Comparative Safety and Immunogenicity of VAX128A, VAC128B and VAX128C Novel H1N1 Influenza Vaccine in Healthy Adults
VAX128-01
A Phase I Escalating Dose Ranging Study to Evaluate the Safety and Immunogenicity of the VAX128 A, B, and C Novel H1N1 Influenza Vaccine Constructs in Healthy Adults 18-49 Years of Age and in Community Living Adults ≥65 Years of Age
1 other identifier
interventional
292
1 country
2
Brief Summary
This is a multicenter, escalating dose-ranging study to assess the safety, reactogenicity and immunogenicity of 3 different novel H1N1 influenza vaccine constructs delivered i.m. as a single dose vaccination on day 0.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2010
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
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 26, 2010
CompletedFirst Posted
Study publicly available on registry
July 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedJuly 31, 2012
July 1, 2012
5 months
July 26, 2010
July 30, 2012
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 construct or placebo.
28 days
Secondary Outcomes (1)
Immunogenicity
28 days
Study Arms (2)
VAX128
EXPERIMENTALNovel H1N1 Influenza vaccine
Placebo
PLACEBO COMPARATORone IM injection
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male or female aged 18 - 49 years or \>= 65 years
- Give written informed consent
- Females have a negative urine test for pregnancy before vaccination and use birth control during 28 day study period
- Willing to receive the unlicensed (VAX128) vaccine given as an i.m. injection
- Willing to provide multiple blood specimens collected by venipuncture
You may not qualify if:
- Chronic illness that would interfere with the subject's participation in the study or interpretation of the study results.
- Impaired immune responsiveness
- Received drugs effecting the immunity
- Received or plan to receive a nonstudy vaccine within 30 days prior to vaccination and during the study, including licensed influenza vaccines.
- History of anaphylactic type reaction to injected vaccines.
- History of drug abuse in the year prior to screening.
- History of Guillain-Barré Syndrome.
- Receipt or donation of blood products
- Acute disease within 72 hours prior to vaccination
- History of heart or lung disease
- Has other conditions that might interfere with study objectives.
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
Related Publications (1)
Taylor DN, Treanor JJ, Sheldon EA, Johnson C, Umlauf S, Song L, Kavita U, Liu G, Tussey L, Ozer K, Hofstaetter T, Shaw A. Development of VAX128, a recombinant hemagglutinin (HA) influenza-flagellin fusion vaccine with improved safety and immune response. Vaccine. 2012 Aug 24;30(39):5761-9. doi: 10.1016/j.vaccine.2012.06.086. Epub 2012 Jul 11.
PMID: 22796139DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
David N Taylor, MD
VaxInnate Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2010
First Posted
July 29, 2010
Study Start
July 1, 2010
Primary Completion
December 1, 2010
Study Completion
November 1, 2011
Last Updated
July 31, 2012
Record last verified: 2012-07