A Study of a Bivalent Influenza Peptide Conjugate Vaccine in Healthy Adults
Primary Purpose
Influenza
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
V512
Comparator: Placebo to V512
Sponsored by
About this trial
This is an interventional prevention trial for Influenza
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
V512
Placebo to V512
Outcomes
Primary Outcome Measures
Safety: Safety and tolerability of BIPCV/IMX as assessed by vaccine-related SAEs; Immunogenicity: 1) A/M2 specific immunogenicity; 2) B/HA0 specific immunogenicity
Secondary Outcome Measures
Persistence of A/M2 and B/HA0 immunogenicity
Full Information
NCT ID
NCT00851266
First Posted
February 23, 2009
Last Updated
February 11, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00851266
Brief Title
A Study of a Bivalent Influenza Peptide Conjugate Vaccine in Healthy Adults
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
187 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
V512
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo to V512
Intervention Type
Biological
Intervention Name(s)
V512
Intervention Description
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;
Intervention Type
Biological
Intervention Name(s)
Comparator: Placebo to V512
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Persistence of A/M2 and B/HA0 immunogenicity
Time Frame
Months 12, 18, and 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study of a Bivalent Influenza Peptide Conjugate Vaccine in Healthy Adults
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