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A/H5N1 Virus-Like Particle Antigen Dose Ranging Study With Adjuvant 1

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: NCT01594320
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : February 6, 2014
Department of Health and Human Services
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to evaluate the immunogenicity and safety profile of the Avian flu vaccine with and without adjuvant 1 in healthy, young adults. The study is divided down into Parts A1, A2 and B. Groups within each Part will receive two doses of the assigned test article on Study Days 0 and 21. There will be a Safety Monitoring Committee assessment following Day 7 for each part, prior to allowing vaccination of subjects in subsequent Parts of the study.

Condition or disease Intervention/treatment Phase
Influenza (Pandemic) Biological: Monovalent Avian Influenza VLP (H5N1) Biological: Monovalent Avian Influenza VLP (H5N1); Adjuvant Biological: Saline placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 333 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 1 Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of Monovalent A/Indonesia/05/05 (H5N1) Virus-Like Particle (VLP) Avian Influenza Antigen (Recombinant) in Healthy Young Adults With and Without Adjuvant 1.
Study Start Date : April 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Group A Biological: Monovalent Avian Influenza VLP (H5N1)
Dose A without Adjuvant 1; intramuscular, deltoid, Day 0 & Day 21

Experimental: Group B Biological: Monovalent Avian Influenza VLP (H5N1)
Dose B without Adjuvant 1; intramuscular, deltoid, Day 0 & Day 21

Experimental: Group C Biological: Monovalent Avian Influenza VLP (H5N1); Adjuvant
Dose B with Adjuvant 1; intramuscular, deltoid, Day 0 & Day 21

Experimental: Group D Biological: Monovalent Avian Influenza VLP (H5N1); Adjuvant
Dose C with Adjuvant 1; intramuscular, deltoid, Day 0 & Day 21

Experimental: Group E Biological: Monovalent Avian Influenza VLP (H5N1); Adjuvant
Dose D with Adjuvant 1; intramuscular, deltoid, Day 0 & Day 21

Experimental: Group F Biological: Saline placebo
Placebo; Intramuscular, deltoid, Day 0 & Day 21

Primary Outcome Measures :
  1. Number of solicited and unsolicited adverse events in H5N1 VLP antigen dose groups delivering HA with/without Adjuvant 1. [ Time Frame: Day 42 ]

Secondary Outcome Measures :
  1. Measurement of HAI antibody seroconversion rates and GMT achieved by a constant H5N1 VLP antigen dose alone and in combination with Adjuvant 1. [ Time Frame: Day 42 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Healthy adult male or female, ≥18 and ≤49 years of age,
  2. Willing and able to give informed consent prior to study enrollment,
  3. Able to comply with study requirements, and
  4. Women must have a negative urine pregnancy test prior to each vaccination; will be advised through the Informed Consent process to avoid becoming pregnant over the duration of the study, and must assert that they will employ an effective form of birth control for the duration of the study. Acceptable forms of birth control are: credible history of continuous abstinence from heterosexual activity or prior surgical sterilization, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom or diaphragm, with spermicide), and intrauterine device (IUD).

Exclusion Criteria:

  1. Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care. Asymptomatic conditions (e.g., hypertension, dyslipidemia) that are being managed medically and that are not associated with evidence of end-organ damage are not exclusionary provided they are clinically stable (defined as no unscheduled medical interventions or change in medications for cause within 3 months).
  2. Any history of jaundice, or of hepatic injury due to drug (prescription, OTC, or illicit) or alcohol use or viral hepatitis; or the presence of hepatitis B surface antigen or hepatitis C antibody at screening.
  3. Any grade 1 or higher (as based on the Toxicity Grading Scale [TGS]) abnormality in ALT, AST, alkaline phosphatase or total bilirubin levels.
  4. Any grade 2 or higher (as based on the TGS) vital sign or clinical laboratory abnormality not specified in criterion 3 above. Note that any abnormal vital sign may be repeated at the Investigator's discretion.
  5. Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination.
  6. History of a serious reaction to prior influenza vaccination.
  7. History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza vaccine.
  8. Received any vaccine in the 4 weeks preceding the study vaccination; or any A/H5N1 avian influenza vaccine at any time.
  9. Any known or suspected immunosuppressive condition, acquired or congenital, including HIV infection as determined by history and/or physical examination.
  10. Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
  11. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
  12. Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature >38.0°C on the planned day of vaccine administration).
  13. Known disturbance of coagulation.
  14. Women who are pregnant or breastfeeding, or plan to become pregnant during the study.
  15. Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.
  16. Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting).

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): NCT01594320

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United States, California
Anaheim Clinical Trials
Anaheim, California, United States, 92801
United States, Florida
Miami Research Associates
Miami, Florida, United States, 33143
Broward Research Group
Pembroke Pines, Florida, United States, 33026
United States, Kansas
Johnson County Clin-Trials
Lenexa, Kansas, United States, 66219
United States, Texas
Clinical Trials of Texas
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Department of Health and Human Services
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Study Director: Nigel Thomas, Ph.D Novavax
Additional Information:
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Responsible Party: Novavax Identifier: NCT01594320    
Other Study ID Numbers: NVX778.P101
First Posted: May 9, 2012    Key Record Dates
Last Update Posted: February 6, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases