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

Primary Purpose

Bird Flu, Influenza

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Placebo

Ad4-H5-Vtn

Sanofi Pasteur Influenza Virus Vaccine, H5N1

About this trial

This is an interventional prevention trial for Bird Flu focused on measuring Virus Diseases, Respiratory Tract Diseases, Vaccine

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University of Kentucky
The Center for Pharmaceutical Research
University of Rochester
Coastal Carolina Research Center, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

Arm Description

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

Outcomes

Primary Outcome Measures

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

Immunogenicity (humoral) defined by H5 HAI titer

Secondary Outcome Measures

Immunogenicity (humoral), defined by Ad4 antibody response

Replication/excretion of Ad4-H5-Vtn virus

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

Full Information

NCT ID

NCT01006798

First Posted

November 2, 2009

Last Updated

October 23, 2023

Sponsor

Emergent BioSolutions

1. Study Identification

Unique Protocol Identification Number

NCT01006798

Brief Title

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

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Emergent BioSolutions

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bird Flu, Influenza

Keywords

Virus Diseases, Respiratory Tract Diseases, Vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

166 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Experimental

Arm Description

three vaccinations of 10^7vp Ad4-H5-Vtn or placebo

Arm Title

Cohort 2

Arm Type

Experimental

Arm Description

three vaccinations of the 10^8vp Ad4-H5-Vtn or placebo

Arm Title

Cohort 3

Arm Type

Experimental

Arm Description

three vaccinations of 10^9 Ad4-H5-Vtn or placebo

Arm Title

Cohort 4

Arm Type

Experimental

Arm Description

three vaccinations of 10^10 Ad4-H5-Vtn or placebo

Arm Title

Cohort 5

Arm Type

Experimental

Arm Description

three vaccinations of 10^11 Ad4-H5-Vtn or placebo

Intervention Type

Other

Intervention Name(s)

Placebo

Other Intervention Name(s)

Placebo for Ad4-H5-Vtn

Intervention Description

enteric coated capsule containing no vaccine virus

Intervention Type

Biological

Intervention Name(s)

Ad4-H5-Vtn

Other Intervention Name(s)

Adenovirus Serotype 4-vectored H5N1 Influenza Vaccine

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Sanofi Pasteur Influenza Virus Vaccine, H5N1

Other Intervention Name(s)

FDA-licensed inactivated monovalent Influenza Virus Vaccine, H5N1, licensed H5N1 vaccine

Intervention Description

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

Primary Outcome Measure Information:

Title

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)

Title

Immunogenicity (humoral) defined by H5 HAI titer

Time Frame

At all available timepoints

Secondary Outcome Measure Information:

Title

Immunogenicity (humoral), defined by Ad4 antibody response

Time Frame

At all available timepoints

Title

Replication/excretion of Ad4-H5-Vtn virus

Time Frame

Throughout trial

Title

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

Time Frame

Throughout trial

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marc Gurwith, M.D., J.D.

Organizational Affiliation

Emergent BioSolutions

Official's Role

Study Director

Facility Information:

Facility Name

University of Kentucky

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

Facility Name

The Center for Pharmaceutical Research

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64114

Country

United States

Facility Name

University of Rochester

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Facility Name

Coastal Carolina Research Center, Inc.

City

Mount Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23369412

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.

Results Reference

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

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