Evaluating the Safety and Immune Response to an H5N1 Influenza Vaccine in People Who Have Previously Received an H5N1 or H7N3 Influenza Vaccine and in People Who Have Never Received a Live Attenuated Influenza Vaccine
Condition: H5N1 Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 1

Summary: 
      H5N1 is an influenza virus that has the potential to cause an influenza pandemic. This study
      will evaluate the safety and immune response to an H5N1 influenza vaccine in people who have
      previously received one of two versions of an H5N1 vaccine or have previously received an
      H7N3 vaccine and in people who have not previously received any live attenuated influenza
      vaccine (LAIV).
    

Detailed description: 
      Avian influenza viruses, including H1N1 and H5N1, are capable of causing an influenza
      pandemic. The 2009 H1N1 pandemic caused approximately 10,000 deaths in the United States, and
      H1N1 and H5N1 influenza outbreaks have been observed in countries around the world. Previous
      studies have shown that people who received an H5N1 vaccine and then received another H5N1
      vaccine years later had a greater antibody response than people who only received a single
      vaccination. This study will evaluate the safety and immune response to an inactivated H5N1
      vaccine in healthy adults who have previously received two doses of the H5N1 VN 04 ca vaccine
      or the H5N1 HK 03 ca vaccine or who have previously received two doses of the H7N3 ca
      vaccine, which is another avian influenza vaccine. The study will also enroll people who have
      not previously received any LAIV.

      Participants who previously received an H5N1 or H7N3 vaccine will receive one injection of
      the H5N1 vaccine at baseline. Participants who have not received any previous LAIV will be
      randomly assigned to receive either one dose or two doses of the H5N1 vaccine. At a baseline
      study visit, participants will undergo a medical history review, physical examination, blood
      collection, vital sign measurements, and a pregnancy test for females. All participants will
      then receive one injection of the vaccine in the upper arm. After receiving the vaccine,
      participants will remain in the clinic for 30 minutes for observation and monitoring. All
      participants will attend additional study visits at Days 3 and 7. Participants who are
      assigned to receive one vaccination will also attend study visits at Days 28, 56, and 180.
      Participants who are assigned to receive two vaccinations will attend study visits at Days 28
      (at which time they will receive the second vaccination), 35, 56, 84, and 208. Select
      baseline study procedures will occur at the follow-up study visits.
    

Intervention name(s): H5N1 Vaccine
Intervention type(s): Biological
Intervention description(s): Vaccine will be administered intramuscularly (IM) in the deltoid muscle at baseline for participants in Groups 1-4 and at baseline and Day 28 for participants in Group 5.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention