V710 First-In-Man (FIM) Study (V710-001)
Condition: Staphylococcal Infections
MeSH terms: Staphylococcal Infections
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      Depending on when the subject is enrolled into the study, the following will be completed:
      The subject will receive a single injection of SAV or placebo (an inactive substance) in the
      deltoid muscle of the upper arm. The subject will then be watched for 30 minutes after
      vaccination to monitor for allergic reactions. The subject will be asked to visit the study
      doctor either 6 or 9 times during the 3-month study period. Once enrolled, the subject will
      have blood drawn before receiving the vaccine (baseline) and up to 7 times after that at each
      of the required visits. The blood will be used for tests and/or for testing the subject's
      body's immune response to the SAV, to see if the subjects have developed immunity to S.
      aureus and if immunity continues up to 84 days. A Vaccination Report Card (VRC) will be
      provided to all participants. The participant will be asked to record oral temperatures and
      any reactions that occur at the SAV injection site every day for 5 days after vaccination.
      The participant will also be asked to record any physical adverse effects that they may
      experience, including headaches, nausea, muscle pain or aches, and fatigue every day for 14
      days after vaccination. In additional all medications (including over the counter
      medications) taken during the 14 days post vaccination will be recorded and the VRC will be
      returned to the research staff after 14 days.
    

Intervention name(s): V710; Comparator: Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Single dose of V710 (at dosages of 5 μg, 30 μg, or 90 μg) intramuscularly; Single dose of saline placebo intramuscularly
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: S. aureus;; Vaccine; FIM