A/H5N1 Virus-Like Particle Antigen Dose Ranging Study With Adjuvant 1
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.
1 other identifier
interventional
333
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2012
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 2, 2012
CompletedFirst Posted
Study publicly available on registry
May 9, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedFebruary 6, 2014
February 1, 2014
3 months
May 2, 2012
February 5, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Number of solicited and unsolicited adverse events in H5N1 VLP antigen dose groups delivering HA with/without Adjuvant 1.
Day 42
Secondary Outcomes (1)
Measurement of HAI antibody seroconversion rates and GMT achieved by a constant H5N1 VLP antigen dose alone and in combination with Adjuvant 1.
Day 42
Study Arms (6)
Group A
EXPERIMENTALGroup B
EXPERIMENTALGroup C
EXPERIMENTALGroup D
EXPERIMENTALGroup E
EXPERIMENTALGroup F
EXPERIMENTALInterventions
Dose A without Adjuvant 1; intramuscular, deltoid, Day 0 \& Day 21
Dose B with Adjuvant 1; intramuscular, deltoid, Day 0 \& Day 21
Eligibility Criteria
You may qualify if:
- Healthy adult male or female, ≥18 and ≤49 years of age,
- Willing and able to give informed consent prior to study enrollment,
- Able to comply with study requirements, and
- 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).
You may not qualify if:
- 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.
- Any grade 1 or higher (as based on the Toxicity Grading Scale \[TGS\]) abnormality in ALT, AST, alkaline phosphatase or total bilirubin levels.
- 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.
- Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination.
- History of a serious reaction to prior influenza vaccination.
- History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza vaccine.
- Received any vaccine in the 4 weeks preceding the study vaccination; or any A/H5N1 avian influenza vaccine at any time.
- Any known or suspected immunosuppressive condition, acquired or congenital, including HIV infection as determined by history and/or physical examination.
- 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.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
- 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).
- Known disturbance of coagulation.
- Women who are pregnant or breastfeeding, or plan to become pregnant during the study.
- Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novavaxlead
- Department of Health and Human Servicescollaborator
Study Sites (5)
Anaheim Clinical Trials
Anaheim, California, 92801, United States
Miami Research Associates
Miami, Florida, 33143, United States
Broward Research Group
Pembroke Pines, Florida, 33026, United States
Johnson County Clin-Trials
Lenexa, Kansas, 66219, United States
Clinical Trials of Texas
San Antonio, Texas, 78229, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nigel Thomas, Ph.D
Novavax
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2012
First Posted
May 9, 2012
Study Start
April 1, 2012
Primary Completion
July 1, 2012
Study Completion
August 1, 2013
Last Updated
February 6, 2014
Record last verified: 2014-02