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

Phase 2

Recruiting

• Conditions: Shingles; Herpes Zoster
• Interventions: Biological: Amezosvatein Antigen High Dose Arm A; Biological: Amezosvatein Antigen Low Dose Arm B; Biological: Shingrix; Biological: Amezosvatein Adjuvant Dose Arm D; Biological: Amezosvatein Adjuvant Dose Arm F; Biological: Amezosvatein Adjuvant Dose Arm H; Biological: Amezosvatein Adjuvant Dose Arm J; Biological: Amezosvatein Adjuvant Dose Arm L

• Registration Number: NCT05304351
• Lead Sponsor: Curevo Inc

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 Timeline

• Study First Submitted: 2021-12-07
• Study Start: 2022-02-02
• Study First Submitted QC: 2022-03-22
• Study First Posted: 2022-03-31
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-23
• Last Update Posted: 2025-06-26
• Primary Completion: 2026-06-30
• Study Completion: 2032-03-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1516

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Amezosvatein Antigen High Dose Arm A	Investigational Vaccine
Arm B	Amezosvatein Antigen Low Dose Arm B	Investigational Vaccine
Arm C	Shingrix	Active comparator
Arm D	Amezosvatein Adjuvant Dose Arm D	Investigational Vaccine
Arm E	Shingrix	Active Comparator
Arm F	Amezosvatein Adjuvant Dose Arm F	Investigational Vaccine
Arm G	Shingrix	Active Comparator
Arm H	Amezosvatein Adjuvant Dose Arm H	Investigational Vaccine
I	Shingrix	Active Comparator
Arm J	Amezosvatein Adjuvant Dose Arm J	Investigational Vaccine
Arm K	Shingrix	Active Comparator
Arm L	Amezosvatein Adjuvant Dose Arm L	Investigational Vaccine
Arm M	Shingrix	Active Comparator

Primary Outcome Measures

Name	Time	Method
Occurrence of serious adverse events (SAEs)	Day 0 - Day 421 [Month 14] (as noted in description)	Occurrence and relationship to vaccination of all serious adverse events (SAE) from after first vaccination (Day 0) to main study end (Day 421 \[Month 14\])
Occurrence of solicited local and systemic signs and symptoms	Day 0-Day 6 for each vaccination timepoint	Occurrence, severity, and duration of solicited local injection site reactions within 7 days (Day 0-Day 6) following each vaccination. (i.e., pain, redness, swelling); Occurrence, severity, and duration of solicited systemic reactions within 7 days (Day 0-Day 6) following each vaccination. (i.e., myalgia, fatigue, headache, chills, fever)
To compare the reactogenicity of amezosvatein to that of the standard 2-dose schedule of Shingrix®	Day 0-Day 6 for each vaccination timepoint	Comparison of the proportion of participants reporting solicited local and systemic reactogenicity events following each vaccination
Occurrence of unsolicited non-serious adverse events	Day 0-Day 28 following each vaccination	Occurrence, severity, and relationship to vaccination of unsolicited adverse events within 29 days (Day 0-Day 28) following each vaccination
Occurrence of adverse events (AEs) of special interest	Day 0 - Day 421 [Month 14] (as noted in description)	Occurrence of any Potential Immune-Mediated Medical Conditions (PIMMCs) from post first vaccination (Day 0) to main study end (Day 421 \[Month 14\]); Medically attended adverse events (MAAEs) from post first vaccination (Day 0) to study end (Day 421 \[Month 14\])
To evaluate safety as measured by hematology and biochemistry parameters	Day 7 and Day 63	Occurrence, intensity, and relationship to vaccination of clinically significant hematologic and biochemical adverse events at at Day 7 and Day 63
Vaccine protein-specific antibody concentrations (GMC) elicited by vaccination between Month 0 and Month 3	Month 3	Assess humoral immune response as determined by Enzyme-linked Immunosorbent Assay (ELISA)
Vaccine Response Rate (≥ 4 fold increase in antibody concentration from pre-vaccination) at Month 3 for arms A, B, and C	Month 3	• Assess humoral immune response as determined by Enzyme-linked Immunosorbent Assay (ELISA)
To compare the humoral immune response of Shingrix® to amezosvatein	Month 3	Comparison of humoral response between amezosvatein and Shingrix at Month 3

Secondary Outcome Measures

Name	Time	Method
Fold rise of vaccine protein-specific antibody concentrations elicited in response to vaccination for durability post Month 3	Month 3	• Assess humoral immune response as determined by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-Varicella Zoster Virus (VZV) neutralizing antibody titer in response to vaccination between Day 0 and Month 3 for arms A, B, and C	Month 3	To assess the functional humoral immune response to vaccination (sub-study)
Frequency of vaccine protein-specific CD4+ T cells expressing at least 2 activation markers in response to vaccination between Month 0 and Month 3 for arms A, B, and C	Month 3	To assess the cell-mediated immunity (CMI) immune response to vaccination as determined by intracellular cytokine staining (ICS)
To compare the frequency of vaccine protein-specific CD4+ T cells expressing at least 2 activation markers of Shingrix® to amezosvatein between Month 0 and Month 3 for arms A, B, and C.	Month 3	To compare CMI immune response between amezosvatein and Shingrix® at Month 3
CMI Vaccine Response rate (≥ 2-fold increase in the frequency of vaccine protein-specific CD4+ T cell expressing at least 2 activation markers) at Month 3 for arms A, B, and C.	Month 3	To assess the cell-mediated immunity (CMI) immune response to vaccination as determined by intracellular cytokine staining (ICS)
Vaccine Response Rate (≥ 4 fold increase in antibody concentration from pre-vaccination) at Month 3 for arms D through M	Month 3	Assess humoral immune response as determined by Enzyme-linked Immunosorbent Assay (ELISA)

Trial Locations

Locations (1)

Curevo Investigational Site; 🇺🇸 Salt Lake City, Utah, United States