Clinical trial NCT01006798: Safety and Immunogenicity of Replication-Competent Adenovirus 4-vectored Vaccine for Avian Influenza H5N1
Official title: Phase 1 Evaluation of the Safety and Immunogenicity of a Replication-Competent Adenovirus Serotype 4-vectored H5N1 Influenza Candidate Vaccine - Ad4-H5-Vtn
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bird Flu
Influenza
Keywords: Virus Diseases
Respiratory Tract Diseases
Vaccine
Lead sponsor: Emergent BioSolutions
Sponsor class: INDUSTRY
First posted: 2009-11-03
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Detailed description: At least 160 healthy Vaccinees will be randomized into 5 ascending dosage cohorts each consisting of at least 32 volunteers. In each dosage cohort Vaccinees will be randomly assigned to receive 3 doses of either Ad4-H5-Vtn or placebo separated by approximately 56 days. Volunteers will be followed for 168 days post-third vaccination.

Eligibility criteria: Inclusion Criteria:

* Healthy adults and their healthy adult household contacts.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Safety, defined as the frequency and severity of vaccine-related reactogenicity events and reported AEs
timeFrame: Throughout trial (reactogenicity for 7 days following each vaccination)
measure: Immunogenicity (humoral) defined by H5 HAI titer
timeFrame: At all available timepoints
Secondary outcomes:
measure: Immunogenicity (humoral), defined by Ad4 antibody response
timeFrame: At all available timepoints
measure: Replication/excretion of Ad4-H5-Vtn virus
timeFrame: Throughout trial
measure: Transmission to household contacts as measured by AE assessment and antibody response and viral replication/excretion
timeFrame: Throughout trial
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research
state: Missouri
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center, Inc.
state: South Carolina
Study officials:
affiliation: Emergent BioSolutions
name: Marc Gurwith, M.D., J.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Gurwith 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.