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

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Hong Kong, Queen Mary Hospital, Hong Kong

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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.

Exclusion criteria

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
Were administered an investigational drug within six weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product
Are a member of the team conducting this study or are in a dependent relationship with the study Investigator. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the Investigator or site conducting the study
If female: are pregnant or lactating

Treatment and study plan

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.

Primary outcomes

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

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

Sponsors and collaborators

Lead sponsor

Alachua Government Services, Inc.

Industry

Registry information

Official study title

An Open-Label Phase I/II Study to Assess the Safety and Immunogenicity of Two Doses of a Vero Cell Derived, Whole Virus Clade 2 H5N1 Influenza Vaccine in Healthy Volunteers Aged 21 to 45 Years

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2008
First posted: Aug 17, 2007
Registry last updated: Oct 9, 2015

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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Completed