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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by CureVac GmbH
Sponsor:
Information provided by (Responsible Party):
CureVac GmbH
ClinicalTrials.gov Identifier:
NCT02238756
First received: September 4, 2014
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Rabies
Biological: CV8102
Biological: Rabipur
Biological: CV8102 + Rabipur
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by CureVac GmbH:

Primary Outcome Measures:
  • Number of subjects with serious and non serious adverse events [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Maximum tolerated dose (MTD) of CV8102 among the dose groups 50 ug, 100 ug and 250 ug. [ Time Frame: Up to day 49 ] [ Designated as safety issue: Yes ]
  • MTD of CV8102 in combination with rabies vaccine [ Time Frame: Up to Day 49 ] [ Designated as safety issue: Yes ]
  • Vaccination-elicited serum rabies VNTs among the dose groups [ Time Frame: Up to day 35 ] [ Designated as safety issue: No ]
  • Vaccination-elicited innate and adaptive immune responses [ Time Frame: Up to Day 35 ] [ Designated as safety issue: No ]
    Evaluation of corresponding serum and blood parameters (e.g. relevant cytokines, chemokines, immune effector molecules and lymphocyte phenotyping)


Estimated Enrollment: 72
Study Start Date: September 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CV8102 Biological: CV8102
Subjects will receive 2 intramuscular doses of CV8102 given 21 days apart
Active Comparator: Rabipur Biological: Rabipur
Subjects will receive 2 intramuscular doses of Rabipur given 21 days apart
Experimental: CV8102 + Rabipur Biological: CV8102 + Rabipur
Subjects will receive 2 intramuscular doses of CV8102+Rabipur given 21 days apart

  Eligibility

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

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.
  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: NCT02238756

Contacts
Contact: Angelika Daehling +49 (0) 69 - 7680 587 ext 036 angelika.daehling@curevac.com

Locations
Germany
CRS Clinical Research Services Mönchengladbach GmbH Recruiting
Mönchengladbach, Germany
Contact: Marcus Engel    +49 2161 81199 ext 21      
Principal Investigator: Ingo Meyer, MD         
Sponsors and Collaborators
CureVac GmbH
Investigators
Principal Investigator: Ingo Meyer, MD CRS Clinical Research Services Mönchengladbach GmbH
  More Information

No publications provided

Responsible Party: CureVac GmbH
ClinicalTrials.gov Identifier: NCT02238756     History of Changes
Other Study ID Numbers: CV-8102-201, 2013-004514-18
Study First Received: September 4, 2014
Last Updated: September 12, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

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

ClinicalTrials.gov processed this record on November 20, 2014