H1N1 Vaccine at Two Dose Levels in HIV Positive Adults
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Inactivated Influenza H1N1 vaccine
Intervention description: Two doses inactivated, licensed, Influenza A (H1N1) 2009 monovalent vaccine; 15 or 30 micrograms (mcg) per dose; slightly opalescent suspension in phosphate buffered saline. 15 mcg dose administered as a single 0.5 mL intramuscular (IM) injection. 30 mcg dose administered as two 0.5 mL IM injections.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 192.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: influenza, H1N1, vaccine, human immunodeficiency virus

Summary:

      The purpose of this study is to see how the body reacts to different strengths of the H1N1
      flu shot in persons infected with human immunodeficiency virus (HIV). This study will also
      compare how the CD4 count (cells that help fight disease) affects the body's response to the
      H1N1 flu shot. In this study, 2 strengths of the H1N1 flu shot will be given twice, about 3
      weeks apart. The results of this study will help researchers find out if the different
      strengths of the H1N1 flu shot make the body produce H1N1 antibodies that are better at
      fighting H1N1 flu. About 240 HIV positive subjects, ages 18-64 years, will be asked to take
      part in this study. Study procedures include: blood sampling, physical exams, and use of
      memory aids to record temperature, medications and symptoms. The length of patient
      participation is about 7 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Human immunodeficiency virus (HIV) infection defined as documented by an enzyme-linked
             immunosorbent assay (ELISA) and confirmed with a Western blot at any time prior to
             study entry. Serum HIV-1 antigen, plasma HIV-1 ribonucleic acid (RNA), or any Food and
             Drug Administration (FDA) approved antibody test by a method other than ELISA is
             acceptable as an alternative confirmatory test.

          -  Males or non-pregnant females age 18-64, inclusive.

          -  Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral
             oophorectomy or hysterectomy or who are not postmenopausal for greater than or equal
             to 1 year) must agree to practice adequate contraception that may include, but is not
             limited to, abstinence, monogamous relationship with vasectomized partner, barrier
             methods such as condoms, diaphragms, spermicides, intrauterine devices, Depo-Provera
             injections or Implanon implants for at least 30 days following the last vaccination.

          -  Are medically stable, as determined by the Investigator (based on review of health
             status, vital signs, medical history, and targeted physical examination. Vital signs
             must be within normal ranges prior to the first vaccination (heart rate 55-100, blood
             pressure systolic <160, blood pressure diastolic <90).

          -  Receipt of the 2009-2010 seasonal influenza vaccine at least two weeks prior to
             enrollment in this study.

          -  Intend to be available for follow-up visits and phone call access through 7 months
             following receipt of H1N1 vaccine.

          -  Are able to understand and comply with planned study procedures.

          -  Subject receiving regular medical follow-up care for HIV.

          -  Has a documented platelet count of >50,000mm^3 and an absolute neutrophil count (ANC)
             of >500mm^3 within the 3 months prior to study entry.

          -  Provide written informed consent prior to initiation of any study procedures.

        Exclusion Criteria:

          -  Treatment for an opportunistic infection (OI) initiated within 2 weeks prior to
             enrollment, or have symptoms that have not stabilized.

          -  Have a known allergy to eggs or other components of the vaccine (including polymyxin,
             neomycin, and chicken protein).

          -  Women who are pregnant or breastfeeding.

          -  Have a positive urine or serum pregnancy test within 24 hours prior to vaccination.

          -  Use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding
             36 months.

          -  Have a neoplastic disease that will be treated with chemotherapy or radiation, or a
             history of any hematologic malignancy.

          -  Have long term use of glucocorticoids including oral, parenteral or high-dose inhaled
             steroids. For oral or parenteral: prednisone or equivalent (greater than or equal to
             2.0 mg/kg per day or greater than or equal to 20 mg total dose) for more than 2
             consecutive weeks (or 2 weeks total) in the past 3 months. For inhaled steroids: >800
             mcg/day of beclomethasone dipropionate or equivalent within the preceding 6 months.
             (Nasal and topical steroids are allowed.)

          -  Have an uncontrolled major psychiatric diagnosis.

          -  Have a history of receiving immunoglobulin or other blood products within the 3 months
             prior to vaccination in this study.

          -  Received an experimental agent (vaccine, drug, biologic, device, or medication) within
             1 month prior to vaccination in this study or expect to receive an experimental agent
             during this study (prior to the Day 201 follow-up call).

          -  Have received any live licensed vaccines within 4 weeks or inactivated licensed
             vaccines within 2 weeks prior to vaccination in this study or plan receipt of such
             vaccines within 21 days following the second vaccination.

          -  Have an acute or chronic medical condition that, in the opinion of the investigator,
             would render vaccination unsafe, or would interfere with the evaluation of responses.

          -  Have a history of severe reactions following previous immunization with influenza
             virus vaccines.

          -  Have a moderate-severe acute illness, including an oral temperature greater than 100.4
             degrees Fahrenheit, within 72 hours prior to vaccination. (This may result in a
             temporary delay of vaccination).

          -  Have any condition that would, in the opinion of the site investigator, place them at
             an unacceptable risk of injury or render the subject unable to meet the requirements
             of the protocol.

          -  Participated in a novel influenza 2009 H1N1 influenza vaccine study or have history of
             novel 2009 H1N1 influenza infection prior to enrollment.

          -  Have a history of alcohol or drug abuse in the last 3 months.

          -  Plan to travel outside of North America at any time between the first vaccination and
             42 days following the first vaccination.

          -  Have a history of Guillain-Barré Syndrome.

          -  Have any condition that the investigator believes may interfere with successful
             completion of the study.