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

NCT00572910 | Completed Phase 2 Results

• 2 other identifiers: V710-0052007_609
• Study Type: interventional
• Target: 206
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Staphylococcus Aureus Infection

Outcome Measures

Primary Outcomes (2)

• 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

  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)

  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 Outcomes (4)

• GMFR in 0657n-specific IgG Antibody Concentration From Baseline to Day 28 After the Administration of the First V710 Vaccination

  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

  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

  Prevaccination to 56 days postvaccination

• GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints

  Prevaccination to 360 days post vaccination

Study Arms (6)

V710 - Group 1

EXPERIMENTAL

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)

V710 - Group 2

EXPERIMENTAL

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)

V710 - Group 3

EXPERIMENTAL

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)

V710 - Group 4

EXPERIMENTAL

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)

V710 - Group 5

EXPERIMENTAL

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 6

PLACEBO COMPARATOR

Placebo on Day 1, 28 and 180.

Biological: Comparator: Placebo (PBO)

Interventions

Comparator: Placebo (PBO) BIOLOGICAL

Group 6: Placebo (PBO / PBO / PBO)

Group 6

V710 Comparator: Placebo (PBO) BIOLOGICAL

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

V710 - Group 5

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 22837094 RESULT

MeSH Terms

Conditions

Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2007
• First Posted: December 13, 2007
• Study Start: August 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: April 3, 2015
• Results First Posted: August 15, 2011

Record last verified: 2015-03