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A Study on the Reactogenicity, Safety and Immune Response of a Targeted Immunotherapy Against HSV in Healthy Japanese Participants Aged 18-40 Years

NCT05989672 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-06-12

Study results available
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Summary

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of 2 formulations of Herpes Simplex Virus (HSV)-Targeted Immunotherapy (HSVTI) in HSV-2 seronegative ethnic Japanese adults aged 18-40 years.

Conditions

  • Herpes Simplex

Interventions

BIOLOGICAL

HSVTI Formulation 1

This investigational intervention was administered intramuscularly to HSVTI\_F1 Group.

BIOLOGICAL

HSVTI Formulation 2

This investigational intervention was administered intramuscularly to HSVTI\_F2 Group.

BIOLOGICAL

Placebo

This intervention was administered intramuscularly to Placebo group.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-08
Primary Completion
2023-11-29
Completion
2024-04-24

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05989672 on ClinicalTrials.gov