NCT00851266CompletedPhase 1
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
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 187
- Primary Endpoint
- Safety: Safety and tolerability of BIPCV/IMX as assessed by vaccine-related SAEs; Immunogenicity: 1) A/M2 specific immunogenicity; 2) B/HA0 specific immunogenicity
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
2
Placebo Comparator
Placebo to V512
Intervention: Comparator: Placebo to V512 (Biological)
1
Experimental
V512
Intervention: V512 (Biological)
Outcomes
Primary Outcomes
Safety: Safety and tolerability of BIPCV/IMX as assessed by vaccine-related SAEs; Immunogenicity: 1) A/M2 specific immunogenicity; 2) B/HA0 specific immunogenicity
Time Frame: Safety: 7 months; Immunogenicity: 1) 7 months; 2) 7 months
Secondary Outcomes
- Persistence of A/M2 and B/HA0 immunogenicity(Months 12, 18, and 24)
Investigators
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