Phase I Safety and Immunogenicity Trial of an Investigational RNActive® Rabies Vaccine (CV7201) in Healthy Adults

CureVac2 个研究点分布在 1 个国家目标入组 101 人开始时间: 2013年10月最近更新: 2018年10月29日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: CureVac
入组人数: 101
试验地点: 2
主要终点: Incidence and severity of serious adverse events (SAEs)/adverse events (AEs) and local tolerability assessment of the vaccination site

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this trial is to assess the safety and immunogenicity of an investigational RNActive® rabies vaccine (CV7201) in healthy adults.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Prevention
盲法: None

入排标准

年龄范围: 18 Years 至 40 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy male and female volunteers aged 18 to 40 years inclusive
•Compliant with protocol procedures and available for clinical follow-up through the last planned visit (V9)
•Physical examination and laboratory results without clinically significant findings
•Body Mass Index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2
•Females: Negative human chorionic gonadotropin (HCG) pregnancy test (serum) for women presumed to be of reproductive potential on the day of enrolment
•Females of childbearing potential must use acceptable methods of birth control during the trial and Follow-up period (from 6 weeks before the first administration of the test vaccine for the duration of the trial i.e., until the last planned visit (V9)). The following methods of birth control are acceptable when used consistently and correctly: established use of oral, injected or implanted hormonal methods of contraception; intrauterine devices (IUDs) or intrauterine systems (IUSs) with the exception of steel or copper wire; barrier methods of contraception (condom or occlusive cap [diaphragm or cervical/vault caps] with spermicidal foam/gel/film/cream/suppository); true abstinence (periodic abstinence [e.g., calendar, ovulation, symptothermal and postovulation methods] and withdrawal are not acceptable).
•Males must use reliable forms of contraception (barrier method with spermicidal agent or true abstinence) and must refrain from sperm donation during the trial and Follow-up period i.e., until the last planned visit (V9).

排除标准

•Use of any investigational or non-registered product (drug or vaccine) other than the trial vaccine within 4 weeks preceding the administration of the trial vaccine, or planned use during the trial period
•Subject has received any other licensed vaccines within 4 weeks prior to the administration of the trial vaccine
•Subject has received any investigational or licensed rabies vaccine previously
•Intending to travel to regions/countries for which rabies vaccinations are recommended or where high risk of infections exists according to travel recommendations by the German Society of Tropical Medicine and International Health (DTG) during the trial and up to V9 (Day 91/120) Follow-up
•Any treatment with immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the trial vaccine. The use of inhaled and nasal steroids, as well as topical steroids outside the vaccination area, will be permitted
•Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination
•History of autoimmune disease
•Administration of immunoglobulins (Igs) and/or any blood products within the 3 months preceding the administration of the trial vaccine
•Subject is taking chloroquine for malaria treatment or prophylaxis
•Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness or fever ≥ 38 °C measured orally
•Presence or evidence of significant acute or chronic, uncontrolled medical or psychiatric illness (subjects with uncomplicated chronic diagnoses stable and treated for ≥ 3 months e.g., mild hypertension well-controlled with medication, may be enrolled - provided the condition and its therapy are known not to be associated with an immunocompromised state or an autoimmune disease
•Major congenital defects
•Known allergy to any component of the trial product i.e., protamine. This includes subjects with allergy to fish protein, diabetics with allergy to protamine-containing insulin, or post-vasectomy males
•Known type I allergy to beta lactam antibiotics
•Evidence of current alcohol or drug abuse
•History of any neurological disorders or seizures, with the exception of febrile seizures during childhood
•Seropositivity for human immunodeficiency virus (HIV), hepatitis B virus (HBV) (except in subjects previously vaccinated against HBV) or hepatitis C virus (HCV)
•Foreseeable non-compliance with protocol as judged by the Investigator
•For females: Pregnancy or lactation
•History of any life-threatening anaphylactic reactions.
•Subjects with impaired coagulation in whom an IM injection is contraindicated.