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Improving Immunogenicity of Influenza Vaccine in HIV Infected Individuals

This study has been completed.
Information provided by (Responsible Party):
University of Pennsylvania Identifier:
First received: December 16, 2010
Last updated: March 1, 2017
Last verified: March 2017
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
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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: Baseline to 21 days ]
    To compare the immunogenicity of trivalent Fluzone® High-Dose vaccine vs the regular standard-dose (SD) in HIV infected individuals.

Enrollment: 195
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01262846

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

Responsible Party: University of Pennsylvania Identifier: NCT01262846     History of Changes
Other Study ID Numbers: UPenn FLU 02
Study First Received: December 16, 2010
Results First Received: December 8, 2016
Last Updated: March 1, 2017

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

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases processed this record on May 25, 2017