A Study of a Bivalent Influenza Peptide Conjugate Vaccine in Healthy Adults

Study Overview
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Brief Summary
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This is a first in man study evaluating the tolerability and immunogenicity of BIPCV/IMX (V512) at increasing concentrations of influenza viral peptides A/M2+B/HA0 peptides and IMX, a saponin-based adjuvant.

Official Title
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A Dose-Escalation, Dose-Ranging Study of the Safety, Tolerability, and Immunogenicity of a Bivalent Influenza Peptide Conjugate Vaccine Formulated With Aluminum- and ISCOMATRIX(TM) Containing Adjuvants (BIPCV/IMX) Evaluated in Healthy Adults 18 to 35 Years of Age

Conditions
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Influenza

Intervention / Treatment
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* Biological: V512
* Biological: Comparator: Placebo to V512


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is in good physical health Subject is not in the category of individuals recommended by the CDC to receive influenza vaccine for the upcoming 2 influenza seasons Subject agrees not to seek vaccination with licensed influenza vaccines during the study Female subjects agree to use acceptable birth control for 6 weeks prior to first dose of vaccine until 1 month post Dose 3 Exclusion Criteria: Subject has a history of allergic reaction to the vaccine components Subject has has a fever within 3 days of screening Subject had a vaccination with an inactive virus within 14 days of Dose 1 Subject had a vaccination with a live virus within 30 days of Dose 1

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>V512 | Biological: V512<br>* Subjects received 1 of 8 formulations of the BIPCV/IMX vaccine (V512) in a 3-dose regimen of 0.5 mL injections at Day 1, Month 2, and Month 6: 1) 0.5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 20 mcg IMX; 2) 0.5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 60 mcg IMX; 3) 5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 20 mcg IMX; 4) 5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 60 mcg IMX; 5) 5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 100 mcg IMX; 6) 20 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 20 mcg IMX; 7) 20 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 60 mcg IMX; 8) 20 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 100 mcg IMX;<br>|
| Placebo Comparator: 2<br>Placebo to V512 | Biological: Comparator: Placebo to V512<br>* Subjects received placebo to the BIPCV/IMX vaccine (V512) in a 3-dose regimen of 0.5 mL injections at Day 1, Month 2, and Month 6.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Safety and tolerability of BIPCV/IMX as assessed by vaccine-related SAEs; Immunogenicity: 1) A/M2 specific immunogenicity; 2) B/HA0 specific immunogenicity |  | Safety: 7 months; Immunogenicity: 1) 7 months; 2) 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistence of A/M2 and B/HA0 immunogenicity |  | Months 12, 18, and 24 |