Trial Outcomes & Findings for γ-irradiated BCG to Train Innate Immunity (NCT NCT02259608)

Results Overview

Comparing tnfa production of PBMCs after 24h stimulation with candida before and 3 months after yBCG vaccination. Baseline is set as 1.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

0 weeks and 3 months

Results posted on

2016-06-29

Participant milestones
Measure	BCG Vaccine SSI Healthy volunteers are vaccinated with yBCG. Blood will be drawn before and at several timepoints after vaccination. Cytokine production before vaccination will be used as reference to compare later timepoints with. BCG vaccine SSI: BCG vaccination
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Withdrawal data not reported

γ-irradiated BCG to Train Innate Immunity

Baseline characteristics by cohort
Measure	yBCG n=15 Participants 15 healthy volunteers that receive yBCG at baseline. There is no control group included in this trial.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	23 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Healthy	15 participants n=5 Participants

Timeframe: 0 weeks and 3 months

Population: Ex-vivo cytokine production by PBMCs upon stimulation with several pathogens

Comparing tnfa production of PBMCs after 24h stimulation with candida before and 3 months after yBCG vaccination. Baseline is set as 1.

Outcome measures
Measure	BCG Vaccine SSI n=15 Participants Healthy volunteers are vaccinated with yBCG. Blood will be drawn before and at several timepoints after vaccination. Cytokine production before vaccination will be used as reference to compare later timepoints with. BCG vaccine SSI: BCG vaccination
Cytokine Production Measured by ELISA Compared to Baseline	1.2 ratio Interval 0.5 to 2.2

Timeframe: 0 weeks and 2 weeks

Ex-vivo cytokine production by PBMCs upon stimulation with several pathogens

Outcome measures
Measure	BCG Vaccine SSI n=15 Participants Healthy volunteers are vaccinated with yBCG. Blood will be drawn before and at several timepoints after vaccination. Cytokine production before vaccination will be used as reference to compare later timepoints with. BCG vaccine SSI: BCG vaccination
Cytokine Production Measured by ELISA Compared to Baseline	1.4 ratio Interval 0.6 to 3.4

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	BCG Vaccine SSI n=15 participants at risk Healthy volunteers are vaccinated with yBCG. Blood will be drawn before and at several timepoints after vaccination. Cytokine production before vaccination will be used as reference to compare later timepoints with. BCG vaccine SSI: BCG vaccination
Skin and subcutaneous tissue disorders Local reaction to BCG vaccin	6.7% 1/15

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