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

Influenza Clinical Trial

Official title:

A Phase I/II Dose Escalation Study of a Vero Cell-Derived, Whole Virus H5N1 Influenza Vaccine in Healthy Volunteers Aged 18 to 45 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00349141
• Other study ID #: 810501
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 5, 2006
• Last updated: October 7, 2015
• Start date: June 2006

Study information

• Verified date: October 2007
• Source: Nanotherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women (AGES, PharmMed)Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to assess the safety and immunogenicity of 4 different doses of adjuvanted and non-adjuvanted mock-up pandemic influenza vaccine. Subjects will be enrolled sequentially into 3 study cohorts with 4 escalating doses of H5N1 hemagglutininin antigen (3.75 µg adjuvanted, 7.5 µg adjuvanted/non-adjuvanted, 15 µg adjuvanted/non-adjuvanted, 30 µg adjuvanted). Starting with the lowest dose level, subjects will receive 2 vaccinations (21 days apart) at the dose to which they were assigned. Subjects will be monitored for safety and for antibody response to the vaccine. A data safety monitoring board will review and evaluate all the safety data obtained for a dose level before allowing administration of the next (higher) dose.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

Male and femal subjects who

• are 18 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 medical history and physical examination;

• agree to keep a daily record of symptoms;

• if female and capable of bearing children, have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study.

Exclusion Criteria:

Subjects who

• are at high risk of contracting H5N1 influenza infection (e.g. poultry workers);

• suffer from a significant neurological, cardiac, pulmonary (including asthma), hepatic, rheumatic, autoimmune, hematological or renal disorder;

• are unable to lead an independent life as a result of either physical or mental handicap;

• suffer from any kind of immunodeficiency;

• 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);

• 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;

• if female, are pregnant or lactating.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen

Locations

Country	Name	City	State
Austria	University Hospital, Department of Clinical Pharmacology, General Hospital Vienna	Vienna
Singapore	Changi General Hospital	Singapore
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Nanotherapeutics, Inc.

Countries where clinical trial is conducted

Austria,  Singapore,