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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01006798
• Other study ID #: PXVX-H5-103-001
• Status: Completed
• Phase: Phase 1
• Start date: October 2009
• Est. completion date: September 2011

Study information

• Verified date: March 2024
• Source: Emergent BioSolutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bird Flu
• Influenza
• Influenza, Human

Intervention

Other:
• Placebo
enteric coated capsule containing no vaccine virus

Biological:
• 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
• 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.

Locations

Country	Name	City	State
United States	The Center for Pharmaceutical Research	Kansas City	Missouri
United States	University of Kentucky	Lexington	Kentucky
United States	Coastal Carolina Research Center, Inc.	Mount Pleasant	South Carolina
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Emergent BioSolutions

Country where clinical trial is conducted

United States, 

References & Publications (2)

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, doub — View Citation

Khurana S, Coyle EM, Manischewitz J, King LR, Ishioka G, Alexander J, Smith J, Gurwith M, Golding H. Oral priming with replicating adenovirus serotype 4 followed by subunit H5N1 vaccine boost promotes antibody affinity maturation and expands H5N1 cross-clade neutralization. PLoS One. 2015 Jan 28;10(1):e0115476. doi: 10.1371/journal.pone.0115476. eCollection 2015. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety, defined as the frequency and severity of vaccine-related reactogenicity events and reported AEs		Throughout trial (reactogenicity for 7 days following each vaccination)
Primary	Immunogenicity (humoral) defined by H5 HAI titer		At all available timepoints
Secondary	Immunogenicity (humoral), defined by Ad4 antibody response		At all available timepoints
Secondary	Replication/excretion of Ad4-H5-Vtn virus		Throughout trial
Secondary	Transmission to household contacts as measured by AE assessment and antibody response and viral replication/excretion		Throughout trial