Bird Flu, Influenza
Conditions
Keywords
Virus Diseases, Respiratory Tract Diseases, Vaccine
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.
Interventions
OTHERPlacebo
enteric coated capsule containing no vaccine virus
BIOLOGICALAd4-H5-Vtn
a live, replication-competent, recombinant Ad4 virus expressing the HA of H5N1 influenza (A/Vietnam/1194/2004) in an enteric capsule for oral administration
BIOLOGICALSanofi Pasteur Influenza Virus Vaccine, H5N1
Single administration of a heterologous boost given to volunteers 3 to 15 months following their last vaccination with Ad4-H5-Vtn or placebo.
Sponsors
Emergent BioSolutions
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed