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

NCT ID: NCT03713086

Last Updated: 2024-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-12
• Study Completion Date: 2021-11-23

Brief Summary

The primary objective of this clinical study is to assess the safety, and reactogenicity of CV7202 mRNA-rabies vaccine in healthy adults. Immunogenicity is also assessed.

Conditions

Rabies

Keywords

Rabies; Vaccine; Safety; Reactogenicity; Immunogenicity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Rabipur®

Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations.

Group Type: ACTIVE_COMPARATOR

Rabipur®

Intervention Type: BIOLOGICAL

3 doses administered IM at Days 1, 8 and 29 in the deltoid region of the arm

CV7202 1 mcg

Participants received messenger ribonucleic acid (mRNA) CV7202 1 microgram (mcg) intramuscular injection at Day 1, of whom half of the participants received a second dose of CV7202 1 mcg at Day 29.

Group Type: EXPERIMENTAL

Rabies mRNA vaccine CV7202

Intervention Type: BIOLOGICAL

CV7202 administered IM at Days 1 and 29 in the deltoid region of the arm

CV7202 2 mcg

Participants received mRNA CV7202 2 mcg intramuscular injection at Day 1, of whom half of the participants received a second dose of CV7202 2 mcg at Day 29.

Group Type: EXPERIMENTAL

Rabies mRNA vaccine CV7202

Intervention Type: BIOLOGICAL

CV7202 administered IM at Days 1 and 29 in the deltoid region of the arm

CV7202 5 mcg

Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1.

Group Type: EXPERIMENTAL

Rabies mRNA vaccine CV7202

Intervention Type: BIOLOGICAL

CV7202 administered IM at Days 1 and 29 in the deltoid region of the arm

Interventions

Rabipur®

3 doses administered IM at Days 1, 8 and 29 in the deltoid region of the arm

Intervention Type: BIOLOGICAL

Rabies mRNA vaccine CV7202

CV7202 administered IM at Days 1 and 29 in the deltoid region of the arm

Intervention Type: BIOLOGICAL

Rabies mRNA vaccine CV7202

CV7202 administered IM at Days 1 and 29 in the deltoid region of the arm

Intervention Type: BIOLOGICAL

Rabies mRNA vaccine CV7202

CV7202 administered IM at Days 1 and 29 in the deltoid region of the arm

Intervention Type: BIOLOGICAL

Other Intervention Names

Licensed rabies vaccine containing inactivated rabies virus

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CureVac

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Ghent

Ghent, , Belgium

Department of Infectious Diseases and Tropical Medicine (DITM), Medical Center of the University of Munich

Munich, Bavaria, Germany

Countries

Belgium; Germany

References

Aldrich C, Leroux-Roels I, Huang KB, Bica MA, Loeliger E, Schoenborn-Kellenberger O, Walz L, Leroux-Roels G, von Sonnenburg F, Oostvogels L. Proof-of-concept of a low-dose unmodified mRNA-based rabies vaccine formulated with lipid nanoparticles in human volunteers: A phase 1 trial. Vaccine. 2021 Feb 22;39(8):1310-1318. doi: 10.1016/j.vaccine.2020.12.070. Epub 2021 Jan 22.

Reference Type: DERIVED

PMID: 33487468 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-002856-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CV-7202-104

Identifier Type: -

Identifier Source: org_study_id