Title
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
Phase
Phase 1Lead Sponsor
PaxVax, Inc.Study Type
InterventionalStatus
Completed No Results PostedIntervention/Treatment
ad4-h5-vtn inactivated influenza vaccine ...Study Participants
166The 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).
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.
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.
three vaccinations of 10^7vp Ad4-H5-Vtn or placebo
three vaccinations of the 10^8vp Ad4-H5-Vtn or placebo
three vaccinations of 10^9 Ad4-H5-Vtn or placebo
three vaccinations of 10^10 Ad4-H5-Vtn or placebo
three vaccinations of 10^11 Ad4-H5-Vtn or placebo
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.
