Immune Responses to Pneumococcal Vaccination Among HIV-infected Subjects

HIV Infections Clinical Trial

Official title:

Immune Responses to Pneumococcal Vaccination Among HIV-Infected Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00706550
• Other study ID #: INDA-002-08S
• Status: Completed
• Phase: N/A
• First received: June 24, 2008
• Last updated: March 27, 2014
• Start date: October 2008
• Est. completion date: September 2012

Study information

• Verified date: March 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: September 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

Biological:
• (PV) 23-valent pneumococcal polysaccharide vaccine
Currently commercially available pneumococcal polysaccharide vaccine
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Michael E DeBakey VA Medical Center	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	Albert Einstein College of Medicine of Yeshiva University, Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunoglobulin G (IgG) Levels	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.	Baseline	No
Primary	IgG Levels	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.	One-month post-vaccine	No
Primary	Immunoglobulin M (IgM) Levels	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.	Baseline	No
Primary	IgM Levels	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.	One-month post-vaccine	No
Primary	Opsonophagocytic Killing Activity (OPA)	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. As explained previously for the immunoglobulins' assays, we measure the baseline point to be able to determine the increase after the vaccine is administered.	Baseline	No
Primary	Opsonophagocytic Killing Activity (OPA)	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.	One-month post-vaccine	No