Recruitment

Recruitment Status
Unknown status
Estimated Enrollment
320

Inclusion Criterias

If the subject is a female of childbearing potential, she must use adequate contraceptive precautions (e.g., intrauterine contraceptive device, oral contraceptives or other equivalent hormonal contraception) for 2 months prior to vaccination and continue to use such precautions for a minimum of three months after vaccination. She must also have a negative urine pregnancy test within 24 hours prior to receiving study vaccine. Women at least one year post-menopausal or surgically sterile will not be considered of childbearing potential.
Males and females aged 18-40 years of age at the time of vaccination in good health as determined by medical history, physical exam, laboratory assessments and the clinical judgment of the Principal Investigator
Willing to provide multiple blood specimens collected by venipuncture
...
If the subject is a female of childbearing potential, she must use adequate contraceptive precautions (e.g., intrauterine contraceptive device, oral contraceptives or other equivalent hormonal contraception) for 2 months prior to vaccination and continue to use such precautions for a minimum of three months after vaccination. She must also have a negative urine pregnancy test within 24 hours prior to receiving study vaccine. Women at least one year post-menopausal or surgically sterile will not be considered of childbearing potential.
Males and females aged 18-40 years of age at the time of vaccination in good health as determined by medical history, physical exam, laboratory assessments and the clinical judgment of the Principal Investigator
Willing to provide multiple blood specimens collected by venipuncture
Able to provide informed consent indicating that they understand the purpose of this study and are willing to adhere to the procedures described in this protocol
Willing to receive the unlicensed vaccine given as an IM injection

Exclusion Criterias

An oral temperature >100.4° or acute disease within 72 hours prior to vaccination, defined as the presence of a moderate or severe illness (as determined by the investigator through medical history and physical examination; for example, those requiring an absence from work) with or without fever.
Has received any licensed or other investigational influenza vaccine within 3 months prior to enrollment in this study or expected receipt of any influenza vaccination before the Day 21 blood collection
A clinical diagnosis of influenza within the previous 12 months
...
An oral temperature >100.4° or acute disease within 72 hours prior to vaccination, defined as the presence of a moderate or severe illness (as determined by the investigator through medical history and physical examination; for example, those requiring an absence from work) with or without fever.
Has received any licensed or other investigational influenza vaccine within 3 months prior to enrollment in this study or expected receipt of any influenza vaccination before the Day 21 blood collection
A clinical diagnosis of influenza within the previous 12 months
Tobacco use within 3 months of enrollment and throughout first 6 months of the study
Clinically significant abnormal liver function tests at screening
Any other condition or circumstance which, in the opinion of the Principal Investigator, poses an unacceptable risk for participation in the study
Persons with a history of severe allergic reaction after previous vaccinations or hypersensitivity to any seasonal influenza vaccine component
Persons with a history of Guillain-Barré Syndrome
Positive serology for HBsAg, HCV or HIV antibodies
Receipt of blood or blood products 8 weeks prior to vaccination or planned administration during the three week study period following vaccination
History of excessive alcohol use, drug abuse or significant psychiatric illness
Having cancer or have received treatment for cancer within three years (persons with a history of cancer who are disease-free without treatment for three years or more are eligible), excluding minor skin cancers, which are allowed unless located at the vaccination site
Any disorder of coagulation
Persons with impaired immune responsiveness (of any cause), including diabetes mellitus and autoimmune disorders
Persons presently receiving or having a recent history of receiving (within the past six months) any medication or therapeutic modality that affects the immune system such as allergy shots, immune globulin, interferon, immunomodulators, radiation therapy, cytotoxic drugs or drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable). Inhaled and topical corticosteroids are allowed.
Use of any investigational or non-registered drug or vaccine product within 30 days preceding the administration of the study vaccine or planned use within the first six weeks of the study period
Body Mass Index >29.9
Has a chronic illness (e.g., liver or kidney disease), receiving a concomitant therapy or have any other condition that could interfere with the subject's participation in the study or in the interpretation of the study results
Pregnant or lactating female
Donation of blood or blood products within 8 weeks prior to vaccination or during the three week study period following

Summary

Conditions
Influenza
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 40 years
Gender
Both males and females

Description

This is a multi-center, open-label, dose escalating study in which up to 320 healthy subjects age 18-40 years will be administered VAX2012Q at one of up to 7 dose levels. VAX2012Q vaccine will be formulated at the clinical site ("field mix") from the four components (VAX128C, VAX181, VAX173 and VAX1...

This is a multi-center, open-label, dose escalating study in which up to 320 healthy subjects age 18-40 years will be administered VAX2012Q at one of up to 7 dose levels. VAX2012Q vaccine will be formulated at the clinical site ("field mix") from the four components (VAX128C, VAX181, VAX173 and VAX172) in diluent to produce ten doses in a multi-dose vial for use within 12 hours of preparation. The dose will be prepared from appropriate dilutions from the monovalent drug product vials. Data for safety and immunogenicity will be collected after each dose with safety being assessed after each dose level and immune response, after dose level 4. Reactogenicity and safety labs through Day 1 will be reviewed by the Safety Monitoring Committee (SMC) prior to enrolling in the next dose level.

Inclusion Criterias

If the subject is a female of childbearing potential, she must use adequate contraceptive precautions (e.g., intrauterine contraceptive device, oral contraceptives or other equivalent hormonal contraception) for 2 months prior to vaccination and continue to use such precautions for a minimum of three months after vaccination. She must also have a negative urine pregnancy test within 24 hours prior to receiving study vaccine. Women at least one year post-menopausal or surgically sterile will not be considered of childbearing potential.
Males and females aged 18-40 years of age at the time of vaccination in good health as determined by medical history, physical exam, laboratory assessments and the clinical judgment of the Principal Investigator
Willing to provide multiple blood specimens collected by venipuncture
...
If the subject is a female of childbearing potential, she must use adequate contraceptive precautions (e.g., intrauterine contraceptive device, oral contraceptives or other equivalent hormonal contraception) for 2 months prior to vaccination and continue to use such precautions for a minimum of three months after vaccination. She must also have a negative urine pregnancy test within 24 hours prior to receiving study vaccine. Women at least one year post-menopausal or surgically sterile will not be considered of childbearing potential.
Males and females aged 18-40 years of age at the time of vaccination in good health as determined by medical history, physical exam, laboratory assessments and the clinical judgment of the Principal Investigator
Willing to provide multiple blood specimens collected by venipuncture
Able to provide informed consent indicating that they understand the purpose of this study and are willing to adhere to the procedures described in this protocol
Willing to receive the unlicensed vaccine given as an IM injection

Exclusion Criterias

An oral temperature >100.4° or acute disease within 72 hours prior to vaccination, defined as the presence of a moderate or severe illness (as determined by the investigator through medical history and physical examination; for example, those requiring an absence from work) with or without fever.
Has received any licensed or other investigational influenza vaccine within 3 months prior to enrollment in this study or expected receipt of any influenza vaccination before the Day 21 blood collection
A clinical diagnosis of influenza within the previous 12 months
...
An oral temperature >100.4° or acute disease within 72 hours prior to vaccination, defined as the presence of a moderate or severe illness (as determined by the investigator through medical history and physical examination; for example, those requiring an absence from work) with or without fever.
Has received any licensed or other investigational influenza vaccine within 3 months prior to enrollment in this study or expected receipt of any influenza vaccination before the Day 21 blood collection
A clinical diagnosis of influenza within the previous 12 months
Tobacco use within 3 months of enrollment and throughout first 6 months of the study
Clinically significant abnormal liver function tests at screening
Any other condition or circumstance which, in the opinion of the Principal Investigator, poses an unacceptable risk for participation in the study
Persons with a history of severe allergic reaction after previous vaccinations or hypersensitivity to any seasonal influenza vaccine component
Persons with a history of Guillain-Barré Syndrome
Positive serology for HBsAg, HCV or HIV antibodies
Receipt of blood or blood products 8 weeks prior to vaccination or planned administration during the three week study period following vaccination
History of excessive alcohol use, drug abuse or significant psychiatric illness
Having cancer or have received treatment for cancer within three years (persons with a history of cancer who are disease-free without treatment for three years or more are eligible), excluding minor skin cancers, which are allowed unless located at the vaccination site
Any disorder of coagulation
Persons with impaired immune responsiveness (of any cause), including diabetes mellitus and autoimmune disorders
Persons presently receiving or having a recent history of receiving (within the past six months) any medication or therapeutic modality that affects the immune system such as allergy shots, immune globulin, interferon, immunomodulators, radiation therapy, cytotoxic drugs or drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable). Inhaled and topical corticosteroids are allowed.
Use of any investigational or non-registered drug or vaccine product within 30 days preceding the administration of the study vaccine or planned use within the first six weeks of the study period
Body Mass Index >29.9
Has a chronic illness (e.g., liver or kidney disease), receiving a concomitant therapy or have any other condition that could interfere with the subject's participation in the study or in the interpretation of the study results
Pregnant or lactating female
Donation of blood or blood products within 8 weeks prior to vaccination or during the three week study period following

Locations

Austin, Texas, 78745
Rochester, New York, 14609
Lenexa, Kansas, 66219
Mt. Pleasant, South Carolina, 29464
...
Austin, Texas, 78745
Rochester, New York, 14609
Lenexa, Kansas, 66219
Mt. Pleasant, South Carolina, 29464

Tracking Information

NCT #
NCT02015494
Collaborators
Not Provided
Investigators
Study Director: C. Jo White, MD VaxInnate Corporation