At a glance
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A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Human Cytomegalovirus Vaccine (V160) in Healthy Adults
In Brief
A Phase 1 clinical trial evaluating V160 Low Dose IM, V160 Medium Dose IM, and 7 other interventions for Cytomegalovirus Infections. Completed, enrolled 190 participants.
Detailed Summary
This study will evaluate the safety, tolerability, and immunogenicity of various doses, formulations, and routes of administration of Human Cytomegalovirus (HCMV) vaccine V160 administered in a 3-dose regimen in healthy adults. The initial treatment arm of HCMV seropositive participants will receive V160 Low Dose without adjuvant by intramuscular injection. Escalation of the V160 dose, inclusion of adjuvant, administration by intradermal injection, and vaccination of HCMV seronegative participants will be performed only after review of safety data of previous treatment arms. The purpose of the study is to identify vaccine formulations associated with optimal safety profile and HCMV-specific immune response for evaluation in subsequent clinical studies of V160.
Study Details
Timeline
Interventions
V160 administered as a 0.75 mL intramuscular injection
V160 administered as a 0.75 mL intramuscular injection
V160 administered as a 0.75 mL intramuscular injection
V160 plus MAPA administered as a 0.75 mL intramuscular injection
V160 plus MAPA administered as a 0.75 mL intramuscular injection
V160 administered as a 0.75 mL intramuscular injection
Placebo administered as a 0.75 mL intramuscular injection
V160 administered as a 0.1 mL intradermal injection
Placebo administered as a 0.1 mL intradermal injection