Herpes ZosterPhase 2NCT05304351
Safety and Immunogenicity of CRV-101 Vaccine for the Prevention of Herpes Zoster in Adults Aged 50 Years and Older
A Phase 2 study testing Amezosvatein Antigen High Dose Arm A, Amezosvatein Antigen Low Dose Arm B and Shingrix in people with Herpes Zoster and Shingles, run by Curevo Inc at 14 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Herpes Zoster, Shingles
- What is being tested?
- Amezosvatein Antigen High Dose Arm A, Amezosvatein Antigen Low Dose Arm B and Shingrix
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,516 participants
- Where
- 14 sitesUnited States
- Study dates
- 2 Feb 2022to 6 Mar 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Male and non-pregnant female participant must be ≥50 years of age inclusive, at the time of signing the informed consent.
- Arms A, B, C, J, K, L, and M will enroll participants ≥50 years of age
- Arms D, E, F, G, H, and I will enroll participants ≥50 to <70 years of age
- Participants who are healthy as determined by medical evaluation including comprehensive medical history, comprehensive physical examination, vital signs*, and screening laboratory tests conducted no more than 30 days prior to first study injection administration (Day 0).
- Vital signs within grade 1 on the severity grading scale, excluding temperature, are allowed. If vital sign parameter meets grade 2 criteria, then subject must be excluded. Vital signs may be repeated 3 times after a period of rest as needed if transient abnormal fluctuation is suspected.
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- (Applicable only for arms A through I) Completed an Emergency Use Authorization (EUA) or Conditional Marketing Authorization or licensed initial COVID-19 vaccine series (as applicable) ≥30 days prior to enrollment (i.e., at least 30 days prior to the Day 0 visit).
- Screening laboratory values [sodium, potassium, blood urea nitrogen (BUN), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), total bilirubin, alkaline phosphatase, creatinine, random glucose, white blood cell count with differential, hemoglobin, and platelet count] must be within normal ranges or considered not clinically significant by the PI.**
- Negative HIV 1/2 antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody at screening. If HIV 1/2 antibody is positive, and confirmation testing is negative the participant may be enrolled.
- Normal urinalysis or, if abnormal, urinalysis determined to be not clinically significant by the PI at screening.**
- Screening laboratory values that are abnormal but are considered abnormal due to an acute illness or process may be repeated once. Careful consideration regarding enrolling subjects with screening lab values meeting grade 2 severity that are considered not clinically significant must be made as there is less room for fluctuations to increase to gr ade 3 (severe) lab events.
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
- Is a woman of nonchildbearing potential (WONCBP). OR
- Is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method as defined below during the 30 days prior to Day 0 (i.e., the first study vaccine) and is willing to continue to do so during the study until at least 90 days after the last dose of study vaccine, and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relation to the timing of the first dose of study vaccine.
- A WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test on the day of each study vaccine (prior to vaccination). If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
- WONCBP is as defined as
- Postmenopausal: A postmenopausal state is defined as least 12 months of spontaneous amenorrhea.
- Permanently sterile: Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, bilateral oophorectomy, and successful Essure® placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or <1 year since of the last menses if menopausal.
- WOCBP is defined as
- Any woman or adolescent who has begun menstruation. Acceptable contraception methods include, but are not limited to, sexual abstinence, monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the participant receiving study product, barrier methods such as condoms or diaphragms with spermicide or foam, effective intrauterine devices, NuvaRing®, and licensed hormonal methods such as implants, injectables, or oral contraceptives ("the pill").
- Capable of understanding and giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol prior to any screening procedures.
- Willing to abstain from donating whole blood or blood derivatives until after Day 84 visit, and within 60 days prior to each study visit after Day 84.
- Be able and willing to participate in all study visits and be reachable by telephone or personal contact by the study site personnel.
- Participants who the investigator believes will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits, have regular contact to allow evaluation during the study).
- Capable of understanding and completing diary card. Arms A, B, and C use electronic diary and require access to web browser. Arms D through M use paper diary
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- History of herpes zoster (shingles).
- History or presence of acute or chronic illness (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, hematological, metabolic, gastrointestinal, endocrinologic or renal disorders, or uncontrolled hypertension) which in the opinion of the Principal Investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine.
- History of autoimmune disease or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, HIV infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders) that is likely to affect the immune response to vaccination as determined by the PI.
- Rash, tattoos, or any other dermatological condition that could adversely affect the vaccine injection site or interfere with its evaluation.
- Abnormal blood pressure >150 mm Hg systolic or >95 mm Hg diastolic prior to first study injection administration (Day 0).***
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- If abnormal, BP may be repeated up to 3 times after a rest period of 5 minutes between each measurement.
- History of significant psychiatric illness (including history of suicidal ideation or attempt) with or without current medication.
- BMI ≥40kg/m2 at screening (where BMI >34.9 kg/m2, clinically-significant abnormal serum glucose at screening determined by the PI, or clinically-significant diseases or medical conditions, as determined by the PI, is exclusionary.)
- Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 4 years).
- Acute disease and/or fever at the time of enrollment (Day 0).
- Fever is defined as body temperature ≥38 °C (100.4 °F); oral acquisition will be the preferred route for recording temperature throughout this study.
- Participants with a minor illness (such as mild diarrhea or mild upper respiratory infection) without fever may be enrolled after resolution of the minor illness, at the discretion of the investigator.
- Immunized with a vaccine against herpes zoster (Zostavax®, Shingrix®, other licensed or investigational HZ vaccine).
- Prior varicella vaccination at any time.
- Received any vaccine within 30 days prior to enrollment (Day 0) or received any non-investigational immunizations while on study except for seasonal influenza, pneumococcal vaccines, other vaccines per the ACIP recommendations, or any licensed or emergency use authorization or conditional marketing authorized COVID-19 booster. Administration of these immunizations must not occur until 30 days after the final study vaccination and completion of the Day 84 immunology blood draw and must not occur within the 30 days prior to each on-study immunology blood draw after Day 84. Receipt of any VZV vaccine is prohibited on the study.
- Use of any medication that, in the opinion of the Principal Investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine.
- (a) Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs (e.g., oral or injected steroids, such as prednisone; high-dose inhaled steroids; biologics (e.g., tumor necrosis factor [TNF] inhibitor, or other cytokine inhibitors within 14 days of Day 0 through Day 84, and within 14 days of each on study immunogenicity blood draw after Day 84; Exclusionary corticosteroid administration is defined as prednisone >20 mg/day (or equivalent) for any frequency; low-dose inhaled and topical and ocular steroids are allowed; (b) or cytotoxic therapies, such as chemotherapy drugs or radiation, from 180 days prior to enrollment, during the study through Day 421.
- Participants who meet this criterion from 14a and 14b after Day 56, should continue to be followed for safety and immunogenicity but will not be in included in the per protocol population from the date of meeting the criterion.
- Received a blood transfusion, platelets, plasma, or immunoglobulin 90 days prior to first dose of study vaccine (Day 0) or planned administration of such products during the study.
- Donated blood products (platelets, whole blood, plasma, etc.) within 60 days prior to enrollment (Day 0).
- Participation in another experimental protocol which includes the receipt of any investigational products/vaccines or devices within 90 days prior to enrollment (Day 0) in this study, or planned participation in another experimental protocol which includes investigational product/vaccine or device receipt during the study period through D421*. After the D421 visit, participation in another clinical study and with concurrent receipt of another experimental investigational product/vaccine or device is allowed with medical monitor approval. Any other investigational product/vaccine with immune modulating effect which would complicate the assessment of humoral and cellular responses, including investigational vaccines, must not be used 60 days prior to each LTFU extension year visit. Receipt of another experimental VZV vaccine or HSV vaccine is prohibited on the study.
- Prior to Day 421, concurrent participation in a study which previously included investigational product/vaccine receipt but is no longer receiving investigational products/vaccine, such as in an observational phase of the other study, is allowed.
- History of previous anaphylaxis or severe allergic reaction to vaccines or sensitivity to any of the study vaccines, or components thereof, or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study.
- Known or suspected alcohol or drug abuse within 5 years prior to enrollment (Day 0).
- ≥20 pack-years for a current smoker or a former smoker at screening.
- Unlikely to cooperate with the requirements of the study protocol, or deemed unreliable in attending study visits, or otherwise determined by the investigator not to be a good candidate to participate in this study.
- [protocol v8.0]
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Curevo Investigational Site
Austin, Texas, 78745
Curevo Investigational Site
Coral Gables, Florida, 33134
Curevo Investigational Site
Dallas, Texas, 75251
Curevo Investigational Site
Edmond, Oklahoma, 73013
Curevo Investigational Site
Euless, Texas, 76040
Curevo Investigational Site
Knoxville, Tennessee, 37909
Curevo Investigational Site
Las Vegas, Nevada, 89119
Curevo Investigational Site
Lenexa, Kansas, 66219
Curevo Investigational Site
Lexington, Kentucky, 40509
Curevo Investigational Site
Newton, Kansas, 67114
Curevo Investigational Site
Oak Brook, Illinois, 60523
Curevo Investigational Site
Salt Lake City, Utah, 84107
Curevo Investigational Site
Tampa, Florida, 33616
Curevo Investigational Site
Tempe, Arizona, 85281
About this study
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
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
Read the 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
- Being tested
- Amezosvatein Antigen High Dose Arm A, Amezosvatein Antigen Low Dose Arm B, Shingrix, Amezosvatein Adjuvant Dose Arm D, Amezosvatein Adjuvant Dose Arm F
- Keywords
- Herpes Zoster, Shingles, Varicella Zoster Virus, Vaccine
- Medical subject headings
- Herpes Zoster, Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amezosvatein Antigen High Dose Arm ABiological
Suspension for injection administered intramuscularly (IM) in the deltoid region of the non-dominant arm in Month 0 and Month 2 per study schedule
Amezosvatein Antigen Low Dose Arm BBiological
Suspension for injection administered intramuscularly (IM) in the deltoid region of the non-dominant arm in Month 0 and Month 2 per study schedule
ShingrixBiological
Suspension for injection administered intramuscularly (IM) in the deltoid region of the non-dominant arm in Month 0 and Month 2 per study schedule
Amezosvatein Adjuvant Dose Arm DBiological
Suspension for injection administered intramuscularly (IM) in the deltoid region of the non-dominant arm in Month 0 and Month 2 per study schedule
Amezosvatein Adjuvant Dose Arm FBiological
Suspension for injection administered intramuscularly (IM) in the deltoid region of the non-dominant arm in Month 0 and Month 2 per study schedule
Amezosvatein Adjuvant Dose Arm HBiological
Suspension for injection administered intramuscularly (IM) in the deltoid region of the non-dominant arm in Month 0 and Month 2 per study schedule
Amezosvatein Adjuvant Dose Arm JBiological
Suspension for injection administered intramuscularly (IM) in the deltoid region of the non-dominant arm in Month 0 and Month 2 per study schedule
Amezosvatein Adjuvant Dose Arm LBiological
Suspension for injection administered intramuscularly (IM) in the deltoid region of the non-dominant arm in Month 0 and Month 2 per study schedule
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Investigational Vaccine Receives: Biological: Amezosvatein Antigen High Dose Arm A |
| Arm B | Experimental | Investigational Vaccine Receives: Biological: Amezosvatein Antigen Low Dose Arm B |
| Arm C | Active comparator | Active comparator Receives: Biological: Shingrix |
| Arm D | Experimental | Investigational Vaccine Receives: Biological: Amezosvatein Adjuvant Dose Arm D |
| Arm E | Active comparator | Active Comparator Receives: Biological: Shingrix |
| Arm F | Experimental | Investigational Vaccine Receives: Biological: Amezosvatein Adjuvant Dose Arm F |
| Arm G | Active comparator | Active Comparator Receives: Biological: Shingrix |
| Arm H | Experimental | Investigational Vaccine Receives: Biological: Amezosvatein Adjuvant Dose Arm H |
| I | Active comparator | Active Comparator Receives: Biological: Shingrix |
| Arm J | Experimental | Investigational Vaccine Receives: Biological: Amezosvatein Adjuvant Dose Arm J |
| Arm K | Active comparator | Active Comparator Receives: Biological: Shingrix |
| Arm L | Experimental | Investigational Vaccine Receives: Biological: Amezosvatein Adjuvant Dose Arm L |
| Arm M | Active comparator | Active Comparator Receives: Biological: Shingrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of solicited local and systemic signs and symptoms
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)
Measured: Day 0-Day 6 for each vaccination timepoint
To compare the reactogenicity of amezosvatein to that of the standard 2-dose schedule of Shingrix®
Comparison of the proportion of participants reporting solicited local and systemic reactogenicity events following each vaccination
Measured: Day 0-Day 6 for each vaccination timepoint
Occurrence of unsolicited non-serious adverse events
Occurrence, severity, and relationship to vaccination of unsolicited adverse events within 29 days (Day 0-Day 28) following each vaccination
Measured: Day 0-Day 28 following each vaccination
Occurrence of serious adverse events (SAEs)
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])
Measured: Day 0 - Day 421 [Month 14] (as noted in description)
Occurrence of adverse events (AEs) of special interest
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])
Measured: Day 0 - Day 421 [Month 14] (as noted in description)
To evaluate safety as measured by hematology and biochemistry parameters
Occurrence, intensity, and relationship to vaccination of clinically significant hematologic and biochemical adverse events at at Day 7 and Day 63
Measured: Day 7 and Day 63
Vaccine protein-specific antibody concentrations (GMC) elicited by vaccination between Month 0 and Month 3
Assess humoral immune response as determined by Enzyme-linked Immunosorbent Assay (ELISA)
Measured: Month 3
Vaccine Response Rate (≥ 4 fold increase in antibody concentration from pre-vaccination) at Month 3 for arms A, B, and C
- Assess humoral immune response as determined by Enzyme-linked Immunosorbent Assay (ELISA)
Measured: Month 3
To compare the humoral immune response of Shingrix® to amezosvatein
Comparison of humoral response between amezosvatein and Shingrix at Month 3
Measured: Month 3
Secondary outcomes (6)
Fold rise of vaccine protein-specific antibody concentrations elicited in response to vaccination for durability post Month 3
- Assess humoral immune response as determined by Enzyme-linked Immunosorbent Assay (ELISA)
Measured: Month 3
Anti-Varicella Zoster Virus (VZV) neutralizing antibody titer in response to vaccination between Day 0 and Month 3 for arms A, B, and C
To assess the functional humoral immune response to vaccination (sub-study)
Measured: Month 3
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
To assess the cell-mediated immunity (CMI) immune response to vaccination as determined by intracellular cytokine staining (ICS)
Measured: Month 3
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.
To compare CMI immune response between amezosvatein and Shingrix® at Month 3
Measured: 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.
To assess the cell-mediated immunity (CMI) immune response to vaccination as determined by intracellular cytokine staining (ICS)
Measured: Month 3
Vaccine Response Rate (≥ 4 fold increase in antibody concentration from pre-vaccination) at Month 3 for arms D through M
Assess humoral immune response as determined by Enzyme-linked Immunosorbent Assay (ELISA)
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start2 Feb 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion6 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,516 participants (actual)
Sponsor and investigators
- Lead sponsor
- Curevo Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa Shelton, ARNP, Study director, Curevo IncGuy De La Rosa, MD, Study director, Curevo Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05304351
- Sponsor's protocol ID
- CRV-101-101
- Status last verified
- Sep 2025
- First submitted
- 7 Dec 2021
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05304351
- Acronym / sponsor ID
- CRV-101-101
- Conditions
- Herpes Zoster, Shingles
- Keywords
- Herpes Zoster, Shingles, Varicella Zoster Virus, Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,516 participants (actual)
- Lead sponsor
- Curevo IncIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 6 Mar 2032 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Biological: Amezosvatein Antigen High Dose Arm AInvestigational Vaccine |
| Arm B | Experimental | Biological: Amezosvatein Antigen Low Dose Arm BInvestigational Vaccine |
| Arm C | Active comparator | Biological: ShingrixActive comparator |
| Arm D | Experimental | Biological: Amezosvatein Adjuvant Dose Arm DInvestigational Vaccine |
| Arm E | Active comparator | Biological: ShingrixActive Comparator |
| Arm F | Experimental | Biological: Amezosvatein Adjuvant Dose Arm FInvestigational Vaccine |
| Arm G | Active comparator | Biological: ShingrixActive Comparator |
| Arm H | Experimental | Biological: Amezosvatein Adjuvant Dose Arm HInvestigational Vaccine |
| I | Active comparator | Biological: ShingrixActive Comparator |
| Arm J | Experimental | Biological: Amezosvatein Adjuvant Dose Arm JInvestigational Vaccine |
| Arm K | Active comparator | Biological: ShingrixActive Comparator |
| Arm L | Experimental | Biological: Amezosvatein Adjuvant Dose Arm LInvestigational Vaccine |
| Arm M | Active comparator | Biological: ShingrixActive Comparator |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Male and non-pregnant female participant must be ≥50 years of age inclusive, at the time of signing the informed consent.
- Participants who are healthy as determined by medical evaluation including comprehensive medical history, comprehensive physical examination, vital signs*, and screening laboratory tests conducted no more than 30 days prior to first study injection administration (Day 0).
- (Applicable only for arms A through I) Completed an Emergency Use Authorization (EUA) or Conditional Marketing Authorization or licensed initial COVID-19 vaccine series (as applicable) ≥30 days prior to enrollment (i.e., at least 30 days prior to the Day 0 visit).
- Screening laboratory values [sodium, potassium, blood urea nitrogen (BUN), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), total bilirubin, alkaline phosphatase, creatinine, random glucose, white blood cell count with differential, hemoglobin, and platelet count] must be within normal ranges or considered not clinically significant by the PI.**
Key exclusion criteria (28 listed)
- History of herpes zoster (shingles).
- History or presence of acute or chronic illness (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, hematological, metabolic, gastrointestinal, endocrinologic or renal disorders, or uncontrolled hypertension) which in the opinion of the Principal Investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine.
- History of autoimmune disease or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, HIV infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders) that is likely to affect the immune response to vaccination as determined by the PI.
- Rash, tattoos, or any other dermatological condition that could adversely affect the vaccine injection site or interfere with its evaluation.
- Abnormal blood pressure >150 mm Hg systolic or >95 mm Hg diastolic prior to first study injection administration (Day 0).***
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amezosvatein Antigen High Dose Arm ASuspension for injection administered intramuscularly (IM) in the deltoid region of the non-dominant arm in Month 0 and Month 2 per study schedule | Biological | Arm A |
| Amezosvatein Antigen Low Dose Arm BSuspension for injection administered intramuscularly (IM) in the deltoid region of the non-dominant arm in Month 0 and Month 2 per study schedule | Biological | Arm B |
| ShingrixSuspension for injection administered intramuscularly (IM) in the deltoid region of the non-dominant arm in Month 0 and Month 2 per study schedule | Biological | Arm C, Arm E, Arm G, Arm K, Arm M, I |
| Amezosvatein Adjuvant Dose Arm DSuspension for injection administered intramuscularly (IM) in the deltoid region of the non-dominant arm in Month 0 and Month 2 per study schedule | Biological | Arm D |
| Amezosvatein Adjuvant Dose Arm FSuspension for injection administered intramuscularly (IM) in the deltoid region of the non-dominant arm in Month 0 and Month 2 per study schedule | Biological | Arm F |
| Amezosvatein Adjuvant Dose Arm HSuspension for injection administered intramuscularly (IM) in the deltoid region of the non-dominant arm in Month 0 and Month 2 per study schedule | Biological | Arm H |
| Amezosvatein Adjuvant Dose Arm JSuspension for injection administered intramuscularly (IM) in the deltoid region of the non-dominant arm in Month 0 and Month 2 per study schedule | Biological | Arm J |
| Amezosvatein Adjuvant Dose Arm LSuspension for injection administered intramuscularly (IM) in the deltoid region of the non-dominant arm in Month 0 and Month 2 per study schedule | Biological | Arm L |
Primary outcome
Occurrence of solicited local and systemic signs and symptoms
Time frame: 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®
Time frame: 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
Time frame: 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)
Time frame: 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 adverse events (AEs) of special interest
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Month 3
• Assess humoral immune response as determined by Enzyme-linked Immunosorbent Assay (ELISA)
To compare the humoral immune response of Shingrix® to amezosvatein
Time frame: Month 3
Comparison of humoral response between amezosvatein and Shingrix at Month 3
6 secondary outcomes
Fold rise of vaccine protein-specific antibody concentrations elicited in response to vaccination for durability post Month 3
Time frame: Month 3
Anti-Varicella Zoster Virus (VZV) neutralizing antibody titer in response to vaccination between Day 0 and Month 3 for arms A, B, and C
Time frame: Month 3
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
Time frame: Month 3
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.
Time frame: 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.
Time frame: Month 3
Vaccine Response Rate (≥ 4 fold increase in antibody concentration from pre-vaccination) at Month 3 for arms D through M
Time frame: Month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Shelton, ARNP study director
Curevo Inc
Guy De La Rosa, MD study director
Curevo Inc
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amezosvatein Antigen High Dose Arm A, Amezosvatein Antigen Low Dose Arm B and Shingrix in people with Herpes Zoster and Shingles, run by Curevo Inc at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of solicited local and systemic signs and symptoms (time frame: Day 0-Day 6 for each vaccination timepoint). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.