Improving Immunogenicity of Influenza Vaccine in HIV Infected Individuals

NCT01262846 | Completed Phase 4 Results

• 1 other identifier: UPenn FLU 02
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

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

Conditions

HIV Infection

Keywords

HIV; Flu vaccination; HIV infected individuals; Fluzone SD; Fluzone HD

Outcome Measures

Primary Outcomes (1)

• Immunogenicity

  To compare the immunogenicity of trivalent Fluzone® High-Dose vaccine vs the regular standard-dose (SD) in HIV infected individuals.

  Baseline to 21 days

Study Arms (2)

Fluzone SD

ACTIVE COMPARATOR

Fluzone® Standard dose

Biological: Fluzone®

Fluzone® High dose

EXPERIMENTAL

Fluzone® High dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles.

Biological: Fluzone®

Interventions

Fluzone® BIOLOGICAL

Fluzone® Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles.

Fluzone SD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \> 18 years
• Able to understand and comply with planned study procedures.
• Provides written informed consent prior to initiation of any study procedures.
• 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.

You may not qualify if:

• 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).
• Has a history, in the opinion of the site investigator, of severe reactions following previous immunization with seasonal TIV.
• Participation in a novel H1N1 influenza vaccine study in the past two years.
• 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.
• Received any other live licensed vaccine within 4 weeks or inactivated licensed vaccine within 1 week prior to study entry.
• 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.
• 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.
• An acute illness and/or an oral temperature greater than or equal to 100.0 degrees F within 24 hours prior to study entry.
• 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).
• Active neoplastic disease (excluding non-melanoma skin cancer, and HPV-related cervical dysplasia, CIN grades 1, 2 or 3).
• 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.
• Received immunoglobulin or other blood products
• Current diagnosis of uncontrolled major psychiatric disorder.
• History of Guillain-Barré Syndrome in the subject or subject's family (parents, siblings, half siblings, or children).
• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Clinical Trials Unit. University of Pennsylvania

Philadelphia, Pennsylvania, 19104--607, United States

Location

Related Publications (2)

• Tebas P, Frank I, Lewis M, Quinn J, Zifchak L, Thomas A, Kenney T, Kappes R, Wagner W, Maffei K, Sullivan K; Center for AIDS Research and Clinical Trials Unit of the University of Pennsylvania. Poor immunogenicity of the H1N1 2009 vaccine in well controlled HIV-infected individuals. AIDS. 2010 Sep 10;24(14):2187-92. doi: 10.1097/QAD.0b013e32833c6d5c.

  PMID: 20616698 BACKGROUND

• McKittrick N, Frank I, Jacobson JM, White CJ, Kim D, Kappes R, DiGiorgio C, Kenney T, Boyer J, Tebas P. Improved immunogenicity with high-dose seasonal influenza vaccine in HIV-infected persons: a single-center, parallel, randomized trial. Ann Intern Med. 2013 Jan 1;158(1):19-26. doi: 10.7326/0003-4819-158-1-201301010-00005.

  PMID: 23277897 RESULT

MeSH Terms

Conditions

HIV Infections; Influenza, Human

Interventions

Influenza 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; Respiratory Tract Infections; Orthomyxoviridae Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Limitations and Caveats

Caution The trial was not powered to determine clinical efficacy or to detect differences in the occurrence of less common adverse events.

Results Point of Contact

• Title: Pablo Tebas
• Organization: University of Pennsylvania

pablo.tebas@uphs.upenn.edu

215-6626932

Study Officials

• PABLO TEBAS, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2010
• First Posted: December 17, 2010
• Study Start: November 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: April 13, 2017
• Results First Posted: April 13, 2017

Record last verified: 2017-03

Locations

US (1)