Pneumococcal Conjugate Vaccine (PCV) in HIV- Infected Children
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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 |
|---|---|
|
Acquired Immunodeficiency Syndrome |
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 |
- 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.
- 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.
| Estimated Enrollment: | 90 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | June 2011 |
| Estimated 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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
HIV - infected children
- HIV infected individuals
- Age between 2 months to 9 years
- Signed written informed consent
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| Contact: Thanyawee Puthanakit, MD | thanyawee.p@hivnat.org | |
| Contact: Chareeya Thanee, MD | chareeya_thn@hotmail.com |
| Thailand | |
| Pediatric infectious diseases section, King Chulalongkorn Memorial hospital | Recruiting |
| Bangkok, Thailand, 10330 | |
| Contact: Thanyawee Puthanakit, MD thanyawee.p@hivnat.org | |
| Contact: Chareeya Thanee, MD chareeya_thn@hotmail.com | |
| Principal Investigator: Chitsanu Pancharoen, MD | |
| HIV-NAT, The Thai Red Cross AIDS Research Center | Recruiting |
| Bangkok, Thailand, 10330 | |
| Contact: Thanyawee Puthanakit, MD thanyawee.p@hivnat.org | |
| Contact: Wasana Prasitsuebsai, MD 662-652-3040 ext 148 wasana.p@hivnat.org | |
| Principal Investigator: | Chitsanu Pancharoen, MD | Pediatric infectious diseases unit, Chulalongkorn University |
More Information
Additional Information:
No publications provided by The HIV Netherlands Australia Thailand Research Collaboration
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Chitsanu Pancharoen, Pediatric infectious diseases unit, Chulalongkorn University |
| ClinicalTrials.gov Identifier: | NCT01135082 History of Changes |
| Other Study ID Numbers: | HIV-NAT 135 |
| Study First Received: | June 1, 2010 |
| Last Updated: | February 16, 2011 |
| 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:
|
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on March 10, 2013
