Pneumococcal Conjugate Vaccination in HIV in Comparison to Polysaccharide Vaccine Boosting

NCT ID: NCT00622843

Last Updated: 2025-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 275 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-12-31
• Study Completion Date: 2013-07-31

Brief 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.

Conditions

HIV Infections; Streptococcus Pneumoniae

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group 1

PCV, 210 patients

Group Type: EXPERIMENTAL

pneumococcal conjugate vaccine

Intervention Type: BIOLOGICAL

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.

Group 2

PPV, 110 patients

Group Type: ACTIVE_COMPARATOR

pneumococcal polysaccharide vaccine

Intervention Type: BIOLOGICAL

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.

Group 3

PCV, HIV-negative, 25 patients

Group Type: ACTIVE_COMPARATOR

pneumococcal conjugate vaccine

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

Other Intervention Names

PCV; PPV

Eligibility Criteria

Inclusion Criteria

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.

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

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Infectious Diseases Clinical Research Program

OTHER

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

US Military HIV Research Program

NETWORK

Sponsor Role: collaborator

Uniformed Services University of the Health Sciences

FED

Sponsor Role: collaborator

Henry M. Jackson Foundation for the Advancement of Military Medicine

OTHER

Sponsor Role: lead

Responsible Party

Brian Agan

Deputy Science Director, IDCRP

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian Agan, MD

Role: PRINCIPAL_INVESTIGATOR

Uniformed Services University of the Health Sciences

Locations

Naval Medical Center San Diego

San Diego, California, United States

Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Tripler Army Medical Center

Tripler AMC, Hawaii, United States

National Naval Medical Center

Bethesda, Maryland, United States

San Antonio Military Medical Center

Lackland Air Force Base, Texas, United States

Naval Medical Center Portsmouth

Portsmouth, Virginia, United States

Countries

United States

References

Crum-Cianflone NF, Roediger M, Huppler Hullsiek K, Ganesan A, Landrum M, Weintrob A, Agan B, Medina S, Rahkola J, Hale B, Janoff EN; Infectious Disease Clinical Research Program HIV Working Group. The association of ethnicity with antibody responses to pneumococcal vaccination among adults with HIV infection. Vaccine. 2010 Nov 10;28(48):7583-8. doi: 10.1016/j.vaccine.2010.09.056. Epub 2010 Sep 29.

Reference Type: RESULT

PMID: 20887830 (View on PubMed)

Crum-Cianflone NF, Huppler Hullsiek K, Roediger M, Ganesan A, Patel S, Landrum ML, Weintrob A, Agan BK, Medina S, Rahkola J, Hale BR, Janoff EN; Infectious Disease Clinical Research Program HIV Working Group. A randomized clinical trial comparing revaccination with pneumococcal conjugate vaccine to polysaccharide vaccine among HIV-infected adults. J Infect Dis. 2010 Oct 1;202(7):1114-25. doi: 10.1086/656147.

Reference Type: RESULT

PMID: 20795819 (View on PubMed)

Other Identifiers

RV150 Prevnar

Identifier Type: -

Identifier Source: org_study_id