63 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe primary outcome measure is development of COVID19 infection. This will be reported as the number of individuals receiving the intervention who are PCR-positive or seroconvert, defined as number of new cases during the 6 month time period
Outcome measures
| Measure |
BCG Group
n=263 Participants
FDA-approved BCG Tice strain, procured from Merck, will be used. The vaccine will be reconstituted according to the package insert. In brief, a vial containing \~1x10\^8 CFU of lyophilized BCG will be reconstituted in 50 mL of saline. A single dose will consist of 0.1 mL (\~2x10\^5 CFU) will be administered by slow intradermal injection using a 25 gauge/ 0.5 mm syringe in the deltoid area.
BCG Vaccine: BCG vaccine will be administered by research nurses. Participants and investigators will be blinded.
|
Placebo Group
n=266 Participants
A single dose will consist of 0.1 mL saline
Placebo Vaccine: Placebo vaccine will be administered by research nurses. Participants and investigators will be blinded.
|
|---|---|---|
|
Number of New COVID 19 Infections
|
25 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: 6 monthsThe secondary outcome measure is disease severity calculated using the Covid Severity Scale Scoring of 0 -10. A score of 10 is worse and a score of 0 is best. Disease severity score will be based on the level of care required for individuals who test positive for COVID19 as follows: non-hospital-based care; patient hospitalized but no oxygen required; hospitalized and oxygen required; patient treated in intensive care and/or on mechanical ventilation; patient died. Additional WHO criteria for severity include severe pneumonia, respiratory failure, acute respiratory distress syndrome, sepsis and septic shock.
Outcome measures
| Measure |
BCG Group
n=25 Participants
FDA-approved BCG Tice strain, procured from Merck, will be used. The vaccine will be reconstituted according to the package insert. In brief, a vial containing \~1x10\^8 CFU of lyophilized BCG will be reconstituted in 50 mL of saline. A single dose will consist of 0.1 mL (\~2x10\^5 CFU) will be administered by slow intradermal injection using a 25 gauge/ 0.5 mm syringe in the deltoid area.
BCG Vaccine: BCG vaccine will be administered by research nurses. Participants and investigators will be blinded.
|
Placebo Group
n=21 Participants
A single dose will consist of 0.1 mL saline
Placebo Vaccine: Placebo vaccine will be administered by research nurses. Participants and investigators will be blinded.
|
|---|---|---|
|
Disease Severity
|
2 score on a scale
Interval 2.0 to 2.0
|
2 score on a scale
Interval 2.0 to 2.0
|
Adverse Events
BCG Group
Serious events: 1 serious events
Other events: 75 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 73 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BCG Group
n=263 participants at risk
FDA-approved BCG Tice strain, procured from Merck, will be used. The vaccine will be reconstituted according to the package insert. In brief, a vial containing \~1x10\^8 CFU of lyophilized BCG will be reconstituted in 50 mL of saline. A single dose will consist of 0.1 mL (\~2x10\^5 CFU) will be administered by slow intradermal injection using a 25 gauge/ 0.5 mm syringe in the deltoid area.
BCG Vaccine: BCG vaccine will be administered by research nurses. Participants and investigators will be blinded.
|
Placebo Group
n=266 participants at risk
A single dose will consist of 0.1 mL saline
Placebo Vaccine: Placebo vaccine will be administered by research nurses. Participants and investigators will be blinded.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Dental caries
|
0.38%
1/263 • Data were collected during the 6 months of the study plus a 6 month optional followup period for disease outcome.
Participants reported unsolicited AEs through the electronic survey.
|
0.00%
0/266 • Data were collected during the 6 months of the study plus a 6 month optional followup period for disease outcome.
Participants reported unsolicited AEs through the electronic survey.
|
Other adverse events
| Measure |
BCG Group
n=263 participants at risk
FDA-approved BCG Tice strain, procured from Merck, will be used. The vaccine will be reconstituted according to the package insert. In brief, a vial containing \~1x10\^8 CFU of lyophilized BCG will be reconstituted in 50 mL of saline. A single dose will consist of 0.1 mL (\~2x10\^5 CFU) will be administered by slow intradermal injection using a 25 gauge/ 0.5 mm syringe in the deltoid area.
BCG Vaccine: BCG vaccine will be administered by research nurses. Participants and investigators will be blinded.
|
Placebo Group
n=266 participants at risk
A single dose will consist of 0.1 mL saline
Placebo Vaccine: Placebo vaccine will be administered by research nurses. Participants and investigators will be blinded.
|
|---|---|---|
|
General disorders
Cough, headache, myalgias
|
28.5%
75/263 • Data were collected during the 6 months of the study plus a 6 month optional followup period for disease outcome.
Participants reported unsolicited AEs through the electronic survey.
|
27.4%
73/266 • Data were collected during the 6 months of the study plus a 6 month optional followup period for disease outcome.
Participants reported unsolicited AEs through the electronic survey.
|
Additional Information
Jeffrey D. Cirillo
Texas A&M University College of Medicine
Phone: 979-436-0343
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place