Safety and Immunogenicity of CRV-101 Vaccine for the Prevention of Herpes Zoster in Adults Aged 50 Years and Older
- Conditions
- ShinglesHerpes Zoster
- Interventions
- Biological: CRV-101 Vaccine Antigen High DoseBiological: CRV-101 Vaccine Adjuvant Low DoseBiological: CRV-101 Vaccine Antigen Low DoseBiological: CRV-101 Vaccine Adjuvant Middle DoseBiological: CRV-101 Vaccine Adjuvant High Dose
- Registration Number
- NCT05304351
- Lead Sponsor
- Curevo Inc
- Brief Summary
The purpose of this study is to assess the safety and immunogenicity of 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 CRV-101 Vaccine high antigen dose, CRV-101 Vaccine low antigen dose, or Shingrix. In the second part of the trial, participants will be randomized 5:1 to receive CRV-101 high adjuvant dose, middle adjuvant dose, or low adjuvant dose versus Shingrix. Both study vaccines, CRV-101 Vaccine 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 up to 6 years.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 876
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Arm A CRV-101 Vaccine Antigen High Dose Investigational Vaccine Arm C & G Shingrix Active comparator Arm F CRV-101 Vaccine Adjuvant Low Dose Investigational Vaccine Arm B CRV-101 Vaccine Antigen Low Dose Investigational Vaccine Arm E CRV-101 Vaccine Adjuvant Middle Dose Investigational Vaccine Arm D CRV-101 Vaccine Adjuvant High Dose Investigational Vaccine
- Primary Outcome Measures
Name Time Method 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 serious adverse events (SAEs) Day 0 - Extension year 6 (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 and relationship to vaccination of all related or fatal serious adverse events (SAE) in study participants in long-term follow up (LTFU) up to 6 years.
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 CRV-101 Vaccine 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 adverse events (AEs) of special interest Day 0 - Extension year 6 (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 \[Month 14\]), and in LTFU up to 6 years.
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 Month 0 and Month 3
To compare the humoral immune response of Shingrix® to CRV-101 Vaccine Month 3 Comparison of humoral response between CRV-101 Vaccine and Shingrix at Month 3
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 Month 3 • Assess humoral immune response as determined by Enzyme-linked Immunosorbent Assay (ELISA)
- 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 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 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 CRV-101 Vaccine between Month 0 and Month 3 Month 3 To compare CMI immune response between CRV-101 Vaccine 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 Month 3 To assess the cell-mediated immunity (CMI) immune response to vaccination as determined by intracellular cytokine staining (ICS)
Trial Locations
- Locations (1)
Curevo Investigational Site
🇺🇸San Antonio, Texas, United States