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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02238756
First Posted: September 12, 2014
Last Update Posted: July 29, 2016
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.
Information provided by (Responsible Party):
CureVac AG
  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
Intervention Model: Single Group Assignment
Masking: None (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 AG:

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

Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 72
Study Start Date: September 2014
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: August 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

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.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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
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): NCT02238756


Locations
Germany
CRS Clinical Research Services Mönchengladbach GmbH
Mönchengladbach, Germany
Sponsors and Collaborators
CureVac AG
Investigators
Principal Investigator: Ingo Meyer, MD CRS Clinical Research Services Mönchengladbach GmbH
  More Information

Responsible Party: CureVac AG
ClinicalTrials.gov Identifier: NCT02238756     History of Changes
Other Study ID Numbers: CV-8102-201
2013-004514-18 ( EudraCT Number )
First Submitted: September 4, 2014
First Posted: September 12, 2014
Last Update Posted: July 29, 2016
Last Verified: July 2016

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