Overview

H5N8 Mix and Match With or Without AS03 or MF59 in Healthy Adults

Status:
Completed
Trial end date:
2018-01-30
Target enrollment:
0
Participant gender:
All
Summary
This is a Phase I randomized, double-blind, controlled trial in 275 males and non-pregnant females, 19 to 64 years old, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of a monovalent inactivated influenza A/H5N8 virus vaccine manufactured by bioCSL administered at different dosages (7.5 or 15 mcg of HA/0.5 mL dose) given with or without AS03 or MF59 adjuvants manufactured by GlaxoSmithKline Biologicals and Novartis Vaccines and Diagnostics, respectively.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Treatments:
MF59 oil emulsion
Vaccines
Criteria
Inclusion Criteria:

1. Provide written informed consent prior to initiation of any study procedures. 2. Are
able to understand and comply with planned study procedures and be available for all study
visits. 3. Are males or non-pregnant females, 19 to 64 years old, inclusive. 4. Are in good
health. Note: As determined by medical history and physical examination to evaluate acute
or currently ongoing chronic medical diagnoses or conditions, defined as those that have
been present for at least 90 days, that would affect the assessment of the safety of
subjects or the immunogenicity of study vaccinations. Chronic medical diagnoses or
conditions should be stable for the last 60 days. This includes no change in chronic
prescription medication, dose, or frequency as a result of deterioration of the chronic
medical diagnosis or condition in the 60 days prior to enrollment. Any prescription change
that is due to change of health care provider, insurance company, etc., or that is done for
financial reasons, as long as in the same class of medication, will not be considered a
deviation of this inclusion criterion. Any change in prescription medication due to
improvement of a disease outcome, as determined by the site principal investigator or
appropriate sub-investigator, will not be considered a deviation of this inclusion
criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of
the site principal investigator or appropriate sub-investigator, they pose no additional
risk to subject safety or assessment of reactogenicity and immunogenicity and do not
indicate a worsening of medical diagnosis or condition. Similarly, medication changes
subsequent to enrollment and study vaccination are acceptable provided there was no
deterioration in the subject's chronic medical condition that necessitated a medication
change, and there is no additional risk to the subject or interference with the evaluation
of responses to study vaccination. Note: Topical, nasal, and inhaled medications (with the
exception of inhaled corticosteroids as outlined in the Subject Exclusion Criteria (see
Section 5.1.2)), herbals, vitamins, and supplements are permitted. 5. Oral temperature is
less than 100.0°F. 6. Pulse is 50 to 115 bpm, inclusive. 7. Systolic blood pressure is 85
to 150 mmHg, inclusive. 8. Diastolic blood pressure is 55 to 95 mmHg, inclusive. 9.
Erythrocyte sedimentation rate (ESR) is less than 30 mm per hour. 10. Alanine
aminotransferase (ALT) is less than 44 IU/L for females or is less than 61 IU/L for males.
11. Creatinine is less than 1.11 mg/dL for females or is less than 1.38 mg/dL for males.
12. White blood cells (WBC) are greater than 3.9 x10^3/µL and less than 10.6 x10^3/µL. 13.
Hemoglobin (Hgb) is greater than 11.4 g/dL for females or is greater than 12.4 g/dL for
males. 14. Platelets are greater than 139 x10^3/µL and less than 416 x10^3/µL. 15. Total
bilirubin is less than 1.3 mg/dL. 16. Women of childbearing potential* must use an
acceptable contraception method** from 30 days before the first study vaccination until 60
days after the last study vaccination. *Not sterilized via tubal ligation, bilateral
oophorectomy, hysterectomy or successful Essure® placement with documented radiological
confirmation test at least 90 days after the procedure, and still menstruating or <1 year
of the last menses if menopausal. **Includes, but is not limited to, non-male sexual
relationships, abstinence from sexual intercourse with a male partner, monogamous
relationship with vasectomized partner who has been vasectomized for 180 days or more prior
to the subject receiving the first study vaccination, barrier methods such as condoms or
diaphragms with spermicide or foam, effective intrauterine devices, NuvaRing®, and licensed
hormonal methods such as implants, injectables or oral contraceptives ("the pill"). 17.
Women of childbearing potential must have a negative urine or serum pregnancy test within
24 hours prior to study vaccination.

Exclusion Criteria:

1. Have an acute illness*, as determined by the site principal investigator or appropriate
sub-investigator, within 72 hours prior to study vaccination. *An acute illness which is
nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion
of the site principal investigator or appropriate sub-investigator, the residual symptoms
will not interfere with the ability to assess safety parameters as required by the
protocol. 2. Have any medical disease or condition that, in the opinion of the site
principal investigator or appropriate sub-investigator, is a contraindication to study
participation**. **Including acute or chronic medical disease or condition, defined as
persisting for at least 90 days, that would place the subject at an unacceptable risk of
injury, render the subject unable to meet the requirements of the protocol, or may
interfere with the evaluation of responses or the subject's successful completion of this
trial. 3. Have immunosuppression as a result of an underlying illness or treatment, or use
of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study
vaccination. 4. Have known active neoplastic disease or a history of any hematologic
malignancy. Non-melanoma skin cancers are permitted. 5. Have known human immunodeficiency
virus (HIV), hepatitis B, or hepatitis C infection. 6. Have known hypersensitivity or
allergy to eggs, egg or chicken protein, squalene-based adjuvants, or other components of
the study vaccine. 7. Have a history of severe reactions following previous immunization
with licensed or unlicensed influenza virus vaccines. 8. Have a personal or family history
of narcolepsy. 9. Have a history of Guillain-Barré syndrome. 10. Have a history of
convulsions or encephalomyelitis within 90 days prior to study vaccination. 11. Have a
history of autoimmune or auto-inflammatory disease***. ***Including, but not limited to,
autoimmune or auto-inflammaory processes resulting in neuralgia, paresthesia, neuritis,
neuroinflammatory diseases, vasculitis, clotting disorders, dermatitis, arthritis,
thyroiditis, hypothyroidism, hyperthyroidism, or muscle, liver, or kidney disease. Refer as
well to the list of AESIs. 12. Have a history of alcohol or drug abuse within 5 years prior
to study vaccination. 13. Have any diagnosis, current or past, of schizophrenia, bipolar
disease, or other psychiatric diagnosis that may interfere with subject compliance or
safety evaluations. 14. Have been hospitalized for psychiatric illness, history of suicide
attempt, or confinement for danger to self or others within 10 years prior to study
vaccination. 15. Have taken oral or parenteral (including intraarticular) corticosteroids
of any dose within 30 days prior to study vaccination. 16. Have taken high-dose inhaled
corticosteroids within 30 days prior to study vaccination. High-dose defined as >840
mcg/day of beclomethasone dipropionate CFC or equivalent. 17. Received a licensed live
vaccine within 30 days prior to the first study vaccination, or plan to receive a licensed
live vaccine within 30 days before or after each study vaccination. 18. Received a licensed
inactivated vaccine within 14 days prior to the first study vaccination, or plan to receive
a licensed inactivated vaccine within 14 days before or after each study vaccination. 19.
Received immunoglobulin or other blood products (with exception of Rho D immunoglobulin)
within 90 days prior to study vaccination. 20. Received an experimental agent7 within 30
days prior to the first study vaccination, or expect to receive an experimental agent8
during the 13-month trial-reporting period. 7Including vaccine, drug, biologic, device,
blood product, or medication. 8Other than from participation in this trial. 21. Are
participating or plan to participate in another clinical trial with an interventional
agent**** that will be received during the 13-month trial-reporting period. ****Including
licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication. 22.
Prior participation in a clinical trial of influenza A/H5 vaccine***** or have a history of
influenza A/H5 virus actual or potential exposure or infection prior to the first study
vaccination. *****And assigned to a group receiving influenza A/H5 vaccine, does not apply
to documented placebo recipients. 23. Occupational exposure to or substantial direct
physical contact (Note) with birds in the past year or during the 21 days after each study
vaccination. Note: Casual contact with birds at petting zoos, county or state fairs, or
having pet birds does not exclude subjects from study participation. 24. Female subjects
who are breastfeeding or plan to breastfeed at any given time from the first study
vaccination until 30 days after the last study vaccination. 25. Plan to travel outside the
US (continental US, Hawaii, and Alaska) within 21 days after each study vaccination.