Immune Responses to Pneumococcal Vaccination Among HIV-infected Subjects

US Department of Veterans Affairs (VA)

Status: Completed

Conditions: HIV Infections

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

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00706550

INDA-002-08S

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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107 participants in 2 patient groups

Immediate

Other group

Description:

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

Treatment:

Biological: (PV) 23-valent pneumococcal polysaccharide vaccine

Biological: Placebo

Delayed

Other group

Description:

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

Treatment:

Biological: (PV) 23-valent pneumococcal polysaccharide vaccine

Biological: Placebo