In the 20th century, influenza pandemics occurred in 1918, 1957, and 1968, and were associated with significant morbidity and mortality. It is estimated that, in the United States alone, the next influenza pandemic could cause approximately 200,000 deaths and 750,000 hospitalizations. Thus, the development of a vaccine against potential influenza strains has become a priority. The purpose of this study is to determine the safety and immune response to an H6N1 influenza vaccine candidate.
H6 influenza viruses are of the low pathogenicity phenotype in poultry, and in the last decade, outbreaks of H6 influenza infection have been reported both in the United States and South Africa. The prevalence of H6 influenza viruses in a wide range of domestic and wild birds, and their propensity for reassortment has raised concerns regarding the pandemic potential of these viruses. This vaccine, therefore, is an important priority in the development of vaccines against potential pandemic influenza strains. This vaccine trial will be conducted in the Center for Immunization Research inpatient unit in the Mason F. Lord Building at the Johns Hopkins Bayview Medical Center (Baltimore, MD). The study will be initiated between April 1st and December 20th, 2008, when wild-type influenza is unlikely to be circulating in the Baltimore area. An individual's participation in the study will last approximately 90 days. All participants will receive two vaccinations approximately 4 - 8 weeks apart. After each vaccination, participants will remain in isolation at the study site for at least nine days or until rRT-PCR assays for influenza are negative for 2 consecutive days. A physical examination and nasal wash will occur each day during the isolation period. Blood collection will occur on the day of admission, the following day, and day 7 after vaccination. Follow-up outpatient visits are scheduled on Days 28 and 56 after the first vaccination and on Day 28 after the second vaccination. Follow-up visits will include serum collection, nasal wash, and interim medical history.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
22
Approximately 0.2 ml of 10\^7 TCID50 doses of vaccine administered intranasally
Johns Hopkins Bayview Medical Center, CIR Unit at the Mason F Lord Building
Baltimore, Maryland, United States
Frequency of vaccine-related reactogenicity events and other adverse events
Time frame: Throughout study
Amount of vaccine virus shed by each participant
Time frame: Throughout study
Amount of serum and nasal wash antibody induced by the vaccine
Time frame: Throughout study
Number of participants infected with the H6N1 Teal HK 97/AA ca recombinant vaccine
Time frame: Throughout study
Phenotypic stability of vaccine virus shed
Time frame: Throughout study
Determine whether immunogenicity is enhanced by a second dose of vaccine, and whether the first dose of vaccine restricts replication of the second dose
Time frame: Throughout study
T-cell mediated and innate immune responses against the H6N1 Teal HK 97/AA ca recombinant vaccine
Time frame: Throughout study
Development of serum bank so that the capacity of the H6N1 Teal HK 97/AA ca recombinant vaccine to elicit HA1 and neutralizing antibodies to future H6 influenza viruses can be tested
Time frame: Throughout study
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