Conditions: Cytomegalovirus Infections
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)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 128
Healthy volunteers: yes

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

Detailed description:
This study is designed to assess safety and immunogenicity of four dose formulations of cytomegalovirus (CMV) vaccine (0.5 μg gB content with aluminum phosphate (alum), 1.0 μg glycoprotein B (gB) content with alum, 2.0 μg gB content with alum, or 1.0 μg gB content (without alum) as compared with placebo in approximately 125 healthy CMV-seronegative volunteer participants between 18 and 40 years of age.

Arms:
arm 1: 0.5µg CMV vaccine with adjuvant arm 2: 1.0µg CMV vaccine with adjuvant arm 3: 2.0 µg CMV vaccine with adjuvant arm 4: 1.0µg CMV vaccine without adjuvant arm 5: Buffer/sucrose used for VBI-1501 suspension

Interventions: intervention 1: VBI-1501A 0.5 μg intervention 2: VBI-1501A 1.0 μg intervention 3: VBI-1501A 2.0 μg intervention 4: VBI-1501 1.0 μg intervention 5: Placebo
Intervention descriptions: intervention 1: VBI-1501A: 0.5 μg with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 intervention 2: VBI-1501A: 1.0 μg with alum with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 intervention 3: VBI-1501A: 2.0 μg with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 intervention 4: VBI-1501: 1.0 μg without alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 intervention 5: buffer/sucrose used for VBI-1501 suspension- administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168.

Protocol document: