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

NCT ID: NCT00516035

Last Updated: 2015-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2007-12-31

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.

Detailed Description

The current pandemic risk associated with avian influenza H7N3 infection is significant as an increasing number of humans are infected. H7 influenza transmission usually occurs in humans when they are exposed through direct contact to infected poultry or surfaces and objects contaminated by infected poultry feces. A pandemic occurs when a new influenza subtype emerges that infects humans, causes serious illness, and spreads easily between humans. The development of a safe and effective vaccine is necessary, should a pandemic occur. The purpose of this study is to evaluate the safety and immunogenicity of a live, attenuated AI virus vaccine, H7N3 (6-2) AA ca Recombinant (A/chicken/British Columbia/CN-6/2004 x A/Ann Arbor/6/60 ca).

This study will last approximately 90 days. Participation in this study includes two 12-day hospital stays in an isolation unit at the Johns Hopkins Bayview Medical Center. All participants will receive two doses of vaccine in nasal spray form, at study entry and sometime between 4 and 8 weeks after initial vaccination. Participants will be admitted to the isolation unit 2 days prior to each vaccination. A targeted physical exam, vital signs measurement, and a nasal wash will occur daily following each vaccination until discharge. Participants will be discharged after three consecutive nasal washes on or after Day 6 are negative. Blood and urine collection will occur at selected timepoints throughout the study. A follow-up outpatient visit will occur approximately 4 weeks following each vaccination.

Conditions

Influenza; Virus Diseases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

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)

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Vaccine given by nasal spray

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)

Vaccine given by nasal spray

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Good general health
• Available for the duration of the trial
• Willing to use acceptable forms of contraception for the duration of the study

Exclusion Criteria

• 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.
• Live vaccines within 4 weeks prior to study vaccination
• Killed vaccines within 2 weeks prior to study vaccination
• Absence of spleen
• Blood products within 6 months prior to study vaccination
• Current smoker unwilling to stop smoking for the duration of the study
• Have traveled to the Southern Hemisphere, Asia, or the United Kingdom within 14 days prior to study vaccination
• Have traveled on a cruise ship within 14 days prior to study vaccination
• Work in the poultry industry
• Other investigational vaccine or drug within 30 days prior to study vaccination
• Allergy to eggs or egg products
• Purified protein derivative (PPD) positive (positive tuberculosis [TB] test)
• Have family member with immunodeficiency
• Other condition that, in the opinion of the investigator, may interfere with the study
• Pregnancy or breastfeeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Center for Immunization Research, Johns Hopkins School of Public Health

Principal Investigators

Kawsar Talaat, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

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

Baltimore, Maryland, United States

Countries

United States

References

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

Reference Type: BACKGROUND

PMID: 16447497 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17634234 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17200390 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 19464558 (View on PubMed)

Related Links

http://www.jhsph.edu/cir

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

Other Identifiers

WIRB Protocol Number 20071381

Identifier Type: -

Identifier Source: secondary_id

CIR 241

Identifier Type: -

Identifier Source: org_study_id