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| Name | Class |
|---|---|
| Access to Advanced Health Institute (AAHI) | OTHER |
| Mogam Biotechnology Research Institute | UNKNOWN |
| Green Cross Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRV 101 | Biological | (Different formulations) |
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| Measure | Description | Time Frame |
|---|---|---|
| The number of subjects experiencing solicited local injection site reactions within 7 days following each study injection. | 7 Days | |
| The number of subjects experiencing solicited systemic reactions within 7 days following each study injection. | 7 Days | |
| The number of subjects spontaneously reporting unsolicited adverse events from Day 0 through 28 days after the last injection. | 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 | 421 Days |
| Measure | Description | Time Frame |
|---|---|---|
| The frequencies of vaccine protein-specific T cells elicited by the CRV101 study vaccine at specified time points. | 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 |
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Inclusion Criteria:
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.
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John E Ervin, MD | The Center for Pharmaceutical Research | Principal Investigator |
| Corey Casper, MD | Access to Advanced Health Institute (AAHI) | Study Director |
| Lisa Shelton | Curevo Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Center for Pharmaceutical Research | Kansas City | Missouri | 64114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23863052 | Background | Cohen JI. Clinical practice: Herpes zoster. N Engl J Med. 2013 Jul 18;369(3):255-63. doi: 10.1056/NEJMcp1302674. |
| Label | URL |
|---|---|
| Centers for Disease Control and Prevention: Shingles (Herpes Zoster): Clinical Overview | View source |
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| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Placebo | Biological | 2 doses administered IM in deltoid region of non-dominant arm |
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| Day 0, 7, 28, 56, 63, 84, 196, and 365 |
| D007239 | Infections |
| D017670 |
| Sodium Compounds |