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Safety and Immunogenicity of CRV-101 Vaccine for the Prevention of Herpes Zoster in Adults Aged 50 Years and Older

NCT05304351 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1516

Last updated 2025-09-30

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and immunogenicity of amezosvatein (CRV-101), an investigational vaccine compared to Shingrix® for the prevention of herpes zoster in adults aged 50 years and older

Conditions

  • Herpes Zoster
  • Shingles

Interventions

BIOLOGICAL

Amezosvatein Antigen High Dose Arm A

Suspension for injection administered intramuscularly (IM) in the deltoid region of the non-dominant arm in Month 0 and Month 2 per study schedule

BIOLOGICAL

Amezosvatein Antigen Low Dose Arm B

Suspension for injection administered intramuscularly (IM) in the deltoid region of the non-dominant arm in Month 0 and Month 2 per study schedule

BIOLOGICAL

Shingrix

Suspension for injection administered intramuscularly (IM) in the deltoid region of the non-dominant arm in Month 0 and Month 2 per study schedule

BIOLOGICAL

Amezosvatein Adjuvant Dose Arm D

Suspension for injection administered intramuscularly (IM) in the deltoid region of the non-dominant arm in Month 0 and Month 2 per study schedule

BIOLOGICAL

Amezosvatein Adjuvant Dose Arm F

Suspension for injection administered intramuscularly (IM) in the deltoid region of the non-dominant arm in Month 0 and Month 2 per study schedule

BIOLOGICAL

Amezosvatein Adjuvant Dose Arm H

Suspension for injection administered intramuscularly (IM) in the deltoid region of the non-dominant arm in Month 0 and Month 2 per study schedule

BIOLOGICAL

Amezosvatein Adjuvant Dose Arm J

Suspension for injection administered intramuscularly (IM) in the deltoid region of the non-dominant arm in Month 0 and Month 2 per study schedule

BIOLOGICAL

Amezosvatein Adjuvant Dose Arm L

Suspension for injection administered intramuscularly (IM) in the deltoid region of the non-dominant arm in Month 0 and Month 2 per study schedule

Sponsors & Collaborators

  • Curevo Inc

    lead INDUSTRY

Principal Investigators

  • Lisa Shelton, ARNP · Curevo Inc

  • Guy De La Rosa, MD · Curevo Inc

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-02
Primary Completion
2026-06-30
Completion
2032-03-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05304351 on ClinicalTrials.gov