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A Study to Assess the Safety, Reactogenicity and Immune Response of CureVac's Candidate Rabies mRNA Vaccine 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: NCT03713086
Recruitment Status : Active, not recruiting
First Posted : October 19, 2018
Last Update Posted : March 16, 2020
Sponsor:
Information provided by (Responsible Party):
CureVac AG

Tracking Information
First Submitted Date  ICMJE October 18, 2018
First Posted Date  ICMJE October 19, 2018
Last Update Posted Date March 16, 2020
Actual Study Start Date  ICMJE October 12, 2018
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2019)
  • Primary endpoint [ Time Frame: During a 8-day follow-up period (i.e.on the day of vaccination and 7 subsequent days) after each vaccination] ]
    The percentages of subjects with, and the frequencies and intensities of solicited local adverse events (AEs)
  • Primary endpoint [ Time Frame: During a 8-day follow-up period (i.e., on the day of vaccination and 7 subsequent days) after each vaccination] ]
    The percentages of subjects with, and the frequencies, intensities and relationship to vaccination, of solicited systemic AEs
  • Primary endpoint [ Time Frame: During a 8-day follow-up period (i.e., on the day of vaccination and 7 subsequent days) after each vaccination] ]
    The duration (in days) of solicited local AEs, of solicited systemic AEs and of the individual solicited AEs
  • Primary endpoint [ Time Frame: During a 29-day follow-up period (i.e., on the day of vaccination and 28 subsequent days) after each vaccination] ]
    The percentages of subjects with and frequencies and intensities of any unsolicited and related unsolicited AEs
  • Primary endpoint [ Time Frame: 0 - 12 months ]
    The percentages of subjects with and frequencies and relationship to vaccination of any serious adverse events (SAEs) and any medically-attended AEs (MAAEs)
  • Primary endpoint [ Time Frame: 0 - 12 months ]
    The percentages of subjects with and frequencies and relationship to vaccination of any adverse events of special interest (AESIs)
Original Primary Outcome Measures  ICMJE
 (submitted: October 18, 2018)
  • Number of participants with any solicited local adverse events (AEs) [ Time Frame: During a 8-day follow-up period (i.e., on the day of vaccination and 7 subsequent days) after each vaccination ]
  • Number of participants with any solicited systemic AEs [ Time Frame: During a 8-day follow-up period (i.e., on the day of vaccination and 7 subsequent days) after each vaccination ]
  • Duration (in days) of solicited local AEs and solicited systemic AEs [ Time Frame: During a 8-day follow-up period (i.e., on the day of vaccination and 7 subsequent days) after each vaccination ]
  • Number of participants with any unsolicited AEs [ Time Frame: During a 29-day follow-up period (i.e., on the day of vaccination and 28 subsequent days) after each vaccination ]
  • Number of participants with any serious adverse events (SAEs) [ Time Frame: During the entire study period (up to 12 months after the last dose) ]
  • Number of participants with any adverse events of special interest (AESI) [ Time Frame: During the entire study period (up to 12 months after the last dose) ]
  • Number of participants with any medically attended (AEs) [ Time Frame: During the entire study period (up to 12 months after the last dose) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2019)
  • Secondary endpoint [ Time Frame: 12 - 24 months ]
    The percentages of subjects with and frequencies of SAEs and MAAEs related to study vaccination
  • Secondary endpoint [ Time Frame: 12 - 24 months ]
    The percentages of subjects with and frequencies and relationship to vaccination of any AESIs
  • Secondary endpoint [ Time Frame: 0-24 months ]
    Percentages of subjects with rabies-specific serum VNTs ≥0.5 IU/ml by trial Group.
  • Secondary endpoint [ Time Frame: 0-24 months ]
    Serum geometric mean titers (GMTs) of virus-neutralizing antibodies by trial group
Original Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2018)
  • Percentages of participants with rabies-specific serum virus-neutralizing antibody titers (VNTs) ≥0.5 international units (IU)/milliliter (ml) [ Time Frame: On Days 1, 15, 43 and 12 months after the last dose. ]
  • Serum geometric mean titers (GMTs) of VNTs [ Time Frame: On Days 1, 8, 15, 29, 36, 43, 57, and 2, 6 and 12 months after the last dose. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Safety, Reactogenicity and Immune Response of CureVac's Candidate Rabies mRNA Vaccine in Healthy Adults
Official Title  ICMJE A Non-Randomized, Open Label, Controlled, Dose-Escalation, Phase I Clinical Trial to Evaluate the Safety, Reactogenicity and Immunogenicity of One or Two Administrations of Candidate Rabies mRNA Vaccine CV7202 in Healthy Adult Subjects
Brief Summary

Rabies infection is a disease that is caused by a virus and which is transmitted in many countries by rabid animals (dogs, monkeys, bats, etc.) through bites, scratches or licking of wounds. In most cases, humans die from it once the disease has broken out.

CV7202 is a new vaccine which has not yet been studied in humans and does not consist of virus protein. Instead, the "building block" for the protein in the form of a so-called messenger RNA (mRNA) will be used. All living organisms have mRNA in their body. mRNA is the carrier of the information that the cells require to form proteins. In this study, mRNA that carries the information for the formation of the rabies virus protein called RABV-G will be injected into the muscle. Following the vaccination, the vaccinated individual's own cells will produce the RABV-G protein. The immune system recognizes the protein and an immune response is triggered.

This clinical study will assess the safety, reactogenicity and immunogenicity of CV7202 mRNA-rabies vaccine in healthy adults.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Rabies
Intervention  ICMJE
  • Biological: Rabipur®
    3 doses administered IM at Days 1, 8 and 29 in the deltoid region of the arm
    Other Name: Licensed rabies vaccine containing inactivated rabies virus
  • Biological: Rabies mRNA vaccine CV7202 Dose level 1
    1 or 2 doses administered IM at Days 1 and 29 in the deltoid region of the arm
  • Biological: Rabies mRNA vaccine CV7202 Dose level 2
    1 or 2 doses administered IM at Days 1 and 29 in the deltoid region of the arm
  • Biological: Rabies mRNA vaccine CV7202 Dose level 3
    1 or 2 doses administered IM at Days 1 and 29 in the deltoid region of the arm
Study Arms  ICMJE
  • Active Comparator: Rabipur®
    Intervention: Biological: Rabipur®
  • Experimental: CV7202 Dose level 1
    Intervention: Biological: Rabies mRNA vaccine CV7202 Dose level 1
  • Experimental: CV7202 Dose level 2
    Intervention: Biological: Rabies mRNA vaccine CV7202 Dose level 2
  • Experimental: CV7202 Dose level 3
    Intervention: Biological: Rabies mRNA vaccine CV7202 Dose level 3
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 13, 2020)
53
Original Estimated Enrollment  ICMJE
 (submitted: October 18, 2018)
130
Estimated Study Completion Date  ICMJE January 2023
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria: Subjects must satisfy the following criteria at trial entry:

  1. Healthy male and female subjects aged 18 to 40 years inclusive. Healthy Subject is defined as an individual who is in good general health, not having any mental or physical disorder requiring regular or frequent medication.
  2. Expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit.
  3. Physical examination and laboratory results without clinically significant findings.
  4. Body Mass Index (BMI) ≥18.0 and ≤32.0 kg/m2.
  5. Females: At the time of screening, negative human chorionic gonadotropin (hCG) pregnancy test (serum) for women presumed to be of childbearing potential on the day of enrolment. On Day 1 (pre-vaccination): negative urine pregnancy test (hCG), (only required if the screening visit serum pregnancy test was performed more than 3 days before).
  6. Females of childbearing potential must use acceptable methods of birth control from 2 weeks before the first administration of the test vaccine until 3 months following the last administration.
  7. Males must use reliable forms of contraception (condom) from the moment of the first administration of the test vaccine until 3 months following the last administration and must refrain from sperm donation from the moment of the first administration of the test vaccine until 3 months after the last administration.

Exclusion Criteria Any trial subject who meets any of the following criteria will not qualify for entry into the trial

  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. Receipt of any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this trial or planned receipt of any vaccine within 28 days of any trial vaccine administration.
  3. Receipt of any licensed or investigational rabies vaccine prior to the administration of the trial vaccine.
  4. Planning 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 during the trial and up to the end of the trial.
  5. Any treatment with immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the trial vaccine or planned use during the trial, with the exception of inhaled and nasal steroids, or topically-applied steroids.
  6. Any medically diagnosed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination, including human immunodeficiency virus (HIV) infection, hepatitis B virus (HBV) infection and hepatitis C virus (HCV) infection.
  7. History of a potential immune mediated disease.
  8. Administration of immunoglobulins (Igs) and/or any blood products within the 3 months preceding the administration of any dose of the trial vaccine.
  9. Presence or evidence of significant acute or chronic, uncontrolled medical or psychiatric illness.
  10. Known allergy to any component of CV7202 such as type I allergy to beta-lactam antibiotics or Rabipur®.
  11. Evidence of current alcohol or drug abuse.
  12. History of any neurological disorders or seizures including Guillain-Barré syndrome (GBS), with the exception of febrile seizures during childhood.
  13. Foreseeable non-compliance with protocol as judged by the investigator.
  14. For females: Pregnancy or lactation.
  15. History of any life-threatening anaphylactic reactions.
  16. Subjects with impaired coagulation or any bleeding disorder in whom an i.m. injection or a blood draw is contraindicated.
  17. Known relatives of site research staff working on this trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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 Belgium,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03713086
Other Study ID Numbers  ICMJE CV-7202-104
2017-002856-10 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CureVac AG
Study Sponsor  ICMJE CureVac AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account CureVac AG
Verification Date October 2019

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