Pneumococcal Conjugate Vaccine (PCV) in HIV- Infected Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by The HIV Netherlands Australia Thailand Research Collaboration.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Pediatric infectious diseases section, King Chulalongkorn Memorial hospital, Chulalongkorn University
Information provided by:
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT01135082
First received: June 1, 2010
Last updated: February 16, 2011
Last verified: February 2011

June 1, 2010
February 16, 2011
April 2010
December 2010   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01135082 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Pneumococcal Conjugate Vaccine (PCV) in HIV- Infected Children
The Immunogenicity and Safety of Pneumococcal Conjugate Vaccine in Human Immunodeficiency Virus - Infected Children

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Acquired Immunodeficiency Syndrome
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.
  • 1
    Receive valent pneumococcal conjugated vaccine in HIV - infected children
    Intervention: Biological: valent pneumococcal conjugated vaccine
  • 2
    Receive valent pneumococcal conjugated vaccine in HIV negative children
    Intervention: Biological: valent pneumococcal conjugated vaccine
Thanee C, Pancharoen C, Likitnukul S, Luangwedchakarn V, Umrod P, Phasomsap C, Apornpong T, Chuanchareon T, Butterworth O, Puthanakit T. The immunogenicity and safety of pneumococcal conjugate vaccine in human immunodeficiency virus-infected Thai children. Vaccine. 2011 Aug 11;29(35):5886-91. Epub 2011 Jul 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
June 2011
December 2010   (final data collection date for primary outcome measure)

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
Both
2 Months to 9 Years
Yes
Contact: Thanyawee Puthanakit, MD thanyawee.p@hivnat.org
Contact: Chareeya Thanee, MD chareeya_thn@hotmail.com
Thailand
 
NCT01135082
HIV-NAT 135
No
Chitsanu Pancharoen, Pediatric infectious diseases unit, Chulalongkorn University
The HIV Netherlands Australia Thailand Research Collaboration
Pediatric infectious diseases section, King Chulalongkorn Memorial hospital, Chulalongkorn University
Principal Investigator: Chitsanu Pancharoen, MD Pediatric infectious diseases unit, Chulalongkorn University
The HIV Netherlands Australia Thailand Research Collaboration
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP