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

Phase 1

Completed

• Conditions: Bird Flu; Influenza
• Interventions: Other: Placebo; Biological: Ad4-H5-Vtn; Biological: Sanofi Pasteur Influenza Virus Vaccine, H5N1

• Registration Number: NCT01006798
• Lead Sponsor: Emergent BioSolutions

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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-11-02
• Study First Submitted QC: 2009-11-02
• Study First Posted: 2009-11-03
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	Sanofi Pasteur Influenza Virus Vaccine, H5N1	three vaccinations of 10\^7vp Ad4-H5-Vtn or placebo
Cohort 2	Ad4-H5-Vtn	three vaccinations of the 10\^8vp Ad4-H5-Vtn or placebo
Cohort 5	Sanofi Pasteur Influenza Virus Vaccine, H5N1	three vaccinations of 10\^11 Ad4-H5-Vtn or placebo
Cohort 1	Placebo	three vaccinations of 10\^7vp Ad4-H5-Vtn or placebo
Cohort 1	Ad4-H5-Vtn	three vaccinations of 10\^7vp Ad4-H5-Vtn or placebo
Cohort 2	Placebo	three vaccinations of the 10\^8vp Ad4-H5-Vtn or placebo
Cohort 3	Ad4-H5-Vtn	three vaccinations of 10\^9 Ad4-H5-Vtn or placebo
Cohort 3	Sanofi Pasteur Influenza Virus Vaccine, H5N1	three vaccinations of 10\^9 Ad4-H5-Vtn or placebo
Cohort 2	Sanofi Pasteur Influenza Virus Vaccine, H5N1	three vaccinations of the 10\^8vp Ad4-H5-Vtn or placebo
Cohort 3	Placebo	three vaccinations of 10\^9 Ad4-H5-Vtn or placebo
Cohort 4	Sanofi Pasteur Influenza Virus Vaccine, H5N1	three vaccinations of 10\^10 Ad4-H5-Vtn or placebo
Cohort 5	Placebo	three vaccinations of 10\^11 Ad4-H5-Vtn or placebo
Cohort 4	Placebo	three vaccinations of 10\^10 Ad4-H5-Vtn or placebo
Cohort 4	Ad4-H5-Vtn	three vaccinations of 10\^10 Ad4-H5-Vtn or placebo
Cohort 5	Ad4-H5-Vtn	three vaccinations of 10\^11 Ad4-H5-Vtn or placebo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Immunogenicity (humoral), defined by Ad4 antibody response	At all available timepoints

Trial Locations

Locations (4)

The Center for Pharmaceutical Research; 🇺🇸 Kansas City, Missouri, United States

Coastal Carolina Research Center, Inc.; 🇺🇸 Mount Pleasant, South Carolina, United States

University of Rochester; 🇺🇸 Rochester, New York, United States

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States