Last updated on February 2018

Early Versus Late BCG Vaccination in HIV-1 Exposed Infants in Uganda in Uganda

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Malaria | Septicemia | Malaria Vaccines | Diarrhea | Lower Respiratory Infection | Severe Illness
  • Age: - 1 Years
  • Gender: Male or Female

Inclusion Criteria:

A baby born at a participating study clinic will be included if s/he:

  1. has a mother with a positive HIV test (ELISA or rapid test)
  2. is receiving peri-exposure prophylaxis as part of the standard/national guidelines in Uganda
  3. has a mother that is of legal age for participation in clinical research studies in Uganda or is an emancipated minor
  4. has a mother/caregiver that resides within the study area, is not intending to move out of the area in the next 4 months and is likely to be traceable for up to 12 months
  5. has a mother/caregiver that gives informed consent to random assignment to either of the two trial arms
  6. has a mother that has received antiretroviral therapy (ART) for at least 4 weeks

Exclusion Criteria:

A new-born child will be excluded if she/he has:

  1. serious congenital malformation(s)
  2. severe illness requiring hospitalization
  3. a birth weight < 2.0 kg
  4. a mother participating in another clinical trial on the day of enrolment or a mother who will participate in another clinical trial within the next month.
  5. a mother or other household member with symptoms and signs of tuberculosis on the day of enrolment
  6. a severely ill mother with (a) condition(s) requiring hospitalization

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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