Safety, Tolerability, and Immunogenicity of a Single Dose of Merck 0657nI Staphylococcus Aureus Vaccine With or Without Merck Aluminum Adjuvant (V710-002)
Condition: Staphylococcal Infections
MeSH terms: Staphylococcal Infections
Intervention: V710 (30 µg) with MAA; V710 (30 µg) without MAA
Intervention description: Single 0.5-mL injection (30-µg) of V710 with MAA, intramuscularly; Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bacterial Vaccines; Staphylococcus Aureus; Adjuvanted Vaccine

Summary:

      The purpose of this study was to evaluate the safety, tolerability, and immunogenicity of the
      Merck 0657nI S. aureus vaccine (V710) either with or without Merck Aluminum Adjuvant (MAA).
    

Eligibility criteria:

        Inclusion criteria:

          -  Participant was in good physical health

          -  Participant was able to understand study procedures and agreed to participate in the
             study by providing written informed consent.

          -  Participant was willing and able to participate in the entire study duration planned
             for up to 12 months (~360 days).

          -  Female participants of reproductive potential were required to have a negative urine
             pregnancy test immediately prior to study vaccination. Female participants of
             reproductive potential must have used an acceptable method of birth control for 2
             weeks prior to enrollment, and agreed to use an acceptable method of birth control for
             1 month after vaccination.

        Exclusion criteria:

          -  Participant suffered from a chronic skin condition that predisposed the individual to
             the development of chronic skin or soft-tissue infections (e.g., psoriasis, chronic
             granulomatous disease, atopic dermatitis).

          -  Participant developed a serious infection (e.g., bacteremia, pneumonia, mediastinitis)
             attributed to S. aureus in the 12 months prior to screening.

          -  Participant had a history of anaphylaxis to aluminum-containing adjuvant or other
             vaccine components.

          -  Participant had a temperature of ≥100.4ºF (≥38.0ºC), oral equivalent, within 48 hours
             prior to receipt of V710.

          -  Participant had received a live virus vaccine within 30 days prior to receipt of V710
             or was scheduled to receive vaccination with a live virus vaccine within 30 days
             following study entry.

          -  Participant had received any other licensed vaccine (including non-live virus
             vaccines) within 14 days prior to receipt of V710 or was scheduled to receive any
             other licensed vaccine (including non-live virus vaccines) within 30 days following
             study entry.

          -  Participant had received V710 in a prior clinical study (Merck V710 Protocol 001).

          -  Participant was administered immunoglobulin or blood product within 90 days prior to
             receipt of V710 or was scheduled to receive such products within 30 days following
             study entry.

          -  Participant had received treatment with systemic (intramuscular, oral, or intravenous)
             corticosteroids or another immunosuppressive medication (e.g., calcineurin inhibitors,
             mycophenolate, azathioprine) or biological agents (e.g., rituximab) in the 14 days
             prior to receipt of V710 or was anticipated to receive such medications for a chronic
             medical condition during the course of the study.

          -  Participant had a condition that required active medical intervention or monitoring to
             avert serious danger to the participant's health or well-being, such as diabetes
             mellitus, autoimmune disease, or clinically significant chronic medical conditions
             that were considered progressive, including but not limited to: coronary artery
             disease, congestive heart failure, cardiomyopathy, progressive valvular heart disease,
             chronic obstructive pulmonary disease, pulmonary fibrosis, active peptic ulcer
             disease, chronic renal disease, chronic hepatic disease, multiple sclerosis,
             progressive neuropathies, or seizure disorder requiring therapy in the past 3 years.

          -  Participant had known or suspected impairment of immunologic function including, but
             not limited to, the following conditions: autoimmune disease, diabetes mellitus,
             endstage renal disease, hepatic insufficiency/cirrhosis, splenectomy, or human
             immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS).

          -  Participant had a condition in which repeated venipuncture or injections posed more
             than minimal risk for the subject, such as hemophilia, other severe coagulation
             disorders, or significantly impaired venous access.

          -  Participant was pregnant or breastfeeding, or planning to conceive within the 12-month
             study duration period.

          -  Participant had clinically significant abnormalities based on the participant or
             physical examination.

          -  Participant had recent history (within the past 5 years) or current evidence of drug
             or alcohol abuse.

          -  Participant had a major psychiatric illness, including any history of schizophrenia or
             severe psychosis, bipolar disorder requiring therapy, or any subject with suicidal
             ideation within the previous 3 years.

          -  Participant was legally or mentally incapacitated.

          -  Participant had participated in another clinical study in the past 4 weeks, or
             participant planned to participate in a treatment-based study or study in which an
             invasive procedure was to be performed during the first 3 months of this study
             (through Day 84).

          -  Participant had a history of any condition which, in the opinion of the investigator,
             posed an additional risk for the subject or confounded the results of the study.