Effects of Age on Response to the 2009 H1N1 Virus Vaccine

April 26, 2016 updated by: John Treanor, University of Rochester

Assessment of the Effect of Age on the Immunological and Virological Response to a Live Attenuated Influenza Vaccine for the 2009 H1N1 Virus

Unlike most influenza viruses, the 2009 H1N1 virus has affected people between 5 and 40 years old more often than people 60 years old or older. It may be that older people have had greater exposure to previous strains of H1N1 influenza, and this previous exposure protects them from infection. This study will examine how older people respond to a version of the H1N1 virus vaccine that includes a live, noninfectious version of the virus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Unlike most influenza viruses, the 2009 H1N1 virus affects many individuals between 5 and 40 years old, but very few 60 years old or older. It is not completely understood why, but scientists believe it may be because older people may have been exposed to other H1N1 viruses in their lives. H1N1 viruses were common until 1957, when they were eclipsed by H2N2 viruses.

In order to test susceptibility to the 2009 H1N1 virus, this study will examine how often people older than 60 get infected by the 2009 H1N1 live attenuated influenza vaccine (LAIV). The LAIV is made from a live virus that has been weakened, so the ability of the immune system to combat this weakened form is likely to mimic its ability to combat the normal form. Additionally, this study will examine how LAIVs work in older people; inactivated virus vaccines are used more often than LAIVs in older people, so little is known of LAIV's effects on this population.

Participation in this study will last 6 months. Participants will be people older than 60, divided into equal groups of people between the ages of 60 and 70 and people older than 70. Both groups will receive one dose of LAIV for 2009 H1N1 vaccine.

There will be six study visits, occurring at baseline and 2, 5, 7, 28, and 180 days after vaccination. Nasal wicks and throat swabs will be taken on Days 2, 5, and 7; a nasal wick alone will be taken at baseline and on Day 28. Blood samples will be taken at baseline and on Days 7 and 28. Participants will undergo physical exams at each visit.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center, Vaccine Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • No prior history of infection with novel H1N1 virus or immunization with novel H1N1 vaccine documented by a laboratory
  • Female participants must not be capable of becoming pregnant or take steps to prevent pregnancy from 30 days before enrollment to 30 days after receiving the study vaccine
  • In good health, as determined by medical history and targeted physical examination
  • Able to understand and comply with the planned study procedures, including being available for all study visits

Exclusion Criteria:

  • Pregnancy
  • Previous history of vaccination against novel H1N1 virus or a laboratory documented history of previous novel H1N1 infection
  • Immunosuppressed as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs or use of anticancer chemotherapy or radiation therapy within the preceding 36 months
  • Active neoplastic disease (excluding nonmelanoma skin cancer or prostate cancer that is stable in the absence of therapy) or a history of any hematological malignancy. For this criterion, "active" is defined as having received treatment within the past 5 years.
  • Long-term (greater than 2 weeks) use of oral or parenteral steroids or high-dose inhaled steroids (greater than 800 mcg/day of beclomethasone dipropionate or equivalent) within the 6 months prior to study enrollment (nasal and topical steroids are allowed)
  • Received immunoglobulin or another blood product within the 3 months prior to enrollment in this study
  • Received an inactivated vaccine within 2 weeks or a live vaccine within 4 weeks prior to enrollment in this study or plans to receive another vaccine within the next 28 days
  • Has an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses.
  • Has had an acute illness or an oral temperature greater than 99.9°F (37.7°C) within 3 days prior to enrollment or vaccination. Subjects who had an acute illness that was treated with symptoms resolved are eligible to enroll as long as treatment is completed and symptoms are resolved more than 3 days prior to enrollment.
  • Currently participating or plans to participate in a study that involves an experimental agent (vaccine, drug, biologic, device, blood product, or medication), has received an experimental agent within 1 month prior to enrollment in this study, expects to receive another experimental agent during participation in this study, or intends to donate blood during the study period
  • History of alcohol or drug abuse in the 5 years prior to enrollment
  • Has a known human immunodeficiency virus (HIV) or hepatitis B or C infection
  • Has a previous history of Guillain-Barré syndrome
  • Allergic to eggs or egg proteins, gentamicin, gelatin, or arginine or has experienced life-threatening reactions to previous influenza vaccination
  • Has any other condition that would, in the opinion of the site investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2009 H1N1 Vaccine
Participants will be stratified by age into two groups: those between 60 and 70 years old, and those older than 70 years of age. All participants will receive the 2009 H1N1 vaccine.
Biological: 2009 H1N1 Virus Vaccine
Single 0.2 mL dose of live monovalent vaccine, delivered through nasal spray
Other Names:
  • Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Shed Virus
Time Frame: day 0 to day 7 post vaccination
number of participants who shed virus above the limit of detection at any timepoint after vaccine. The limit of detection is 0.5 tissue culture infectious doses per mL of nasal wash.
day 0 to day 7 post vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

National Institutes of Health (NIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

January 5, 2010

First Submitted That Met QC Criteria

January 21, 2010

First Posted (Estimate)

January 25, 2010

Study Record Updates

Last Update Posted (Estimate)

May 30, 2016

Last Update Submitted That Met QC Criteria

April 26, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URMC 09-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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