Trivalent rHA Dose Escalation Study in Elderly Subjects

NCT ID: NCT00170443

Last Updated: 2011-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 399 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2004-06-30

Brief Summary

This study will compare the safety and immunogenicity of three different dose levels of an experimental recombinant influenza HA protein vaccine to a standard inactivated influenza vaccine in heallthy elderly subjects ages 65-80. Blood and nasal secretions for assessment of antibody responses will be obtained from all subjects prior to and one month after vaccination.

Detailed Description

Approximately 400 healthy, ambulatory adults ages 65-80 will be randomized into one of four study groups to receive a single immunization of a licensed trivalent inactivated influenza vaccine or one of three dose levels of an investigatioanl trivalent recombinant influenza HA protein vaccine. The study will be conducted in 2 stages. In the first stage, 80 subjects will be randomized (20 per group) and receive one vaccination on Day 0. Safety will be evaluated after Stage 1 subjects have completed a 7 day follow-up. Enrollment of Stage 2 subjects will begin after the safety data for Stage 1 has been reviewed. In Stage 2, 320 subjects will be randomized (80 per group) and receive one vaccination on Day 0. Blood and nasal secretions will be collected prior to an approximately one month after vaccination to assess antibody responses.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

rHAO Trivalent Influenza Vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Medically stable adult age 65 -80.
• Able to give informed consent.
• Able to comply with all study procedures.
• Community dwelling.

Exclusion Criteria

• History of immunodeficiency or treatment with immunosuppressive medications. (use of inhaled steroids or of topical steroids is not considered immunosuppressive).
• Allergy to eggs, egg proteins, thimerosal, or other vaccine components.
• Acute febrile illness or upper respiratory tract illness within 72 hours of vaccination.
• Life expectancy less than 6 months.
• Use of experimental vaccines or medications within one month of study entry.
• Receipt of parenteral immunoglobulin within one month of study entry.
• Any acute or chronic condition which in the opinion of the investigator would render vaccination unsafe or interfere with the evaluation of response.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

HHS/NIAID/DMID

Locations

University of Rochester

Rochester, New York, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

Other Identifiers

03-119

Identifier Type: -

Identifier Source: org_study_id