H1N1 Influenza Vaccine Immunogenicity in HIV-1 Infected Patients

HIV Infections Clinical Trial

Official title:

Evaluating the Safety and Immunogenicity of an Inactivated Swine-Origin H1N1 Influenza Vaccine in HIV-1 Infected Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01111162
• Other study ID #: Upenn HIV-H1N1-001
• Status: Completed
• Phase: Phase 4
• First received: April 13, 2010
• Last updated: January 7, 2014
• Start date: December 2009
• Est. completion date: December 2010

Study information

• Verified date: January 2014
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The overall goal of this study is to study influenza vaccine responses in HIV infected individuals. Immunocompromised individuals require special protection from influenza, but may not respond appropriately to the standard killed vaccine. Patients who receive the H1N1 flu vaccine as part of their standard of care will be asked to donate blood samples for immunologic studies. These studies will determine whether participants were able to produce the appropriate antibodies to the vaccine and possibly identify predictors of vaccine responsiveness.

Our hypothesis is that vaccine responsiveness to the new H1N1 influenza vaccine will be compromised in HIV infected patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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. Regular seasonal flu vaccination will be allowed if is separated more than 7 days from the administration of the H1N1 vaccine.

7. Received a non-licensed agent (vaccine, drug, biologic, device, blood product, or medication) within 4 weeks prior to vaccination in this study

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. Long term use of glucocorticoids, including oral or parenteral prednisone or equivalent (more than 2.0 mg/kg per day or more than 20 mg total dose) for more than 2 consecutive weeks (or 2 weeks total) in the past 3 months, or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the past 3 months (nasal and topical steroids are allowed).

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Biological:
• H1N1 vaccination
Novartis unadjuvanted inactivated S-OIV H1N1 influenza vaccine 15 mcg administered as single-0.5mL (15mcg) injection intramuscularly into one of the subject's deltoid muscles

Locations

Country	Name	City	State
United States	University of Pennsylvania. Clinical Trials Unit	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 controll — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	To assess the safety of inactivated swine-origin H1N1 influenza vaccine in HIV-1 infected individuals (received as part of standard of care).; Adverse Events of Grade 3 or higher severity, including: Abnormal laboratory values, signs and symptoms or diagnoses.; Solicited local AEs, including pain, tenderness, redness, and swelling post each vaccination.; Solicited systemic AEs, including feverishness, malaise, body aches (exclusive of the injection site), nausea, and headache post each vaccination.	21-28 days	Yes
Primary	Immunogenicity	Immunologic response, defined as HAI titer = 1:40, at 21 days after vaccine dose.; CMI responses, as measured by B-cell and T-cell ELISPOT values.	21-28 days	No