A Study to Evaluate the Safety and Immunogenicity of V710 in Adults With Kidney Disease on Hemodialysis (V710-005)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00572910
First received: December 11, 2007
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

This is a study to evaluate the safety and immunogenicity of V710 with and without Merck Aluminum Adjuvant (MAA) in adult participants with end-stage kidney disease who are on hemodialysis.


Condition Intervention Phase
Staphylococcus Aureus Infection
Biological: Comparator: Placebo (PBO)
Biological: V710 Comparator: Placebo (PBO)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints [ Time Frame: Prevaccination to 360 days post vaccination ] [ Designated as safety issue: No ]
    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.


Enrollment: 206
Study Start Date: August 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: V710 Comparator: Placebo (PBO)

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.
Biological: V710 Comparator: Placebo (PBO)

Group 2A: V710 (60 mcg / PBO / 60 mcg) without MAA

Group 2B: V710 (60 mcg / PBO / 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.
Biological: V710 Comparator: Placebo (PBO)

Group 3A: V710 (60 mcg / 60 mcg / 60 mcg) with MAA

Group 3B: V710 (60 mcg / 60 mcg / PBO) with 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.
Biological: V710 Comparator: Placebo (PBO)

Group 4A: V710 (60 mcg / PBO / 60 mcg) with MAA

Group 4B: V710 (60 mcg / PBO / PBO) with 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.
Biological: V710 Comparator: Placebo (PBO)

Group 5A: V710 (90 mcg / 90 mcg / 90 mcg) with MAA

Group 5B: V710 (90 mcg / 90 mcg / PBO) with MAA

Placebo Comparator: Group 6
Placebo on Day 1, 28 and 180.
Biological: Comparator: Placebo (PBO)
Group 6: Placebo (PBO / PBO / PBO)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572910

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00572910     History of Changes
Other Study ID Numbers: V710-005, 2007_609
Study First Received: December 11, 2007
Results First Received: July 20, 2011
Last Updated: March 31, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 23, 2014