Group Study of the Safety of and Immune Response to a Single Dose of Bird Flu Vaccine (H7N3) in Healthy Adults

NCT00853255 | Completed Phase 1

• 1 other identifier: CIR 260
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Over the past decade, avian influenza (AI) has become a major health concern. The development of safe and effective vaccines against avian strains that infect people is important. The purpose of this study is to determine the safety of and immune response of an investigational AI vaccine in healthy adults against the H7N3 strain of avian influenza.

Conditions

Influenza; Virus Diseases

Keywords

Bird Flu

Outcome Measures

Primary Outcomes (3)

• Frequency of vaccine-related reactogenicity events

  During inpatient stage

• Area under the curve of nasal viral shedding

  Days 2 through 9

• Development of serum antibody assessed by either HAI or MN assays

  Throughout study

Secondary Outcomes (3)

• Number of participants infected with the recombinant vaccine candidate

  Throughout study

• T-cell mediated and innate immune responses against recombinant vaccine candidate

  Throughout study

• Development of serum bank for testing effectiveness of vaccine against future viruses

  Throughout study

Study Arms (1)

1

EXPERIMENTAL

Participants will receive 0.5 mL of vaccine intranasally via an Accuspray device (0.25 mL in each nostril)

Biological: Live Influenza A Vaccine H7N3 (6-2) AA ca Recombinant (A/chicken/British Columbia/CN-6/2004 x A/Ann Arbor/6/60 ca)

Interventions

Live Influenza A Vaccine H7N3 (6-2) AA ca Recombinant (A/chicken/British Columbia/CN-6/2004 x A/Ann Arbor/6/60 ca) BIOLOGICAL

Vaccine administered by nasal spray

1

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Good general health
• Available for the duration of the trial
• For females, willing to use acceptable forms of contraception for the duration of the study. More information on this criterion can be found in the protocol.

You may not qualify if:

• Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease
• Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may affect study participation
• Previously enrolled in an H7N3 influenza vaccine trial or in any study of an avian influenza vaccine
• Seropositive to the H7N3 influenza A virus (serum hemagglutination inhibition \[HI\] titer greater than 1:8)
• Illegal drug use or dependency determined by urine test
• Medical, work, or family problems as a result of alcohol or illicit drug use within 12 months prior to study entry
• History of severe allergic reaction
• Allergy to oseltamivir
• Asthma or reactive airways disease within 2 years prior to study entry
• History of Guillain-Barre syndrome
• HIV-infected
• Hepatitis C virus infected
• Positive for hepatitis B surface antigen (HBsAg)
• Known immunodeficiency syndrome
• Use of corticosteroids or immunosuppressive drugs within 30 days prior to vaccination. Participants who have used topical corticosteroids are not excluded.

Sponsors & Collaborators

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

Study Sites (1)

University of Rochester Vaccine Evaluation Isolation Unit, St. Mary's Hospital

Rochester, New York, 55902, United States

Location

Related Publications (4)

• Alexander DJ. Avian influenza viruses and human health. Dev Biol (Basel). 2006;124:77-84.

  PMID: 16447497 BACKGROUND

• Joseph T, McAuliffe J, Lu B, Jin H, Kemble G, Subbarao K. Evaluation of replication and pathogenicity of avian influenza a H7 subtype viruses in a mouse model. J Virol. 2007 Oct;81(19):10558-66. doi: 10.1128/JVI.00970-07. Epub 2007 Jul 18.

  PMID: 17634234 BACKGROUND

• Joseph T, McAuliffe J, Lu B, Vogel L, Swayne D, Jin H, Kemble G, Subbarao K. A live attenuated cold-adapted influenza A H7N3 virus vaccine provides protection against homologous and heterologous H7 viruses in mice and ferrets. Virology. 2008 Aug 15;378(1):123-32. doi: 10.1016/j.virol.2008.05.021. Epub 2008 Jun 27.

  PMID: 18585748 BACKGROUND

• Skowronski DM, Li Y, Tweed SA, Tam TW, Petric M, David ST, Marra F, Bastien N, Lee SW, Krajden M, Brunham RC. Protective measures and human antibody response during an avian influenza H7N3 outbreak in poultry in British Columbia, Canada. CMAJ. 2007 Jan 2;176(1):47-53. doi: 10.1503/cmaj.060204.

  PMID: 17200390 BACKGROUND

MeSH Terms

Conditions

Influenza, Human; Virus Diseases; Influenza in Birds

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Respiratory Tract Diseases; Bird Diseases; Animal Diseases

Study Officials

• John Treanor, MD

  Infectious Diseases Division, University of Rochester Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 26, 2009
• First Posted: March 2, 2009
• Study Start: July 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 3, 2013

Record last verified: 2012-12

Locations

US (1)