Pneumococcal Conjugate Vaccination in HIV in Comparison to Polysaccharide Vaccine Boosting

NCT00622843 | Completed Phase 3 Results DMC

• 1 other identifier: RV150 Prevnar
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 6

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

Keywords

pneumococcal conjugate vaccine; polysaccharide vaccine; PPV; PCV; Streptococcus pneumoniae; Prevnar; Pneumovax; HIV

Outcome Measures

Primary Outcomes (2)

• Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms

  The primary end point is greater than or equal to a 2-fold increase in the IgG level for at least 2 of the 4 serotypes on day 60, with levels greater than or equal to 1000 ng/mL.

  Day 14, 60, and 180 after vaccination

• Adverse Events (AEs) Occurring Temporally (Within 7 Days) in Association With Pneumococcal Vaccination

  Day 7 after vaccination

Secondary Outcomes (3)

• Assessment of CD4+ Cell Count Changes Caused by Vaccination With PCV and PPV.

  Day 14, 60, and 180 after vaccination

• Assessment of the Importance of the Host Immune Status (CD4+ Count) on the PCV and PPV Immunologic Response.

  Day 60 after vaccination

• Assessment of Viral Load Changes Caused by Vaccination With PCV and PPV.

  Day 14, 60, and 180 after vaccination

Study Arms (3)

Group 1

EXPERIMENTAL

PCV, 210 patients

Biological: pneumococcal conjugate vaccine

Group 2

ACTIVE COMPARATOR

PPV, 110 patients

Biological: pneumococcal polysaccharide vaccine

Group 3

ACTIVE COMPARATOR

PCV, HIV-negative, 25 patients

Biological: pneumococcal conjugate vaccine

Interventions

pneumococcal conjugate vaccine 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.

Also known as: PCV

Group 1; Group 3

pneumococcal polysaccharide vaccine 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.

Also known as: PPV

Group 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• Infectious Diseases Clinical Research Program: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• US Military HIV Research Program: collaborator
• Uniformed Services University of the Health Sciences: collaborator

Study Sites (6)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

Location

Tripler Army Medical Center

Tripler AMC, Hawaii, 96859, United States

Location

National Naval Medical Center

Bethesda, Maryland, 20814, United States

Location

San Antonio Military Medical Center

Lackland Air Force Base, Texas, 78236, United States

Location

Naval Medical Center Portsmouth

Portsmouth, Virginia, 23708, United States

Location

Related Publications (2)

• 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.

  PMID: 20887830 RESULT

• 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.

  PMID: 20795819 RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

Pneumococcal Vaccines

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Limitations and Caveats

Limitations include: enrollment halted before full recruitment, no defined correlate of protective pneumococcal immunity in adults, prior pneumococcal vaccination may result in blunted responses to subsequent vaccination, and limiting to 4 serotypes.

Results Point of Contact

• Title: Dr. Brian Agan, Deputy Science Director
• Organization: Infectious Disease Clinical Research Program, Uniformed Services University and HJF

bagan@idcrp.org

240-694-2946

Study Officials

• Brian Agan, MD

  Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Science Director, IDCRP

Study Record Dates

• First Submitted: February 13, 2008
• First Posted: February 25, 2008
• Study Start: December 1, 2002
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: June 8, 2025
• Results First Posted: June 8, 2025

Record last verified: 2025-05

Locations

US (6)