Safety, Tolerability, and Immunogenicity of CRV-101 in Healthy Adult Subjects



Status:Recruiting
Conditions:Shingles, Infectious Disease
Therapuetic Areas:Dermatology / Plastic Surgery, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 49
Updated:2/13/2019
Start Date:January 3, 2019
End Date:September 1, 2020
Contact:Lisa Shelton, ARNP
Email:office@curevovaccine.com
Phone:2064925722

Use our guide to learn which trials are right for you!

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.


Inclusion Criteria:

1. Males and non-pregnant females ≥ 18 to < 50 years of age at the time of enrollment.

2. 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.

3. 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.

4. Negative HIV 1/2 antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus
(HCV) antibody.

5. 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).

6. 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.

7. 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").

8. 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.

9. Must be able to understand informed consent in English and capable of completing a
study diary card in English.

10. 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.

11. Willing to abstain from donating whole blood or blood derivatives until after Day 365
visit.

Exclusion Criteria:

1. History of chickenpox or herpes zoster in the past 3 years.

2. Immunization with a vaccine against herpes zoster (Zostavax® or Shingrix®).

3. 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.

4. 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.

5. Received a blood transfusion or immunoglobulin within past 90 days of enrollment.

6. Donated blood products (platelets, whole blood, plasma, etc.) within past 60 days of
enrollment.

7. 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).

8. History of autoimmune disease or other causes of immunosuppressive states.

9. 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.

10. Rash, tattoos, or any other dermatological condition that could adversely affect the
vaccine injection site or interfere with its evaluation.

11. BMI that poses a health risk in the opinion of the Principal Investigator.

12. Hypertension (systolic >150 or diastolic >95).

13. History of significant psychiatric illness (including past history of suicidal
ideation or attempt) with or without current use of medication.

14. Known or suspected alcohol or drug abuse within the past 5 years.

15. Chronic smoker (> 20 pack years).

16. Subjects with a history of previous anaphylaxis or severe allergic reaction to
vaccines or unknown allergens.

17. 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.
We found this trial at
1
site
Kansas City, Missouri 64114
Principal Investigator: John E Ervin, MD
Phone: 816-943-0770
?
mi
from
Kansas City, MO
Click here to add this to my saved trials