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
Sponsor study identifier
Secondary identifiers
interventional
48
1 country
1
Study Start
October 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2009
Actual (reported)Study Completion
December 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 17, 2008
Actual (reported)September 19, 2008
Actual (reported)October 2008
Date type not reportedThis date has not been verified as actual or estimated.
September 2009
Actual (reported)December 2011
Actual (reported)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
Determination of immunogenicity and correlates of protection based on HI titers in vaccinates
28 days and 56 days post vaccination
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).
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).
Undetermined
Alabama Vaccine Research Center (UAB)
Birmingham, Alabama, 35294-2050, United States
Scott D. Parker, M.D.
Alabama Vaccine Research Clinic, University of Alabama at Birmingham
48 participants (actual enrollment reported by the registry).
First Submitted
September 17, 2008
First Posted
September 19, 2008
Study Start
October 2008
Date type not reportedThis date has not been verified as actual or estimated.
Phase II Study of Pandemic Influenza Vaccine
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).
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
September 2009
Actual (reported)Study Completion
December 2011
Actual (reported)Last Updated
May 29, 2025
Record last verified: 2025-05
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Source: ClinicalTrials.gov.
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