N/A
N=107
Immune Responses to Pneumococcal Vaccination Among HIV-infected Subjects
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00706550 ↗Enrolled (actual)
107
Serious AEs
13.1%
Results posted
Dec 2013
Primary outcome: Primary: Immunoglobulin G (IgG) Levels — 5.12; 5.17; 1.80; 1.83 Micrograms/ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- (PV) 23-valent pneumococcal polysaccharide vaccine (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Immunoglobulin G (IgG) Levels |
5.12; 5.17; 1.80; 1.83 | — |
| PRIMARY IgG Levels |
7.85; 5.79; 2.50; 2.41 | — |
| PRIMARY Immunoglobulin M (IgM) Levels |
1.89; 1.85; 0.59; 0.78 | — |
| PRIMARY IgM Levels |
2.18; 2.26; 0.65; 0.84 | — |
| PRIMARY Opsonophagocytic Killing Activity (OPA) |
23.0; 13.7; 4.7; 3.3 | — |
| PRIMARY Opsonophagocytic Killing Activity (OPA) |
23.0; 13.7; 4.7; 3.3 | — |
Summary
The purpose of this study is to evaluate the best timing for administering pneumococcal vaccine (PV) to HIV-infected adults that have CD4 cell counts of more than 200 and are not yet receiving combination antiretroviral treatment (ART). Participants in this study will be assigned by chance to receive vaccination with PV prior to starting ART or after at least 6 months of ART. Antibody levels to components of the PV will be measured at 6 months and 12 months after vaccination. The results will tell us if patients that receive PV after 6 months of ART have better response to the vaccine than those that get vaccinated prior to treatment.
Eligibility Criteria
Inclusion Criteria
- HIV infected
- CD4 count >200
- no acute illness
- no pneumococcal vaccination within 3 years
- naive to treatment or if previously on treatment, no antiretroviral treatment for at least 6 months
- willingness to start antiretroviral treatment as recommended by current guidelines
Exclusion Criteria
- prior pneumococcal vaccination within 3 years
- prior AIDS diagnosis based on opportunistic disease
- acute illness
Data sourced from ClinicalTrials.gov (NCT00706550). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.