The objectives of this phase 2 study are to evaluate immunogenicity, safety and tolerability of AD07030, a trivalent influenza virus antigens vaccine, given intranasally in 2 doses in healthy adult volunteers.
This is a Phase 2 prospective, randomized controlled, double-blind, multi-center study to evaluate the immunogenicity, safety and tolerability of AD07030, a trivalent influenza virus antigens vaccine, given intranasally in healthy adult volunteers. About 358 healthy subjects, meeting all the eligibility criteria will be enrolled into the study and randomized into 3 study groups (in 2:2:1 ratio) to receive either the study vaccine at one of the dose levels of adjuvant AD07010 (30μg or 45μg LTh(αK)) in combination with hemagglutinin (HA) antigens or to receive control vaccine consisting of HA antigens alone. The 3 study groups are as follows: * Group 1: 22.5μg HA with 30μg AD07010 * Group 2: 22.5μg HA with 45μg AD07010 * Group 3: 22.5μg HA alone Each subject will receive intranasal administration of 2 doses of IP (study or control vaccine) at same dosages, given 7 days apart on study Day 1 and Day 8. Solicited local and general AEs will be recorded after each vaccination in the subject's diary card for up to 7 days (the vaccine administration day and 6 days following it). Subjects will be followed up for monitoring of safety and immunogenicity for 180 days. AE and SAE and concomitant medication/vaccination will be collected throughout the study. There will be total of 6 study visits and a telephone call.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
345
A protein based adjuvant
Inactivated trivalent seasonal influenza vaccine
Advagene Biopharma
Taipei, Taiwan
Geometric mean titer changes on Day 29
Change from pre- to post-vaccination serum Geometric mean titers (GMT) of hemagglutinin inhibition (HI) antibody at Day 29(±2)
Time frame: 29 days
Immunogenicity (HI titers)
Derived variables: in terms of HI titers for: Seroconversion Rate (SCR), Seroconversion Factor (SCF), and Seroprotection Rate (SPR)
Time frame: 29, 90 and 180 days
Immunogenicity (IgA titers)
Change from pre- to post-vaccination GMT of mucosal anti-HA IgA antibody
Time frame: 29, 90 and 180 days
Immunogenicity (anti-LTh(αK) antibodies)
Change from pre- to post-vaccination GMT of anti- LTh(αK) antibodies
Time frame: 29, 90 and 180 days
Viral neutralization
Change from pre- to post-vaccination GMT of virus neutralization titer
Time frame: 29, 90 and 180 days
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