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Safety, Reactogenicity and Immunogenicity of an H5N1 VLP

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novavax
ClinicalTrials.gov Identifier:
NCT00519389
First received: August 20, 2007
Last updated: March 21, 2012
Last verified: March 2012
History of Changes
  Purpose

This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the safety, reactogenicity, and immunogenicity of 3 potencies (dosages) of H5N1 VLP vaccine or placebo in healthy adults 18 to 40 years of age.


Condition Intervention Phase
Pandemic Influenza
 Biological: H5/N1 VLP Vaccine
Biological: Placebo
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase I/IIa Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of an H5N1 Virus-Like Particle (VLP) Influenza Vaccine (Recombinant)

Resource links provided by NLM:

MedlinePlus related topics: Bird Flu Flu
U.S. FDA Resources

Further study details as provided by Novavax:

Primary Outcome Measures:
  • Safety and reactogenicity of H5N1 VLP Vaccine [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immunogenicity of H5N1 VLP Influenza vaccine [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 230
Study Start Date: July 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose H5N1 Biological: H5/N1 VLP Vaccine
Two doses - Day 0 & Day 28
Experimental: Mid dose H5/N1 Biological: H5/N1 VLP Vaccine
Two doses - Day 0 & Day 28
Experimental: High dose H5/N1 Biological: H5/N1 VLP Vaccine
Two doses - Day 0 & Day 28
Placebo Comparator: Placebo Biological: Placebo
Two doses - Day 0 & Day 28

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female 18 to 40 years of age at the time of the vaccination.
  2. Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., return for follow-up visits and completion of the data collection tool).
  3. Available by telephone.
  4. Free of obvious health problems as established by medical history and clinical examination before entering the study.
  5. If subject is of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (e.g., intrauterine contraceptive device; oral contraceptives or other equivalent hormonal contraception) for 30 days prior to vaccination. She must also have a negative pregnancy test at study entry and must agree to continue such precautions for two months after completion of vaccination.
  6. Must provide written, informed consent.

Exclusion Criteria:

  1. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
  2. Has received any other licensed vaccines within 4 weeks prior to enrollment in this study.
  3. Has received any influenza vaccine within the prior 12 month period.
  4. Has received any investigational vaccine designed for protection against avian influenza.
  5. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine. The use of inhaled and nasal steroids will be permitted.
  6. Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination.
  7. Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study.
  8. Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever ≥ 100.5º F.
  9. Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  10. Major congenital defects or serious chronic illness.
  11. History of any neurological disorders or seizures, with the exception of febrile seizures during childhood.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00519389

Locations
United States, Texas
Healthcare Discoveries, Inc.
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Novavax
Investigators
Principal Investigator: George Atiee, M.D. Healthcare Discoveries, Inc.
  More Information

No publications provided

Responsible Party: Novavax
ClinicalTrials.gov Identifier: NCT00519389     History of Changes
Other Study ID Numbers: H5N1 VLP-1
Study First Received: August 20, 2007
Last Updated: March 21, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 17, 2013