Influenza A 2009 H1N1 Challenge Study in Healthy Adults

Phase 1

Completed

Conditions: Influenza

Interventions: Biological: Ca/04/2009/H1N1 Vero Grown Challenge Virus

Registration Number: NCT01646138

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary: Background:

- A challenge study exposes a person to a disease and allows researchers to study the disease through the body's healing process. An influenza challenge study that looks at different amounts of the flu virus can provide more information on the smallest amount needed to cause an infection. Researchers want to give one dose of the Influenza A H1N1 virus to healthy volunteers to see how the body responds to the virus.

Objectives:

* To find the smallest dose of Influenza A H1N1 virus that may cause a mild to moderate flu infection in a healthy adult.

* To study how the body s immune system responds to the virus.

Eligibility:

* Healthy volunteers at least 18 years of age.

* Participants must be willing to remain in isolation for a minimum of 9 days.

Design:

* Participants will be admitted to a hospital inpatient isolation unit. They will be screened with a physical exam and medical history. They will also have heart and lung function tests. Blood, urine, and nasal swab/wash samples will be collected.

* Participants will receive a single nasal spray of the flu virus. They will stay on the inpatient unit for at least 9 days.

* Participants will be monitored for the length of their stay. They will have frequent blood tests and other procedures as needed.

* Participants will be allowed to go home once they have had two negative tests for the virus. The tests will be given on two consecutive days....

Detailed Description: The high morbidity and mortality associated with both pandemic and seasonal influenza, and the anticipation of future influenza pandemics, puts influenza front and center in infectious disease research. Because the natural history and pathogenesis of human influenza has not been well characterized and cannot be adequately studied in animal models or with current in vitro techniques, important questions about influenza pathogenesis can only be approached through human challenge studies.

Previous human challenge studies have addressed some aspects of the natural history of influenza by evaluating the timing of viral replication, shedding, clinical symptoms, and innate and adaptive immune responses. Although these studies have provided important information, in the United States, all but 1 were performed prior to 1990. Without exception, these studies had limitations due to the scope of the study and/or the scientific techniques available at that time.

The primary objective of this study is to determine the dose of influenza A 2009 H1N1 human challenge virus that will induce a mild to moderate uncomplicated influenza infection in healthy volunteers. This protocol will examine some of the basic questions that remain unanswered regarding the pathogenesis of influenza in humans, namely, a detailed clinical and immunological characterization of uncomplicated influenza viral pathogenesis in healthy adult volunteers.

Secondary objectives will evaluate clinical disease, length of viral shedding, and pathogenesis in those with influenza infection including identification of clinical markers of the disease. Notably, the exploratory objectives will seek to discover viral factors necessary for human infection/adaptation and to evaluate host immune response, viral replication, viral fitness, and the intrahost evolution.

Collaboration between National Institute of Allergy and Infectious Diseases (NIAID) investigators and outside scientists will generate opportunities to further develop and expand areas of clinical influenza research based on the proposed challenge model.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 49

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Challenge Virus	Ca/04/2009/H1N1 Vero Grown Challenge Virus	The Ca/04/2009/H1N1 Vero Grown Challenge Virus was administered intranasally to each participant using a nasal sprayer. A total volume of up to 1 mL of virus will be administered.

Primary Outcome Measures

Name	Time	Method
Percent MMID	67 days after influenza inoculation	Percent of individuals experiencing mild to moderate influenza infection (MMID, defined as active shedding and symptoms of influenza A) in each dosing group.

Secondary Outcome Measures