Influenza, Human Clinical Trial
Official title:
Evaluation of Correlates of Protective Efficacy of Seasonal Live Attenuated Influenza Vaccine (LAIV) by Utilization of a Human Challenge Model of Infection With Wild-type (wt) Influenza A/California/2009 (H1N1)-Like Virus
The purpose of this study is to evaluate the immune response produced by a seasonal live attenuated influenza vaccine (LAIV) when compared to placebo. The initial vaccination will be followed 2 months later by an inpatient trial evaluating safety, infectivity, clinical response, and viral shedding after exposure to the wild-type A/California/2009-like influenza challenge virus.
This study will evaluate the immune response produced by a seasonal LAIV. The initial
vaccination will be followed 2 months later by an open-label inpatient trial evaluating the
subsequent response (safety, infectivity, clinical response, and viral shedding) following
administration of the wild-type A/California/2009-like influenza challenge virus.
Healthy adult participants will be randomized into two groups. On Day 0, Group 1 will receive
a single dose of an intranasal LAIV. Group 2 will receive a single dose of intranasal
placebo. Study visits will occur on Days 0, 3, 7, 14, and 28.
On Day 54, participants will be admitted to the isolation unit for the inpatient portion of
the study, and both groups will receive an intranasal dose of wild-type
A/California/2009-like influenza challenge virus on Day 56. On Day 65, participants who are
no longer shedding virus will be discharged.
Follow-up study visits will occur after discharge from the isolation unit on Days 70, 84,
112, and 180. Study visits during either the inpatient or outpatient portions of the trial
may include physical examinations, collection of blood and urine samples, electrocardiogram
(ECG), nasal washes and swabs, and nasal mucus weighing.
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