Two Doses of Multimeric-001 (M-001) Followed by Two Doses of an Influenza A/H7N9 Vaccine

• Status: Not yet recruiting
• Trial end date: 0000-00-00
• Target enrollment: 240
• Participant gender: All

Summary

This is a Phase II randomized, double-blind, placebo-controlled trial in 240 males and non-pregnant females, 18 to 45 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 two priming doses of M-001 followed by boosting with two doses of MF59-adjuvanted or non-adjuvanted monovalent influenza A/H7N9 IIV. The monovalent influenza A/H7N9 IIV was derived from the HA of the influenza A/Shanghai/2/2013 (H7N9) virus. Primary objectives: To assess the safety and reactogenicity of M-001 vaccine following receipt of two doses; To assess the safety and reactogenicity of a monovalent inactivated influenza A/H7N9 vaccine (A/H7N9 IIV; two doses) administered with or without MF59 adjuvant following immunization with two doses of M-001 vaccine or placebo, and to assess the serum hemagglutination inhibition (HAI) antibody responses to the A/H7N9 IIV virus after receipt of the first and second dose of MF59 adjuvanted or non-adjuvanted A/H7N9 IIV when administered to adults following receipt of placebo or two doses of M-001 vaccine.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: MF59 oil emulsion; Vaccines
• Last Updated: 2017-04-27

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, 18 to 45 years old, inclusive.

4. Are in good health, as determined by vital signs%, medical history, and targeted physical examination to ensure any existing medical diagnoses or conditions (except those exclusionary) are stable.

• Vital signs include oral temperature, pulse, and blood pressure.

--Stable chronic medical condition - no change in prescription medication, dose, or frequency of medication in the last 3 months (defined as 90 days) and health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months (defined as 180 days). Any 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 violation 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 violation 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. Note: Topical, nasal, and inhaled medications (with the exception of steroids as outlined in the Subject Exclusion Criteria (see Section 5.2)), vitamins, and contraceptives 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 mm Hg, inclusive.

8. Diastolic blood pressure is 55 to 95 mmHg, inclusive.

9. Women of childbearing potential‡ must use an acceptable method of contraception§ from 30 days prior to vaccination until 60 days after the last study vaccination.

• Not sterilized via tubal ligation, bilateral oophorectomy, hysterectomy, or successful Essure® placement (permanent, non-surgical, non-hormonal sterilization) 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 a vasectomized partner, male condoms with the use of applied spermicide, intrauterine devices, NuvaRing®, and licensed hormonal methods such as implants, injectables, contraceptive patches or oral contraceptives ("the pill"). Method of contraception will be captured on the appropriate data collection form.

10. Female subjects 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 illness1, as determined by the site PI 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 PI 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 PI or appropriate sub-investigator, is a contraindication to study participation2.

-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 study.

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 that are not active are permitted.

5. Have known HIV, hepatitis B, or hepatitis C infection.

6. Have known hypersensitivity or allergy to eggs, egg or chicken protein, or other components of the study vaccine.

7. Have a history of severe reactions following previous immunization with licensed or unlicensed influenza vaccines.

8. Have a history of Guillain-Barré Syndrome.

9. Have a history of alcohol or drug abuse within 5 years prior to study vaccination.

10. Have any diagnosis, current or past, of schizophrenia, bipolar disease, or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations.

11. 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.

12. Have taken oral or parenteral (including intraarticular) corticosteroids of any dose within 30 days prior to study vaccination.

13. Have taken high-dose3 dose inhaled corticosteroids within 30 days prior to study vaccination.

• High-dose defined as >840 mcg/day of beclomethasone dipropionate CFC or equivalent.

• Topical and nasal steroids are permissible.

14. Received any licensed live vaccine within 30 days prior to the first study vaccination.

15. Received a licensed inactivated vaccine within 14 days prior to the first study vaccination.

16. Received any influenza vaccine (inactivated or live) within 30 days prior to the first study vaccination.

17. Plans to receive any licensed vaccine from the time of the first study vaccination through the follow-up visit at approximately 21 days after the last study vaccination.

18. Received immunoglobulin or other blood products (with exception of Rho D immunoglobulin) within 90 days prior to study vaccination.

19. Received an experimental agent5 within 30 days prior to the first study vaccination, or expects to receive an experimental agent6 during the 15-month trial-reporting period.

• Including vaccine, drug, biologic, device, blood product, or medication.

• Other than from participation in this study.

20. Are participating or plan to participate in another clinical trial with an interventional agent7 that will be received during the 15-month trial-reporting period.

-including agent (licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication) during the 9-month study period.

21. Prior participation in a clinical trial of influenza A/H7 vaccine or have a history of A/H7 actual or potential exposure or infection prior to the first study vaccination.

-assigned to a group receiving influenza A/H7 vaccine (does not apply to documented placebo recipients)

22. Plan to travel outside the U.S. (continental U.S., Hawaii and Alaska) in the time between the first study vaccination and 21 days after the last study vaccination.

23. 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.

24. Blood donation or planned blood donation within 30 days prior to the study vaccination through 30 days after the last blood drawn for this study.

25. Have signs or symptoms that could confound or confuse assessment of study vaccine reactogenicity.

-The study vaccination should be postponed/deferred until signs or symptoms have resolved and if within the acceptable protocol-specified window for that visit.

26. Have a history of convulsions or encephalomyelitis within 90 days prior to study vaccination.

27. Have a history of a potentially immune-mediated medical condition.