Improving Immunogenicity of Influenza Vaccine in HIV Infected Individuals

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pablo Tebas, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01262846
First received: December 16, 2010
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

The overall goal of this study is to compare the safety and immunogenicity of trivalent Fluzone® High-Dose vaccine vs the regular standard-dose (SD) in HIV infected individuals. Our hypothesis is that Fluzone® HD will be safe and more immunogenic than the currently used vaccine


Condition Intervention Phase
HIV Infection
Biological: Fluzone®
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Improving Immunogenicity of Influenza Vaccine in HIV Infected Individuals

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Immunogenicity [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    To compare the immunogenicity of trivalent Fluzone® High-Dose vaccine vs the regular standard-dose (SD) in HIV infected individuals.

  • Safety and tolerability [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
    To compare the safety of trivalent Fluzone® High-Dose vaccine vs the regular standard-dose (SD) in HIV infected individuals.


Secondary Outcome Measures:
  • Immune activation and immune senescence [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    To evaluate the role that residual immune activation and T immunesenescence in spite of HIV-1 virological control play in the lack of response to influenza vaccination among HIV infected patients receiving antiretroviral therapy


Enrollment: 232
Study Start Date: November 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fluzone SD
Fluzone® Standard dose
Biological: Fluzone®
Fluzone® Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles.
Experimental: Fluzone® High dose
Fluzone® High dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles.
Biological: Fluzone®
Fluzone® High dose or Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A confirmed diagnosis of HIV-1 infection as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry or any measurable HIV RNA viral load in the chart. Serum HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test.
  2. > 18 years
  3. Able to understand and comply with planned study procedures.
  4. Provides written informed consent prior to initiation of any study procedures.
  5. Subject should be 1) on stable antiretroviral therapy as outlined in the DHHS treatment guidelines for HIV-1 infected individuals OR 2) not on antiretroviral therapy and not intending to start treatment within the next 30 days.

Exclusion Criteria:

  1. Has a known allergy to eggs or other components in the vaccines (these may include, but are not limited to: gelatin, formaldehyde, octoxinol and chicken protein).
  2. Has a history, in the opinion of the site investigator, of severe reactions following previous immunization with seasonal TIV.
  3. Participation in a novel H1N1 influenza vaccine study in the past two years.
  4. Proven history, by RT-PCR, of novel influenza H1N1 infection, or, has a positive influenza diagnostic testing since June 2009 (specificity to H1N1 not required) prior to study entry.
  5. Received any other live licensed vaccine within 4 weeks or inactivated licensed vaccine within 1 week prior to study entry.
  6. Scheduled administration of any live virus vaccine or inactivated vaccine at or between entry and the Day 21 visit. NOTE: Live or inactivated vaccines expected to be administered between study entry and the Day 21 visit should be excluded to prevent potential interference with immunogenicity responses and confounding safety results.
  7. Received a non-licensed agent (vaccine, drug, biologic, device, blood product, or medication) within 4 weeks prior to vaccination in this study with the exception of new antiretroviral medications as part of a phase 3 trial.
  8. An acute illness and/or an oral temperature greater than or equal to 100.0 degrees F within 24 hours prior to study entry.
  9. Use of anti-cancer chemotherapy or radiation therapy within the preceding 36 months of study enrollment, or has immunosuppression as a result of an underlying illness or treatment (other than HIV-1 infection).
  10. Active neoplastic disease (excluding non-melanoma skin cancer, and HPV-related cervical dysplasia, CIN grades 1, 2 or 3).
  11. Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to study entry. NOTE: Subjects receiving stable physiologic glucocorticoid doses, defined as prednisone ≤10 mg/day, will not be excluded. Subjects receiving corticosteroids for acute therapy for an opportunistic infection such as Pneumocystis jiroveci pneumonia (PCP), or receiving a short course (defined as ≤2 weeks) of pharmacologic glucocorticoid therapy will not be excluded.
  12. Received immunoglobulin or other blood products
  13. Current diagnosis of uncontrolled major psychiatric disorder.
  14. History of Guillain-Barré Syndrome in the subject or subject's family (parents, siblings, half siblings, or children).
  15. Any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262846

Locations
United States, Pennsylvania
Clinical Trials Unit. University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104--607
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: PABLO TEBAS, MD University of Pennsylvania
  More Information

Publications:
Responsible Party: Pablo Tebas, Professor of Medicine, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01262846     History of Changes
Other Study ID Numbers: UPenn FLU 02
Study First Received: December 16, 2010
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
HIV
Flu vaccination
HIV infected individuals
Fluzone SD
Fluzone HD

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Influenza, Human
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
Orthomyxoviridae Infections
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 23, 2014