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: September 26, 2013
Last verified: September 2013
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: 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 between Nov. 2008 and Feb. 2011 in the Michael E. DeBakey VA Medical Center, Thomas Street Clinic and Legacy Clinic in Houston, TX.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm 1

Both groups will receive PV, the intervention is the time for vaccination (before or after starting antiretroviral treatment).

Arm 1 will receive PV prior to starting antiretroviral treatment and will receive placebo after at least 6 months of starting antiretroviral treatment.

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

Arm 2

Arm 2 will receive placebo prior to starting antiretroviral treatment and will receive PV after at least 6 months of starting antiretroviral treatment.

Placebo : Arm 2 will receive placebo prior to starting antiretroviral treatment and will receive PV after at least 6 months of starting antiretroviral treatment


Participant Flow for 2 periods

Period 1:   Arm 1: PV / Arm 2: Placebo (Pre & Post)
    Arm 1     Arm 2  
STARTED     43     64  
COMPLETED     36     56  
NOT COMPLETED     7     8  

Period 2:   Arm 1: Placebo / Arm 2: PV (Pre & Post)
    Arm 1     Arm 2  
STARTED     29     43  
COMPLETED     21     36  
NOT COMPLETED     8     7  



  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.
The number of participants analyzed was based on the number of subjects who came for the one-month follow-up after receiving PV. Thus, although the number of participants who started the flow period differs with the number of participants included in the analysis.

Reporting Groups
  Description
Arm 1

Both groups will receive PV, the intervention is the time for vaccination (before or after starting antiretroviral treatment).

Arm 1 will receive PV prior to starting antiretroviral treatment and will receive placebo after at least 6 months of starting antiretroviral treatment.

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

Arm 2

Arm 2 will receive placebo prior to starting antiretroviral treatment and will receive PV after at least 6 months of starting antiretroviral treatment.

Placebo : Arm 2 will receive placebo prior to starting antiretroviral treatment and will receive PV after at least 6 months of starting antiretroviral treatment

Total Total of all reporting groups

Baseline Measures
    Arm 1     Arm 2     Total  
Number of Participants  
[units: participants]
  43     64     107  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     35     35     70  
>=65 years     1     1     2  
Age  
[units: years]
Mean ± Standard Deviation
  43.2  ± 13.2     43.9  ± 10.4     43.6  ± 11.8  
Gender  
[units: participants]
     
Female     4     7     11  
Male     32     29     61  
Region of Enrollment  
[units: participants]
     
United States     36     36     72  



  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


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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
No text entered.  


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: September 26, 2013
Health Authority: United States: Federal Government