Clinical trial NCT00622843: Pneumococcal Conjugate Vaccination in HIV in Comparison to Polysaccharide Vaccine Boosting
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Streptococcus Pneumoniae
Keywords: pneumococcal conjugate vaccine
polysaccharide vaccine
PPV
PCV
Streptococcus pneumoniae
Prevnar
Pneumovax
HIV
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor class: OTHER
Collaborators: name: Infectious Diseases Clinical Research Program
name: National Institute of Allergy and Infectious Diseases (NIAID)
name: US Military HIV Research Program
name: Uniformed Services University of the Health Sciences
First posted: 2008-02-25
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms
timeFrame: Day 14, 60, and 180 after vaccination
measure: Adverse Events (AEs) Occurring Temporally (Within 7 Days) in Association With Pneumococcal Vaccination
timeFrame: Day 7 after vaccination
Secondary outcomes:
measure: Assessment of CD4+ Cell Count Changes Caused by Vaccination With PCV and PPV.
timeFrame: Day 14, 60, and 180 after vaccination
measure: Assessment of the Importance of the Host Immune Status (CD4+ Count) on the PCV and PPV Immunologic Response.
timeFrame: Day 60 after vaccination
measure: Assessment of Viral Load Changes Caused by Vaccination With PCV and PPV.
timeFrame: Day 14, 60, and 180 after vaccination
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
city: Tripler AMC
country: United States
facility: Tripler Army Medical Center
state: Hawaii
city: Bethesda
country: United States
facility: National Naval Medical Center
state: Maryland
city: Lackland Air Force Base
country: United States
facility: San Antonio Military Medical Center
state: Texas
city: Portsmouth
country: United States
facility: Naval Medical Center Portsmouth
state: Virginia
Study officials:
affiliation: Uniformed Services University of the Health Sciences
name: Brian Agan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.