H1N1 Vaccine at Two Dose Levels in HIV Positive Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Recently, a novel swine-origin influenza A/H1N1 virus was identified as a significant cause
      of febrile respiratory illnesses in Mexico and the United States. It rapidly spread to many
      countries around the world, prompting the World Health Organization (WHO) to declare a
      pandemic on June 11, 2009. The immunosuppression associated with human immunodeficiency virus
      (HIV)-infection has been related to diminished immune responses to vaccination against
      multiple pathogens, including influenza. The widespread use of antiretroviral therapy has
      resulted in a significant decrease in the mortality from HIV/acquired immune deficiency
      syndrome (AIDS) and, as a result, HIV-infected subjects constitute a demographically growing
      subpopulation in the United States. Currently, novel H1N1 vaccines are being evaluated in the
      general population. Researchers propose to evaluate the safety and immunogenicity of the
      novel H1N1 vaccines in HIV-infected subjects, because the data from clinical trials enrolling
      healthy subjects may not apply to immunosuppressed individuals; and an evaluation of the
      immune responses to vaccination against new, pandemic influenza viruses has never been
      performed in HIV-infected subjects. This is a randomized, open label, Phase II study in HIV
      seropositive males and non-pregnant females, aged 18-64 years. This study is designed to
      investigate the safety, reactogenicity, and immunogenicity of an inactivated influenza H1N1
      virus vaccine at 2 dose levels. Subjects will be randomized into 2 dose groups, stratified by
      cluster of differentiation (CD4) cell count at enrollment (120 subjects per dose group with
      60 subjects per CD4 cell count stratum, <200/mL or greater than or equal to 200/mL) to
      receive intramuscular (IM) inactivated influenza H1N1 vaccine at 15 mcg (Group 1) or 30 mcg
      (Group 2). The H1N1 vaccine will be administered at Day 0 and Day 21. Following immunization,
      safety will be measured by assessment of adverse events through 21 days following the last
      vaccination (Day 42 for those receiving both doses and Day 21 for those who do not receive
      the second dose), serious adverse events and new-onset chronic medical conditions through 7
      months post first vaccination (Day 201), and reactogenicity to the vaccine for 8 days
      following each vaccination (Day 0-7). A CD4/CD8 panel and viral load will be measured prior
      to first vaccination on Day 0 and at Day 10 post the second vaccination. Immunogenicity
      testing will include hemagglutination inhibition assay (HAI) and neutralizing antibody
      testing on serum obtained on the day of each vaccination (prior to vaccination), on Day 10
      after each vaccination, 21 days following the second vaccination (Day 42) and 6 months after
      the second vaccination (Day 201). The primary objectives of this study are: (safety), to
      assess the safety of the unadjuvanted, inactivated H1N1 vaccine in HIV-1 seropositive adults
      when administered at the 15 mcg or 30 mcg dose and (immunogenicity) to assess the antibody
      response following 1 and 2 doses of inactivated H1N1 vaccine administered intramuscularly at
      the 15 mcg or 30 mcg dose levels in HIV-1 seropositive adults stratified by CD4 count at
      enrollment.
    

Intervention name(s): Inactivated Influenza H1N1 vaccine
Intervention type(s): Biological
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: influenza, H1N1, vaccine, human immunodeficiency virus