Immune Responses to Pneumococcal Vaccination Among HIV-infected Subjects

Not Applicable

Completed

Conditions: HIV Infections

Interventions: Biological: (PV) 23-valent pneumococcal polysaccharide vaccine
Biological: Placebo

Registration Number: NCT00706550

Lead Sponsor: US Department of Veterans Affairs

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 107

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate	(PV) 23-valent pneumococcal polysaccharide vaccine	Arm 1 will receive PV (23-valent pneumococcal polysaccharide vaccine) prior to starting antiretroviral treatment and will receive PLACEBO after at least 6 months of starting antiretroviral treatment. PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine
Immediate	Placebo	Arm 1 will receive PV (23-valent pneumococcal polysaccharide vaccine) prior to starting antiretroviral treatment and will receive PLACEBO after at least 6 months of starting antiretroviral treatment. PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine
Delayed	(PV) 23-valent pneumococcal polysaccharide vaccine	Arm 2 will receive PLACEBO prior to starting antiretroviral treatment and will receive PV (23-valent pneumococcal polysaccharide vaccine) after at least 6 months of starting antiretroviral treatment. PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine
Delayed	Placebo	Arm 2 will receive PLACEBO prior to starting antiretroviral treatment and will receive PV (23-valent pneumococcal polysaccharide vaccine) after at least 6 months of starting antiretroviral treatment. PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine

Primary Outcome Measures

Name	Time	Method
Immunoglobulin G (IgG) Levels	Baseline	Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgG is the most common antibody. We measure baseline levels (before the vaccine is administered) to know how much antibody the subject has at the start point to be able to evaluate how much antibody is produced after the vaccine is administered.
IgG Levels	One-month post-vaccine	Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgG is the most common antibody. This point of time (one-month after vaccine), gives the information about how much antibody was produced by the participant's immune system in response to the vaccine.
Immunoglobulin M (IgM) Levels	Baseline	Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgM is the first antibody produced by the immune system to fight a new infection. We measure baseline levels (before the vaccine is administered) to know how much antibody the subject has at the start point to be able to evaluate how much antibody is produced after the vaccine is administered.
IgM Levels	One-month post-vaccine	Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgM is the first antibody produced by the immune system to fight a new infection. This point of time (one-month after vaccine), gives the information about how much antibody was produced by the participant's immune system in response to the vaccine.
Opsonophagocytic Killing Activity (OPA)	One-month post-vaccine	This assay helps us to know how the antibody produced by the body are working to kill the bacteria against which the antibody is produced. This point of time (one-month after vaccine), gives the information about how much the killing activity increased 1 month after the vaccine was administered.