Mucosal and Systemic Immunity After Viral Challenge of Healthy Volunteers Vaccinated With Inactivated Influenza Vaccine Via the Intranasal Versus Intramuscular Route

Completed · Phase 2

Conditions studied: Influenza

In brief

Background: Influenza (flu) is a contagious respiratory virus that makes humans sick. Usually its symptoms are mild, but they can be dangerous. Researchers want to see if one way of giving the flu vaccine is more effective than another. Objective: To compare the body s ability to fight infection when a flu vaccine is given in the nose versus the arm. Eligibility: Healthy, nonsmoking adults ages 18 55. They must be willing to stay in isolation for at least 9 days. They must not have had the flu vaccine since September 1, 2018. Design: Participants must be willing to use birth control or abstinence from visit 1 until 8 weeks after getting the flu virus. Participants will have at least 3 clinic visits over about a month. Visits may include: Medical history Physical exam Blood and urine tests Nasal samples collected Heart and lung function tests At the first visit, participants will get either: Flu vaccine as injection in an arm muscle plus salt water sprays in the nose OR flu vaccine as sprays in the nose plus salt water injection in an arm Within the next few months, participants will stay in an isolation room for at least 9 days. They will be with up to 20 participants. Those who test positive for recreational drugs will leave the study. Participants will: Repeat study tests Answer questions about flu symptoms Have the flu virus sprayed into their nose once Be monitored by a medical team Participants will have at least 2 follow-up visits and repeat study tests.

Key facts

Study ID

NCT03845231

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

82

Starts

2019-04-29

Expected to finish

2020-10-28

Last updated by the study team

2020-11-10

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Presence of self-reported or medically documented significant medical condition including but not limited to:
• Chronic pulmonary disease (e.g., asthma, emphysema).
• Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects).
• Chronic medical conditions requiring close medical follow-up or hospitalization during the past 5 years (e.g., insulin-dependent diabetes mellitus, renal dysfunction, hemoglobinopathies).
• Immunosuppression, immune deficiency (such as IgA deficiency) or ongoing malignancy.
• Neurological and neurodevelopmental conditions (e.g., Bell s palsy, cerebral palsy, epilepsy, stroke, seizures).
• Postinfectious or postvaccine neurological sequelae including Guillain Barre syndrome.
• Individual with body mass index less than or equal to 18 and greater than or equal to 40.
• Have close or household (i.e., share the same apartment or house) high-risk contacts including but not limited to:
• Persons greater than or equal to 65 years of age.
• Children less than or equal to 5 years of age.
• Residents of nursing homes.
• Persons of any age with significant chronic medical conditions such as:
• Chronic pulmonary disease (e.g., severe asthma, chronic obstructive pulmonary disease).
• Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects).
• Contacts who required medical follow-up or hospitalization during the past 5 years because of chronic metabolic disease (e.g., insulin-dependent diabetes mellitus, renal dysfunction, hemoglobinopathies).
• Immunosuppression or cancer.
• Neurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures).
• Individuals who are receiving long-term aspirin therapy.
• Women who are pregnant or who are trying to become pregnant.
• Acute illness within 7 days prior to quadrivalent IIV administration or inoculation with the human challenge virus.
• Individuals who have grade 3 or above clinically significant laboratory values outside the limits thus specified by normal laboratory parameters.
• Clinically significant abnormality as deemed by the PI on echocardiographic (ECHO) testing.
• Clinically significant abnormality as deemed by the PI on the pulmonary function test (PFT).
• Known allergy to influenza vaccination or excipients contained in the influenza vaccine used.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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