Pneumococcal Conjugate Vaccine (PCV) in HIV- Infected Children
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| ClinicalTrials.gov Identifier: NCT01135082 |
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Recruitment Status :
Completed
First Posted : June 2, 2010
Last Update Posted : September 4, 2014
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV | Biological: valent pneumococcal conjugated vaccine | Not Applicable |
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 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 |
| Arm | Intervention/treatment |
|---|---|
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1
Receive valent pneumococcal conjugated vaccine in HIV - infected children
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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. |
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2
Receive valent pneumococcal conjugated vaccine in HIV negative children
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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. |
- immunogenicity [ Time Frame: 28 days ]Proportion of children with PCV serotype - specific IgG antibody at 28 days after completion of primary series of vaccination.
- Safety [ Time Frame: 28 days ]Number of adverse events after PCV administration
- 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.
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| Ages Eligible for Study: | 2 Months to 9 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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HIV - infected children
- HIV infected individuals
- Age between 2 months to 9 years
- Signed written informed consent
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01135082
| Thailand | |
| HIV-NAT, The Thai Red Cross AIDS Research Center | |
| Bangkok, Thailand, 10330 | |
| Pediatric infectious diseases section, King Chulalongkorn Memorial hospital | |
| Bangkok, Thailand, 10330 | |
| Principal Investigator: | Chitsanu Pancharoen, MD | Pediatric infectious diseases unit, Chulalongkorn University |
Additional Information:
Publications of Results:
| 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 Key Record Dates |
| Last Update Posted: | September 4, 2014 |
| Last Verified: | September 2014 |
Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
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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:
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Vaccines Heptavalent Pneumococcal Conjugate Vaccine Immunologic Factors Physiological Effects of Drugs |