Healthy
Conditions
Keywords
study in healthy subjects
Brief summary
This study is being performed to evaluate a single 60 Mcg dose of lyophilized formulation of Merck Staphylococcus aureus vaccine (V710) in healthy subjects. This study is intended to provide necessary safety and immunogenicity data for the lyophilized formulation of V710 prior to its subsequent evaluation in patients at risk for developing serious S. aureus infections.
Interventions
BIOLOGICALComparator: V710
Single dose V710 (60 Mcg/0.5 mL) by intramuscular injection.
BIOLOGICALComparator: placebo
Single dose of buffered saline placebo (0.5 mL) by intramuscular injection.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* 18 to 80 years of age * Good physical health based upon medical history and physical examination * Willing and able to participate in the entire study duration * Female subject with a negative urine pregnancy test immediately prior to study vaccination
Exclusion criteria
* Chronic skin infections or a chronic skin condition (e.g. psoriasis) * Serious S. aureus infection in the last 12 months * Allergy to aluminum-containing substance taken in the body or to any other vaccine component * Oral temperature equal to or greater than 100.4ºF (38.0ºC), within the past 2 days * Participation in a prior V710 vaccine clinical study * Participation in any other clinical study in the past 4 weeks, or during the 3-month study duration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Fold-rise (GMFR) After the Administration of the Lyophilized Formulation of V710 (60 mcg). | Prevaccination to 14 days postvaccination | Participants whose geometric mean fold-rise (GMFR) in anti-0657n IgG was measured 14 days after a single dose of the lyophilized formulation of V710 (60 mcg) by a LUMINEX™ assay for IgG antibodies directly binding to the 0651nI S. aureus antigen. The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) prevaccination (pre)/14 days postvaccination (postvac). |
Other
| Measure | Time frame | Description |
|---|---|---|
| GMFR by Age | Prevaccination to 14 days postvaccination | Participants whose geometric mean fold-rise (GMFR) in anti-0657n IgG was measured among two age groups (18 to 59 years of age and 60 to 70 years of age)14 days after a single dose of the lyophilized formulation of V710 (60 Mcg) by a LUMINEX™ assay for IgG antibodies directly binding to the 0657nI S.aureus antigen. The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) pre/14 days postvac. |
| GMFR in Antibody Concentration From Baseline | Prevaccination to Days 10, 14, 28, and 84 postvaccination | An assessment of the kinetics of the immune response in the V710 group over time from baseline measurement and all postvaccination time points (Days 10, 14, 28, and 84). The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) pre/all (10, 14, 28, and 84) days postvac. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| V710 (60 mcg) Lyophilized V710 (60 mcg) single dose at baseline. | 41 |
| Placebo Saline placebo single dose at baseline. | 10 |
| Total | 51 |
Baseline characteristics
| Characteristic | V710 (60 mcg) Lyophilized | Placebo | Total |
|---|---|---|---|
| Age, Customized 17 years of age and under | 0 participants | 0 participants | 0 participants |
| Age, Customized 18 to 29 years of age | 6 participants | 1 participants | 7 participants |
| Age, Customized 30 to 39 years of age | 5 participants | 0 participants | 5 participants |
| Age, Customized 40 to 49 years of age | 8 participants | 4 participants | 12 participants |
| Age, Customized 50 to 59 years of age | 1 participants | 0 participants | 1 participants |
| Age, Customized 60 to 69 years of age | 10 participants | 5 participants | 15 participants |
| Age, Customized 70 to 80 years of age | 11 participants | 0 participants | 11 participants |
| Sex: Female, Male Female | 22 Participants | 4 Participants | 26 Participants |
| Sex: Female, Male Male | 19 Participants | 6 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 15 / 41 | 3 / 10 |
| serious Total, serious adverse events | 0 / 41 | 0 / 10 |
Outcome results
Primary
Geometric Mean Fold-rise (GMFR) After the Administration of the Lyophilized Formulation of V710 (60 mcg).
Participants whose geometric mean fold-rise (GMFR) in anti-0657n IgG was measured 14 days after a single dose of the lyophilized formulation of V710 (60 mcg) by a LUMINEX™ assay for IgG antibodies directly binding to the 0651nI S. aureus antigen. The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) prevaccination (pre)/14 days postvaccination (postvac).
Time frame: Prevaccination to 14 days postvaccination
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| V710 (60 mcg) Lyophilized | Geometric Mean Fold-rise (GMFR) After the Administration of the Lyophilized Formulation of V710 (60 mcg). | 5.3 Ratio |
| Placebo | Geometric Mean Fold-rise (GMFR) After the Administration of the Lyophilized Formulation of V710 (60 mcg). | 1.0 Ratio |
Other Pre-specified
GMFR by Age
Participants whose geometric mean fold-rise (GMFR) in anti-0657n IgG was measured among two age groups (18 to 59 years of age and 60 to 70 years of age)14 days after a single dose of the lyophilized formulation of V710 (60 Mcg) by a LUMINEX™ assay for IgG antibodies directly binding to the 0657nI S.aureus antigen. The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) pre/14 days postvac.
Time frame: Prevaccination to 14 days postvaccination
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V710 (60 mcg) Lyophilized | GMFR by Age | Age <60 years | 4.0 Ratio |
| V710 (60 mcg) Lyophilized | GMFR by Age | Age ≥60 years | 6.8 Ratio |
| Placebo | GMFR by Age | Age <60 years | 0.9 Ratio |
| Placebo | GMFR by Age | Age ≥60 years | 1.0 Ratio |
Other Pre-specified
GMFR in Antibody Concentration From Baseline
An assessment of the kinetics of the immune response in the V710 group over time from baseline measurement and all postvaccination time points (Days 10, 14, 28, and 84). The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) pre/all (10, 14, 28, and 84) days postvac.
Time frame: Prevaccination to Days 10, 14, 28, and 84 postvaccination
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V710 (60 mcg) Lyophilized | GMFR in Antibody Concentration From Baseline | Day 84 | 7.8 Ratio |
| V710 (60 mcg) Lyophilized | GMFR in Antibody Concentration From Baseline | Day 10 | 3.6 Ratio |
| V710 (60 mcg) Lyophilized | GMFR in Antibody Concentration From Baseline | Day 14 | 5.3 Ratio |
| V710 (60 mcg) Lyophilized | GMFR in Antibody Concentration From Baseline | Day 28 | 6.9 Ratio |
| Placebo | GMFR in Antibody Concentration From Baseline | Day 28 | 0.9 Ratio |
| Placebo | GMFR in Antibody Concentration From Baseline | Day 84 | 0.9 Ratio |
| Placebo | GMFR in Antibody Concentration From Baseline | Day 14 | 1.0 Ratio |
| Placebo | GMFR in Antibody Concentration From Baseline | Day 10 | 1.2 Ratio |