Pneumococcal Conjugate Vaccine (PCV) in HIV- Infected Children

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
HIV	Biological: valent pneumococcal conjugated vaccine	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	90 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	The Immunogenicity and Safety of Pneumococcal Conjugate Vaccine in Human Immunodeficiency Virus - Infected Children
Study Start Date :	April 2010
Actual Primary Completion Date :	December 2010
Actual Study Completion Date :	June 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

1. immunogenicity [ Time Frame: 28 days ]
   Proportion of children with PCV serotype - specific IgG antibody at 28 days after completion of primary series of vaccination.

Secondary Outcome Measures :

1. Safety [ Time Frame: 28 days ]
   Number of adverse events after PCV administration
2. compare serotype [ Time Frame: 28 days ]
   Compare proportion of PCV serotype - specific IgG antibody in HIV - infected children by baseline clinical staging, CD4 and viral load.

Eligibility Criteria

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Ages Eligible for Study:	2 Months to 9 Years (Child)
Sexes Eligible for Study:	All
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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) 

Publications of Results:

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. doi: 10.1016/j.vaccine.2011.06.072. Epub 2011 Jul 3. Erratum in: Vaccine. 2011 Oct 26;29(46):8470.

Responsible Party:	The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:	NCT01135082 History of Changes
Other Study ID Numbers:	HIV-NAT 135
First Posted:	June 2, 2010
Last Update Posted:	September 4, 2014
Last Verified:	September 2014

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