Safety and Immunogenicity Study of Two Doses of an Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived)

NCT00517517 | Completed Phase 1 DMC

• 1 other identifier: 810701
• Study Type: interventional
• Target: 110
• Locations: 2 countries
• Sites: 4

Brief Summary

The objectives of this Phase I/II study are to assess the safety and immunogenicity of two different dose levels of a non-adjuvanted H5N1 influenza vaccine in a healthy young adult population. Subjects will be randomized 1:1 to receive two intramuscular injections (21 days apart) of the vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation. Subjects will be monitored for safety and for antibody response to the vaccine. A data safety monitoring board will review the safety data after the first and second vaccination.

Conditions

Influenza

Keywords

Pandemic influenza

Outcome Measures

Primary Outcomes (1)

• Number of subjects with antibody response to the vaccine strain associated with protection 21 days after the second vaccination defined as titer measured by Microneutralization (MN) test >= 1:20

  21 days after the second vaccination (= Day 42 in the study)

Study Arms (2)

1

EXPERIMENTAL

Intramuscular injection of whole virion, Vero cell-derived influenza vaccine containing 7.5 µg of H5N1 HA antigen per 0.5 mL in a non-adjuvanted formulation

Biological: Whole virion, Vero cell-derived influenza vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation

2

EXPERIMENTAL

Intramuscular injection of whole virion, Vero cell-derived influenza vaccine containing 3.75 µg of H5N1 HA antigen per 0.25 mL in a non-adjuvanted formulation

Biological: Whole virion, Vero cell-derived influenza vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation

Interventions

Whole virion, Vero cell-derived influenza vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation BIOLOGICAL

Subjects will be randomized 1:1 to receive two intramuscular injections of the whole virion, Vero cell-derived influenza vaccine containing either 3.75 mg or 7.5 mg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation on Day 0 and Day 21.

1; 2

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Are 21 to 45 years of age, inclusive, on the day of screening
• Have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry
• Are clinically healthy, as determined by the Investigator's clinical judgment through collection of medical history and performance of a physical examination
• Are physically and mentally capable of participating in the study
• Agree to keep a daily record of symptoms for the duration of the study
• If female and capable of bearing children, have a negative urine pregnancy test result within 24 hours of the scheduled first vaccination and agree to employ adequate birth control measures for the duration of the study.

You may not qualify if:

• Have a history of exposure to H5N1 virus or a history of vaccination with an H5N1 influenza virus
• Are at high risk of contracting H5N1 influenza infection (e.g. poultry workers)
• Suffer from or have a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder
• Suffer from any inherited or acquired immunodeficiency
• Test positive for Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HbsAg) or Hepatitis C Virus (HCV)
• Suffer from a disease or are undergoing a form of treatment that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (\>800µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs
• Have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré syndrome)
• Have a history of severe allergic reactions or anaphylaxis
• Have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating
• Have received a blood transfusion or immunoglobulins within 90 days of study entry
• Have donated blood or plasma within 30 days of study entry
• Have received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study
• Have undergone systemic corticoid therapy within 30 days prior to study entry
• Have a functional or surgical asplenia
• Have a known or suspected problem with alcohol or drug abuse

Sponsors & Collaborators

• Alachua Government Services, Inc.: lead

Study Sites (4)

University of Hong Kong, Queen Mary Hospital

Hong Kong, Hong Kong

Location

Chinese University of Hong Kong, Prince of Wales Hospital

Shatin, Hong Kong

Location

National University Hospital

Singapore, 119074, Singapore

Location

Changi General Hospital

Singapore, 529889, Singapore

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Antigens

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biological Factors

Study Officials

• Baxter Bio Science Investigator

  Baxter Healthcare Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2007
• First Posted: August 17, 2007
• Study Start: July 1, 2007
• Primary Completion: September 1, 2007
• Study Completion: February 1, 2008
• Last Updated: October 9, 2015

Record last verified: 2011-09

Locations

HK (2); SG (2)