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Safety, Reactogenicity and Immunogenicity of an H5N1 VLP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00519389
Recruitment Status : Completed
First Posted : August 22, 2007
Last Update Posted : June 21, 2013
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Pandemic Influenza Biological: H5N1 VLP Vaccine Biological: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : July 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Low dose H5N1 VLP Vaccine Biological: H5N1 VLP Vaccine
Two doses - Day 0 & Day 28

Experimental: Mid dose H5N1 VLP Vaccine Biological: H5N1 VLP Vaccine
Two doses - Day 0 & Day 28

Experimental: High dose H5N1 VLP Vaccine Biological: H5N1 VLP Vaccine
Two doses - Day 0 & Day 28

Placebo Comparator: Placebo Biological: Placebo
Two doses - Day 0 & Day 28

Primary Outcome Measures :
  1. Safety and reactogenicity of H5N1 VLP Vaccine [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Immunogenicity of H5N1 VLP Influenza vaccine [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00519389

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

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Responsible Party: Novavax Identifier: NCT00519389    
Other Study ID Numbers: H5N1 VLP-1
First Posted: August 22, 2007    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: March 2012
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases