V710 First-In-Man (FIM) Study (V710-001)
Condition: Staphylococcal Infections
MeSH terms: Staphylococcal Infections
Intervention: V710; Comparator: Placebo
Intervention description: Single dose of V710 (at dosages of 5 μg, 30 μg, or 90 μg) intramuscularly; Single dose of saline placebo intramuscularly
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: S. aureus;; Vaccine; FIM

Summary:

      This is a randomized, Multicenter, double-blind (subject, investigator, and Merck Research
      Laboratories (MRL) clinical personnel directly involved in the study), placebo-controlled,
      dose-ranging study in healthy adults 18 to 55 years of age. It is the first in man (FIM)
      study evaluating the tolerability and immunogenicity of the 0657nI S. aureus vaccine. For
      this Phase I study, approximately 120 healthy adults will be enrolled in the study and
      randomized to receive a single 0.5 mL vaccination of either 0657nI S. aureus vaccine (3
      different dosage levels of 5 μg, 30 μg or 90 μg of the 0657nI vaccine) or saline placebo.
      Vaccine/placebo will be administered intramuscularly (IM) in the deltoid muscle. Because this
      study will be the first study evaluating the tolerability and immunogenicity of 0657nI S.
      aureus vaccine in humans, a dose-escalation phase will be conducted in a small number of
      subjects randomized in a 3:1 ratio (n=36, consisting of 9 subjects for each of 3 vaccine
      dosage levels and 9 placebo subjects) to evaluate the vaccine safety at increasing dose
      levels of the 0657nI protein in Panel A, before expanding the enrollment to the remaining 84
      subjects in Panel B.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is 18 to 55 years of age

          -  Subject is in good physical health based upon medical history, physical examination,
             and screening laboratory studies. NOTE: Lab studies will only be collected in Panel A,
             the dose-escalating portion of the study

          -  Subject is able to understand study procedures and agrees to participate in the study
             by providing written informed consent

          -  Subject is willing and able to participate in the entire study duration planned for 3
             months (~84 days)

          -  Female subjects are required to have a negative urine pregnancy test immediately prior
             to study vaccination. Female subjects of childbearing potential must have been using
             an acceptable method of birth control for 2 weeks prior to enrollment, and agree to
             use an acceptable method of birth control for 1 month after vaccination. (Acceptable
             methods of birth control include use of hormonal contraceptives, intrauterine device
             (IUD), diaphragm with spermicide, contraceptive sponge, tubal ligation, condoms, or
             abstinence)

        Exclusion Criteria:

          -  Subject suffers from a chronic skin condition that predisposes the individual to the
             development of chronic skin or soft-tissue infections (e.g., psoriasis, chronic
             granulomatous disease).

          -  Subject developed a serious infection (e.g., bacteremia, pneumonia, mediastinitis)
             attributed to S. aureus in the 12 months prior to screening

          -  Subject has a history of anaphylaxis to aluminum-containing adjuvant or other vaccine
             components

          -  Subject has a temperature of ≥100.4ºF (≥38.0ºC), oral equivalent, within 48 hours
             prior to receipt of 0657nI S. aureus vaccine/placebo

          -  Subject has received a live virus vaccine within 30 days prior to receipt of 0657nI S.
             aureus vaccine/placebo or is scheduled to receive vaccination with a live virus
             vaccine within 30 days following study entry

          -  Subject has received any other licensed vaccine (including non-live virus vaccines)
             within 14 days prior to receipt of 0657nI S. aureus vaccine/placebo or is scheduled to
             receive any other licensed vaccine (including non-live virus vaccines) within 30 days
             following study entry. (Note: Influenza vaccines may be administered during the study,
             but must be given at least 7 days prior to receipt of the study vaccine or at least 15
             days after receipt of the study vaccine)

          -  Subject was administered immunoglobulin or blood product within 90 days prior to
             receipt of 0657nI S. aureus vaccine/placebo or is scheduled to receive such products
             within 30 days following study entry

          -  Subject has received treatment with systemic (intramuscular, oral, or intravenous)
             corticosteroids or another immunosuppressive medication (e.g., calcineurin inhibitors,
             mycophenolate, azathioprine) in the 14 days prior to receipt of 0657nI S. aureus
             vaccine/placebo or is anticipated to receive such medications for a chronic medical
             condition during the course of the study

          -  Subject has a condition that requires active medical intervention or monitoring to
             avert serious danger to the subject's health or well-being, such as diabetes mellitus,
             autoimmune disease, or clinically significant chronic medical conditions that are
             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

          -  Subject has known or suspected impairment of immunologic function including, but not
             limited to, the following conditions: autoimmune disease, diabetes mellitus, end-stage
             renal disease, hepatic insufficiency/cirrhosis, splenectomy, or HIV/AIDS

          -  Subject has a condition in which repeated venipuncture or injections pose more than
             minimal risk for the subject, such as hemophilia, other severe coagulation disorders,
             or significantly impaired venous access

          -  Subject is currently pregnant or breastfeeding, or planning to conceive within the
             3-month study duration period

          -  Subject has clinically significant abnormalities based on the subject's medical
             history, physical examination, or screening laboratory studies (as described in
             Appendix 1 of the Multicenter protocol). NOTE: Lab studies will only be collected in
             Panel A, the dose escalating portion of the study

          -  Subject has recent history (within the past 5 years) or current evidence of drug or
             alcohol abuse

          -  Subject has 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

          -  Subject is legally or mentally incapacitated

          -  Subject has participated in another clinical study in the past 4 weeks, or plans to
             participate in a treatment-based study or study in which an invasive procedure is to
             be performed while enrolled in this study. NOTE: Participation in a safety
             surveillance study is acceptable

          -  Subject has a history of any condition which, in the opinion of the investigator, may
             pose an additional risk for the subject or confound the results of the study