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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-09-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Bird Flu Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1

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

Group Type EXPERIMENTAL

Placebo

Intervention Type OTHER

enteric coated capsule containing no vaccine virus

Ad4-H5-Vtn

Intervention Type BIOLOGICAL

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, H5N1

Intervention Type BIOLOGICAL

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

Cohort 2

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

Group Type EXPERIMENTAL

Placebo

Intervention Type OTHER

enteric coated capsule containing no vaccine virus

Ad4-H5-Vtn

Intervention Type BIOLOGICAL

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, H5N1

Intervention Type BIOLOGICAL

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

Cohort 3

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

Group Type EXPERIMENTAL

Placebo

Intervention Type OTHER

enteric coated capsule containing no vaccine virus

Ad4-H5-Vtn

Intervention Type BIOLOGICAL

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, H5N1

Intervention Type BIOLOGICAL

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

Cohort 4

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

Group Type EXPERIMENTAL

Placebo

Intervention Type OTHER

enteric coated capsule containing no vaccine virus

Ad4-H5-Vtn

Intervention Type BIOLOGICAL

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, H5N1

Intervention Type BIOLOGICAL

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

Cohort 5

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

Group Type EXPERIMENTAL

Placebo

Intervention Type OTHER

enteric coated capsule containing no vaccine virus

Ad4-H5-Vtn

Intervention Type BIOLOGICAL

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, H5N1

Intervention Type BIOLOGICAL

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

Interventions

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Placebo

enteric coated capsule containing no vaccine virus

Intervention Type OTHER

Ad4-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

Intervention Type BIOLOGICAL

Sanofi 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.

Intervention Type BIOLOGICAL

Other Intervention Names

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Placebo for Ad4-H5-Vtn Adenovirus Serotype 4-vectored H5N1 Influenza Vaccine FDA-licensed inactivated monovalent Influenza Virus Vaccine, H5N1 licensed H5N1 vaccine

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes