- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02241135
RNActive® Rabies Vaccine (CV7201) in Healthy Adults
October 25, 2018 updated by: CureVac
Phase I Safety and Immunogenicity Trial of an Investigational RNActive® Rabies Vaccine (CV7201) in Healthy Adults
The purpose of this trial is to assess the safety and immunogenicity of an investigational RNActive® rabies vaccine (CV7201) in healthy adults.
Study Overview
Study Type
Interventional
Enrollment (Actual)
101
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Munich, Germany, 80802
- Abteilung für Infektions- und Tropenmedizin der Ludwig-Maximilians-Universität
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 80 µg CV7201 mRNA short
Vaccination by injection on days 0, 7, 28.
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CV7201 is composed of 1 RNActive® mRNA that encodes the rabies virus glycoprotein.
Other Names:
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Experimental: 160µg CV7201 mRNA short
Vaccination by injection on days 0, 7, 28.
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CV7201 is composed of 1 RNActive® mRNA that encodes the rabies virus glycoprotein.
Other Names:
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Experimental: 80 µg CV7201 mRNA long
Vaccination by injection on days 0, 28, 56.
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CV7201 is composed of 1 RNActive® mRNA that encodes the rabies virus glycoprotein.
Other Names:
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Experimental: 160 µg CV7201 mRNA long
Vaccination by injection on days 0, 28, 56.
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CV7201 is composed of 1 RNActive® mRNA that encodes the rabies virus glycoprotein.
Other Names:
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Experimental: 320 µg CV7201 mRNA long
Vaccination by injection on days 0, 28, 56.
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CV7201 is composed of 1 RNActive® mRNA that encodes the rabies virus glycoprotein.
Other Names:
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Experimental: 640 µg CV7201 mRNA long
Vaccination by injection on days 0, 28.
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CV7201 is composed of 1 RNActive® mRNA that encodes the rabies virus glycoprotein.
Other Names:
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Experimental: 200 µg CV7201 mRNA long
Vaccination by injection on days 0, 28, 56.
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CV7201 is composed of 1 RNActive® mRNA that encodes the rabies virus glycoprotein.
Other Names:
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Experimental: 400 µg CV7201 mRNA long
Vaccination by injection on days 0, 28, 56.
|
CV7201 is composed of 1 RNActive® mRNA that encodes the rabies virus glycoprotein.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence and severity of serious adverse events (SAEs)/adverse events (AEs) and local tolerability assessment of the vaccination site
Time Frame: up to 64 days after the last vaccination
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The occurrence of AEs will be assessed by non-directive questioning of the subject at each visit.
Further, AEs volunteered by the subject during or between visits - as subject diary card entries - or detected through observation, physical examination, laboratory test, or other assessments during the entire observation period, will be documented.
Subjects will be instructed that they must immediately report any AEs, subjective complaints or objective changes in their well-being to the Investigator or the clinic personnel, regardless of the perceived relationship between the event and the test product.
The Investigator is responsible for reporting all AEs in the eCRF that are observed or described by the subject, regardless of their relationship to the trial vaccine or their clinical significance.
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up to 64 days after the last vaccination
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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The lowest CV7201 dose to elicit rabies VNTs ≥ 0.5 IE/ml
Time Frame: Rabies VNTs measured 14 days after the 3rd vaccination (Visit 8)
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Rabies virus neutralizing titers (VNTs) measured in serum blood samples taken 14 days after the the last vaccination (Visit 8).
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Rabies VNTs measured 14 days after the 3rd vaccination (Visit 8)
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Number of treatment discontinuation due to IMP-related AEs/SAEs
Time Frame: up to 64 days after the last vaccination
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Number of subjects discontinued from treatment after the first or second vaccination due to vaccination-related reactions or AEs/SAEs. Period for observation in order to decide on withdrawal of subjects from next vaccination starts with Visit 1 (day 0, first vaccination) and lasts until the day of the third scheduled vaccination (pre-vaccination examination). |
up to 64 days after the last vaccination
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Franz-Josef Falkner von Sonnenburg, MD, Ludwig-Maximilians - University of Munich
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
February 8, 2018
Study Completion (Actual)
February 8, 2018
Study Registration Dates
First Submitted
August 22, 2014
First Submitted That Met QC Criteria
September 12, 2014
First Posted (Estimate)
September 16, 2014
Study Record Updates
Last Update Posted (Actual)
October 29, 2018
Last Update Submitted That Met QC Criteria
October 25, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CV-7201-102
- 2013-002171-17 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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