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

NCT03845231 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2020-11-10

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

Flucelvax(R)

Cohort 1 will receive IM quadrivalent IIV (Flucelvax (R)) at the standard dose of 15 micrograms HA per strain (60 micrograms HA total).

OTHER

Human Challenge virus

A dose of 10\^7 50% tissue culture infective dose (TCID50) of human challenge virus will be administered intranasally to all participants using a nasal sprayer.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Matthew J Memoli, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-29
Primary Completion
2019-12-20
Completion
2020-10-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03845231 on ClinicalTrials.gov