NCT01986010

Safety, Tolerability, and Immunogenicity of the Human Cytomegalovirus Vaccine (V160) in Healthy Adults (V160-001)

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cytomegalovirus Infections

Interventions

Type	Name	Description
BIOLOGICAL	V160 Low Dose IM	V160 administered as a 0.75 mL intramuscular injection
BIOLOGICAL	V160 Medium Dose IM	V160 administered as a 0.75 mL intramuscular injection
BIOLOGICAL	V160 High Dose IM	V160 administered as a 0.75 mL intramuscular injection
BIOLOGICAL	V160 Medium Dose plus Merck Aluminum Phosphate Adjuvant (MAPA) 225 µg /dose IM	V160 plus MAPA administered as a 0.75 mL intramuscular injection
BIOLOGICAL	V160 High Dose plus MAPA 225 µg /dose IM	V160 plus MAPA administered as a 0.75 mL intramuscular injection
BIOLOGICAL	V160 Maximum Dose IM	V160 administered as a 0.75 mL intramuscular injection
OTHER	Placebo IM	Placebo administered as a 0.75 mL intramuscular injection
BIOLOGICAL	V160 Medium Dose ID	V160 administered as a 0.1 mL intradermal injection
OTHER	Placebo ID	Placebo administered as a 0.1 mL intradermal injection

Timeline

• Start date: 2013-11-25
• Primary completion: 2016-04-19
• Completion: 2017-03-14
• First posted: 2013-11-18
• Last updated: 2021-11-01
• Results posted: 2021-11-01