Assess the Safety & Immunogenicity of Prime-Boost Vaccination Strategies Using H5Nx Virus Vaccine Adjuvanted With AS03 or MF59
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
1 other identifier
interventional
720
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2018
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2018
CompletedStudy Start
First participant enrolled
March 15, 2018
CompletedFirst Posted
Study publicly available on registry
April 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 19, 2019
CompletedResults Posted
Study results publicly available
July 14, 2020
CompletedJuly 14, 2020
June 1, 2020
1.7 years
March 13, 2018
June 11, 2020
June 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of Local Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series
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
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
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
Serum hemagglutination inhibition (HAI) antibody seroprotection rate (SPR)
Day 163
Study Arms (12)
a VN with AS03 Adjuvant, then gf/WA with AS03 Adjuvant
EXPERIMENTALSingle 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).
b IN with AS03 Adjuvant, then gf/WA with AS03 Adjuvant
EXPERIMENTALSingle 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).
c dk/BANG with AS03 Adjuvant, then gf/WA with AS03 Adjuvant
EXPERIMENTALSingle 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).
d gf/WA with AS03 Adjuvant, then IN with AS03 Adjuvant
EXPERIMENTALSingle 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).
e dk/BANG with AS03 Adjuvant, then bhg/QL with AS03 Adjuvant
EXPERIMENTALTwo 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).
f gf/WA with AS03 Adjuvant, then bhg/QL with AS03 Adjuvant
EXPERIMENTALTwo 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)
g VN with MF59 Adjuvant, then gf/WA with MF59 Adjuvant
EXPERIMENTALSingle 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).
h IN with MF59 Adjuvant, then gf/WA with MF59 Adjuvant
EXPERIMENTALSingle 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).
i dk/BANG with MF59 Adjuvant, then gf/WA with MF59 Adjuvant
EXPERIMENTALSingle 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).
j gf/WA with MF59 Adjuvant, then IN with MF59 Adjuvant
EXPERIMENTALSingle 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).
k dk/BANG with MF59 Adjuvant, then bhg/QL with MF59 Adjuvant
EXPERIMENTALTwo 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).
l gf/WA with MF59 Adjuvant, then bhg/QL with MF59 Adjuvant
EXPERIMENTALTwo 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).
Interventions
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Optimal Research
San Diego, California, 92108, United States
Optimal Research
Peoria, Illinois, 61614, United States
Johnson County Clin-Trials
Lenexa, Kansas, 66219, United States
Central Kentucky Research Associates Inc
Lexington, Kentucky, 40509, United States
Optimal Research
Rockville, Maryland, 20850, United States
Rochester Clinical Research, Inc
Rochester, New York, 14609, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Silvija Tresnjak-Smith, Regulatory Operations Branch Chief, Regulatory and Quality Affairs Division
- Organization
- BARDA
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2018
First Posted
April 13, 2018
Study Start
March 15, 2018
Primary Completion
November 19, 2019
Study Completion
November 19, 2019
Last Updated
July 14, 2020
Results First Posted
July 14, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share