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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

About this trial

This is an interventional prevention trial for Influenza

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

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

Arm Type

Experimental

Arm Description

V512

Arm Title

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

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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