Herpes ZosterPhase 1NCT03820414
Safety, Tolerability, and Immunogenicity of CRV-101 in Healthy Adult Subjects
A Phase 1 study testing CRV 101 in people with Herpes Zoster and Varicella Zoster, run by Curevo Inc at 1 site in United States.
Trial summary
The purpose of this clinical trial is to evaluate the safety, tolerability, and immunogenicity of vaccine candidate CRV-101, investigational vaccine in healthy adult subjects in the United States. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Herpes Zoster, Varicella Zoster
- What is being tested?
- CRV 101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2019to 30 Apr 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and non-pregnant females ≥ 18 to < 50 years of age at the time of enrollment.
- In good general health as confirmed by a medical history and physical exam, vital signs*, and screening laboratories conducted no more than 30 days prior to study injection administration.
- Oral Temperature <38°C, respiratory rate < 17 breaths pm, heart rate ≤100 bpm and >54 bpm, systolic blood pressure ≤150 mmHg and >89 mmHg, diastolic blood pressure ≤95 mmHg.
- NOTE: Athletically trained subjects with a heart rate ≥40 may be enrolled at the discretion of the principal investigator or designated licensed clinical investigator and reasoning must be documented.
- Screening laboratory values must be within normal range or not clinically significant as determined by the PI and approved by the Medical Monitor: sodium, potassium, BUN, ALT, AST, total bilirubin, alkaline phosphatase, creatinine, random glucose, WBC with differential, hemoglobin, and platelet count.
- Negative HIV 1/2 antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody.
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- Normal urinalysis or if abnormal determined to be not clinically significant by the PI and the Medical Monitor (trace protein is acceptable without medical monitor approval).
- Urine test result for recreational drugs/drugs of abuse that in the opinion of the PI would not be a concern for subject's safety, or ability to reliably attend visits, and perform required protocol procedures. If urine drug test is positive, reasoning for inclusion must be documented.
- Females of childbearing potential* must have a negative serum pregnancy test at screening and a negative urine pregnancy test on the day of each study vaccination (prior to vaccination), must not be breast-feeding, and women in sexual relationships with men must agree to practice acceptable contraception** for the 30-day period before Day 0 through 90 days after the last study injection. These precautions are necessary due to unknown effects that CRV-101 might cause in a fetus or newborn infant.
- Not sterilized via tubal ligation, bilateral oophorectomy, hysterectomy or 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 of the last menses if menopausal). Post-menopausal defined as at least 12 months spontaneous amenorrhea and confirmed with FSH > 40 mIU/ml.
- Includes, but is not limited to, sexual abstinence, monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the subject 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").
- Exposure to VZV as documented by one of the following: subject reported clinical history of chickenpox, previous vaccination against VZV with Varivax® (or other low-titer live-attenuated varicella vaccine), or positive serology test for VZV.
- Must be able to understand informed consent in English and capable of completing a study diary card in English.
- Must provide informed consent prior to any screening procedures performed, be able and willing to make all study visits, be reachable by telephone or personal contact by the study site personnel, and have a permanent address.
- Willing to abstain from donating whole blood or blood derivatives until after Day 365 visit.
Who cannot join
- History of chickenpox or herpes zoster in the past 3 years.
- Immunization with a vaccine against herpes zoster (Zostavax® or Shingrix®).
- Participation in another experimental protocol with last receipt of any device, vaccine, or other immunomodulator investigational products within the past 180 days of enrollment, or last receipt of non-device, non-vaccine, non-immunomodulator investigational products with in the last 90 days of enrollment or 5 half-lives whichever is greater, or planned participation in any other investigational study during the study period.
- 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. TNF inhibitor, or other cytokine inhibitors) or cytotoxic therapies, such as chemotherapy drugs or radiation) within 180 days prior to enrollment and during the study through Day 365 visit. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Low dose inhaled and topical steroids are allowed.
- Received a blood transfusion or immunoglobulin within past 90 days of enrollment.
- Donated blood products (platelets, whole blood, plasma, etc.) within past 60 days of enrollment.
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- Received any vaccine within past 30 days prior to enrollment and no planned immunizations while on study with the exception of seasonal influenza vaccine which must not be given until 30 days after the last study injection and the Day 84 immunology blood has been drawn and a 30 day window prior to each immunology blood draw (Day 196, 365).
- History of autoimmune disease or other causes of immunosuppressive states.
- History of any acute or chronic illness (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, hematological, metabolic or renal disorders, controlled hypertension), or use of medication that, in the opinion of the Principal Investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine.
- Rash, tattoos, or any other dermatological condition that could adversely affect the vaccine injection site or interfere with its evaluation.
- BMI that poses a health risk in the opinion of the Principal Investigator.
- Hypertension (systolic >150 or diastolic >95).
- History of significant psychiatric illness (including past history of suicidal ideation or attempt) with or without current use of medication.
- Known or suspected alcohol or drug abuse within the past 5 years.
- Chronic smoker (> 20 pack years).
- Subjects with a history of previous anaphylaxis or severe allergic reaction to vaccines or unknown allergens.
- Subjects who are unlikely to cooperate with the requirements of the study protocol or who are likely to be unreliable in attending study visits or other reason that the Principal Investigator determines that the subject will not be a good candidate to participate in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114
About this study
Official title: A Phase 1, Randomized, Placebo-Controlled, Observer-Blind, Antigen Dose-Escalation and Adjuvant Dose-Ranging Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of CRV-101 in Healthy Adult Subjects
The purpose of this clinical trial is to evaluate the safety, tolerability, and immunogenicity of vaccine candidate CRV-101, investigational vaccine in healthy adult subjects in the United States.
- Conditions
- Herpes Zoster, Varicella Zoster
- Being tested
- CRV 101, Placebo
- Keywords
- VZV, Vaccine, Shingles
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRV 101Biological
(Different formulations)
PlaceboBiological
Also called Saline injection
2 doses administered IM in deltoid region of non-dominant arm
| Study group | Role | What they receive |
|---|---|---|
| CRV101 Group 1 | Experimental | Subjects receive 2 doses of the candidate CRV-101 formulation 1, administered intramuscularly (IM) in deltoid region of non-dominant arm, according to a 0, 2 Month schedule. Receives: Biological: CRV 101 |
| CRV 101 Group 2 | Experimental | Subjects receive 2 doses of the candidate CRV-101 formulation 2, administered intramuscularly (IM) in deltoid region of non-dominant arm, according to a 0, 2 Month schedule. Receives: Biological: CRV 101 |
| CRV 101 Group 3 | Experimental | Subjects receive 2 doses of the candidate CRV-101 formulation 3, administered intramuscularly (IM) in deltoid region of non-dominant arm, according to a 0, 2 Month schedule. Receives: Biological: CRV 101 |
| CRV 101 Group 4 | Experimental | Subjects receive 2 doses of the candidate CRV-101 formulation 4, administered intramuscularly (IM) in deltoid region of non-dominant arm, according to a 0, 2 Month schedule. Receives: Biological: CRV 101 |
| Control Group | Placebo comparator | Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of non-dominant arm, according to a 0, 2 Month schedule. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of subjects experiencing solicited local injection site reactions within 7 days following each study injection.
Measured: 7 Days
The number of subjects experiencing solicited systemic reactions within 7 days following each study injection.
Measured: 7 Days
The number of subjects spontaneously reporting unsolicited adverse events from Day 0 through 28 days after the last injection.
Measured: 28 Days
The number of medically-attended adverse events considered related to any of the study injections reported at any point during the study period events and potential immune-mediated medical conditions considered related to any of the study injections
Measured: 421 Days
Secondary outcomes (2)
The frequencies of vaccine protein-specific T cells elicited by the CRV101 study vaccine at specified time points.
Measured: Day 0, 7, 28, 56, 63, 84, 196, and 365
The levels of vaccine protein-specific antibodies elicited by the CRV101 study vaccine at specified time points
Measured: Day 0, 7, 28, 56, 63, 84, 196, and 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start3 Jan 2019
- Primary completion4 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Curevo Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Access to Advanced Health Institute (AAHI), Mogam Biotechnology Research Institute, Green Cross Corporation
- Responsible party
- Sponsor
- Investigators
- John E Ervin, MD, Principal investigator, The Center for Pharmaceutical ResearchCorey Casper, MD, Study director, Access to Advanced Health Institute (AAHI)Lisa Shelton, Study chair, Curevo Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820414
- Sponsor's protocol ID
- CRV-101-100
- Status last verified
- Feb 2021
- First submitted
- 24 Jan 2019
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cohen JI. Clinical practice: Herpes zoster. N Engl J Med. 2013 Jul 18;369(3):255-63. doi: 10.1056/NEJMcp1302674.
PubMed 23863052
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-Controlled, Observer-Blind, Antigen Dose-Escalation and Adjuvant Dose-Ranging Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of CRV-101 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03820414
- Acronym / sponsor ID
- CRV-101-100
- Conditions
- Herpes Zoster, Varicella Zoster
- Keywords
- VZV, Vaccine, Shingles
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Curevo IncIndustry (pharma, biotech, devices)
- Collaborators
- Access to Advanced Health Institute (AAHI), Mogam Biotechnology Research Institute, Green Cross Corporation
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 4 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 29 Jan 2019 (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 clinical trial is to evaluate the safety, tolerability, and immunogenicity of vaccine candidate CRV-101, investigational vaccine in healthy adult subjects in the United States.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CRV101 Group 1 | Experimental | Biological: CRV 101Subjects receive 2 doses of the candidate CRV-101 formulation 1, administered intramuscularly (IM) in deltoid region of non-dominant arm, according to a 0, 2 Month schedule. |
| CRV 101 Group 2 | Experimental | Biological: CRV 101Subjects receive 2 doses of the candidate CRV-101 formulation 2, administered intramuscularly (IM) in deltoid region of non-dominant arm, according to a 0, 2 Month schedule. |
| CRV 101 Group 3 | Experimental | Biological: CRV 101Subjects receive 2 doses of the candidate CRV-101 formulation 3, administered intramuscularly (IM) in deltoid region of non-dominant arm, according to a 0, 2 Month schedule. |
| CRV 101 Group 4 | Experimental | Biological: CRV 101Subjects receive 2 doses of the candidate CRV-101 formulation 4, administered intramuscularly (IM) in deltoid region of non-dominant arm, according to a 0, 2 Month schedule. |
| Control Group | Placebo comparator | Biological: PlaceboSubjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of non-dominant arm, according to a 0, 2 Month schedule. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Males and non-pregnant females ≥ 18 to < 50 years of age at the time of enrollment.
- In good general health as confirmed by a medical history and physical exam, vital signs*, and screening laboratories conducted no more than 30 days prior to study injection administration.
- Oral Temperature <38°C, respiratory rate < 17 breaths pm, heart rate ≤100 bpm and >54 bpm, systolic blood pressure ≤150 mmHg and >89 mmHg, diastolic blood pressure ≤95 mmHg.
- NOTE: Athletically trained subjects with a heart rate ≥40 may be enrolled at the discretion of the principal investigator or designated licensed clinical investigator and reasoning must be documented.
- Screening laboratory values must be within normal range or not clinically significant as determined by the PI and approved by the Medical Monitor: sodium, potassium, BUN, ALT, AST, total bilirubin, alkaline phosphatase, creatinine, random glucose, WBC with differential, hemoglobin, and platelet count.
Key exclusion criteria (17 listed)
- History of chickenpox or herpes zoster in the past 3 years.
- Immunization with a vaccine against herpes zoster (Zostavax® or Shingrix®).
- Participation in another experimental protocol with last receipt of any device, vaccine, or other immunomodulator investigational products within the past 180 days of enrollment, or last receipt of non-device, non-vaccine, non-immunomodulator investigational products with in the last 90 days of enrollment or 5 half-lives whichever is greater, or planned participation in any other investigational study during the study period.
- 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. TNF inhibitor, or other cytokine inhibitors) or cytotoxic therapies, such as chemotherapy drugs or radiation) within 180 days prior to enrollment and during the study through Day 365 visit. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Low dose inhaled and topical steroids are allowed.
- Received a blood transfusion or immunoglobulin within past 90 days of enrollment.
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 |
|---|---|---|
| CRV 101(Different formulations) | Biological | CRV 101 Group 2, CRV 101 Group 3, CRV 101 Group 4, CRV101 Group 1 |
| PlaceboAlso: Saline injection2 doses administered IM in deltoid region of non-dominant arm | Biological | Control Group |
Primary outcome
The number of subjects experiencing solicited local injection site reactions within 7 days following each study injection.
Time frame: 7 Days
The number of subjects experiencing solicited systemic reactions within 7 days following each study injection.
Time frame: 7 Days
The number of subjects spontaneously reporting unsolicited adverse events from Day 0 through 28 days after the last injection.
Time frame: 28 Days
The number of medically-attended adverse events considered related to any of the study injections reported at any point during the study period events and potential immune-mediated medical conditions considered related to any of the study injections
Time frame: 421 Days
2 secondary outcomes
The frequencies of vaccine protein-specific T cells elicited by the CRV101 study vaccine at specified time points.
Time frame: Day 0, 7, 28, 56, 63, 84, 196, and 365
The levels of vaccine protein-specific antibodies elicited by the CRV101 study vaccine at specified time points
Time frame: Day 0, 7, 28, 56, 63, 84, 196, and 365
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Background: PubMed 23863052Cohen JI. Clinical practice: Herpes zoster. N Engl J Med. 2013 Jul 18;369(3):255-63. doi: 10.1056/NEJMcp1302674.
- Centers for Disease Control and Prevention: Shingles (Herpes Zoster): Clinical OverviewLink provided by the sponsor.
- 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.
John E Ervin, MD principal investigator
The Center for Pharmaceutical Research
Corey Casper, MD study director
Access to Advanced Health Institute (AAHI)
Lisa Shelton study chair
Curevo Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CRV 101 in people with Herpes Zoster and Varicella Zoster, run by Curevo Inc at 1 site 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 15 inclusion and 17 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: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The number of subjects experiencing solicited local injection site reactions within 7 days following each study injection. (time frame: 7 Days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03820414, which also lists 1 linked publication.
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 11 Feb 2021.