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

NCT00516035 | Completed Phase 1

• 2 other identifiers: CIR 241WIRB Protocol Number 20071381
• Study Type: interventional
• Target: 22
• 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 infecting people is important. The purpose of this study is to determine the safety of and immune response to a new AI vaccine in healthy adults against the H7N3 strain of avian influenza.

Conditions

Influenza; Virus Diseases

Keywords

Bird Flu

Outcome Measures

Primary Outcomes (3)

• Safety, defined as the frequency of vaccine-related reactogenicity events that occur during the acute monitoring (inpatient) phase of the study

  Daily for 9 days after vaccination

• Immunogenicity, determined by anti-H7N3 antibody titer

  Before the first vaccination, 28 days after the first vaccination but before the second vaccination, and 28 days after the second vaccination

• Quantifying the amount of vaccine virus shed by each recipient; and determining the amount of serum and nasal wash antibody induced by the vaccine

  Daily for 9 days after vaccination

Secondary Outcomes (5)

• To determine the number of vaccinees infected with the vaccine virus

  Daily for 8 days after each vaccination

• To determine the phenotypic stability of the vaccine virus

  Throughout study

• To determine whether immunogenicity is enhanced by a second dose of vaccine

  At study completion

• To evaluate T-cell mediated and innate immune responses against the vaccine virus

  Throughout study

• To develop a serum bank to evaluate future H7 influenza vaccines

  Throughout study

Study Arms (1)

1

EXPERIMENTAL

0.50 ml (0.25 ml in each nostril) of Influenza A Vaccine H7N3 (6-2) AA ca Recombinant (A/chicken/British Columbia/CN-6/2004 x A/Ann Arbor/6/60 ca) administered by nasal spray at two timepoints (at study entry and between Weeks 4 and 8)

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 given 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
• Willing to use acceptable forms of contraception for the duration of the study

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
• Johns Hopkins Bloomberg School of Public Health: collaborator

Study Sites (1)

Center for Immunization Research Inpatient Unit, Mason F. Lord Building, 4940 Eastern Avenue

Baltimore, Maryland, 21224, 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

• 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

• Talaat KR, Karron RA, Callahan KA, Luke CJ, DiLorenzo SC, Chen GL, Lamirande EW, Jin H, Coelingh KL, Murphy BR, Kemble G, Subbarao K. A live attenuated H7N3 influenza virus vaccine is well tolerated and immunogenic in a Phase I trial in healthy adults. Vaccine. 2009 Jun 8;27(28):3744-53. doi: 10.1016/j.vaccine.2009.03.082. Epub 2009 Apr 17.

  PMID: 19464558 DERIVED

Related Links

• Click here for the Johns Hopkins Bloomberg School of Public Health - Center for Immunization Research (CIR) Web site

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

• Kawsar Talaat, MD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 13, 2007
• First Posted: August 14, 2007
• Study Start: September 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: May 18, 2015

Record last verified: 2015-05

Locations

US (1)