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

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

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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC

  lead INDUSTRY

Principal Investigators

• Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-11-25

Primary Completion

2016-04-19

Completion

2017-03-14