Safety and Immunogenicity of Replication-Competent Adenovirus 4-vectored Vaccine for Avian Influenza H5N1

Emergent BioSolutions166 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

166

Conditions

Bird Flu Influenza

Interventions

PlaceboOTHER

enteric coated capsule containing no vaccine virus

Ad4-H5-VtnBIOLOGICAL

a live, replication-competent, recombinant Ad4 virus expressing the HA of H5N1 influenza (A/Vietnam/1194/2004) in an enteric capsule for oral administration

Sanofi Pasteur Influenza Virus Vaccine, H5N1BIOLOGICAL

Single administration of a heterologous boost given to volunteers 3 to 15 months following their last vaccination with Ad4-H5-Vtn or placebo.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (4)

University of Kentucky

Lexington, Kentucky, United States

The Center for Pharmaceutical Research

Kansas City, Missouri, United States

University of Rochester

Rochester, New York, United States

Coastal Carolina Research Center, Inc.

Mt. Pleasant, South Carolina, United States

Outcomes

Primary Outcomes

Safety, defined as the frequency and severity of vaccine-related reactogenicity events and reported AEs

Time frame: Throughout trial (reactogenicity for 7 days following each vaccination)

Immunogenicity (humoral) defined by H5 HAI titer

Time frame: At all available timepoints

Secondary Outcomes

Immunogenicity (humoral), defined by Ad4 antibody response

Time frame: At all available timepoints

Replication/excretion of Ad4-H5-Vtn virus

Time frame: Throughout trial

Transmission to household contacts as measured by AE assessment and antibody response and viral replication/excretion

Time frame: Throughout trial

Data from ClinicalTrials.gov

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