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

Influenza Clinical Trial

Official title:

Phase 1 Inpatient Study of the Safety and Immunogenicity of Live Influenza A Vaccine H7N3 (6-2) AA ca Recombinant (A/Chicken/British Columbia/CN-6/2004 x A/Ann Arbor/6/60 ca), a Live Attenuated Virus Vaccine Candidate for the Prevention of Avian Influenza H7N3 Infection in the Event of a Pandemic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00516035
• Other study ID #: CIR 241
• Secondary ID: WIRB Protocol Nu
• Status: Completed
• Phase: Phase 1
• First received: August 13, 2007
• Last updated: May 15, 2015
• Start date: September 2007
• Est. completion date: December 2007

Study information

• Verified date: May 2015
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Virus Diseases

Intervention

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)
Vaccine given by nasal spray

Locations

Country	Name	City	State
United States	Center for Immunization Research Inpatient Unit, Mason F. Lord Building, 4940 Eastern Avenue	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Johns Hopkins Bloomberg School of Public Health

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

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. Epub 2007 Jul 18. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No
Primary	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	No
Secondary	To determine the number of vaccinees infected with the vaccine virus		Daily for 8 days after each vaccination	No
Secondary	To determine the phenotypic stability of the vaccine virus		Throughout study	No
Secondary	To determine whether immunogenicity is enhanced by a second dose of vaccine		At study completion	No
Secondary	To evaluate T-cell mediated and innate immune responses against the vaccine virus		Throughout study	No
Secondary	To develop a serum bank to evaluate future H7 influenza vaccines		Throughout study	No

External Links

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