Assess the Safety & Immunogenicity of Prime-Boost Vaccination Strategies Using H5Nx Virus Vaccine Adjuvanted With AS03 or MF59
June 30, 2020 updated by: Biomedical Advanced Research and Development Authority
Randomized, Double-Blinded, Phase 2 Study to Assess Safety and Immunogenicity of Homologous and Heterologous Prime-Boost Vaccination Strategies With Stockpiled Inactivated Monovalent Influenza A(H5) Vaccines Administered Intramuscularly With Either AS03 or MF59® as Adjuvant
The main purpose of this study is to assess the ability of H5 influenza virus vaccines and adjuvants present in the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) to generate an immune response to homologous and to antigenically distant heterologous H5 influenza virus strains.
The study is designed to evaluate the safety and immunogenicity of vaccination strategies with homologous or antigenically distant heterologous H5 influenza virus vaccines administered with AS03 or MF59 adjuvant.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
720
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Diego, California, United States, 92108
- Optimal Research
-
-
Illinois
-
Peoria, Illinois, United States, 61614
- Optimal Research
-
-
Kansas
-
Lenexa, Kansas, United States, 66219
- Johnson County Clin-Trials
-
-
Kentucky
-
Lexington, Kentucky, United States, 40509
- Central Kentucky Research Associates Inc
-
-
Maryland
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Rockville, Maryland, United States, 20850
- Optimal Research
-
-
New York
-
Rochester, New York, United States, 14609
- Rochester Clinical Research, Inc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 49 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Is a male or nonpregnant female 18 to 49 years of age, inclusive, on Day 1 (first vaccination).
- Will avoid nonstudy vaccinations until 21 days after the last vaccination.
- Provides written informed consent prior to the initiation of any study-related procedures.
- Has a stable health status, as established by physical examination, vital sign measurements, and medical history.
- Has access to a consistent and reliable means of telephone contact, which may be in the home, workplace, or by personal mobile electronic device.
- Is able to understand and comply with planned study procedures.
- Lives a reasonable distance from the site to be able to travel to and from the site for follow-up visits and agrees to go to the site for evaluation in the case of an adverse event.
- Agrees to stay in contact with the site for the duration of the study, has no current plans to move from the study area, and provides updated contact information as necessary.
Exclusion Criteria:
- Has a known allergy to eggs or other components of the vaccine (including gelatin, formaldehyde, octoxinol-9, thimerosal, or chicken protein), or allergy to squalene-based adjuvants or has had severe reactions following previous immunizations with contemporary influenza virus vaccines.
- A woman who has a positive urine pregnancy test prior to vaccination in this study or a woman who is breastfeeding.
A female of childbearing potential (a) who refuses to use an acceptable method of birth control (b) from Day 1 (first vaccination) to end-of-study visit and, if sexually active, who has not used a reliable birth control method for at least 2 months prior to Day 1 (first vaccination).
- Female of childbearing potential is defined as post-onset menarche and premenopausal female capable of becoming pregnant. This does not include females who meet any of the following conditions: menopausal >1 year, tubal ligation >1 year, bilateral salpingo-oophorectomy, or hysterectomy.
- Adequate contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label, for example: abstinence from penile-vaginal intercourse; oral contraceptives, either combined or progestogen alone; injectable progestogen; implants of etonogestrel or levonorgestrel; estrogenic vaginal ring; percutaneous contraceptive patches; intrauterine device or intrauterine system; male partner sterilization at least 6 months prior to the female Day 1 (first vaccination), and this male is the sole partner for that subject (The information on the male sterility can come from the site personnel's review of the subject's medical records or interview with the subject on her medical history); male condom combined with a vaginal spermicide (foam, gel, film, cream, or suppository); male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository).
- Is immunosuppressed as a result of an underlying illness or treatment, or anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months prior to Day 1 (first vaccination).
- Has an active neoplastic disease or a history of any hematologic malignancy. A subject with superficial skin cancer who does not require intervention other than local excision is not excluded.
- Has long-term use (≥14 consecutive days) of glucocorticoids including oral or parenteral prednisone or equivalent (>20 mg total dose per day) or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within 1 month prior to screening. (Low-dose [≤800 mcg/day of beclomethasone dipropionate or equivalent] inhaled and topical steroids are allowed).
- Has a diagnosis of schizophrenia, bipolar disease, or other major psychiatric diagnosis.
- Has been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others, within the past 10 years.
- Has a neurological or psychiatric diagnosis, which, although stable, is judged by the investigator to render the potential subject unable or unlikely to comply with the protocol or to provide accurate safety reports.
- Has received immunoglobulin or other blood product (with the exception of Rho[D] immune globulin) within the 3 months prior to Day 1 (first vaccination).
- Has received any live vaccine within 4 weeks or inactivated vaccines within 2 weeks prior to Day 1 (first vaccination). This includes seasonal influenza vaccines.
- Has an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses. This includes potentially immune-mediated medical conditions such as Guillain-Barré syndrome, narcolepsy, current or history of autoimmune or chronic inflammatory disease.
- Has a first-degree relative with narcolepsy.
- Has an acute illness, including body temperature greater than 100.4°F, at screening, immediately prior to each vaccination or, per subject report, within 3 days prior to each vaccination. Subjects with an acute illness can be rescheduled for a vaccination as long as the vaccination visit is within the visit window. Note that subjects may return for randomization following resolution of the acute illness as long as recruitment remains open and subjects are within 14 days of signing consent.
- Has a Grade 2 or greater (by US Food and Drug Administration toxicity grade) safety laboratory value at screening.
- Has received an experimental agent (vaccine, biologic, device, blood product, or medication) within 1 month prior to Day 1 (first vaccination) in this study or plans receipt of an experimental agent during the study period.
- Is participating or plans to participate in another interventional clinical study (either active or follow-up phase) during the study period.
- Has received an influenza H5 vaccine in the past or has a history of H5 influenza infection prior to enrollment.
- Has known human immunodeficiency virus, hepatitis B, or hepatitis C infection.
- Has a history of alcohol or drug abuse within 5 years prior to Day 1 (first vaccination).
- Has a body mass index >35 kg/m2.
- Has any condition that would, in the opinion of the investigator, place him or her at an unacceptable risk of injury or render him or her unable to meet the requirements of the protocol (including site of injection reactogenicity assessments).
- Is a first-degree relative of any person working on this study: site or sponsor.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: a VN with AS03 Adjuvant, then gf/WA with AS03 Adjuvant
Single dose of Vietnam (VN) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/Washington (WA) (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
|
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Names:
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Names:
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
|
EXPERIMENTAL: b IN with AS03 Adjuvant, then gf/WA with AS03 Adjuvant
Single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
|
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Names:
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Names:
|
|
EXPERIMENTAL: c dk/BANG with AS03 Adjuvant, then gf/WA with AS03 Adjuvant
Single dose of dk/Bangladesh (BANG) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
|
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Names:
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Names:
|
|
EXPERIMENTAL: d gf/WA with AS03 Adjuvant, then IN with AS03 Adjuvant
Single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
|
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Names:
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Names:
|
|
EXPERIMENTAL: e dk/BANG with AS03 Adjuvant, then bhg/QL with AS03 Adjuvant
Two doses of dk/BANG (H5N1) vaccine with AS03 Adjuvant (Dose1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/Qinghai Lake(QL) (H5N1) vaccine with AS03 Adjuvant (Day 142).
|
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Names:
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Names:
|
|
EXPERIMENTAL: f gf/WA with AS03 Adjuvant, then bhg/QL with AS03 Adjuvant
Two doses of gf/WA (H5N3) vaccine with AS03 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with AS03 Adjuvant (Day 142)
|
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Names:
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Names:
|
|
EXPERIMENTAL: g VN with MF59 Adjuvant, then gf/WA with MF59 Adjuvant
Single dose of VN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
|
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Names:
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Names:
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
|
EXPERIMENTAL: h IN with MF59 Adjuvant, then gf/WA with MF59 Adjuvant
Single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
|
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Names:
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Names:
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
|
EXPERIMENTAL: i dk/BANG with MF59 Adjuvant, then gf/WA with MF59 Adjuvant
Single dose of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
|
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Names:
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Names:
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
|
EXPERIMENTAL: j gf/WA with MF59 Adjuvant, then IN with MF59 Adjuvant
Single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
|
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Names:
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Names:
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
|
EXPERIMENTAL: k dk/BANG with MF59 Adjuvant, then bhg/QL with MF59 Adjuvant
Two doses of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22); followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142).
|
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Names:
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Names:
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
|
EXPERIMENTAL: l gf/WA with MF59 Adjuvant, then bhg/QL with MF59 Adjuvant
Two doses of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142).
|
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Names:
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Names:
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Local Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series
Time Frame: 8 days post-vaccination
|
Safety of 2-dose and 3-dose H5 influenza vaccination series as determined by occurrence of mild, moderate, or severe solicited local reactogenicity symptoms. Subjects in A-D and G-J did not receive 3 doses |
8 days post-vaccination
|
|
Number of Systemic Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series
Time Frame: 8 days post-vaccination
|
Safety of 2-dose and 3-dose H5 influenza vaccination series as determined by occurrence of mild, moderate, or severe solicited systemic reactogenicity symptoms Subjects in A-D and G-J did not receive 3 doses
|
8 days post-vaccination
|
|
Percentage of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Seroprotection Against Vaccine Strains Following 2-dose H5 Influenza Vaccination Series
Time Frame: Day 43
|
Serum hemagglutination inhibition (HAI) antibody seroprotection rate (SPR)
|
Day 43
|
|
Percentage of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Seroprotection Against Vaccine Strains Following 3-dose H5 Influenza Vaccination Series
Time Frame: Day 163
|
Serum hemagglutination inhibition (HAI) antibody seroprotection rate (SPR)
|
Day 163
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 15, 2018
Primary Completion (ACTUAL)
November 19, 2019
Study Completion (ACTUAL)
November 19, 2019
Study Registration Dates
First Submitted
March 13, 2018
First Submitted That Met QC Criteria
April 6, 2018
First Posted (ACTUAL)
April 13, 2018
Study Record Updates
Last Update Posted (ACTUAL)
July 14, 2020
Last Update Submitted That Met QC Criteria
June 30, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BP-I-16-005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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