MedDataX Logo

Trial Outcomes & Findings for Early Versus Delayed BCG Vaccination of HIV-exposed Infants (NCT NCT02062580)

NCT ID: NCT02062580

Last Updated: 2017-03-15

Results Overview

Percentage of all CD4+ T cells expressing HLADR (NOT BCG-specific activation as in Tchakoute et al and as in secondary outcome). The n is smaller than the enrollment number as some participants were lost to follow-up, some were excluded due to HIV infection etc, and some samples did not have sufficient cells to analyse.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

149 participants

Primary outcome timeframe

at 6 weeks

Results posted on

2017-03-15

Participant Flow

Participant milestones

Participant milestones
Measure
Delayed BCG
BCG delayed to 8 weeks of age BCG
Early BCG
BCG at birth; standard of care BCG
Overall Study
STARTED
71
78
Overall Study
COMPLETED
59
65
Overall Study
NOT COMPLETED
12
13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Early Versus Delayed BCG Vaccination of HIV-exposed Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Delayed BCG
n=71 Participants
BCG delayed to 8 weeks of age BCG
Early BCG
n=78 Participants
BCG at birth; standard of care BCG
Total
n=149 Participants
Total of all reporting groups
Age, Categorical
<=18 years
71 Participants
n=5 Participants
78 Participants
n=7 Participants
149 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
39 weeks
n=5 Participants
40 weeks
n=7 Participants
39.5 weeks
n=5 Participants
Sex: Female, Male
Female
41 Participants
n=5 Participants
46 Participants
n=7 Participants
87 Participants
n=5 Participants
Sex: Female, Male
Male
30 Participants
n=5 Participants
32 Participants
n=7 Participants
62 Participants
n=5 Participants
Region of Enrollment
South Africa
70 count of participants
n=5 Participants
76 count of participants
n=7 Participants
146 count of participants
n=5 Participants
Birth weight
3.15 kg
n=5 Participants
3.12 kg
n=7 Participants
3.13 kg
n=5 Participants
Maternal CD4 T cell count
358 cells/mm^3
n=5 Participants
366 cells/mm^3
n=7 Participants
362 cells/mm^3
n=5 Participants
Breastfed
yes
8 participants
n=5 Participants
12 participants
n=7 Participants
20 participants
n=5 Participants
Breastfed
no
62 participants
n=5 Participants
64 participants
n=7 Participants
126 participants
n=5 Participants

PRIMARY outcome

Timeframe: at 6 weeks

Percentage of all CD4+ T cells expressing HLADR (NOT BCG-specific activation as in Tchakoute et al and as in secondary outcome). The n is smaller than the enrollment number as some participants were lost to follow-up, some were excluded due to HIV infection etc, and some samples did not have sufficient cells to analyse.

Outcome measures

Outcome measures
Measure
Delayed BCG
n=63 Participants
BCG delayed to 8 weeks of age BCG
Early BCG
n=68 Participants
BCG at birth; standard of care BCG
T Cell Activation
1.8 percentage of CD4+ T cells
Interval 1.0 to 2.8
1.3 percentage of CD4+ T cells
Interval 0.8 to 2.4

SECONDARY outcome

Timeframe: 6 weeks after BCG vaccination

Population: Analysis population n is smaller than enrollment numbers as we calculated that that only 28 were needing in each arm to detect a difference.

Percent of CD4+ T cells expressing Ki67 after stimulation in vitro with BCG.

Outcome measures

Outcome measures
Measure
Delayed BCG
n=28 Participants
BCG delayed to 8 weeks of age BCG
Early BCG
n=28 Participants
BCG at birth; standard of care BCG
Vaccine Immunogenicity
22.4 percentage of Ki67% CD4+ T cells
Interval 4.7 to 28.5
20.5 percentage of Ki67% CD4+ T cells
Interval 10.0 to 31.5

Adverse Events

Delayed BCG

Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths

Early BCG

Serious events: 7 serious events
Other events: 30 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Delayed BCG
n=71 participants at risk
BCG delayed to 8 weeks of age BCG
Early BCG
n=78 participants at risk
BCG at birth; standard of care BCG
Immune system disorders
HIV infection
2.8%
2/71 • Number of events 2
5.1%
4/78
General disorders
Death
0.00%
0/71
3.8%
3/78

Other adverse events

Other adverse events
Measure
Delayed BCG
n=71 participants at risk
BCG delayed to 8 weeks of age BCG
Early BCG
n=78 participants at risk
BCG at birth; standard of care BCG
Respiratory, thoracic and mediastinal disorders
Blocked nostrils
5.6%
4/71 • Number of events 4
14.1%
11/78 • Number of events 11
Respiratory, thoracic and mediastinal disorders
Cough
12.7%
9/71 • Number of events 9
19.2%
15/78 • Number of events 15
General disorders
Fever
8.5%
6/71 • Number of events 6
7.7%
6/78 • Number of events 6
Skin and subcutaneous tissue disorders
Rash- nonspecific
12.7%
9/71 • Number of events 9
12.8%
10/78 • Number of events 10
Skin and subcutaneous tissue disorders
Diaper Rash
9.9%
7/71 • Number of events 7
6.4%
5/78 • Number of events 5

Additional Information

Heather Jaspan

University of Cape Town and University of Washington

Phone: +2721 4066823

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place