Immunogenicity of pneumococcal vaccination after prime boosting in HIV-Infected Adults: A Randomised Controlled Trial

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.

Registration Number: EUCTR2011-000260-99-IE

Lead Sponsor: Department of Genitourinary medicine and Infectious Diseases, St James's Hospital, Dublin 8

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

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
F.1.3 Elderly (>=65 years) no
F.1.3.1 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objectives of this study are to:<br><br>1.Prospectively evaluate immunological response to vaccination with the 23-valent polysaccharide vaccine (PPV23) in HIV infected patients over a one year period.<br><br>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.<br>;Secondary Objective: The secondary objectives of this study are to:<br><br>3.Determine the association if any between HIV RNA, CD4 count, HAART and immunological response to above pneumococcal vaccination strategies<br>;Primary end point(s): The primary endpoint of the study is the proportion of patients who have antibody responses against specific vaccine pneumococcal polysaccharides at Week 8. Secondary endpoints include the persistence of antibody responses at Weeks 24.

Secondary Outcome Measures