Safety and Immunogenicity of Replication-Competent Adenovirus 4-vectored Vaccine for Avian Influenza H5N1
Phase 1 Evaluation of the Safety and Immunogenicity of a Replication-Competent Adenovirus Serotype 4-vectored H5N1 Influenza Candidate Vaccine - Ad4-H5-Vtn
1 other identifier
interventional
166
1 country
4
Brief Summary
The purpose of this study is to compare the safety and immunogenicity over a 9-month period of five different dosages of Ad4-H5-Vtn in volunteers (Vaccinees) who receive three doses of the study vaccine or placebo. In addition, transmission of Ad4-H5-Vtn will be evaluated in all Household Contacts residing with the vaccinated volunteers. Vaccinees also may participate in a substudy in which they receive a booster vaccination with the licensed Influenza Virus Vaccine, H5N1 (Sanofi Pasteur).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2009
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 2, 2009
CompletedFirst Posted
Study publicly available on registry
November 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedMarch 18, 2024
March 1, 2024
1.9 years
November 2, 2009
March 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety, defined as the frequency and severity of vaccine-related reactogenicity events and reported AEs
Throughout trial (reactogenicity for 7 days following each vaccination)
Immunogenicity (humoral) defined by H5 HAI titer
At all available timepoints
Secondary Outcomes (3)
Immunogenicity (humoral), defined by Ad4 antibody response
At all available timepoints
Replication/excretion of Ad4-H5-Vtn virus
Throughout trial
Transmission to household contacts as measured by AE assessment and antibody response and viral replication/excretion
Throughout trial
Study Arms (5)
Cohort 1
EXPERIMENTALthree vaccinations of 10\^7vp Ad4-H5-Vtn or placebo
Cohort 2
EXPERIMENTALthree vaccinations of the 10\^8vp Ad4-H5-Vtn or placebo
Cohort 3
EXPERIMENTALthree vaccinations of 10\^9 Ad4-H5-Vtn or placebo
Cohort 4
EXPERIMENTALthree vaccinations of 10\^10 Ad4-H5-Vtn or placebo
Cohort 5
EXPERIMENTALthree vaccinations of 10\^11 Ad4-H5-Vtn or placebo
Interventions
enteric coated capsule containing no vaccine virus
a live, replication-competent, recombinant Ad4 virus expressing the HA of H5N1 influenza (A/Vietnam/1194/2004) in an enteric capsule for oral administration
Single administration of a heterologous boost given to volunteers 3 to 15 months following their last vaccination with Ad4-H5-Vtn or placebo.
Eligibility Criteria
You may qualify if:
- Healthy adults and their healthy adult household contacts.
You may not qualify if:
- Healthcare workers who have direct contact with patients who are immunodeficient, are HIV-positive, have an unstable medical condition, or are under the age of 18.
- Childcare workers who have direct contact with children 5 years old and younger.
- Resides with Household Contacts who are under the age of 18 or over the age of 65.
- Received or plans to receive licensed inactivated 2009 H1N1 influenza vaccine from 14 days prior to 14 days after any study vaccination.
- Received or plans to receive any other licensed vaccines from 30 days prior to the first study vaccination until 30 days after the third study vaccination.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
University of Kentucky
Lexington, Kentucky, 40536, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114, United States
University of Rochester
Rochester, New York, 14642, United States
Coastal Carolina Research Center, Inc.
Mt. Pleasant, South Carolina, 29464, United States
Related Publications (2)
Khurana S, Coyle EM, Manischewitz J, King LR, Ishioka G, Alexander J, Smith J, Gurwith M, Golding H. Oral priming with replicating adenovirus serotype 4 followed by subunit H5N1 vaccine boost promotes antibody affinity maturation and expands H5N1 cross-clade neutralization. PLoS One. 2015 Jan 28;10(1):e0115476. doi: 10.1371/journal.pone.0115476. eCollection 2015.
PMID: 25629161BACKGROUNDGurwith M, Lock M, Taylor EM, Ishioka G, Alexander J, Mayall T, Ervin JE, Greenberg RN, Strout C, Treanor JJ, Webby R, Wright PF. Safety and immunogenicity of an oral, replicating adenovirus serotype 4 vector vaccine for H5N1 influenza: a randomised, double-blind, placebo-controlled, phase 1 study. Lancet Infect Dis. 2013 Mar;13(3):238-50. doi: 10.1016/S1473-3099(12)70345-6. Epub 2013 Jan 29.
PMID: 23369412RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Marc Gurwith, M.D., J.D.
Emergent BioSolutions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2009
First Posted
November 3, 2009
Study Start
October 1, 2009
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
March 18, 2024
Record last verified: 2024-03