Influenza, Human Clinical Trial
Official title:
A Phase IA/IB Trial to Evaluate the Safety, Tolerance, and Immunogenicity of MAS-1-Adjuvanted Seasonal Inactivated Influenza Vaccine (MER4101) With Hemagglutinin Dose Escalation Compared to Non-Adjuvanted Comparator Inactivated Influenza Vaccine (IIV) Standard Dose (SD) in Healthy Adults and High Dose (HD) IIV in Ambulatory Elderly Subjects
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.
The study is a Phase 1A, 1B and 1B extension, randomized, double-blind, single-center,
clinical trial, in healthy adults (18-49 years old) and ambulatory elderly subjects (aged 65
years and older). Phase IA evaluated the safety, tolerability and hemagglutination inhibition
assay (HAI) antibody response to MER4101 at each of four escalating doses of seasonal
inactivated influenza vaccine (IIV) hemagglutinin (HA) antigen with a fixed dose of a
water-in-oil emulsion adjuvant MAS-1 (Mercia Adjuvant System-1), compared with licensed,
unadjuvanted, standard dose (SD) of licensed inactivated trivalent influenza virus vaccine
(IIV). Phase IB evaluated the optimal dose of IIV in MAS-1 selected under phase IA for
safety, tolerability and HAI antibody response (from Phase 1A known to be 9 µg of HA antigen
in 0.3 mL dose of MAS-1 adjuvanted emulsion) in ambulatory elderly subjects compared to high
dose (HD) IIV. The Phase 1B extension will evaluate if the increased dose volume of MAS-1
(0.5 mL vs 0.3 mL) at the same 9 µg/HA adjuvanted IIV vaccine is safe, well tolerated and
immunogenic, and then whether the increased dose of 15 µg/HA in 0.5 mL MAS-1 is safe, well
tolerated and still more immunogenic in elderly subjects.
The ability of standard dose (SD) IIV to protect against seasonal influenza virus infection
in the elderly is less than vaccine efficacy observed in healthy young adults. The
MAS-1-adjuvanted influenza virus vaccine offers the potential for higher seroconversion and
seroprotection rates, hemagglutination inhibition (HAI) antibody titers relative to
pre-vaccination HAI titers (GMFI), hemagglutinin (HA) antigen dose-sparing and
cross-protection against antigenically divergent viral strains, and importantly, prolonged
duration of protective immunity lasting up to at least 6 months post-vaccination in both the
general adult population and the elderly, thereby providing potentially protective immunity
throughout the influenza season. This study will determine if the adjuvanted vaccine
formulated with one or more of the reduced HA antigen doses is safe. The study will also
determine if it is likely to induce an improved HA antibody response (HAI) when compared to
SD IIV in healthy adults and HD IIV in elderly subjects. This trial will inform future
clinical trials in at-risk populations of older patients.
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