Improving Immunogenicity of Influenza Vaccine in HIV Infected Individuals

Condition(s) targeted: HIV Infection

Intervention: Fluzone® (Biological); Fluzone® (Biological)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Pennsylvania

Official(s) and/or principal investigator(s):
PABLO TEBAS, MD, Principal Investigator, Affiliation: University of Pennsylvania

Overall contact:
Joseph Quinn, RN, Phone: 2153498091, Email: joseph.quinn@uphs.upenn.edu

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

Official title: Improving Immunogenicity of Influenza Vaccine in HIV Infected Individuals

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome:

Immunogenicity

Safety and tolerability

Secondary outcome: Immune activation and immune senescence

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Joseph Quinn, RN, Phone: 2153498091, Email: joseph.quinn@uphs.upenn.edu

Clinical Trials Unit. University of Pennsylvania, Philadelphia, Pennsylvania 19104--607, United States; Recruiting

Related publications:

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.

Starting date: November 2010
Last updated: December 16, 2010