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.
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Percentage of Participants With an Adverse Event (AE)
Timeframe: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)
Percentage of Participants With an Injection-site AE
Timeframe: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)
Percentage of Participants With a Systemic AE
Timeframe: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)
Percentage of Participants With a Serious Adverse Event (SAE)
Timeframe: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)
Percentage of Participants With a Serious Vaccine-Related Adverse Event
Timeframe: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)
Percentage of Participants Who Discontinued Study Treatment Due to an AE
Timeframe: Up to Month 6
Percentage of Participants With Events of Clinical Interest (ECI)
Timeframe: Up to 18 months
Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccination 3
Timeframe: Month 7 (1 month after vaccination 3 at Month 6)