The Safety, Tolerance, and Immunogenicity of MAS-1-Adjuvanted Seasonal Inactivated Influenza Vaccine (MER4101)

Status unconfirmed · Phase 1

Conditions studied: Influenza, Human

In brief

The purpose of this study is to evaluate the safety, tolerance, and immunogenicity of MAS-1-Adjuvanted seasonal inactivated influenza vaccine (IIV) (MER4101) with hemagglutinin dose escalation compared to non-adjuvanted comparator IIV standard dose (SD) in healthy adults and high dose (HD) IIV in ambulatory elderly subjects. Hypothesis: Reduced HA dose IIV formulated in MAS-1 adjuvant (MER4101) has been shown under Phase 1A to be safe, tolerable and demonstrated a more robust and durable immune response to IIV over 6 months post-vaccination in healthy young adults 18 - 49 years of age compared to SD IIV. Under phase 1B, the 9 µg/HA dose of IIV in 0.3 mL MAS-1 was safe and well tolerated and immunogenically comparable to or better than 60 µg/HA HD IIV control over 3 to 6 months post-vaccination than HD IIV control. It is anticipated that the increased total dose of 15 µg HA antigen administered concurrently to opposite arms in 2 doses of 7.5 µg/HA IIV in 0.25 mL MAS-1 adjuvant emulsion will be safe, well tolerated, and more immunogenic than 9 µg/HA IIV in MAS-1, and will be more immunogenic when compared to HD IIV control in adults who are 65 years of age and older with the potential to provide better protection throughout the influenza season.

Key facts

Study ID

NCT02500680

Run by

Nova Immunotherapeutics Limited

People needed

102

Starts

2015-07-01

Expected to finish

2020-12-01

Last updated by the study team

2019-09-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Specifically Phase 1A:
• Males or non-pregnant females, 18 to 49 years old, inclusive.
• Female subjects of childbearing potential who must agree to practice avoidance of pregnancy, including use of acceptable forms of contraception.
• Pulse is 55 to 100 bpm, inclusive.
• Systolic blood pressure is 90 to 140 mmHg, inclusive.
• Diastolic blood pressure is 55 to 90 mmHg, inclusive.
• For Phase 1B and Phase 1B Extension:
• Ambulatory persons aged at least 65 years or older on the day of enrollment. Subjects will be considered ambulatory if they are not institutionalized, bedridden, or homebound.
• Pulse is 50 to 115 bpm, inclusive.
• Systolic blood pressure is 85 to 160 mmHg, inclusive.
• Diastolic blood pressure is 55 to 95 mmHg, inclusive.
• For Phase 1A, Phase 1B, and Phase 1B Extension:
• Written informed consent form and Authorization to Obtain and Release Protected Health Information (HIPAA) form signed, prior to initiation of any study procedures
• Are able to understand and comply with planned study procedures and be available for all study visits.
• Are in good health, as determined by vital signs, medical history, and physical examination based on medical history to ensure any existing medical diagnoses or conditions are stable.
• Stable chronic medical condition
• Oral temperature is less than 100.4°F
• Within institutional normal ranges for safety labs
• Have a Body Mass Index (BMI) of 18-35

You may not qualify if…

• Specifically Phase 1A:
• Female subjects who are breastfeeding or plan to breastfeed at any given time from the study vaccination until 30 days after the study vaccination will be ineligible
• Receipt of 2014-2015 and 2015-2016 seasonal influenza vaccine.
• After 03 September 2015, any subject who intends to receive the 2015-2016 licensed influenza vaccine within 3 months after receiving study vaccination.
• After 03 September 2015, any subject who has household contact with infants less than 1 year of age, persons 65 years of age and older, or immunocompromised individuals.
• For Phase 1B and Phase 1B Extension:
• Receipt of seasonal influenza vaccine in the past six months and planned receipt of seasonal influenza vaccine within 3 months after receiving study vaccination.
• Specifically Phase 1B Extension:
• History of medically-attended altered mental status or inner ear (not including hearing loss), labyrinth and cerebellar disorders within 3 months prior to enrollment.
• Use of concomitant medications that may be nephrotoxic as judged by the investigator.
• For Phase 1A, Phase 1B and Phase 1B Extension:
• Inability to provide informed consent or complete study activities, for example, due to dementia or other impairment.
• Have an acute illness within 72 hours prior to study vaccination
• An acute febrile illness within 24 hours prior to vaccination. Vaccination will be deferred until the participant has been afebrile for at least 24 hours.
• Signs and symptoms of an acute infectious respiratory illness. Vaccination will be deferred until the symptoms resolve.
• 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.
• Have immunosuppression as a result of an underlying illness or immunosuppressive treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination.
• Have known active neoplastic disease or a history of any hematologic malignancy.
• Thrombocytopenia or bleeding disorder contraindicating IM vaccination. Receipt of anticoagulants in the three weeks preceding inclusion.
• Positive screen for HIV, hepatitis B, or hepatitis C infection.
• Have known hypersensitivity or allergy to eggs, egg or chicken protein, squalene or squalene-based adjuvants, or other components of the study vaccine.
• Have a history of severe or life threatening reactions following previous immunization with licensed or unlicensed influenza virus vaccines or a vaccine containing any of the same substances.
• Have a history of Guillain-Barré Syndrome.
• Have a history of neuralgia, paresthesia, neuritis, convulsions, or encephalomyelitis within 90 days prior to study vaccination.
• Have a history of autoimmune disease, including, but not limited to, neuroinflammatory diseases, vasculitis, clotting disorders, dermatitis, arthritis, thyroiditis, or muscle or liver disease.

Where it is running

• Saint Louis University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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