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Trial record 3 of 8 for:    curevac

RNActive® Rabies Vaccine (CV7201) in Healthy Adults

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by CureVac GmbH
Sponsor:
Information provided by (Responsible Party):
CureVac GmbH
ClinicalTrials.gov Identifier:
NCT02241135
First received: August 22, 2014
Last updated: November 6, 2014
Last verified: November 2014
  Purpose

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


Condition Intervention Phase
Rabies
Biological: CV7201 mRNA
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase I Safety and Immunogenicity Trial of an Investigational RNActive® Rabies Vaccine (CV7201) in Healthy Adults

Resource links provided by NLM:


Further study details as provided by CureVac GmbH:

Primary Outcome Measures:
  • Number of drug related adverse events/serious adverse events (AEs/SAEs) [ Time Frame: up to 210 days ] [ Designated as safety issue: Yes ]

    Intraindividually SAEs are collected and reported from ICF signature (pre-screening visit) to the end-of-study visit V9 (= day 91 in cohorts 1 - 4, day 120 in cohorts 5 - 13) . The time from pre-screening to V1 (day 0, 1st vaccination) may vary from 15 to 90 days, hence the duration of SAE monitoring may vary depending on the cohort number and the individual interval between pre-screening visit (Vps) and first vaccination (V1) between 106 and 210 days.

    IMP-related AEs/SAEs are recorded from the first vaccination (visit V1 = day0) to visit V9, day 91/120).



Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    Rabies virus neutralizing titers (VNTs) measured in serum blood samples taken 14 days after the the last vaccination (Visit 8). V8 in cohorts 1 to 4 =day 42 after the first vaccination; V8 in cohorts 5 - 13 = day 70 after the first vaccination.

  • Number of treatment discontinuation due to IMP-related AEs/SAEs [ Time Frame: 28 days (for cohorts 1 - 4) or 56 days (for cohorts 5 - 13), i.e. from visits V1 to V5 ] [ Designated as safety issue: Yes ]

    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).



Estimated Enrollment: 142
Study Start Date: October 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1: 80 µg CV7201 mRNA
Vaccination by injection on days 0, 7, 28.
Biological: CV7201 mRNA
CV7201 is composed of 1 RNActive® mRNA that encodes the rabies virus glycoprotein.
Other Names:
  • CV7201 messenger RNA
  • CV7201 RNActive®
Experimental: Cohort 2: 40 µg CV7201 mRNA
Vaccination by injection on days 0, 7, 28.
Biological: CV7201 mRNA
CV7201 is composed of 1 RNActive® mRNA that encodes the rabies virus glycoprotein.
Other Names:
  • CV7201 messenger RNA
  • CV7201 RNActive®
Experimental: Cohort 3: 160µg CV7201 mRNA
Vaccination by injection on days 0, 7, 28.
Biological: CV7201 mRNA
CV7201 is composed of 1 RNActive® mRNA that encodes the rabies virus glycoprotein.
Other Names:
  • CV7201 messenger RNA
  • CV7201 RNActive®
Experimental: Cohort 4: 80µg CV7201 mRNA
Vaccination by injection on days 0, 7, 28.
Biological: CV7201 mRNA
CV7201 is composed of 1 RNActive® mRNA that encodes the rabies virus glycoprotein.
Other Names:
  • CV7201 messenger RNA
  • CV7201 RNActive®
Experimental: Cohort 5: 80 µg CV7201 mRNA
Vaccination by injection on days 0, 28, 56.
Biological: CV7201 mRNA
CV7201 is composed of 1 RNActive® mRNA that encodes the rabies virus glycoprotein.
Other Names:
  • CV7201 messenger RNA
  • CV7201 RNActive®
Experimental: Cohort 6: 160 µg CV7201 mRNA
Vaccination by injection on days 0, 28, 56.
Biological: CV7201 mRNA
CV7201 is composed of 1 RNActive® mRNA that encodes the rabies virus glycoprotein.
Other Names:
  • CV7201 messenger RNA
  • CV7201 RNActive®
Experimental: Cohort 7: 320 µg CV7201 mRNA
Vaccination by injection on days 0, 28, 56.
Biological: CV7201 mRNA
CV7201 is composed of 1 RNActive® mRNA that encodes the rabies virus glycoprotein.
Other Names:
  • CV7201 messenger RNA
  • CV7201 RNActive®
Experimental: Cohort 8: 160 µg CV7201 mRNA
Vaccination by injection on days 0, 28, 56.
Biological: CV7201 mRNA
CV7201 is composed of 1 RNActive® mRNA that encodes the rabies virus glycoprotein.
Other Names:
  • CV7201 messenger RNA
  • CV7201 RNActive®
Experimental: Cohort 9: 320 µg CV7201 mRNA
Vaccination by injection on days 0, 28, 56.
Biological: CV7201 mRNA
CV7201 is composed of 1 RNActive® mRNA that encodes the rabies virus glycoprotein.
Other Names:
  • CV7201 messenger RNA
  • CV7201 RNActive®
Experimental: Cohort 10: 80 µg CV7201 mRNA
Vaccination by injection on days 0, 28, 56.
Biological: CV7201 mRNA
CV7201 is composed of 1 RNActive® mRNA that encodes the rabies virus glycoprotein.
Other Names:
  • CV7201 messenger RNA
  • CV7201 RNActive®
Experimental: Cohort 11: 160 µg CV7201 mRNA
Vaccination by injection on days 0, 28, 56.
Biological: CV7201 mRNA
CV7201 is composed of 1 RNActive® mRNA that encodes the rabies virus glycoprotein.
Other Names:
  • CV7201 messenger RNA
  • CV7201 RNActive®
Experimental: Cohort 12: 320 µg CV7201 mRNA
Vaccination by injection on days 0, 28, 56.
Biological: CV7201 mRNA
CV7201 is composed of 1 RNActive® mRNA that encodes the rabies virus glycoprotein.
Other Names:
  • CV7201 messenger RNA
  • CV7201 RNActive®
Experimental: Cohort 13: 640 µg CV7201 mRNA
Vaccination by injection on days 0, 28, 56.
Biological: CV7201 mRNA
CV7201 is composed of 1 RNActive® mRNA that encodes the rabies virus glycoprotein.
Other Names:
  • CV7201 messenger RNA
  • CV7201 RNActive®

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male and female volunteers aged 18 to 40 years inclusive
  2. Compliant with protocol procedures and available for clinical follow-up through the last planned visit (V9)
  3. Physical examination and laboratory results without clinically significant findings
  4. Body Mass Index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2
  5. Females: Negative human chorionic gonadotropin (HCG) pregnancy test (serum) for women presumed to be of reproductive potential on the day of enrolment
  6. 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).
  7. 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:

  1. 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
  2. Subject has received any other licensed vaccines within 4 weeks prior to the administration of the trial vaccine
  3. Subject has received any investigational or licensed rabies vaccine previously
  4. 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
  5. 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
  6. Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination
  7. History of autoimmune disease
  8. Administration of immunoglobulins (Igs) and/or any blood products within the 3 months preceding the administration of the trial vaccine
  9. Subject is taking chloroquine for malaria treatment or prophylaxis
  10. 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
  11. 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
  12. Major congenital defects
  13. 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
  14. Known type I allergy to beta lactam antibiotics
  15. Evidence of current alcohol or drug abuse
  16. History of any neurological disorders or seizures, with the exception of febrile seizures during childhood
  17. Seropositivity for human immunodeficiency virus (HIV), hepatitis B virus (HBV) (except in subjects previously vaccinated against HBV) or hepatitis C virus (HCV)
  18. Foreseeable non-compliance with protocol as judged by the Investigator
  19. For females: Pregnancy or lactation
  20. History of any life-threatening anaphylactic reactions.
  21. Subjects with impaired coagulation in whom an IM injection is contraindicated.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02241135

Contacts
Contact: Martin Alberer, MD +498921803517 Martin.Alberer@lrz.uni-muenchen.de
Contact: Franz-Josef von Sonnenburg, MD +4989218017610 sonnenburg@lrz.uni-muenchen.de

Locations
Germany
Abteilung für Infektions- und Tropenmedizin der Ludwig-Maximilians-Universität Recruiting
Munich, Germany, 80802
Contact: Franz-Josef Falkner von Sonnenburg, Apl. Prof. Dr. med.         
Principal Investigator: Franz-Josef F von Sonnenburg, MD         
Sponsors and Collaborators
CureVac GmbH
Investigators
Principal Investigator: Franz-Josef von Sonnenburg, MD Ludwig-Maximilians - University of Munich
  More Information

No publications provided

Responsible Party: CureVac GmbH
ClinicalTrials.gov Identifier: NCT02241135     History of Changes
Other Study ID Numbers: CV-7201-102, 2013-002171-17
Study First Received: August 22, 2014
Last Updated: November 6, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by CureVac GmbH:
Rav G protein
rabies
VNT
immunogenicity
PrEP vaccination
mRNA
CV7201

Additional relevant MeSH terms:
Rabies
Mononegavirales Infections
RNA Virus Infections
Rhabdoviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014