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Improving Immunogenicity of Influenza Vaccine in HIV Infected Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01262846
Recruitment Status : Completed
First Posted : December 17, 2010
Results First Posted : April 13, 2017
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE December 16, 2010
First Posted Date  ICMJE December 17, 2010
Results First Submitted Date  ICMJE December 8, 2016
Results First Posted Date  ICMJE April 13, 2017
Last Update Posted Date April 13, 2017
Study Start Date  ICMJE November 2010
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 16, 2010)
  • Immunogenicity [ Time Frame: 21 days ]
    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 ]
    To compare the safety of trivalent Fluzone® High-Dose vaccine vs the regular standard-dose (SD) in HIV infected individuals.
Change History Complete list of historical versions of study NCT01262846 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2010)
Immune activation and immune senescence [ Time Frame: 21 days ]
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Immunogenicity of Influenza Vaccine in HIV Infected Individuals
Official Title  ICMJE Improving Immunogenicity of Influenza Vaccine in HIV Infected Individuals
Brief Summary 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE HIV Infection
Intervention  ICMJE
  • Biological: Fluzone®
    Fluzone® Standard 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.
Study Arms  ICMJE
  • Active Comparator: Fluzone SD
    Fluzone® Standard dose
    Intervention: Biological: Fluzone®
  • 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.
    Intervention: Biological: Fluzone®
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 1, 2017)
195
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2010)
232
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01262846
Other Study ID Numbers  ICMJE UPenn FLU 02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: PABLO TEBAS, MD University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP