Safety and Immunogenicity of a Novel H5N1 Influenza Vaccine in Healthy Adults Age 18-49 Years
Phase I Study of the Safety and Immunogenicity of a Novel H5N1 Influenza Vaccine in Healthy Adults Age 18-49 Years
1 other identifier
interventional
224
1 country
2
Brief Summary
This study will evaluate the safety and immunogenicity of VAX161B \[STF2.HA5 H5N1\], a recombinant, inactivated, subunit influenza vaccine given as a two dose regimen at a range of doses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2012
2 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
First Submitted
Initial submission to the registry
February 14, 2012
CompletedFirst Posted
Study publicly available on registry
March 22, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedSeptember 23, 2014
September 1, 2014
1 year
February 14, 2012
September 22, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety
Assess safety, reactogenicity and tolerability. Symptoms will be collected from the memory aid and from the information collected at the clinic visits. All symptoms will be graded according to severity. Response to vaccine will be categorized as local (arm pain, redness, bruising, etc.) or systemic (headache, muscle aches, fatigue, etc.) symptoms. Laboratory tests such as CRP, WBC, LFTs and cytokines collected before and after vaccination will also be analyzed. We will compare the types and severity of symptoms and laboratory results based on vaccine dose.
1 year
Secondary Outcomes (1)
Immunogenicity
6 mos.
Study Arms (1)
VAX161B
EXPERIMENTALDose escalating study where subjects are treated with VAX161B at one of six dose levels. Subjects will be injected with VAX161B twice during the study at Day 0 and Day 21. The dosages are: 1 mcg; 2.5 mcg; 4 mcg; 6 mcg; 8 mcg; and 12 mcg.
Interventions
Eligibility Criteria
You may qualify if:
- male or female aged 18 - 49 years inclusive
- give written informed consent to participate
- healthy, as determined by medical history, physical examination
- comprehension of the study requirements
- willing to provide multiple blood specimens collected by venipuncture.
You may not qualify if:
- Subjects who have a psychiatric illness, a chronic illness that would interfere with participation or interpretation of results
- clinically significant abnormal liver function tests
- positive serology for HBsAg or HCV antibodies
- impaired immune responses
- history of anaphylactic type reaction to injected vaccines
- history of drug or chemical abuse in the year prior to screening
- history of Guillain-Barré Syndrome
- history of chronic obstructive pulmonary disease or history of other lung disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Miami Research Associates
Miami, Florida, 33143, United States
Johnson County Clin-Trials
Lenexa, Kansas, 66219, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Sheldon, MD
Miami Research Associates
- PRINCIPAL INVESTIGATOR
Casey Johnson, DO
Johnson County Clin-Trials
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2012
First Posted
March 22, 2012
Study Start
June 1, 2012
Primary Completion
June 1, 2013
Study Completion
November 1, 2013
Last Updated
September 23, 2014
Record last verified: 2014-09