Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT05304351
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-30
First Post:
2021-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity of CRV-101 Vaccine for the Prevention of Herpes Zoster in Adults Aged 50 Years and Older
Sponsor:
Curevo Inc
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: