Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

Pneumococcal Conjugate Vaccine (PCV) in HIV- Infected Children

This study has been completed.
Sponsor:
Collaborator:
Pediatric infectious diseases section, King Chulalongkorn Memorial hospital, Chulalongkorn University
Information provided by (Responsible Party):
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT01135082
First received: June 1, 2010
Last updated: September 3, 2014
Last verified: September 2014
History of Changes
  Purpose
The purpose of this study is to evaluate the immunogenicity and safety of 7 - valent pneumococcal conjugated vaccine in HIV - infected children, and assess the predictive factors for protective antibody responses after receiving the vaccine.

Condition Intervention
HIV
 Biological: valent pneumococcal conjugated vaccine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Immunogenicity and Safety of Pneumococcal Conjugate Vaccine in Human Immunodeficiency Virus - Infected Children

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:

Primary Outcome Measures:
  • immunogenicity [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Proportion of children with PCV serotype - specific IgG antibody at 28 days after completion of primary series of vaccination.


Secondary Outcome Measures:
  • Safety [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Number of adverse events after PCV administration

  • compare serotype [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Compare proportion of PCV serotype - specific IgG antibody in HIV - infected children by baseline clinical staging, CD4 and viral load.
Enrollment: 90
Study Start Date: April 2010
Study Completion Date: June 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Receive valent pneumococcal conjugated vaccine in HIV - infected children
 Biological: valent pneumococcal conjugated vaccine
Dosage: 0.5 ml per dose Administration: intramuscular injection Location: left deltoid area x 1 injection Frequency: depend on first dose of vaccination. If 2-6 months of age, vaccination at month 0, 2, and 4. If 7-23 months of age, vaccination at month 0 and 2. If 2-9 years of age, vaccination at month 0. If patient is HIV positive, vacciation months 0 and 2 if age is 2-9 years.
2
Receive valent pneumococcal conjugated vaccine in HIV negative children
 Biological: valent pneumococcal conjugated vaccine
Dosage: 0.5 ml per dose Administration: intramuscular injection Location: left deltoid area x 1 injection Frequency: depend on first dose of vaccination. If 2-6 months of age, vaccination at month 0, 2, and 4. If 7-23 months of age, vaccination at month 0 and 2. If 2-9 years of age, vaccination at month 0. If patient is HIV positive, vacciation months 0 and 2 if age is 2-9 years.

Detailed Description:

S. pneumoniae is an important cause of severe invasive bacterial disease in human immunodeficiency disease (HIV) infected children. The incidence of pneumococcal bacteremia cases requiring hospitalization among Thai children aged < 5 years had a range of 10.6-28.9 cases per 100,000 persons.[1]

Children infected with HIV have a markedly increased risk for pneumococcal infection compared with those who are not HIV-infected. HIV-infected children had rates of invasive pneumococcal disease (IPD) that were 2.8 and 12.6 times the rate among HIV-negative children aged <5 and <3 years, respectively. Incidence of IPD is 6.1 cases/100 patient-years among HIV-infected children through age 7 years [2]

Recent important strategy in prevention of invasive pneumococcal disease (IPD) is an implementation of pneumococcal conjugate vaccine (PCV), which can induce immunity starting from 2 months of age. In a small study of 5-valent PCV among children < 2 years of age, serotype-specific IgG antibodies (ELISA) response after 3 doses was found to be immunogenic among both groups.[3] The Pediatric AIDS Clinical Trials Group Study 292 show that the immunologic responses to 7- valent PCV were similar for all serotypes among asymptomatic and symptomatic HIV - infected children.[4] The study of quantitative and qualitative antibody responses to 9 - valent PCV in HIV-infected children in South Africa shows similar quantitative antibody responses but poorer qualitative antibody responses to the pneumococcal conjugate vaccine when compared to HIV-negative children.[5].

In Thailand, 7 - valent PCV (Prevnar® ) was available in 2003. It is recommended for young children and highly recommended for high risk children such as HIV-infected children, congenital heart disease or premature infants. However, one of the major obstacles for large scale implementation is cost issue. There is no previous study about immunogenicity, safety or efficacy of 7 - valent PCV in HIV -infected Thai children, the objective of this study is to assess the safety and immunogenicity of a 7 - valent PCV vaccine among HIV - infected compared with HIV - exposed children.

  Eligibility
Ages Eligible for Study:   2 Months to 9 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. HIV - infected children

    • HIV infected individuals
    • Age between 2 months to 9 years
    • Signed written informed consent

  2. HIV - exposed negative children

    • Maternal HIV infection, documented prior to delivery.
    • Age between 2 months to 9 years
    • Signed written informed consent

Exclusion Criteria:

  • Active opportunistic infection
  • History of hypersensitivity to pneumococcal conjugate vaccine or diphtheria toxoid
  • Using oral steroid or immunosuppressive drugs
  • Received pneumococcal conjugate vaccine, or pnuemococal polysaccharide vaccine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01135082

Locations
Thailand
HIV-NAT, The Thai Red Cross AIDS Research Center
Bangkok, Thailand, 10330
Pediatric infectious diseases section, King Chulalongkorn Memorial hospital
Bangkok, Thailand, 10330
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
Pediatric infectious diseases section, King Chulalongkorn Memorial hospital, Chulalongkorn University
Investigators
Principal Investigator: Chitsanu Pancharoen, MD Pediatric infectious diseases unit, Chulalongkorn University
  More Information

Additional Information:
HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier: NCT01135082     History of Changes
Other Study ID Numbers: HIV-NAT 135 
Study First Received: June 1, 2010
Last Updated: September 3, 2014
Health Authority: Thailand: Ethical Committee

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
immunogenicity
safety
Pneumococcal conjugate vaccine
HIV infected children
objective of this study is to assess the safety and immunogenicity of a 7 - valent PCV vaccine among HIV - infected compared with HIV - exposed children

Additional relevant MeSH terms:
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2016