Safety & Immunogenicity of 13vPnC in HIV-Infected Subjects Aged 18 or Older Who Were Previously I… (NCT00963235) | Clinical Trial Compass
CompletedPhase 3
Safety & Immunogenicity of 13vPnC in HIV-Infected Subjects Aged 18 or Older Who Were Previously Immunized With 23vPS
United States331 participantsStarted 2009-11
Plain-language summary
The study will evaluate the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) in HIV-infected subjects 18 years of age or older who have been previously immunized with at least one dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). All subjects will receive 3 doses of 13vPnC, with each study vaccine dose given approximately 6 months apart.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male or female subjects aged 18 years or older at the time of enrollment.
* All female and male subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control from the signing of the informed consent form (ICF) until 3 months after the last dose of investigational product.
* Documented vaccination with 1 or more doses of 23vPS at least 6 months before study enrollment.
* CD4+ T-cell count \>= 200 cells/µ, obtained on the most recent 2 occasions within 6 months before the first investigational product vaccination.
* HIV-infected subjects with viral load \<50,000 copies/mL, obtained on the most recent 2 occasions within 6 months before the first investigational product vaccination.
* Subject is receiving a stable dose of HAART for at least 6 weeks prior to the first investigational product vaccination, or not currently receiving antiretroviral therapy.
* Subject is expected to be available for the entire study period (approximately 18 months) and can be contacted by telephone.
* Subject must be able to complete an electronic diary (e-diary) and complete all relevant study procedures during study participation.
* Subject is deemed to be eligible for the study on the basis of medical history, physical examination, and clinical judgment. (Note: Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 6 week…
What they're measuring
1
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC