Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in HIV-Infected Subjects 6 Years of Age or Older Who Are Naive to Pneumococcal Vaccine
NCT ID: NCT00962780
Last Updated: 2014-11-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
303 participants
INTERVENTIONAL
2010-03-31
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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1
3 doses of 13vPnC and 1 dose of 23vPS, each dose given approximately 1 month apart
13-valent Pneumococcal Conjugate Vaccine (13vPnC)
13vPnC; 3 vaccinations given at approximately 1 month intervals at visits 1-3
23-valent Pneumococcal Polysaccharide Vaccine (23vPS)
23vPS; 1 vaccination given at visit 4 (approximately 1 month after visit 3)
Blood draw
Blood draw; 5 blood draws approximately 1 month apart taken prior to vaccination at visits 1-4 and visit 5 (approximately 1 month after visit 4).
Blood draw
1 or 2 blood draws for CD4+ T cell count and HIV viral load at least 6 weeks apart, if subject does not have 2 CD4+ T cell counts and HIV viral load counts within 6 months before visit 1.
Interventions
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13-valent Pneumococcal Conjugate Vaccine (13vPnC)
13vPnC; 3 vaccinations given at approximately 1 month intervals at visits 1-3
23-valent Pneumococcal Polysaccharide Vaccine (23vPS)
23vPS; 1 vaccination given at visit 4 (approximately 1 month after visit 3)
Blood draw
Blood draw; 5 blood draws approximately 1 month apart taken prior to vaccination at visits 1-4 and visit 5 (approximately 1 month after visit 4).
Blood draw
1 or 2 blood draws for CD4+ T cell count and HIV viral load at least 6 weeks apart, if subject does not have 2 CD4+ T cell counts and HIV viral load counts within 6 months before visit 1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Viral load \< 50,000 copies/mL and CD4+ T cell count \>= 200/uL within 6 months before study vaccination
* Receiving stable highly active antiretroviral therapy (HAART) or not currently receiving any antiretroviral therapy
* No previous vaccination with a pneumococcal vaccine
* Subject or parent/legal guardian able to complete an electronic diary
Exclusion Criteria
* Current illicit substance and/or alcohol abuse
* History of active chronic viral hepatitis
* Previous anaphylactic reaction to a vaccine or vaccine-related component
* Serious chronic disorders including metastatic malignancy and end-stage renal disease
6 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Bucharest, , Romania
Pfizer Investigational Site
Bucharest, , Romania
Pfizer Investigational Site
Constanța, , Romania
Pfizer Investigational Site
Johannesburg, Gauteng, South Africa
Pfizer Investigational Site
Pretoria, Gauteng, South Africa
Pfizer Investigational Site
Pretoria, Gauteng, South Africa
Pfizer Investigational Site
Soweto, Gauteng, South Africa
Pfizer Investigational Site
Dundee, KwaZulu-Natal, South Africa
Pfizer Investigational Site
Worcester, Western Cape, South Africa
Pfizer Investigational Site
Bloemfontein, , South Africa
Pfizer Investigational Site
Paarl, , South Africa
Countries
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References
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Bhorat AE, Madhi SA, Laudat F, Sundaraiyer V, Gurtman A, Jansen KU, Scott DA, Emini EA, Gruber WC, Schmoele-Thoma B. Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine in HIV-infected individuals naive to pneumococcal vaccination. AIDS. 2015 Jul 17;29(11):1345-54. doi: 10.1097/QAD.0000000000000689.
Related Links
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Other Identifiers
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B1851021
Identifier Type: -
Identifier Source: secondary_id
6115A1-3002
Identifier Type: -
Identifier Source: org_study_id
NCT01098370
Identifier Type: -
Identifier Source: nct_alias