NCT05304351

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

A Randomized, Observer-Blind, Phase 2 Study To Assess the Safety and Immunogenicity of CRV-101 Vaccine Head-To-Head With SHINGRIX® for the Prevention of Herpes Zoster in Adults Aged 50 Years and Older

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,516 (actual)
• Sponsor: Curevo Inc · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

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

Detailed description

In the first part of the trial, participants will be randomized 1:1:1 to amezosvatein high antigen dose (Arm A), amezosvatein low antigen dose (B), or Shingrix (C). In the second part of the trial, participants will be randomized 5:1 to receive amezosvatein adjuvant dose D or Shingrix (E), adjuvant dose F or Shingrix (G), or adjuvant dose H or Shingrix (I). In the third part of the trial, participants will be randomized 3:1 to receive amezosvatein adjuvant dose J or Shingrix (K) or amezosvatein adjuvant dose L or Shingrix (M). Both study vaccines, amezosvatein and Shingrix, will be administered by intramuscular injection on Month 0 and Month 2. Safety, reactogenicity, and immunogenicity analysis will be performed overall and by age group. Participants will be followed for safety, immunogenicity, and herpes zoster cases from Day 0 to the main study end (Month 14), and through the long-term follow up (LTFU) extension period of up to 5 additional years.

Conditions

• Herpes Zoster
• Shingles

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-02-02
• Primary completion: 2026-06-30
• Completion: 2032-03-06
• First posted: 2022-03-31
• Last updated: 2025-09-30

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study