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

NCT00755703 | Completed Phase 1 DMC

• 2 other identifiers: H-0701-2#1-UCI-AI-06205-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza A Subtype H5N1 Infection

Keywords

Influenza; Vaccine; Pandemic; Avian influenza; Adenovirus strain 5; Vectored vaccine; Intranasal; Tissue-culture derived; Non-replicating

Outcome Measures

Primary Outcomes (1)

• To assess the safety of a nasally administered adenovirus-vectored pandemic influenza vaccine in healthy human adults.

  56 day observations with 2 year follow-up

Secondary Outcomes (1)

• Determination of immunogenicity and correlates of protection based on HI titers in vaccinates

  28 days and 56 days post vaccination

Study Arms (4)

Group 1

EXPERIMENTAL

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).

Biological: Pandemic Influenza Vaccine

Group 2

EXPERIMENTAL

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).

Biological: Pandemic Influenza Vaccine

Group 3

EXPERIMENTAL

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).

Biological: Pandemic Influenza Vaccine

Experimental: Group 4

PLACEBO COMPARATOR

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).

Biological: Placebo

Interventions

Pandemic Influenza Vaccine BIOLOGICAL

Undetermined

Group 1; Group 2; Group 3

Placebo BIOLOGICAL

Experimental: Group 4

Eligibility Criteria

• Age: 19 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Altimmune, Inc.: lead

Study Sites (1)

Alabama Vaccine Research Center (UAB)

Birmingham, Alabama, 35294-2050, United States

Location

MeSH Terms

Conditions

Influenza, Human; Influenza in Birds

Condition Hierarchy (Ancestors)

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

Study Officials

• Scott D. Parker, M.D.

  Alabama Vaccine Research Clinic, University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2008
• First Posted: September 19, 2008
• Study Start: October 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: December 1, 2011
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

US (1)