Pneumococcal Conjugate Vaccination in HIV in Comparison to Polysaccharide Vaccine Boosting
This study is ongoing, but not recruiting participants.
Sponsor:
Uniformed Services University of the Health Sciences
Collaborators:
Infectious Diseases Clinical Research Program
US Military HIV Research Program
Information provided by (Responsible Party):
Dr. Nancy Crum-Cianflone, Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier:
NCT00622843
First received: February 13, 2008
Last updated: January 18, 2013
Last verified: January 2013
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Purpose
Purpose: To study the immune response of the newly licensed pneumococcal conjugate vaccine (PCV) in comparison to the pneumococcal polysaccharide vaccine (PPV) to determine if a significantly better immunologic response to boosting can be elicited in patients previously vaccinated with PPV.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Streptococcus Pneumoniae |
Biological: pneumococcal conjugate vaccine Biological: pneumococcal polysaccharide vaccine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | An Open-Label, Phase III, Randomized Study of Pneumococcal Conjugate Vaccination in HIV, in Comparison to Polysaccharide Vaccine Boosting in Previously Vaccinated Patients |
Resource links provided by NLM:
Further study details as provided by Uniformed Services University of the Health Sciences:
Primary Outcome Measures:
- The measure of PPV and PCV efficacy will be assessed by the level of serotype-specific antibody levels, measured by ELISA. [ Time Frame: Day 14 after vaccination ] [ Designated as safety issue: No ]
- The measure of PPV and PCV efficacy will be assessed by the level of serotype-specific antibody levels, measured by ELISA. [ Time Frame: Day 60 after vaccination ] [ Designated as safety issue: No ]
- The measure of PPV and PCV efficacy will be assessed by the level of serotype-specific antibody levels, measured by ELISA. [ Time Frame: Day 180 after vaccination ] [ Designated as safety issue: No ]
| Enrollment: | 275 |
| Study Start Date: | December 2002 |
| Estimated Study Completion Date: | December 2013 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
PCV, 210 patients
|
Biological: pneumococcal conjugate vaccine
Prevnar is manufactured as a liquid preparation. Each 0.5 mL dose is formulated to contain: 2 μg of each saccharide for serotypes 4, 9V, 14, 18C, 19F, and 23F, and 4 μg of serotype 6B per dose (16 μg total saccharide); approximately 20 μg of CRM197 carrier protein; and 0.125 mg of aluminum per 0.5 mL dose as aluminum phosphate adjuvant. After shaking, the vaccine is a homogeneous, white suspension. Other Name: PCV
|
|
Active Comparator: Group 2
PPV, 110 patients
|
Biological: pneumococcal polysaccharide vaccine
PNEUMOVAX 23 is manufactured according to methods developed by the Merck Research Laboratories. Each 0.5 mL dose of vaccine contains 25 μg of each polysaccharide type in isotonic saline solution containing 0.25% phenol as a preservative.
Other Name: PPV
|
|
Active Comparator: Group 3
PPV, HIV-negative, 25 patients
|
Biological: pneumococcal polysaccharide vaccine
PNEUMOVAX 23 is manufactured according to methods developed by the Merck Research Laboratories. Each 0.5 mL dose of vaccine contains 25 μg of each polysaccharide type in isotonic saline solution containing 0.25% phenol as a preservative.
Other Name: PPV
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria for HIV positive subjects:
- At least one prior PPV ≥ 3 and < 8 years ago, while HIV positive. There is no upper limit to the number of previously received PPVs.
- HIV-positive (except 25 HIV-negative persons as control group).
- Age between 18 and 60 years of age.
- Availability of patient to remain within the immediate area for the period of the study and be able to comply with protocol requirements.
Exclusion Criteria for HIV positive subjects:
- Prior allergic reaction to the PPV
- Allergic to components of PCV, including diphtheria toxin.
- Pregnant or lactating females as defined by history or positive HCG urine test.
- History of chronic viral hepatitis or biochemical evidence to include pretreatment AST or ALT values greater than 3 fold higher than upper limit of normal, or a creatinine of greater than 1.8 mg/dl
- History of splenectomy
- Temperature of >38C
- Inability to ambulate for more than 1000 meters secondary to fatigue, pain or weakness.
- Patients in whom IM vaccination is not possible because of disease or medication. (e.g. hemophilia, coumadin therapy).
- Patients diagnosed with HIV wasting disease
- Viral load over 50,000 copies/ml.
- History or evidence of recent illicit drug or alcohol abuse.
- Use of immunosuppressive agents, to include corticosteroids and cancer chemotherapeutic agents.
Inclusion Criteria for HIV negative subjects:
- HIV-negative by HIV ELISA within the last 12 months
- Age between 18 and 60 years of age.
- Availability of patient to remain within the immediate area for the period of the study and be able to comply with protocol requirements.
Exclusion Criteria for HIV negative subjects:
- Prior PCV and/or PPV vaccination.
- Prior allergic reaction to the PPV
- Allergic to components of PCV, including diphtheria toxin.
- Pregnant or lactating females as defined by history or positive HCG urine test.
- History of chronic viral hepatitis or biochemical evidence to include pretreatment AST or ALT values greater than 3 fold higher than upper limit of normal, or a creatinine of greater than 1.8 mg/dl
- History of splenectomy
- Temperature of >38C
- Inability to ambulate for more than 1000 meters secondary to fatigue, pain or weakness.
- Patients in whom IM vaccination is not possible because of disease or medication. (e.g. hemophilia, coumadin therapy).
- History or evidence of recent illicit drug or alcohol abuse.
- Use of immunosuppressive agents, to include corticosteroids and cancer chemotherapeutic agents.
- Works in chain of command of primary/associate investigators.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00622843
Locations
| United States, California | |
| Naval Medical Center San Diego | |
| San Diego, California, United States, 92134 | |
| United States, District of Columbia | |
| Walter Reed Army Medical Center | |
| Washington, District of Columbia, United States, 20307 | |
| United States, Hawaii | |
| Tripler Army Medical Center | |
| Tripler AMC, Hawaii, United States, 96859 | |
| United States, Maryland | |
| National Naval Medical Center | |
| Bethesda, Maryland, United States, 20814 | |
| United States, Texas | |
| San Antonio Military Medical Center | |
| Lackland AFB, Texas, United States, 78236 | |
| United States, Virginia | |
| Naval Medical Center Portsmouth | |
| Portsmouth, Virginia, United States, 23708 | |
Sponsors and Collaborators
Uniformed Services University of the Health Sciences
Infectious Diseases Clinical Research Program
US Military HIV Research Program
Investigators
| Principal Investigator: | Braden Hale, MD, MPH | NMCSD |
More Information
No publications provided by Uniformed Services University of the Health Sciences
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr. Nancy Crum-Cianflone, Research Physician, Uniformed Services University of the Health Sciences |
| ClinicalTrials.gov Identifier: | NCT00622843 History of Changes |
| Other Study ID Numbers: | RV150 Prevnar |
| Study First Received: | February 13, 2008 |
| Last Updated: | January 18, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Uniformed Services University of the Health Sciences:
|
pneumococcal conjugate vaccine polysaccharide vaccine PPV PCV |
Streptococcus pneumoniae Prevnar Pneumovax HIV |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Pneumonia Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on May 19, 2013