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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
206
Group 6: Placebo (PBO / PBO / PBO)
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
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.
Time frame: 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.
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.
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.
Time frame: 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
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Time frame: 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
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.
Time frame: Prevaccination to 56 days postvaccination
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.
Time frame: Prevaccination to 360 days post vaccination