Trial record 7 of 27 for:    " March 17, 2010":" April 16, 2010"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

H1N1 Influenza Vaccine Immunogenicity in HIV-1 Infected Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pablo Tebas, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01111162
First received: April 13, 2010
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
HIV Infections
Biological: H1N1 vaccination
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluating the Safety and Immunogenicity of an Inactivated Swine-Origin H1N1 Influenza Vaccine in HIV-1 Infected Patients

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Safety [ Time Frame: 21-28 days ] [ Designated as safety issue: Yes ]

    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.

  • Immunogenicity [ Time Frame: 21-28 days ] [ Designated as safety issue: No ]

    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.



Enrollment: 120
Study Start Date: December 2009
Study Completion Date: December 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaccine
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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01111162

Locations
United States, Pennsylvania
University of Pennsylvania. Clinical Trials Unit
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Pablo Tebas University of Pennsylvania
  More Information

Publications:
Responsible Party: Pablo Tebas, Professor of Medicine, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01111162     History of Changes
Other Study ID Numbers: Upenn HIV-H1N1-001
Study First Received: April 13, 2010
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
HIV
H1N1 vaccination
HIV infected individuals

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Influenza, Human
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Orthomyxoviridae Infections
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 14, 2014