Infectivity, Replication & Immunogenicity of Live nH1N1 Vaccine

November 17, 2015 updated by: John Treanor, University of Rochester

Evaluation of the Infectivity, Replication, and Immunogenicity of Live, Attenuated A/California/07/09 (nH1N1) Influenza Vaccine in Serosusceptible Adults

The purpose of the study is to determine the amount of live virus that can be recovered from the nose of people who are vaccinated with the licensed live vaccine against H1N1, and to describe the immune response to vaccination.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

By looking at the immune response before and after vaccine, we hope to understand the factors that determine the immune response and detailed shedding patterns of live novel H1N1 vaccine.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

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
        • Vaccine Research Unit Room 3-5000

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

18 years to 32 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18-32 years, inclusive
  • No history of Novel H1N1 virus or vaccine
  • Female not able to bear children or not pregnant and agrees to practice effective birth control
  • Female negative pregnancy test
  • Good Health
  • Ability to understand and comply with protocol
  • Provided Informed Consent

Exclusion Criteria:

  • Previous history of vaccination against novel H1N1 or laboratory documented H1N1 infection
  • History of egg allergy or is allergic to other components of the vaccine
  • A women who is pregnant or breastfeeding or intends to get pregnant during the study period between enrollment and 30 days following vaccination
  • Subject is immunosuppressed as the result of underlying illness or treatment with immunosuppressive or cytotoxic drugs or use of chemotherapy or radiation therapy in the preceding 36 months
  • Subject has active neoplastic disease (excluding non-melanoma skin cancer or prostate cancer that is stable in the absence of therapy) or a history of any hematological malignancy. "active is defined as treatment within the past 5 years
  • Long term (greater than 2 weeks) use of oral or parental steroids, or high- dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids allowed)
  • Received immunoglobulin or another blood product within 3 months prior to enrollment in this study
  • Subject has 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 (or 56 days for the vaccine naive recipients)
  • Subject 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. Those conditions include chronic conditions recognized as risk factors for influenza complications or as contraindicated for live vaccination, including chronic cardiac (exclusive of hypertension) or pulmonary conditions (including asthma), diabetes mellitus, or renal impairment
  • Subject has an acute illness or an oral temperature greater then 99.9 degrees F(37.7 C)within 3 days prior to enrollment or vaccination. Subject who has acute illness that was treated, symptoms resolved are eligible to enroll as long as treatment is complete and symptoms resolved > 3 dyas prior to enrollment.
  • Subject is currently participating or plans to participate in a study that involves an experimental agent (vaccine, drug, biologic, device, blood product, or medication) or has received an experimental agent within 1 month prior to enrollment in this study, or intends to donate blood during this period.
  • Subject has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol
  • Subject has a history of alcohol or drug abuse in the 5 years prior to enrollment.
  • Subject has known human immunodeficiency virus, hepatitis B, or hepatitis C infection.
  • Subject has a previous history of Guillain-Barre syndrome within 6 weeks of receipt of influenza vaccine
  • Subject has any condition that the principal investigator (PI) believes may interfere with the successful completion of the study

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
Other: live monovalent H1N1 vaccine
A/California/07/09 live monovalent H1N1 vaccine 0.2 given intranasally, 2 doses given 28 days apart
Biological: A/California/07/09 live monovalent H1N1 vaccine
0.1mL per nares intranasally, second identical dose given 28 days after first vaccine
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: 28 days post vaccine 1 and 28 days vaccine 2
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.
28 days post vaccine 1 and 28 days vaccine 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Difference Between Cycle Time and Detection Threshold
Time Frame: day 10 post vaccine 1
The mean difference was calculated by real-time polymerase chain reaction (PCR) on nasal wash samples. Cycle time is the cycle number at which the PCR reaction is positive with a range of 0-40 cycles. The detection threshold is 40 cycles.
day 10 post vaccine 1

Collaborators and Investigators

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

Sponsor

University of Rochester

Investigators

  • Principal Investigator: John J. Treanor, M.D., University of Rochester

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

November 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

December 1, 2009

First Submitted That Met QC Criteria

December 1, 2009

First Posted (Estimate)

December 2, 2009

Study Record Updates

Last Update Posted (Estimate)

December 23, 2015

Last Update Submitted That Met QC Criteria

November 17, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URMC 09-006

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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