N/A Completed N=107 Randomized Double-blind Prevention

Immune Responses to Pneumococcal Vaccination Among HIV-infected Subjects

HIV

Source: ClinicalTrials.gov NCT00706550 ↗

Enrolled (actual)

107

Serious AEs

13.1%

Results posted

Dec 2013

Primary outcomePrimary: Immunoglobulin G (IgG) Levels — 5.12; 5.17; 1.80; 1.83 Micrograms/ml

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.