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

Emergent BioSolutions

Status and phase: Completed; Phase 1

Conditions: Influenza; Bird Flu

Treatments: Other: Placebo; Biological: Sanofi Pasteur Influenza Virus Vaccine, H5N1; Biological: Ad4-H5-Vtn

Study type: Interventional

Funder types: Industry

Identifiers

NCT01006798

PXVX-H5-103-001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 166 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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166 participants in 5 patient groups

Cohort 1

Experimental group

Description:

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

Treatment:

Biological: Ad4-H5-Vtn

Biological: Sanofi Pasteur Influenza Virus Vaccine, H5N1

Other: Placebo

Cohort 2

Experimental group

Description:

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

Treatment:

Biological: Ad4-H5-Vtn

Biological: Sanofi Pasteur Influenza Virus Vaccine, H5N1

Other: Placebo

Cohort 3

Experimental group

Description:

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

Treatment:

Biological: Ad4-H5-Vtn

Biological: Sanofi Pasteur Influenza Virus Vaccine, H5N1

Other: Placebo

Cohort 4

Experimental group

Description:

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

Treatment:

Biological: Ad4-H5-Vtn

Biological: Sanofi Pasteur Influenza Virus Vaccine, H5N1

Other: Placebo

Cohort 5

Experimental group

Description:

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

Treatment:

Biological: Ad4-H5-Vtn

Biological: Sanofi Pasteur Influenza Virus Vaccine, H5N1

Other: Placebo