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

December 11, 2007
March 31, 2014
August 2008
January 2010   (final data collection date for primary outcome measure)
  • 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.

Not Provided
Complete list of historical versions of study NCT00572910 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
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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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Staphylococcus Aureus Infection
  • Biological: Comparator: Placebo (PBO)
    Group 6: Placebo (PBO / PBO / PBO)
  • 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

  • Biological: V710 Comparator: Placebo (PBO)

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

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

  • 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

  • Biological: V710 Comparator: Placebo (PBO)

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

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

  • 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 1
    V710 (60 mcg without MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
    Intervention: Biological: V710 Comparator: Placebo (PBO)
  • 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.
    Intervention: Biological: V710 Comparator: Placebo (PBO)
  • 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.
    Intervention: Biological: V710 Comparator: Placebo (PBO)
  • 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.
    Intervention: Biological: V710 Comparator: Placebo (PBO)
  • 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.
    Intervention: Biological: V710 Comparator: Placebo (PBO)
  • Placebo Comparator: Group 6
    Placebo on Day 1, 28 and 180.
    Intervention: Biological: Comparator: Placebo (PBO)
Moustafa M, Aronoff GR, Chandran C, Hartzel JS, Smugar SS, Galphin CM, Mailloux LU, Brown E, Dinubile MJ, Kartsonis NA, Guris D. Phase IIa study of the immunogenicity and safety of the novel Staphylococcus aureus vaccine V710 in adults with end-stage renal disease receiving hemodialysis. Clin Vaccine Immunol. 2012 Sep;19(9):1509-16. doi: 10.1128/CVI.00034-12. Epub 2012 Jul 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
206
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00572910
V710-005, 2007_609
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP