Status:
UNKNOWN
Safety of and Immune Response to a Pneumococcal Vaccine (PncCV) in HIV Infected and Uninfected Children
Lead Sponsor:
CIPRA SA
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Pneumococcal Infections
Eligibility:
All Genders
4-10 years
Phase:
NA
Brief Summary
Infection by Streptococcal pneumoniae is a common invasive bacterial infection in HIV infected children. The purpose of this study is to determine the safety of and immune response to a pneumococcal p...
Detailed Description
HIV infected children are at high risk for invasive pneumococcal disease (IPD) caused by the bacterium Streptococcus pneumoniae. Chemoprophylaxis has been used in children with certain diseases for th...
Eligibility Criteria
Inclusion
- Inclusion Criteria for All Infants:
- Birth weight of at least 2 kg (4.4 lbs)
- Written informed consent from parent or guardian
- Mother's HIV status documented after 24th week of pregnancy, if her infant joins Group 5 and is HIV uninfected
- Parent or guardian of infant intends to remain in the study area for the duration of the trial
- Inclusion Criteria for HIV Infected Infants:
- HIV infected
- Participating in CIPRA SA-Project 2
- Exclusion Criteria for All Infants:
- Blood products prior to study entry
- Immunosuppressant agents for more than 2 weeks, within 1 week of study entry
- Unable to tolerate oral medications
- Presence of any major, life-threatening congenital defect
- Acute illness or fever requiring hospitalization within 72 hours of immunization
- Grade 2 vaccine-related allergic reaction
- Grade 3 or 4 clinical or laboratory toxicity related to vaccination
- Use of any antiretroviral therapies other than those allowed in CIPRA SA-Project 2. Infants who received antiretroviral drugs used to prevent mother-to-infant HIV transmission are eligible for this study.
- Use of investigational drugs, systemic cytotoxic chemotherapy, or interleukin or other immune modulators
- Require certain medications
- Exclusion Criteria for HIV Uninfected Infants:
- Vaccines prior to study entry. Infants who have received bacille Calmette-Guerin or oral polio vaccines are not excluded.
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
579 Patients enrolled
Trial Details
Trial ID
NCT00099658
Start Date
April 1 2005
End Date
June 1 2014
Last Update
February 15 2011
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