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Safety and Tolerability of CV8102 Alone and in Combination With a Rabies Virus Vaccine in Healthy Adults

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ClinicalTrials.gov Identifier: NCT02238756
Recruitment Status : Completed
First Posted : September 12, 2014
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
CureVac AG

Tracking Information
First Submitted Date  ICMJE September 4, 2014
First Posted Date  ICMJE September 12, 2014
Last Update Posted Date June 6, 2018
Study Start Date  ICMJE September 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2014)
Number of subjects with serious and non serious adverse events [ Time Frame: Up to 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2015)
  • Maximum tolerated dose (MTD) of CV8102 within the dose range of 25 µg to 250 µg. [ Time Frame: Up to day 49 ]
  • MTD of CV8102 in combination with rabies vaccine [ Time Frame: Up to Day 49 ]
  • Vaccination-elicited serum rabies VNTs among the dose groups [ Time Frame: Up to day 35 ]
  • Vaccination-elicited innate and adaptive immune responses [ Time Frame: Up to Day 35 ]
    Evaluation of corresponding serum and blood parameters (e.g. relevant cytokines, chemokines, immune effector molecules and lymphocyte phenotyping)
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2014)
  • Maximum tolerated dose (MTD) of CV8102 among the dose groups 50 ug, 100 ug and 250 ug. [ Time Frame: Up to day 49 ]
  • MTD of CV8102 in combination with rabies vaccine [ Time Frame: Up to Day 49 ]
  • Vaccination-elicited serum rabies VNTs among the dose groups [ Time Frame: Up to day 35 ]
  • Vaccination-elicited innate and adaptive immune responses [ Time Frame: Up to Day 35 ]
    Evaluation of corresponding serum and blood parameters (e.g. relevant cytokines, chemokines, immune effector molecules and lymphocyte phenotyping)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability of CV8102 Alone and in Combination With a Rabies Virus Vaccine in Healthy Adults
Official Title  ICMJE Phase I Safety and Tolerability Trial of Single and Repeat Doses of the RNA-based Adjuvant CV8102 Alone and in Combination With a Licensed Rabies Virus Vaccine in Healthy Adults
Brief Summary The purpose of this clinical trial is to investigate the safety and tolerability of IM administered CV8102 and an IM administered combination of CV8102 and rabies vaccine in humans.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Rabies
Intervention  ICMJE
  • Biological: CV8102
    Subjects will receive 2 intramuscular doses of CV8102 given 21 days apart
  • Biological: Rabipur
    Subjects will receive 2 intramuscular doses of Rabipur given 21 days apart
  • Biological: CV8102 + Rabipur
    Subjects will receive 2 intramuscular doses of CV8102+Rabipur given 21 days apart
Study Arms  ICMJE
  • Experimental: CV8102
    Intervention: Biological: CV8102
  • Active Comparator: Rabipur
    Intervention: Biological: Rabipur
  • Experimental: CV8102 + Rabipur
    Intervention: Biological: CV8102 + Rabipur
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 9, 2014)
72
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Compliant with protocol procedures and available for clinical F/U until the protocol-defined end of the trial
  2. Physical examination and laboratory results without clinically significant findings
  3. Body Mass Index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2
  4. Subjects must use reliable forms of contraception (barrier method with spermicidal agent or true abstinence) and must refrain from sperm donation during treatment and the 4-week F/U period after the last treatment.

Exclusion Criteria:

  1. Use of any investigational or non-registered product (adjuvant, drug) other than CV8102 within 4 weeks preceding the administration of the CV8102, or planned use of any such agent during the trial period
  2. Subject has received any licensed or non-licensed vaccines within 4 weeks prior to the administration of CV8102 alone or in combination with the licensed rabies vaccine or planned vaccinations during the trial period
  3. Any treatment with immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of CV8102 alone or in combination with the licensed rabies vaccine. The use of inhaled and nasal steroids, as well as topical steroids outside the vaccination area, will be permitted
  4. Any medically diagnosed or suspected immune deficient condition based on medical history and physical examination
  5. History of autoimmune disease or suspected autoimmune disease based on medical history and physical examination that cannot be ruled out based on further examinations
  6. Administration of immunoglobulins (Igs) and/or any blood products within the 3 months preceding the administration of CV8102 or licensed rabies vaccine
  7. Acute disease at the time of enrolment. Acute disease is defined as the presence of any acute condition including but not limited to non-febrile or febrile common colds, urinary tract infections, inflammatory, allergic or traumatic conditions that may interfere with safety assessment of the investigational products
  8. Presence or evidence of significant acute or chronic disease, in particular heart disease including coronary artery disease and chronic pulmonary diseases (e.g., chronic obstructive pulmonary disease [COPD]); 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)
  9. Major congenital defects
  10. Known allergy to any component (or closely related substance) of the licensed rabies vaccine product
  11. Known type I allergy to beta-lactam antibiotics
  12. Evidence of current alcohol or drug abuse
  13. History of any neurological disorders or seizures
  14. Known seropositivity for human immunodeficiency virus (HIV), hepatitis B virus (HBV) (except in subjects previously vaccinated against HBV) or hepatitis C virus (HCV)
  15. Foreseeable non-compliance with protocol as judged by the Investigator
  16. History of any life-threatening anaphylactic reactions
  17. Subjects with impaired coagulation in whom an IM injection is contraindicated.

    Additional exclusion criteria for subjects participating in the (adjuvanted) rabies vaccination part:

  18. Subject has previously received any investigational or licensed rabies vaccine
  19. Intending to travel to regions/countries for which rabies vaccinations are recommended or where high risk of infection exists according to travel recommendations by the German Society of Tropical Medicine and International Health (DTG) during the trial and F/U period
  20. Subject is taking chloroquine for malaria treatment or prophylaxis.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02238756
Other Study ID Numbers  ICMJE CV-8102-201
2013-004514-18 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CureVac AG
Study Sponsor  ICMJE CureVac AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ingo Meyer, MD CRS Clinical Research Services Mönchengladbach GmbH
PRS Account CureVac AG
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP