Immune Responses to Pneumococcal Vaccination Among HIV-infected Subjects
1 other identifier
interventional
107
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv-infections
Started Oct 2008
Longer than P75 for not_applicable hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2008
CompletedFirst Posted
Study publicly available on registry
June 27, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedResults Posted
Study results publicly available
December 12, 2013
CompletedApril 24, 2014
March 1, 2014
2.9 years
June 24, 2008
September 26, 2013
March 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
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
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
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
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
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
Study Arms (2)
Immediate
OTHERArm 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
OTHERArm 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
Interventions
Currently commercially available pneumococcal polysaccharide vaccine
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- prior pneumococcal vaccination within 3 years
- prior AIDS diagnosis based on opportunistic disease
- acute illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- US Department of Veterans Affairslead
- Albert Einstein College of Medicinecollaborator
- Montefiore Medical Centercollaborator
Study Sites (1)
Michael E DeBakey VA Medical Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Maria C. Rodriguez-Barradas
- Organization
- Michael E. DeBakey Veterans Affairs Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Rodriguez-Barradas, MD
Michael E. DeBakey VA Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2008
First Posted
June 27, 2008
Study Start
October 1, 2008
Primary Completion
September 1, 2011
Study Completion
September 1, 2012
Last Updated
April 24, 2014
Results First Posted
December 12, 2013
Record last verified: 2014-03