Study to Evaluate Safety, Tolerability, and Immunogenicity of Candidate Human Cytomegalovirus Vaccine in Healthy Adults
Condition: Cytomegalovirus Infections
MeSH terms: Infections; Cytomegalovirus Infections
Intervention: VBI-1501A 0.5 μg; VBI-1501A 1.0 μg; VBI-1501A 2.0 μg; VBI-1501 1.0 μg; Placebo
Intervention description: VBI-1501A: 0.5 μg with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168; VBI-1501A: 1.0 μg with alum with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168; VBI-1501A: 2.0 μg with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168; VBI-1501: 1.0 μg without alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168; buffer/sucrose used for VBI-1501 suspension- administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: VBI-1501A; VBI-1501; prophylactic vaccine; virus diseases; cytomegalovirus (CMV); cytomegalovirus infections; cytomegalovirus vaccines; Herpesviridae Infections; Phase 1; Human Herpesvirus 5 (HHV5); Vaccines, virus-like particle (VLP); enveloped virus-like particle (eVLP)

Summary:

      The purpose of this study is to compare the safety and effectiveness of four different doses
      of cytomegalovirus vaccines in healthy adults.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Generally healthy adult female and male 18 to 40 years of age, inclusive;

          2. Serologically confirmed to be CMV seronegative at screening;

          3. Female volunteers must agree to use an adequate contraception method as deemed
             appropriate by the investigator

          4. Sign an informed consent document indicating understanding of the purpose and
             procedures required for the study and willingness to participate in the study

        Exclusion Criteria:

          1. History of or current clinically significant medical illness or any other illness that
             in the opinion of the investigator interferes with the interpretation of the study
             results

          2. Clinically significant abnormal physical examination, vital signs, or clinically
             significant abnormal values for hematology, clinical chemistry or urinalysis at
             screening as determined by the investigator

          3. Previous receipt of any cytomegalovirus vaccine

          4. History of allergic reactions or anaphylactic reaction to any vaccine component

          5. Pregnant or breastfeeding or plans to conceive from two weeks before the study start
             through six months after the last dose of study vaccine

          6. Known or suspected impairment of immunological function, including but not limited to
             autoimmune diseases, splenectomy, or HIV/AIDS

          7. Chronic administration (defined as more than 14 days in total) of immune-suppressive
             or other immune-modifying drug with six months prior to the product dose (for
             corticosteroids, this is defined as prednisone ≥20 mg/day or equivalent). Inhaled and
             topical steroids are allowed

          8. Participation in another clinical study within 30 days or plans to participate in
             another treatment based clinical study during the conduct of the present study

          9. Any skin abnormality or tattoo that would limit post-vaccination injection site
             assessment

         10. Any history of cancer requiring chemotherapy or radiation within 5 years of
             randomization or current disease

         11. Are family members of study center staff