Influenza, Human Clinical Trial
Official title:
Exploratory Evaluation of Host Biomarkers That Predict the Vaccine Virus Replication and Immunogenicity of Seasonal and Pandemic Formulations of Live Attenuated Influenza A Virus Vaccines Based on the A/Ann Arbor/6/60 ca Master Donor Virus (MDV)
This study seeks to understand the host factors that affect the replication and immune response of seasonal and candidate pandemic live attenuated influenza vaccine (LAIV) in humans and to develop biomarkers that can predict the viral shedding and immune response to LAIVs.
Influenza A viruses are widely distributed in nature and exist as many different subtypes.
Pandemics of influenza can occur, and vaccine development is focused on those subtypes that
are predicted to represent the greatest pandemic threat to the human population. This study
seeks to understand the host factors that affect the replication and immune response of
seasonal and candidate pandemic LAIVs in humans and to develop biomarkers that can predict
the viral shedding and immune response to LAIVs.
Three vaccines will be evaluated: the licensed seasonal LAIV, with a focus on the H3N2
component; the H9N2 G9/AA ca vaccine, which is among the most immunogenic of the candidate
pandemic LAIVs evaluated to date; and the H2N3 MO 2066/AA ca vaccine, which is among the
least immunogenic of the candidate pandemic LAIVs evaluated to date. The seasonal LAIV will
be evaluated in an outpatient setting, while the other two vaccines will be evaluated in an
inpatient setting. In each setting, some participants will receive a placebo vaccine.
Study participants will be assigned to one of four groups. Participants who are seronegative
to both H9N2 G9/AA ca and H2N3 MO 2006/AA ca viruses will be randomly assigned to receive
one of those vaccines (Group 1: H9N2 G9/AA ca; Group 2: H2N3 MO 2006/AA ca) or placebo
(Group 4) and will remain in an inpatient isolation facility. Participants who are
seronegative to the H3 component of seasonal LAIV will be randomly assigned to receive
either seasonal vaccine (Group 3) or placebo (Group 4) and will be followed as outpatients.
All participants will remain in the study for 56 days. Participants in the inpatient arms
will be admitted on Day -2, will receive study vaccine on Day 0, and will undergo a basic
history, physical examination, and nasal wash each day until discharge. On some study days,
inpatient participants will undergo a blood collection and/or a nasal swab; at the screening
visit and on Day -1 or Day -2, participants will give a urine sample.
Participants in the outpatient arms will receive study vaccine on Day 0 and will have study
visits on Days 1, 2, 3, 4, 5, 6, 7, 14, 28, and 56. On Days 1 through 7, participants will
undergo a basic history, physical examination, and nasal wash. On some visits, participants
may undergo a blood collection and/or a nasal swab; at the screening visit and on Day -1,
participants will give a urine sample. Unused blood or nasal wash samples will be stored and
may be used in future research studies.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
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