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A Study to Assess the Safety, Reactogenicity and Immune Response of CureVac's Candidate Rabies mRNA Vaccine in Healthy Adults

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ClinicalTrials.gov Identifier: NCT03713086
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
CureVac AG

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.


Condition or disease Intervention/treatment Phase
Rabies Biological: Rabipur® Biological: Rabies mRNA vaccine CV7202 Dose level 1 Biological: Rabies mRNA vaccine CV7202 Dose level 2 Biological: Rabies mRNA vaccine CV7202 Dose level 3 Biological: Rabies mRNA vaccine CV7202 Dose level 4 Biological: Rabies mRNA vaccine CV7202 Dose level 5 Biological: Rabies mRNA vaccine CV7202 Dose level 6 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : October 12, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rabies

Arm Intervention/treatment
Active Comparator: Rabipur® 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

Experimental: CV7202 Dose level 1 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

Experimental: CV7202 Dose level 2 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

Experimental: CV7202 Dose level 3 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

Experimental: CV7202 Dose level 4 Biological: Rabies mRNA vaccine CV7202 Dose level 4
1 or 2 doses administered IM at Days 1 and 29 in the deltoid region of the arm

Experimental: CV7202 Dose level 5 Biological: Rabies mRNA vaccine CV7202 Dose level 5
1 or 2 doses administered IM at Days 1 and 29 in the deltoid region of the arm

Experimental: CV7202 Dose level 6 Biological: Rabies mRNA vaccine CV7202 Dose level 6
1 or 2 doses administered IM at Days 1 and 29 in the deltoid region of the arm




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. Number of participants with any serious adverse events (SAEs) [ Time Frame: During the entire study period (up to 12 months after the last dose) ]
  6. 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) ]
  7. Number of participants with any medically attended (AEs) [ Time Frame: During the entire study period (up to 12 months after the last dose) ]

Secondary Outcome Measures :
  1. 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. ]
  2. 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. ]


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:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males and females aged 18 to 40 years.
  • Expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit.
  • Physical examination and laboratory results without clinically significant findings.
  • Body Mass Index (BMI) ≥18.0 and ≤32.0 kg/m2.
  • 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 enrollment. 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).
  • Females of childbearing potential must use acceptable methods of birth control from 4 weeks before the first administration of the test vaccine until 3 months following the last administration. The following methods of birth control are acceptable when used consistently and correctly:
  • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal);
  • progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable);
  • intrauterine devices (IUDs);
  • intrauterine hormone-releasing systems (IUSs);
  • bilateral tubal occlusion;
  • vasectomized partner;
  • sexual abstinence (periodic abstinence [e.g., calendar, ovulation, symptothermal and post-ovulation methods] and withdrawal are not acceptable).
  • Males must use reliable forms of contraception (condom) from 4 weeks before the first administration of the test vaccine until 3 months following the last administration and must refrain from sperm donation from the first administration of the test vaccine until 3 months after the last administration.

Exclusion Criteria:

  • 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.
  • Receipt of any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial or planned receipt of any vaccine within 28 days of any trial vaccine administration.
  • Receipt of any licensed or investigational rabies vaccine prior to the administration of the trial vaccine.
  • 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.
  • 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.
  • 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.
  • History of a potential immune mediated disease.
  • Administration of immunoglobulins (Igs) and/or any blood products within the 3 months preceding the administration of any dose of the trial vaccine.
  • Presence or evidence of significant acute or chronic, uncontrolled medical or psychiatric illness.
  • Known allergy to any component of CV7202 such as type I allergy to beta-lactam antibiotics or Rabipur®.
  • Evidence of current alcohol or drug abuse.
  • History of any neurological disorders or seizures including Guillain-Barré syndrome (GBS), with the exception of febrile seizures during childhood.
  • Foreseeable non-compliance with protocol as judged by the investigator.
  • For females: Pregnancy or lactation.
  • History of any life-threatening anaphylactic reactions.
  • Participants with impaired coagulation or any bleeding disorder in whom an IM injection or a blood draw is contraindicated.
  • Known relatives of site research staff working on this trial.

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): NCT03713086


Contacts
Contact: CureVac AG +49 (0) 697680587-0 clinicaltrials@curevac.com

Locations
Germany
Department of Infectious Diseases and Tropical Medicine (DITM), Medical Center of the University of Munich Recruiting
Munich, Bavaria, Germany, 80802
Contact: Department of Infectious Diseases and Tropical Medicine (DITM) Medical Center of the University of Munich         
Contact    +49-89-4400-598-10    impfstudien@lrz.uni-muenchen.de   
Sponsors and Collaborators
CureVac AG

Responsible Party: CureVac AG
ClinicalTrials.gov Identifier: NCT03713086     History of Changes
Other Study ID Numbers: CV-7202-104
2017-002856-10 ( EudraCT Number )
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by CureVac AG:
Rabies
Vaccine
Safety
Ractogenicity
Immunogenicity

Additional relevant MeSH terms:
Rabies
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs