Safety of and Immune Response to a Pneumococcal Vaccine (PncCV) in HIV Infected and Uninfected Children

February 14, 2011 updated by: CIPRA SA

Evaluation of Quantitative and Qualitative Antibody Responses to Streptococcus Pneumoniae and Haemophilus Influenzae Type b Conjugate Vaccines Amongst HIV-1-Exposed-Infected Children That Are Receiving Vs. Those Not Receiving Antiretroviral Therapy, as Well as Among HIV-1-Exposed-Uninfected Children and HIV-1-Unexposed-Uninfected Children

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 polysaccharide-protein conjugate vaccine (PncCV) in HIV infected and uninfected children. The study will also determine the safety of and immune response to Haemophilus influenzae vaccine (HibCV) in these children. Recruitment for this study will occur at two hospitals in South Africa, and all HIV infected infants participating in this study must also be coenrolled in the CIPRA SA-Project 2 study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 the prevention of IPD, but drug resistance may develop with this prevention strategy. In contrast, a vaccine to prevent IPD would have fewer negative implications on future treatment options than chemoprophylaxis. This study will evaluate the safety of and immune response to PncCV in South African HIV infected and uninfected children. This study will also evaluate the safety of and immune response to HibCV in these children.

This study will last 5.5 years. There will be 5 groups in this study. Group 1 will be HIV uninfected infants born to HIV uninfected mothers. Group 2 will be HIV infected infants in CDC Disease Category 1 who were randomly assigned to the delayed therapy arm (Arm 1) of CIPRA SA-Project 2. Group 3 will be HIV infected infants in CDC Disease Category 1 who were randomly assigned to the first early therapy arm (Arm 2) of CIPRA SA-Project 2. Group 4 will be HIV infected infants in CDC Disease Category 2 or 3 who were randomly assigned to the second early therapy arm (Arm 3) of CIPRA SA-Project 2. Group 5 will be HIV uninfected infants born to HIV infected mothers; Group 5 infants will undergo repeat HIV testing at 4 to 8 months of age, 9 to 11 months of age, and approximately 18 months of age.

There will be 13 study visits; medical history assessment, a physical examination, and blood collection will occur at each visit. At each of 3 study visits before age 24 weeks, all participants will receive an injection of PncCV and an injection of routine pediatric vaccines, including HibCV. Previously vaccinated HIV infected participants will only receive those vaccines they need to complete the South African series of routine pediatric vaccinations. Within each group, participants will be randomly assigned to receive a booster shot of either PncCV or HibCV between 64 and 76 weeks of age. Participants will also receive two measles vaccinations between 38 and 76 weeks of age. Parents or guardians will be asked to complete a diary card after each vaccination and report any adverse effects occurring within the 72 hours post-vaccination.

Study Type

Interventional

Enrollment (Actual)

579

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 2 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
HIV-uninfected infants born to HIV-uninfected mothers
Biological: Pneumococcal polysaccharide-protein conjugate vaccine
Injection administered three times before the age of 24 weeks
Other Names:
  • PncCV
Experimental: 2
HIV-infected infants in CDC Disease Category 1 who were randomly assigned to the delayed therapy arm (Arm 1) of CIPRA SA-Project 2
Biological: Pneumococcal polysaccharide-protein conjugate vaccine
Injection administered three times before the age of 24 weeks
Other Names:
  • PncCV
Experimental: 3
HIV-infected infants in CDC Disease Category 1 who were randomly assigned to the first early therapy arm (Arm 2) of CIPRA SA-Project 2
Biological: Pneumococcal polysaccharide-protein conjugate vaccine
Injection administered three times before the age of 24 weeks
Other Names:
  • PncCV
Experimental: 4
HIV-infected infants in CDC Disease Category 2 or 3 who were randomly assigned to the second early therapy arm (Arm 3) of CIPRA SA-Project 2
Biological: Pneumococcal polysaccharide-protein conjugate vaccine
Injection administered three times before the age of 24 weeks
Other Names:
  • PncCV
Experimental: 5
HIV-uninfected infants born to HIV infected mothers
Biological: Pneumococcal polysaccharide-protein conjugate vaccine
Injection administered three times before the age of 24 weeks
Other Names:
  • PncCV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate to PncCV among children in Group 2 compared to those in Groups 1 and 3
Time Frame: At Weeks 3 and 6
At Weeks 3 and 6
Response rate to PncCV among children in Group 2 compared to those in Groups 1 and 3 before receiving booster vaccine dose
Time Frame: At Weeks 64 through 76
At Weeks 64 through 76
Vaccine safety profiles after each of the three primary doses of PncCV and booster doses of PncCV and HibCV
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CIPRA SA

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Shabir Madhi, MD, MBBCH, Mmed, FCPaeds, PhD, Chris Hani Baragwanath Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

December 17, 2004

First Submitted That Met QC Criteria

December 17, 2004

First Posted (Estimate)

December 20, 2004

Study Record Updates

Last Update Posted (Estimate)

February 15, 2011

Last Update Submitted That Met QC Criteria

February 14, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIPRA-SA Project 4
  • U19AI053217 (U.S. NIH Grant/Contract)
  • CIPRA
  • Project 4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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