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

NCT03820414 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2021-02-11

No results posted yet for this study

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.

Conditions

  • Herpes Zoster
  • Varicella Zoster

Interventions

BIOLOGICAL

CRV 101

(Different formulations)

BIOLOGICAL

Placebo

2 doses administered IM in deltoid region of non-dominant arm

Sponsors & Collaborators

  • Access to Advanced Health Institute (AAHI)

    collaborator OTHER

  • Mogam Biotechnology Research Institute

    collaborator UNKNOWN

  • Green Cross Corporation

    collaborator INDUSTRY

  • Curevo Inc

    lead INDUSTRY

Principal Investigators

  • John E Ervin, MD · The Center for Pharmaceutical Research

  • Corey Casper, MD · Access to Advanced Health Institute (AAHI)

  • Lisa Shelton · Curevo Inc

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-03
Primary Completion
2020-04-04
Completion
2020-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03820414 on ClinicalTrials.gov