NCT01335347

Brief Summary

The purpose of this study is to demonstrate the safety and immunogenicity of an oral vaccine to prevent avian influenza. Volunteers will receive either one or two doses of research vaccine or placebo as part of this study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 14, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

January 3, 2013

Status Verified

January 1, 2013

Enrollment Period

1.3 years

First QC Date

April 10, 2011

Last Update Submit

January 2, 2013

Conditions

Avian InfluenzaBird Flu

Keywords

Influenzapandemicavian influenzaH5N1flu

Outcome Measures

Primary Outcomes (1)

  • Frequency or severity of vaccine related events as measured through reported AEs

    up to 1 year

Secondary Outcomes (2)

  • Magnitude of humoral immune responses to avian influenza as measured by functional assays

    up to 1 year

  • Magnitude of cellular immune responses to avian influenza as measured by functional assays

    up to 1 year

Study Arms (4)

Experimental Low Dose

EXPERIMENTAL

Biological: One dose of a live replication incompetent adenovirus given in a capsule

Biological: ND1.1

Experimental Medium Dose

EXPERIMENTAL

Biological: One or two doses of replication incompetent adenovirus given in a capsule Other: Placebo capsules of the same size and shape

Biological: ND1.1

Experimental High Dose

EXPERIMENTAL

Biological: One dose of replication incompetent adenovirus in a capsule

Biological: ND1.1

Placebo Control

PLACEBO COMPARATOR

Capsules of the same size and shape as the experimental

Biological: Placebo control

Interventions

ND1.1BIOLOGICAL

adenovirus with the dsRNA adjuvant, dried and put into capsules

Also known as: Ad-HA-dsRNA
Experimental High DoseExperimental Low DoseExperimental Medium Dose
Placebo controlBIOLOGICAL

Capsules of the same size and shape as experimental groups

Placebo Control

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • In good health as established by medical history, physical examination and laboratory testing at the time of enrollment.

You may not qualify if:

  • Has had any other vaccines within the past 8 weeks.
  • Has had prior H5 avian influenza investigational vaccine.
  • Current history of chronic alcohol consumption and/or illicit and/or recreational drug use.
  • History of autoimmune related disease.
  • History of any confirmed or suspected immunodeficient or immunosuppressive condition (no congenital or acquired condition that impedes normal immune response, no concurrent immunosuppressive therapy).
  • Positive serology for HIV, HCV, or HBV.
  • Previous serious reactions to vaccination such as anaphylaxis, respiratory problems, hives or abdominal pain.
  • History of irritable bowel disease or other inflammatory digestive or gastrointestinal conditions that could affect the intended distribution or safety evaluation of an orally administered vaccine targeting the mucosa of the small intestine.
  • Use of proton pump inhibitors (Nexium, Prilosec) that substantially increases stomach pH.
  • Stool sample with occult blood at baseline exam

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

San Diego, California, United States

Location

Related Publications (1)

  • Peters W, Brandl JR, Lindbloom JD, Martinez CJ, Scallan CD, Trager GR, Tingley DW, Kabongo ML, Tucker SN. Oral administration of an adenovirus vector encoding both an avian influenza A hemagglutinin and a TLR3 ligand induces antigen specific granzyme B and IFN-gamma T cell responses in humans. Vaccine. 2013 Mar 25;31(13):1752-8. doi: 10.1016/j.vaccine.2013.01.023. Epub 2013 Jan 25.

    PMID: 23357198DERIVED

MeSH Terms

Conditions

Influenza in BirdsInfluenza, Human

Condition Hierarchy (Ancestors)

Orthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesInfectionsBird DiseasesAnimal DiseasesRespiratory Tract InfectionsRespiratory Tract Diseases

Study Officials

  • Sean N Tucker, PhD

    Vaxart

    STUDY DIRECTOR

  • Martin Kabongo, MD, PhD

    Accelovance

    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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2011

First Posted

April 14, 2011

Study Start

April 1, 2011

Primary Completion

August 1, 2012

Study Completion

September 1, 2012

Last Updated

January 3, 2013

Record last verified: 2013-01

Locations

US(1)