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.
Conditions
Interventions
Trade Name: Prevenar 13 (PCV13)
Product Name: Prevenar 13
Pharmaceutical Form: Injection*
Trade Name: Pneumovax 23 (PPV 23)
Product Name: Pneumovax 23
Pharmaceutical Form: Injection*
Sponsors
Department of Genitourinary medicine and Infectious Diseases, St James's Hospital, Dublin 8
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: The secondary objectives of this study are to: 3. Determine the association if any between HIV RNA, CD4 count, HAART and immunological response to above pneumococcal vaccination strategies ;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. | — |
Countries
Ireland
Outcome results
None listed