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

December 31, 2015 updated by: Altimmune, Inc.

A Phase I, Dose-Ranging Safety and Immunogenicity Study of an Adenovirus-vectored Intranasal, Pandemic (Hemagglutinin H5) Influenza Vaccine, ADhVN1203/04.H5, in Healthy Adults

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-2050
        • Alabama Vaccine Research Center (UAB)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Biological: Pandemic Influenza Vaccine
Undetermined
Experimental: 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).
Biological: Pandemic Influenza Vaccine
Undetermined
Experimental: 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).
Biological: Pandemic Influenza Vaccine
Undetermined
Placebo Comparator: 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).
Biological: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the safety of a nasally administered adenovirus-vectored pandemic influenza vaccine in healthy human adults.
Time Frame: 56 day observations with 2 year follow-up
56 day observations with 2 year follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Determination of immunogenicity and correlates of protection based on HI titers in vaccinates
Time Frame: 28 days and 56 days post vaccination
28 days and 56 days post vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Altimmune, Inc.

Investigators

  • Principal Investigator: Scott D. Parker, M.D., Alabama Vaccine Research Clinic, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

September 17, 2008

First Submitted That Met QC Criteria

September 18, 2008

First Posted (Estimate)

September 19, 2008

Study Record Updates

Last Update Posted (Estimate)

January 1, 2016

Last Update Submitted That Met QC Criteria

December 31, 2015

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-0701-2
  • #1-UCI-AI-06205-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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