A Study to Evaluate the Safety and Immunogenicity of V710 in Adults With Kidney Disease on Hemodialysis (V710-005)(COMPLETED)
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of Merck Staphylococcus Aureus Vaccine (V710) in Adult Patients With End-Stage Renal Disease on Chronic Hemodialysis
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosed with end stage kidney disease and is on hemodialysis
- Female patients who are able to have children must have a negative urine pregnancy tests
Exclusion Criteria:
- Developed a serious infection within the past 12 months; allergy to the components of the vaccine
- Has been vaccinated with a live virus within the past 30 days or are scheduled to be vaccinated with a live virus in the next 60 days
- Received V710 vaccine before
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: V710 - Group 1
V710 (60 mcg without MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
|
Group 5A: V710 (90 mcg / 90 mcg / 90 mcg) with MAA Group 5B: V710 (90 mcg / 90 mcg / PBO) with MAA Group 4A: V710 (60 mcg / PBO / 60 mcg) with MAA Group 4B: V710 (60 mcg / PBO / PBO) with MAA Group 3A: V710 (60 mcg / 60 mcg / 60 mcg) with MAA Group 3B: V710 (60 mcg / 60 mcg / PBO) with MAA Group 2A: V710 (60 mcg / PBO / 60 mcg) without MAA Group 2B: V710 (60 mcg / PBO / PBO) without MAA Group 1A: V710 (60 mcg / 60 mcg / 60 mcg) without MAA Group 1B: V710 (60 mcg / 60 mcg / PBO) without MAA |
|
Experimental: V710 - Group 2
V710 (60 mcg without MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180.
|
Group 5A: V710 (90 mcg / 90 mcg / 90 mcg) with MAA Group 5B: V710 (90 mcg / 90 mcg / PBO) with MAA Group 4A: V710 (60 mcg / PBO / 60 mcg) with MAA Group 4B: V710 (60 mcg / PBO / PBO) with MAA Group 3A: V710 (60 mcg / 60 mcg / 60 mcg) with MAA Group 3B: V710 (60 mcg / 60 mcg / PBO) with MAA Group 2A: V710 (60 mcg / PBO / 60 mcg) without MAA Group 2B: V710 (60 mcg / PBO / PBO) without MAA Group 1A: V710 (60 mcg / 60 mcg / 60 mcg) without MAA Group 1B: V710 (60 mcg / 60 mcg / PBO) without MAA |
|
Experimental: V710 - Group 3
V710 (60 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
|
Group 5A: V710 (90 mcg / 90 mcg / 90 mcg) with MAA Group 5B: V710 (90 mcg / 90 mcg / PBO) with MAA Group 4A: V710 (60 mcg / PBO / 60 mcg) with MAA Group 4B: V710 (60 mcg / PBO / PBO) with MAA Group 3A: V710 (60 mcg / 60 mcg / 60 mcg) with MAA Group 3B: V710 (60 mcg / 60 mcg / PBO) with MAA Group 2A: V710 (60 mcg / PBO / 60 mcg) without MAA Group 2B: V710 (60 mcg / PBO / PBO) without MAA Group 1A: V710 (60 mcg / 60 mcg / 60 mcg) without MAA Group 1B: V710 (60 mcg / 60 mcg / PBO) without MAA |
|
Experimental: V710 - Group 4
V710 (60 mcg with MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180.
|
Group 5A: V710 (90 mcg / 90 mcg / 90 mcg) with MAA Group 5B: V710 (90 mcg / 90 mcg / PBO) with MAA Group 4A: V710 (60 mcg / PBO / 60 mcg) with MAA Group 4B: V710 (60 mcg / PBO / PBO) with MAA Group 3A: V710 (60 mcg / 60 mcg / 60 mcg) with MAA Group 3B: V710 (60 mcg / 60 mcg / PBO) with MAA Group 2A: V710 (60 mcg / PBO / 60 mcg) without MAA Group 2B: V710 (60 mcg / PBO / PBO) without MAA Group 1A: V710 (60 mcg / 60 mcg / 60 mcg) without MAA Group 1B: V710 (60 mcg / 60 mcg / PBO) without MAA |
|
Experimental: V710 - Group 5
V710 (90 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
|
Group 5A: V710 (90 mcg / 90 mcg / 90 mcg) with MAA Group 5B: V710 (90 mcg / 90 mcg / PBO) with MAA Group 4A: V710 (60 mcg / PBO / 60 mcg) with MAA Group 4B: V710 (60 mcg / PBO / PBO) with MAA Group 3A: V710 (60 mcg / 60 mcg / 60 mcg) with MAA Group 3B: V710 (60 mcg / 60 mcg / PBO) with MAA Group 2A: V710 (60 mcg / PBO / 60 mcg) without MAA Group 2B: V710 (60 mcg / PBO / PBO) without MAA Group 1A: V710 (60 mcg / 60 mcg / 60 mcg) without MAA Group 1B: V710 (60 mcg / 60 mcg / PBO) without MAA |
|
Placebo Comparator: Group 6
Placebo on Day 1, 28 and 180.
|
Group 6: Placebo (PBO / PBO / PBO)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Geometric Mean Fold-rise (GMFR) in 0657n-specific Immunoglobulin G (IgG) Antibody Concentration From Baseline to 28 Days After the Administration of the Second V710 Vaccination
Time Frame: Prevaccination to 56 days postvaccination
|
Participants whose GMFR in anti-0657n IgG antibody concentration was measured by the LUMINEX™ assay from Baseline to 28 days after the administration of the second vaccination of V710 for the 3 groups receiving 2 doses of V710 (60 mcg without MAA) Group 1, (60 mcg with MAA) Group 3 and (90 mcg with MAA) Group 5.
|
Prevaccination to 56 days postvaccination
|
|
Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE)
Time Frame: Days 1-14 following each vaccination for any AE/SAE and Days 1-360 for any vaccine-related SAEs, S. aureus SAEs, or deaths.
|
Participants with Adverse Experiences (AE) / Serious Adverse Experiences (SAE) occurring Day 1 through Day 14 following vaccinations 1, 2, and 3. Participants with specific SAEs including any vaccine-related SAEs, any SAEs involving a Staphylococcus aureus (S. aureus) infection, or any AEs leading to death occurring Day 1 through Day 360 following vaccination. |
Days 1-14 following each vaccination for any AE/SAE and Days 1-360 for any vaccine-related SAEs, S. aureus SAEs, or deaths.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
GMFR in 0657n-specific IgG Antibody Concentration From Baseline to Day 28 After the Administration of the First V710 Vaccination
Time Frame: Prevaccination to 28 days postvaccination
|
Participants whose GMFR in anti-0657n IgG antibody concentration was measured from Baseline to Day 28 for the 3 Groups receiving 1 dose of V710 (60 mcg without MAA) Group 1 and 2 combined, (60 mcg with MAA) Group 3 and 4 combined and (90 mcg with MAA) Group 5.
|
Prevaccination to 28 days postvaccination
|
|
GMFR in 0657n-specific IgG Antibody Concentration From Baseline to Day 180 After the Administration of the First V710 Vaccination
Time Frame: Prevaccination to 180 days postvaccination
|
Participants whose GMFR in anti-0657n IgG antibody concentration was measured from Baseline to Day 180 for the 3 Groups receiving 2 doses of V710 28 days apart (60 mcg without MAA) Group 1, (60 mcg with MAA) Group 3 and (90 mcg with MAA) Group 5.
|
Prevaccination to 180 days postvaccination
|
|
GMFR in 0657n-specific IgG Antibody Concentration From Baseline to 56 Days After the Administration of a Single V710 Vaccination
Time Frame: Prevaccination to 56 days postvaccination
|
Participants whose GMFR in 0657n-specific IgG antibody concentration from Baseline to Day 56 for the 2 Groups receiving a single dose of V710 (60 mcg without MAA followed by Placebo 28 Days later) Group 2, and (60 mcg with MAA followed by Placebo 28 days later) Group 4.
|
Prevaccination to 56 days postvaccination
|
|
GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints
Time Frame: Prevaccination to 360 days post vaccination
|
Participants whose GMFR in 0657n-specific IgG antibody concentration from baseline through Day 360 for all groups (including Days 28, 56, 84,180, 210, 270, and 360) to assess the durability and kinetics of the immune response.
|
Prevaccination to 360 days post vaccination
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V710-005
- 2007_609
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