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RNActive® Rabies Vaccine (CV7201) in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02241135
Recruitment Status : Completed
First Posted : September 16, 2014
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
CureVac AG

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

Condition or disease Intervention/treatment Phase
Rabies Biological: CV7201 mRNA Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase I Safety and Immunogenicity Trial of an Investigational RNActive® Rabies Vaccine (CV7201) in Healthy Adults
Study Start Date : October 2013
Actual Primary Completion Date : February 8, 2018
Actual Study Completion Date : February 8, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rabies

Arm Intervention/treatment
Experimental: 80 µg CV7201 mRNA short
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: 160µg CV7201 mRNA short
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: 80 µg CV7201 mRNA long
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: 160 µg CV7201 mRNA long
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: 320 µg CV7201 mRNA long
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: 640 µg CV7201 mRNA long
Vaccination by injection on days 0, 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: 200 µg CV7201 mRNA long
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: 400 µg CV7201 mRNA long
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®




Primary Outcome Measures :
  1. 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 ]
    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.


Secondary Outcome Measures :
  1. 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) ]
    Rabies virus neutralizing titers (VNTs) measured in serum blood samples taken 14 days after the the last vaccination (Visit 8).

  2. Number of treatment discontinuation due to IMP-related AEs/SAEs [ Time Frame: up to 64 days after the last vaccination ]

    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).




Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02241135


Locations
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Germany
Abteilung für Infektions- und Tropenmedizin der Ludwig-Maximilians-Universität
Munich, Germany, 80802
Sponsors and Collaborators
CureVac AG
Investigators
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Principal Investigator: Franz-Josef Falkner von Sonnenburg, MD Ludwig-Maximilians - University of Munich
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: CureVac AG
ClinicalTrials.gov Identifier: NCT02241135    
Other Study ID Numbers: CV-7201-102
2013-002171-17 ( EudraCT Number )
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: May 2018
Keywords provided by CureVac AG:
Rav G protein
rabies
VNT
immunogenicity
PrEP vaccination
mRNA
CV7201
Additional relevant MeSH terms:
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Rabies
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases