Safety and Immunogenicity Study of Adenovirus-vectored, Intranasal Pandemic Influenza Vaccine.

NCT ID: NCT00755703

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2011-12-31

Brief Summary

The purpose of this study is to test the recombinant vaccine for safety and immunogenicity in healthy adults volunteers. Single dose, intranasally administered vaccine using an adenovirus-recombinant vector has provided a safe route for inducing protection in animals against pandemic influenza in preclinical studies.

The vaccine is non-replicating, tissue culture based and designed for intranasal delivery.

Detailed Description

Objectives:

The primary objective is to evaluate the safety of the AdhVN1203/04.H5 vaccine when administered intranasally in two doses with an interval of 28 days in healthy adults 19-49 years of age.

The secondary objective is to evaluated the immunogenicity of the AdhVN1203/04.H5 vaccine at three different doses (10e8, 10e9 and 10e10 viral particles) when administered intranasally in two doses with an interval of 28 days in healthy adults 19-49 years of age.

Conditions

Influenza A Subtype H5N1 Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1

There will be 12 subjects in Group 1 that will receive 10e8 viral particles of the Pandemic Influenza Vaccine administered via intranasal spray on day 0 and day 28 (+/- 4d).

Group Type: EXPERIMENTAL

Pandemic Influenza Vaccine

Intervention Type: BIOLOGICAL

Undetermined

Group 2

There will be 12 subjects in Group 2 that will receive 10e9 viral particles of the Pandemic Influenza Vaccine administered via intranasal spray on day 0 and day 28 (+/- 4d).

Group Type: EXPERIMENTAL

Pandemic Influenza Vaccine

Intervention Type: BIOLOGICAL

Undetermined

Group 3

There will be 12 subjects in Group 3 that will receive 10e10 viral particles of the Pandemic Influenza Vaccine administered via intranasal spray on day 0 and day 28 (+/- 4d).

Group Type: EXPERIMENTAL

Pandemic Influenza Vaccine

Intervention Type: BIOLOGICAL

Undetermined

Experimental: Group 4

There will be 12 subjects in Group 4 that will receive a placebo consisting of buffer administered via intranasal spray on day 0 and day 28 (+/- 4d).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Interventions

Pandemic Influenza Vaccine

Undetermined

Intervention Type: BIOLOGICAL

Placebo

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Healthy males and females in good general health, 19-49 years of age
• Subjects must provide written consent
• Willing to participate through study completion
• Willing to undergo nasal washes and swabs and provide urine and blood samples per protocol for safety and immunogenicity analysis
• Female of child-bearing age must have a negative urine pregnancy test and be stable on a reliable means of contraception.
• Meet screening criteria for hematology, chemistry and urinalysis

Exclusion Criteria

• Pregnant (or possibly pregnant) and lactating women
• Any flu/cold symptoms and/or fever greater than 101 degrees in 3 days prior to study enrollment
• Any intranasal steroid medication administered in the 10 days prior to study enrollment
• History of chronic rhinitis or presence of pre-existing nasal septal defects, nasal polyps or other gross abnormalities
• Any previous nasal cautery or significant surgery for nasal septal defects
• Any regular past or current use of intranasal illicit drugs or history of intravenous illicit drug use
• Asthma that is greater than mild in severity
• Diagnosed active Hepatitis B or C
• HIV positive at screening
• Known or suspected malignancy, leukemia, or lymphoma
• Immunosuppressed, altered or compromised immune status as a consequence of disease or treatment with systemic corticosteroids
• Receipt of an influenza vaccine within the past 6 months
• Receipt of any vaccine in the past 30 days
• Receipt of any investigational drug in the past 30 days
• Known Diabetes mellitus
• History of anaphylaxis or angioedema
• Hypertension that is not well controlled
• Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the investigator would serve to interfere or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a participants's ability to give informed consent

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Altimmune, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott D. Parker, M.D.

Role: PRINCIPAL_INVESTIGATOR

Alabama Vaccine Research Clinic, University of Alabama at Birmingham

Locations

Alabama Vaccine Research Center (UAB)

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

#1-UCI-AI-06205-01

Identifier Type: -

Identifier Source: secondary_id

H-0701-2

Identifier Type: -

Identifier Source: org_study_id