Immune Responses to Pneumococcal Vaccination Among HIV-infected Subjects

This study has been completed.
Sponsor:
Collaborators:
Albert Einstein College of Medicine of Yeshiva University
Montefiore Medical Center
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00706550
First received: June 24, 2008
Last updated: March 27, 2014
Last verified: March 2014
Results First Received: September 26, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Prevention
Condition: HIV Infections
Interventions: Biological: (PV) 23-valent pneumococcal polysaccharide vaccine
Biological: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 107 patients were enrolled on the study (11/2008-2/2011 at the Michael E. DeBakey VA Medical Center, at Thomas Street Clinic and at Legacy Clinic, in Houston, TX. Only the patients that completed the 1 month post-PV visit are included in the analysis (N=36 for each arm for a total of 72 out of the 107 initially enrolled).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Immediate: PV Before Starting Antiretroviral Therapy

Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.

PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine.

Delayed: PV After >6 Months of Antiretroviral Therapy

Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment

PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine.


Participant Flow:   Overall Study
    Immediate: PV Before Starting Antiretroviral Therapy     Delayed: PV After >6 Months of Antiretroviral Therapy  
STARTED     43     64  
COMPLETED     36     36  
NOT COMPLETED     7     28  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm 1: PV Before Starting Antiretroviral Therapy

Arm 1 received PV prior to starting antiretroviral treatment.

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

Arm 2: PV After >6 Months of Antiretroviral Therapy

Arm 2 received PV after at least 6 months of antiretroviral treatment.

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

Total Total of all reporting groups

Baseline Measures
    Arm 1: PV Before Starting Antiretroviral Therapy     Arm 2: PV After >6 Months of Antiretroviral Therapy     Total  
Number of Participants  
[units: participants]
  43     64     107  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     42     63     105  
>=65 years     1     1     2  
Age  
[units: years]
Mean ± Standard Deviation
  43.4  ± 12.9     40.8  ± 11.6     41.8  ± 12.1  
Gender  
[units: participants]
     
Female     6     15     21  
Male     37     49     86  
Region of Enrollment  
[units: participants]
     
United States     43     64     107  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Immunoglobulin G (IgG) Levels   [ Time Frame: Baseline ]

2.  Primary:   IgG Levels   [ Time Frame: One-month post-vaccine ]

3.  Primary:   Immunoglobulin M (IgM) Levels   [ Time Frame: Baseline ]

4.  Primary:   IgM Levels   [ Time Frame: One-month post-vaccine ]

5.  Primary:   Opsonophagocytic Killing Activity (OPA)   [ Time Frame: Baseline ]

6.  Primary:   Opsonophagocytic Killing Activity (OPA)   [ Time Frame: One-month post-vaccine ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Maria C. Rodriguez-Barradas
Organization: Michael E. DeBakey Veterans Affairs Medical Center
phone: 713-794-7384
e-mail: Maria.Rodriguez-Barradas2@va.gov


No publications provided


Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00706550     History of Changes
Other Study ID Numbers: INDA-002-08S
Study First Received: June 24, 2008
Results First Received: September 26, 2013
Last Updated: March 27, 2014
Health Authority: United States: Federal Government