EUCTR2011-000260-99-IE
Active, not recruiting
Not Applicable
Immunogenicity of pneumococcal vaccination after prime boosting in HIV-Infected Adults: A Randomised Controlled Trial
Department of Genitourinary medicine and Infectious Diseases, St James's Hospital, Dublin 80 sites150 target enrollmentFebruary 15, 2011
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- The primary objectives of this study are to:1.Prospectively evaluate immunological response to vaccination with the 23-valent polysaccharide vaccine (PPV23) in HIV infected patients over a one year period.2.Evaluate whether a strategy combining a prime with the 13-valent conjugate pneumococcal vaccine (PCV) followed by a boost with the PPV23 would improve immunogenicity against Streptococcus Pneumoniae Polysaccharides (SPP) in HIV-infected patients.
- Sponsor
- Department of Genitourinary medicine and Infectious Diseases, St James's Hospital, Dublin 8
- Enrollment
- 150
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Only patients who meet all of the following inclusion criteria will be eligible for enrolment into this study:
- •1\.Subjects must be HIV\-1 infected adults with a CD4 cell count of \>200cells/ml
- •2\.Subjects must be ARV naïve or stable on antiretroviral therapy
- •3\.Subjects must be free of current bacterial infection
- •4\.Subjects must have no history of prior pneumococcal vaccination
- •5\.Subject must be willing and able to understand and provide written, informed consent prior to participation in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
Exclusion Criteria
- •1\. Pregnant women will be excluded from the study.
- •2\. Anyone who does not satisfy the above inclusion criteria will be excluded from the study.Immunotherapy
- •3\. Immunization with the PPV within the past 5 years
- •4\. Splenectomy
- •5\. Use of intravenous immunoglobulin within the past 2 months
- •6\. Chemotherapy or radiation
- •7\. Any other vaccination within the past 2 months
- •8\. Severe renal failure
- •9\. End\-stage liver disease
Outcomes
Primary Outcomes
Not specified
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