Safety and Immunogenicity of Live Influenza A Vaccine for Avian Influenza H7N7

NCT00922259 | Completed Phase 1

• 1 other identifier: URMC 10-003
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Every year the human population suffers from seasonal outbreaks of influenza resulting in both illness and death. However, the rates of illness and death from seasonal outbreaks are significantly lower than those suffered during times of influenza pandemic, such as those experienced in 1918, 1957, and 1968. The reason for this difference lies in presence of immunity within a population. With seasonal outbreaks of influenza most people have some immunity to the circulating strain and usually only those with weakened immune systems experience serious complications. Influenza pandemics, in contrast, are the result of a completely new viral subtype to which nobody possesses an immunity, leaving everyone vulnerable to the most serious of complications. It has been estimated that the next flu pandemic could cause over 200,000 deaths and over 700,000 hospitalizations in the US alone. The need for an effective viral vaccine is high. The purpose of this study is to test the safety and immunogenicity of a live influenza A strain vaccine, which would be able to combat an influenza pandemic.

Conditions

Influenza A

Keywords

Flu; Influenza; Vaccine; Prevention

Outcome Measures

Primary Outcomes (2)

• Immunogenicity as measured by Anti-H7N7 antibody and seroconversion

  Measured on Days 2 to 9 and 26 to 37

• Determine the frequency of vaccine-related reactogenicity events (REs) and other adverse events (AEs) for 2 doses of vaccine

  Measured on Days 2 to 9 and 26 to 37

Secondary Outcomes (8)

• Frequency of vaccine-related reactogenicity events (REs) and other adverse events (AEs) for each dose

  Measured on Days 2 to 9 and 26 to 37

• Area under the curve of nasal virus shedding after each dose of vaccine

  Measured on Days 2 to 9 and 28 to 37

• Amount of serum and nasal wash antibody induced by the vaccine

  Measured through Day 208

• Number of vaccinees infected with the H7N7 NL 2003/AA ca recombinant vaccine candidate

  Measured through Day 208

• Phenotypic stability of vaccine virus shed

  Measured through Day 208

Study Arms (1)

H7N7 Vaccine

EXPERIMENTAL

Participants will be administered two doses of the candidate live influenza A H7N7 vaccine

Biological: Influenza A H7N7 vaccine

Interventions

Influenza A H7N7 vaccine BIOLOGICAL

Participants will be administered two doses of the candidate vaccine at a dosage of approximately 10\^7.5 50% tissue culture infectious dose (TCID50), in the form of nasal spray. The doses will be administered 28-62 days apart.

H7N7 Vaccine

Eligibility Criteria

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

You may qualify if:

• Able to provide informed consent
• General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator
• Available for the duration of the trial
• 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 study protocol.
• Agrees to store blood specimens for future research

You may not qualify if:

• Pregnancy or breast-feeding
• 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 protocol
• Previous enrollment in an H7 influenza vaccine trial or in any study of an avian influenza vaccine
• Seropositive to the H7N7 influenza A virus (serum HI titer greater than 1:8)
• Positive urine drug toxicology test indicating narcotic use or dependency
• Have medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
• Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant participating in the trial or would render the participant unable to comply with the protocol
• History of anaphylaxis
• Allergy to oseltamivir
• Diagnosis of asthma or reactive airway disease within the past 2 years
• History of Guillain-Barre Syndrome
• Positive ELISA and confirmatory Western blot tests for HIV-1
• Positive ELISA and confirmatory test (for example, recombinant immunoblot assay \[RIBA\]) for hepatitis C virus (HCV)
• Positive test for hepatitis B virus surface antigen (HBsAg) by ELISA.
• Known immunodeficiency syndrome

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (3)

• Kelly H, Carville K, Grant K, Jacoby P, Tran T, Barr I. Estimation of influenza vaccine effectiveness from routine surveillance data. PLoS One. 2009;4(3):e5079. doi: 10.1371/journal.pone.0005079. Epub 2009 Mar 31.

  PMID: 19333374 BACKGROUND

• Roose K, Fiers W, Saelens X. Pandemic preparedness: toward a universal influenza vaccine. Drug News Perspect. 2009 Mar;22(2):80-92. doi: 10.1358/dnp.2009.22.2.1334451.

  PMID: 19330167 BACKGROUND

• Schwehm M, Wilson N. Potential impact of pandemic influenza interventions in New Zealand: a brief modelling study. N Z Med J. 2009 Mar 13;122(1291):117-21. No abstract available.

  PMID: 19322265 BACKGROUND

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

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: May 28, 2009
• First Posted: June 17, 2009
• Study Start: July 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: February 13, 2013

Record last verified: 2013-02

Locations

US (1)