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Completed

NCT Number: NCT01006798

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

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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Key information

Conditions

Bird Flu Animal Diseases Bird Diseases Infections Influenza Influenza in Birds Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Kentucky, Lexington, Kentucky, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Other

enteric coated capsule containing no vaccine virus

Other names: Placebo for Ad4-H5-Vtn

Ad4-H5-Vtn

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

Other names: Adenovirus Serotype 4-vectored H5N1 Influenza Vaccine

Sanofi Pasteur Influenza Virus Vaccine, H5N1

Biological

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

Other names: FDA-licensed inactivated monovalent Influenza Virus Vaccine, H5N1, licensed H5N1 vaccine

Primary outcomes

  1. 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)

  2. Immunogenicity (humoral) defined by H5 HAI titer

    Time frame: At all available timepoints

Secondary outcomes

  1. Immunogenicity (humoral), defined by Ad4 antibody response

    Time frame: At all available timepoints

  2. Replication/excretion of Ad4-H5-Vtn virus

    Time frame: Throughout trial

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

    Time frame: Throughout trial

Sponsors and collaborators

Lead sponsor

Emergent BioSolutions

Industry

Registry information

Official study title

Phase 1 Evaluation of the Safety and Immunogenicity of a Replication-Competent Adenovirus Serotype 4-vectored H5N1 Influenza Candidate Vaccine - Ad4-H5-Vtn

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 3, 2009
Registry last updated
Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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