Pneumococcal Conjugate Vaccination in HIV in Comparison to Polysaccharide Vaccine Boosting

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00622843
• Other study ID #: RV150 Prevnar
• Status: Completed
• Phase: Phase 3
• First received: February 13, 2008
• Last updated: October 7, 2014
• Start date: December 2002
• Est. completion date: July 2013

Study information

• Verified date: October 2014
• Source: Uniformed Services University of the Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria for HIV positive subjects:

1. 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.

2. HIV-positive (except 25 HIV-negative persons as control group).

3. Age between 18 and 60 years of age.

4. 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:

1. Prior allergic reaction to the PPV

2. Allergic to components of PCV, including diphtheria toxin.

3. Pregnant or lactating females as defined by history or positive HCG urine test.

4. 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

5. History of splenectomy

6. Temperature of >38C

7. Inability to ambulate for more than 1000 meters secondary to fatigue, pain or weakness.

8. Patients in whom IM vaccination is not possible because of disease or medication. (e.g. hemophilia, coumadin therapy).

9. Patients diagnosed with HIV wasting disease

10. Viral load over 50,000 copies/ml.

11. History or evidence of recent illicit drug or alcohol abuse.

12. Use of immunosuppressive agents, to include corticosteroids and cancer chemotherapeutic agents.

Inclusion Criteria for HIV negative subjects:

1. HIV-negative by HIV ELISA within the last 12 months

2. Age between 18 and 60 years of age.

3. 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:

1. Prior PCV and/or PPV vaccination.

2. Prior allergic reaction to the PPV

3. Allergic to components of PCV, including diphtheria toxin.

4. Pregnant or lactating females as defined by history or positive HCG urine test.

5. 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

6. History of splenectomy

7. Temperature of >38C

8. Inability to ambulate for more than 1000 meters secondary to fatigue, pain or weakness.

9. Patients in whom IM vaccination is not possible because of disease or medication. (e.g. hemophilia, coumadin therapy).

10. History or evidence of recent illicit drug or alcohol abuse.

11. Use of immunosuppressive agents, to include corticosteroids and cancer chemotherapeutic agents.

12. Works in chain of command of primary/associate investigators.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• HIV Infections
• Pneumonia
• Streptococcus Pneumoniae

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	National Naval Medical Center	Bethesda	Maryland
United States	San Antonio Military Medical Center	Lackland AFB	Texas
United States	Naval Medical Center Portsmouth	Portsmouth	Virginia
United States	Naval Medical Center San Diego	San Diego	California
United States	Tripler Army Medical Center	Tripler AMC	Hawaii
United States	Walter Reed Army Medical Center	Washington	District of Columbia

Sponsors (4)

Lead Sponsor	Collaborator
Uniformed Services University of the Health Sciences	Infectious Diseases Clinical Research Program, National Institute of Allergy and Infectious Diseases (NIAID), US Military HIV Research Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The measure of PPV and PCV efficacy will be assessed by the level of serotype-specific antibody levels, measured by ELISA.		Day 14 after vaccination	No
Primary	The measure of PPV and PCV efficacy will be assessed by the level of serotype-specific antibody levels, measured by ELISA.		Day 60 after vaccination	No
Primary	The measure of PPV and PCV efficacy will be assessed by the level of serotype-specific antibody levels, measured by ELISA.		Day 180 after vaccination	No