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

Brief Title

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

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

Brief 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.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

The number of subjects experiencing solicited local injection site reactions within 7 days following each study injection.

Secondary Outcome

 The frequencies of vaccine protein-specific T cells elicited by the CRV101 study vaccine at specified time points.

Condition

Herpes Zoster

Intervention

CRV 101

Study Arms / Comparison Groups

 CRV101 Group 1
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

90

Start Date

January 3, 2019

Completion Date

April 30, 2020

Primary Completion Date

April 4, 2020

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - 49 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

John E Ervin, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03820414

Organization ID

CRV-101-100


Responsible Party

Sponsor

Study Sponsor

Curevo Inc

Collaborators

 IDRI

Study Sponsor

John E Ervin, MD, Principal Investigator, The Center for Pharmaceutical Research


Verification Date

February 2021