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Early Versus Delayed BCG Vaccination of HIV-exposed Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02062580
First Posted: February 13, 2014
Last Update Posted: March 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Seattle Biomedical Research Institute
University of Stellenbosch
Information provided by (Responsible Party):
Dr Heather Jaspan, University of Cape Town
Results First Submitted: October 25, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions: HIV Exposure
HIV Infection
Intervention: Biological: BCG

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Delayed BCG

BCG delayed to 8 weeks of age

BCG

Early BCG

BCG at birth; standard of care

BCG


Participant Flow:   Overall Study
    Delayed BCG   Early BCG
STARTED   71   78 
COMPLETED   59   65 
NOT COMPLETED   12   13 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Delayed BCG

BCG delayed to 8 weeks of age

BCG

Early BCG

BCG at birth; standard of care

BCG

Total Total of all reporting groups

Baseline Measures
   Delayed BCG   Early BCG   Total 
Overall Participants Analyzed 
[Units: Participants]
 71   78   149 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      71 100.0%      78 100.0%      149 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age [1] 
[Units: Weeks]
Median (Inter-Quartile Range)
 39 
 (38 to 40) 
 40 
 (39 to 40) 
 39.5 
 (38 to 40) 
[1] Median gestational age, in weeks
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      41  57.7%      46  59.0%      87  58.4% 
Male      30  42.3%      32  41.0%      62  41.6% 
Region of Enrollment 
[Units: Count of participants]
     
South Africa   70   76   146 
Birth weight 
[Units: Kg]
Median (Inter-Quartile Range)
 3.15 
 (2.85 to 3.3) 
 3.12 
 (2.8 to 3.4) 
 3.13 
 (2.9 to 3.4) 
Maternal CD4 T cell count 
[Units: Cells/mm^3]
Median (Inter-Quartile Range)
 358 
 (254 to 548) 
 366 
 (271 to 477) 
 362 
 (263 to 513) 
Breastfed 
[Units: Participants]
     
yes   8   12   20 
no   62   64   126 


  Outcome Measures
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1.  Primary:   T Cell Activation   [ Time Frame: at 6 weeks ]

2.  Secondary:   Vaccine Immunogenicity   [ Time Frame: 6 weeks after BCG vaccination ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Heather Jaspan
Organization: University of Cape Town and University of Washington
phone: +2721 4066823
e-mail: hbjaspan@gmail.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr Heather Jaspan, University of Cape Town
ClinicalTrials.gov Identifier: NCT02062580     History of Changes
Other Study ID Numbers: MV-00-9-900-01871
First Submitted: February 12, 2014
First Posted: February 13, 2014
Results First Submitted: October 25, 2016
Results First Posted: March 15, 2017
Last Update Posted: March 15, 2017