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

Staphylococcus Aureus Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00572910
• Other study ID #: V710-005
• Secondary ID: 2007_609
• Status: Completed
• Phase: Phase 2
• First received: December 11, 2007
• Last updated: March 16, 2015
• Start date: August 2008
• Est. completion date: January 2010

Study information

• Verified date: March 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Staphylococcus Aureus Infection

Intervention

Biological:
• Comparator: Placebo (PBO)
Group 6: Placebo (PBO / PBO / PBO)
• 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
• V710 Comparator: Placebo (PBO)
Group 4A: V710 (60 mcg / PBO / 60 mcg) with MAA Group 4B: V710 (60 mcg / PBO / PBO) with MAA
• 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
• V710 Comparator: Placebo (PBO)
Group 2A: V710 (60 mcg / PBO / 60 mcg) without MAA Group 2B: V710 (60 mcg / PBO / PBO) without MAA
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & 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 rena — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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.	Yes
Secondary	GMFR in 0657n-specific IgG Antibody Concentration From Baseline to Day 28 After the Administration of the First V710 Vaccination	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	No
Secondary	GMFR in 0657n-specific IgG Antibody Concentration From Baseline to Day 180 After the Administration of the First V710 Vaccination	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	No
Secondary	GMFR in 0657n-specific IgG Antibody Concentration From Baseline to 56 Days After the Administration of a Single V710 Vaccination	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	No
Secondary	GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints	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	No