Evaluation of the Safety and Immunogenicity of a Live Attenuated Virus Vaccine for the Prevention of H2N3 Influenza

NCT01175122 | Completed Phase 1

• 1 other identifier: URMC 10-004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

In recent years, influenza viruses that have traditionally infected animals have infected humans as well. The H2N3 influenza virus, which first appeared in pigs in the Midwest United States in 2006, may pose a potential health concern to humans. This study will evaluate the safety of and immune response to a vaccine designed to protect people from the H2N3 influenza virus.

Conditions

Influenza A Virus Infection

Outcome Measures

Primary Outcomes (3)

• Frequency of vaccine-related reactogenicity events that occur during the acute monitoring (inpatient) phase of the study

  Measured through Day 37 or until participants are discharged from the isolation unit

• Area under the curve (AUC) of nasal virus shedding after each dose of vaccine as assessed by liquid titration of nasal secretions on Madin Darby canine kidney (MDCK) cells at 33°C

  Measured after each vaccination

• Development of serum antibody assessed by either hemagglutination inhibition (HAI) or microneutralization (MN) assays

  Measured after each vaccination

Secondary Outcomes (3)

• Development of a significant increase in nasal secretion hemagglutinin (HA)-specific antibody assessed by enzyme-linked immunosorbent assay (ELISA)

  Measured until participants are discharged from the isolation unit

• Development of greater than 200 influenza-specific interferon-gamma-secreting cells per million lymphocytes as assessed by enzyme-linked immuno spot assay (ELISPOT) on Day 28 after immunization

  Measured 28 days after vaccination

• Detection of influenza-specific IgG or IgA secreting B cells on Day 7 following vaccination assessed by antibody secreting cells (ASC) assay

  Measured 7 days after vaccination

Study Arms (1)

H2N3 MO 2003/AA ca Vaccine

EXPERIMENTAL

Participants will receive a nasal spray administration of the H2N3 MO 2003/AA ca vaccine on Day 0 and Day 28.

Biological: H2N3 MO 2003/AA ca Vaccine

Interventions

H2N3 MO 2003/AA ca Vaccine BIOLOGICAL

0.2 mL of H2N3 MO 2003/AA ca vaccine delivered by an Accuspray nasal spray device on Day 0 and Day 28

H2N3 MO 2003/AA ca Vaccine

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• In general good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator
• Agree to storage of blood specimens for future research
• Available for the duration of the trial
• Willing to participate in the study as evidenced by signing the informed consent document
• Female participants must agree to use effective birth control methods for the duration of the study. More information on this criterion can be found in the protocol.

You may not qualify if:

• Pregnant or breastfeeding
• Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study procedures
• Previous enrollment in an H2 influenza vaccine trial or in any study of an avian influenza vaccine
• Seropositive to the H2N3 influenza A virus (serum HAI titer greater than 1:8)
• Positive urine drug toxicology test indicating narcotic use/dependency
• Have medical, occupational, or family problems as a result of alcohol or illicit drug use during the 12 months prior to study entry
• Other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a person participating in the trial or would render the person unable to comply with the study procedures
• History of anaphylaxis
• Allergy to oseltamivir as determined by participant report
• Current diagnosis of asthma or reactive airway disease (within the 2 years prior to study entry)
• History of Guillain-Barré Syndrome
• Positive ELISA and confirmatory Western blot tests for human immunodeficiency virus-1 (HIV-1)
• Positive ELISA and confirmatory test (e.g., recombinant immunoblot assay) for hepatitis C virus (HCV)
• Positive hepatitis B virus surface antigen (HBsAg) by ELISA
• Known immunodeficiency syndrome

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (2)

• Ma W, Vincent AL, Gramer MR, Brockwell CB, Lager KM, Janke BH, Gauger PC, Patnayak DP, Webby RJ, Richt JA. Identification of H2N3 influenza A viruses from swine in the United States. Proc Natl Acad Sci U S A. 2007 Dec 26;104(52):20949-54. doi: 10.1073/pnas.0710286104. Epub 2007 Dec 18.

  PMID: 18093945 BACKGROUND

• Chen GL, Lamirande EW, Yang CF, Jin H, Kemble G, Subbarao K. Evaluation of replication and cross-reactive antibody responses of H2 subtype influenza viruses in mice and ferrets. J Virol. 2010 Aug;84(15):7695-702. doi: 10.1128/JVI.00511-10. Epub 2010 May 26.

  PMID: 20504935 BACKGROUND

Study Officials

• John Treanor, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2010
• First Posted: August 4, 2010
• Study Start: September 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: February 11, 2013

Record last verified: 2013-02

Locations

US (1)