RabiesPhase 1NCT03713086

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

A Phase 1 study testing Rabipur® and Rabies mRNA vaccine CV7202 in people with Rabies, run by CureVac at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Rabies
What is being tested?: Rabipur® and Rabies mRNA vaccine CV7202
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 2 sitesin 2 countries
Study dates: 12 Oct 2018to 23 Nov 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

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

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.
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 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).
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.
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

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 enrolment 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.
Subjects with impaired coagulation or any bleeding disorder in whom an i.m. injection or a blood draw is contraindicated.
Known relatives of site research staff working on this trial.

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Belgium1 site

University Hospital Ghent
Ghent, 9000

Other trials in Belgium

Germany1 site

Department of Infectious Diseases and Tropical Medicine (DITM), Medical Center of the University of Munich
Munich, Bavaria, 80802

Other trials in Germany

About this study

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

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
Being tested: Rabipur®, Rabies mRNA vaccine CV7202
Keywords: Rabies, Vaccine, Safety, Reactogenicity, Immunogenicity
Medical subject headings: Rabies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Rabipur®Biological
Also called Licensed rabies vaccine containing inactivated rabies virus
3 doses administered IM at Days 1, 8 and 29 in the deltoid region of the arm
Rabies mRNA vaccine CV7202Biological
CV7202 administered IM at Days 1 and 29 in the deltoid region of the arm
Rabies mRNA vaccine CV7202Biological
CV7202 administered IM at Days 1 and 29 in the deltoid region of the arm
Rabies mRNA vaccine CV7202Biological
CV7202 administered IM at Days 1 and 29 in the deltoid region of the arm

Study groups in NCT03713086
Study group	Role	What they receive
Rabipur®	Active comparator	Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations. Receives: Biological: Rabipur®
CV7202 1 mcg	Experimental	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. Receives: Biological: Rabies mRNA vaccine CV7202
CV7202 2 mcg	Experimental	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. Receives: Biological: Rabies mRNA vaccine CV7202
CV7202 5 mcg	Experimental	Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1. Receives: Biological: Rabies mRNA vaccine CV7202

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Experienced a Local Solicited Adverse Event (AE) Post Dose 1 (Day 1)
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Local solicited AEs included injection site pain, redness, swelling, and itching. All AEs were documented in a diary by the participant.
Measured: From the first dose of vaccination up to 7 days after vaccination (up to Day 8)
Number of Participants With Grade 0, 1, 2 and 3 Local Solicited AEs Post Dose 1 (Day 1)
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. The intensity of local solicited AEs was graded as:Pain at injection site(Grade 0:absent,Grade 1:Does not interfere with activity, Grade 2:Interferes with activity/repeated use of non-narcotic pain reliever greater than [>] 24 hours,Grade 3:prevent daily activity/repeated use of narcotic pain reliever); Redness(Grade 0:less than or equal to [<=]2.5 centimeters(cm), Grade 1:2.5 to 5cm,Grade 2: 5.1 to 10cm, Grade 3: >10cm);Swelling(Grade 0: <=2.5 cm,Grade 1: 2.5 to 5cm and does not interfere with activity,Grade 2:5.1 to 10cm/interferes with activity,Grade 3:>10cm or prevents daily activity);Itching(Grade 0:absent,Grade 1:Mild,no interference with normal activity,Grade 2:Moderate,some interference with normal activity,Grade 3:Significant, prevents normal activity).
Measured: From the first dose of vaccination up to 7 days after vaccination (up to Day 8)
Number of Participants Who Experienced a Systemic Solicited AE and Related Systemic Solicited AE Post Dose 1 (Day 1)
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Systemic solicited AEs included fever, nausea/vomiting, diarrhea, headache, fatigue, myalgia, and arthralgia on the day of vaccination and following 7 days after dose 1. All AEs were documented in diary by the participant.
Measured: From the first dose of vaccination up to 7 days after vaccination (up to Day 8)
Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1)
The intensity of Systemic AEs was graded as: Fever(Grade 0: <38 degree Celsius (°C), Grade 1: >=38°C to 38.4°C, Grade 2:>=38.5°C to 38.9°C, Grade 3: >=39°C); Headache(Grade 0: absent, Grade 1: Mild, Grade 2: Moderate, Grade 3: Significant); Fatigue(Grade 0: Absent, Grade 1: Mild, Grade 2: Moderate, Grade 3: Significant); Chills(Grade 0: Absent, Grade 1: Mild, Grade 2: Moderate, Grade 3: Significant); Myalgia(Grade 0: Absent, Grade 1: Mild, Grade 2: Moderate, Grade 3: Significant); Arthralgia(Grade 0: Absent, Grade 1: Mild, Grade 2: Moderate, Grade 3: Significant); Nausea/Vomiting(Grade 0: Absent, Grade 1: Mild, no interference with activity/1-2 episodes/24 hours, Grade 2: Moderate, some interference with activity/>2 episodes/ 24 hours, Grade 3: Severe, prevents daily activity, requires outpatient intravenous [IV] hydration); Diarrhea(Grade 0: Absent, Grade 1: 2-3 stools, Grade 2: 4-5 stools, Grade 3: 6 or more watery stools or requires outpatient IV hydration).
Measured: From the first dose of vaccination up to 7 days after vaccination (up to Day 8)
Number of Days of Local Solicited AEs Post Dose 1 (Day 1)
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Local solicited AEs included injection site pain, redness, swelling, and itching. All AEs were documented in diary by the participant.
Measured: From Day 1 (post-dose 1) to Day 8
Number of Days of Local Solicited AEs Post Dose 2
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Local solicited AEs included injection site pain, redness, swelling, and itching. All AEs were documented in diary by the participant.
Measured: CV7202: From Day 29 (post-dose 2) to Day 36; Rabipur: Day 8 (post-dose 2) to Day 15
Number of Days of Local Solicited AEs Post Dose 3
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Local solicited AEs included injection site pain, redness, swelling, and itching. All AEs were documented in diary by the participant.
Measured: Day 29 (post-dose 3) to Day 36
Number of Days of Systemic Solicited AEs Post Dose 1
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Systemic solicited AEs included fever, nausea/vomiting, chills, diarrhea, headache, fatigue, myalgia, and arthralgia. All AEs were documented in diary by the participant.
Measured: From Day 1 (post-dose 1) to Day 8
Number of Days of Systemic Solicited AEs Post Dose 2
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Systemic solicited AEs included fever, nausea/vomiting, diarrhea, chills, headache, fatigue, myalgia, and arthralgia. All AEs were documented in diary by the participant.
Measured: CV7202: From Day 29 (post-dose 2) to Day 36; Rabipur: Day 8 (post-dose 2) to Day 15
Number of Days of Systemic Solicited AEs Post Dose 3
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Systemic solicited AEs included fever, nausea/vomiting, diarrhea, headache, fatigue, myalgia, and arthralgia. All AEs were documented in diary by the participant.
Measured: Day 29 (post-dose 3) to Day 36
Number of Participants Who Experienced Unsolicited and Related Unsolicited AEs
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. An unsolicited AE was defined as any other AE reported by the participant via diary cards or during study visits on the day of vaccination and the 28 subsequent days. The number of participants with unsolicited and related unsolicited AEs were reported.
Measured: From the first dose of vaccination up to 28 days after vaccination (up to Day 29)
Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. An unsolicited AE was defined as any other AE reported by the participant via diary cards or during study visits on the day of vaccination and the 28 subsequent days. The intensity of AEs was graded as: 1) Mild (Grade 1): An event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities.; 2) Moderate (Grade 2): An event that caused sufficient discomfort to interfere with normal everyday activities.; 3) Severe (Grade 3): An event that prevented normal everyday activities. Number of participants with Grade 1, 2 and 3 unsolicited and related unsolicited AEs were reported.
Measured: From the first dose of vaccination up to 28 days after vaccination (up to Day 29)
Number of Participants With Any Serious Adverse Events (SAEs) up to 12 Months
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. SAE was defined as any AE if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect.
Measured: From the first dose of vaccination up to 12 months
Number of Participants With Any Medically-attended AEs (MAAEs) up to 12 Months
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Vaccine-related MAAEs include any AEs for which the participant received medical attention, defined as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason for which there is evidence to suggest a causal relationship between the study product and the adverse event. Number of participants with any MAAEs were reported.
Measured: From the first dose of vaccination up to 12 months
Number of Participants With Any Adverse Events of Special Interest (AESIs) and Related AESI up to 12 Month
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. AEs with a suspected potential immune-mediated disease etiology was considered as AESIs. AESI was assessed by the investigator. Vaccine-related AESIs was included as AESIs for which there was evidence to suggest a causal relationship between the study product and the adverse event.
Measured: From the first dose of vaccination up to 12 months

Secondary outcomes (5)

Number of Participants With Related SAEs From 12 Months Post-vaccination up to 24 Months
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. SAE was defined as any AE if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect. Vaccine-related SAEs was included as SAEs for which there is evidence to suggest a causal relationship between the study product and the adverse event.
Measured: From 12 months up to 24 months
Number of Participants With Related MAAEs From 12 Months up to 24 Months
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Vaccine-related MAAEs include any AEs for which the participant received medical attention, defined as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason for which there is evidence to suggest a causal relationship between the study product and the adverse event. Number of participants with related MAAEs were reported.
Measured: From 12 months up to 24 months
Number of Participants With Any Related AESIs From 12 Months up to 24 Months
An AE was defined as any untoward medical occurrence in a clinical study participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. AEs with a suspected potential immune-mediated disease etiology was considered as AESIs. AESI was assessed by the investigator. Vaccine-related AESIs was included as AESIs for which there was evidence to suggest a causal relationship between the study product and the adverse event. Number of participants with any related AESIs were reported.
Measured: From 12 months up to 24 months
Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs)
Rabies-specific serum response was defined as VNT ≥ 0.5 international units per milliliter (IU/mL). Rabies-specific serum VNT were measured using the WHO-recommended rapid fluorescent foci inhibition test (RFFIT). Serial dilutions of each serum sample are mixed with a standard dose of rabies virus before tissue culture cells are added. Virus infected cells are detected via a fluorochrome conjugated rabies-specific antibody. If the serum contains antibodies that bind and neutralize the virus, the infectivity of the virus is reduced. The virus neutralization end-point titer is defined as the highest sample dilution at which 50% of the observed microscopic fields contain ≥ 1 infected cell. The percentages of participants with rabies-specific serum VNTs ≥0.5 were taken as positive and were reported.
Measured: Baseline (Day 1), Days 15, 43, 365, 547, and 730
Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs
Serum geometric mean titer (antilog mean of log-transformed VNTs) was obtained from measuring VNTs using the WHO-recommended rapid fluorescent foci inhibition test. The virus neutralization end-point titer (VNT) is defined as the highest sample dilution at which 50% of the observed microscopic fields contain >=1 infected cell.
Measured: Baseline (Day 1), Days 8, 15, 29, 36, 43, 57, 91, 182, 365, 547, and 730

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Oct 201823 Nov 2021

First posted19 Oct 2018
Study start12 Oct 2018
Primary completion23 Nov 2021
Study completion23 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for RabiesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03713086
Sponsor's protocol ID: CV-7202-104
Other IDs: 2017-002856-10, 2017
Status last verified: Sep 2022
First submitted: 18 Oct 2018
Last updated: 19 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 33487468

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Rabies (Healthy Volunteers)

All Rabies trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03713086
Acronym / sponsor ID: CV-7202-104
Conditions: Rabies
Keywords: Rabies, Vaccine, Safety, Reactogenicity, Immunogenicity
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: CureVacIndustry (pharma, biotech, devices)
Study start: 12 Oct 2018 (actual)
Primary completion: 23 Nov 2021 (actual)
Study completion: 23 Nov 2021 (actual)
First posted: 19 Oct 2018 (actual)
Results: Posted 19 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Rabipur®	Active comparator	Biological: Rabipur®Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations.
CV7202 1 mcg	Experimental	Biological: Rabies mRNA vaccine CV7202Participants 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.
CV7202 2 mcg	Experimental	Biological: Rabies mRNA vaccine CV7202Participants 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.
CV7202 5 mcg	Experimental	Biological: Rabies mRNA vaccine CV7202Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Rabipur®Also: Licensed rabies vaccine containing inactivated rabies virus3 doses administered IM at Days 1, 8 and 29 in the deltoid region of the arm	Biological	Rabipur®
Rabies mRNA vaccine CV7202CV7202 administered IM at Days 1 and 29 in the deltoid region of the arm	Biological	CV7202 1 mcg
Rabies mRNA vaccine CV7202CV7202 administered IM at Days 1 and 29 in the deltoid region of the arm	Biological	CV7202 2 mcg
Rabies mRNA vaccine CV7202CV7202 administered IM at Days 1 and 29 in the deltoid region of the arm	Biological	CV7202 5 mcg

Primary outcome

Number of Participants Who Experienced a Local Solicited Adverse Event (AE) Post Dose 1 (Day 1)
Time frame: From the first dose of vaccination up to 7 days after vaccination (up to Day 8)
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Local solicited AEs included injection site pain, redness, swelling, and itching. All AEs were documented in a diary by the participant.
Number of Participants With Grade 0, 1, 2 and 3 Local Solicited AEs Post Dose 1 (Day 1)
Time frame: From the first dose of vaccination up to 7 days after vaccination (up to Day 8)
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. The intensity of local solicited AEs was graded as:Pain at injection site(Grade 0:absent,Grade 1:Does not interfere with activity, Grade 2:Interferes with activity/repeated use of non-narcotic pain reliever greater than [>] 24 hours,Grade 3:prevent daily activity/repeated use of narcotic pain reliever); Redness(Grade 0:less than or equal to [<=]2.5 centimeters(cm), Grade 1:2.5 to 5cm,Grade 2: 5.1 to 10cm, Grade 3: >10cm);Swelling(Grade 0: <=2.5 cm,Grade 1: 2.5 to 5cm and does not interfere with activity,Grade 2:5.1 to 10cm/interferes with activity,Grade 3:>10cm or prevents daily activity);Itching(Grade 0:absent,Grade 1:Mild,no interference with normal activity,Grade 2:Moderate,some interference with normal activity,Grade 3:Significant, prevents normal activity).
Number of Participants Who Experienced a Systemic Solicited AE and Related Systemic Solicited AE Post Dose 1 (Day 1)
Time frame: From the first dose of vaccination up to 7 days after vaccination (up to Day 8)
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Systemic solicited AEs included fever, nausea/vomiting, diarrhea, headache, fatigue, myalgia, and arthralgia on the day of vaccination and following 7 days after dose 1. All AEs were documented in diary by the participant.
Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1)
Time frame: From the first dose of vaccination up to 7 days after vaccination (up to Day 8)
The intensity of Systemic AEs was graded as: Fever(Grade 0: <38 degree Celsius (°C), Grade 1: >=38°C to 38.4°C, Grade 2:>=38.5°C to 38.9°C, Grade 3: >=39°C); Headache(Grade 0: absent, Grade 1: Mild, Grade 2: Moderate, Grade 3: Significant); Fatigue(Grade 0: Absent, Grade 1: Mild, Grade 2: Moderate, Grade 3: Significant); Chills(Grade 0: Absent, Grade 1: Mild, Grade 2: Moderate, Grade 3: Significant); Myalgia(Grade 0: Absent, Grade 1: Mild, Grade 2: Moderate, Grade 3: Significant); Arthralgia(Grade 0: Absent, Grade 1: Mild, Grade 2: Moderate, Grade 3: Significant); Nausea/Vomiting(Grade 0: Absent, Grade 1: Mild, no interference with activity/1-2 episodes/24 hours, Grade 2: Moderate, some interference with activity/>2 episodes/ 24 hours, Grade 3: Severe, prevents daily activity, requires outpatient intravenous [IV] hydration); Diarrhea(Grade 0: Absent, Grade 1: 2-3 stools, Grade 2: 4-5 stools, Grade 3: 6 or more watery stools or requires outpatient IV hydration).
Number of Days of Local Solicited AEs Post Dose 1 (Day 1)
Time frame: From Day 1 (post-dose 1) to Day 8
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Local solicited AEs included injection site pain, redness, swelling, and itching. All AEs were documented in diary by the participant.
Number of Days of Local Solicited AEs Post Dose 2
Time frame: CV7202: From Day 29 (post-dose 2) to Day 36; Rabipur: Day 8 (post-dose 2) to Day 15
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Local solicited AEs included injection site pain, redness, swelling, and itching. All AEs were documented in diary by the participant.
Number of Days of Local Solicited AEs Post Dose 3
Time frame: Day 29 (post-dose 3) to Day 36
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Local solicited AEs included injection site pain, redness, swelling, and itching. All AEs were documented in diary by the participant.
Number of Days of Systemic Solicited AEs Post Dose 1
Time frame: From Day 1 (post-dose 1) to Day 8
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Systemic solicited AEs included fever, nausea/vomiting, chills, diarrhea, headache, fatigue, myalgia, and arthralgia. All AEs were documented in diary by the participant.
Number of Days of Systemic Solicited AEs Post Dose 2
Time frame: CV7202: From Day 29 (post-dose 2) to Day 36; Rabipur: Day 8 (post-dose 2) to Day 15
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Systemic solicited AEs included fever, nausea/vomiting, diarrhea, chills, headache, fatigue, myalgia, and arthralgia. All AEs were documented in diary by the participant.
Number of Days of Systemic Solicited AEs Post Dose 3
Time frame: Day 29 (post-dose 3) to Day 36
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Systemic solicited AEs included fever, nausea/vomiting, diarrhea, headache, fatigue, myalgia, and arthralgia. All AEs were documented in diary by the participant.
Number of Participants Who Experienced Unsolicited and Related Unsolicited AEs
Time frame: From the first dose of vaccination up to 28 days after vaccination (up to Day 29)
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. An unsolicited AE was defined as any other AE reported by the participant via diary cards or during study visits on the day of vaccination and the 28 subsequent days. The number of participants with unsolicited and related unsolicited AEs were reported.
Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs
Time frame: From the first dose of vaccination up to 28 days after vaccination (up to Day 29)
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. An unsolicited AE was defined as any other AE reported by the participant via diary cards or during study visits on the day of vaccination and the 28 subsequent days. The intensity of AEs was graded as: 1) Mild (Grade 1): An event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities.; 2) Moderate (Grade 2): An event that caused sufficient discomfort to interfere with normal everyday activities.; 3) Severe (Grade 3): An event that prevented normal everyday activities. Number of participants with Grade 1, 2 and 3 unsolicited and related unsolicited AEs were reported.
Number of Participants With Any Serious Adverse Events (SAEs) up to 12 Months
Time frame: From the first dose of vaccination up to 12 months
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. SAE was defined as any AE if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect.
Number of Participants With Any Medically-attended AEs (MAAEs) up to 12 Months
Time frame: From the first dose of vaccination up to 12 months
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. Vaccine-related MAAEs include any AEs for which the participant received medical attention, defined as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason for which there is evidence to suggest a causal relationship between the study product and the adverse event. Number of participants with any MAAEs were reported.
Number of Participants With Any Adverse Events of Special Interest (AESIs) and Related AESI up to 12 Month
Time frame: From the first dose of vaccination up to 12 months
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. AEs with a suspected potential immune-mediated disease etiology was considered as AESIs. AESI was assessed by the investigator. Vaccine-related AESIs was included as AESIs for which there was evidence to suggest a causal relationship between the study product and the adverse event.

5 secondary outcomes

Number of Participants With Related SAEs From 12 Months Post-vaccination up to 24 Months
Time frame: From 12 months up to 24 months
Number of Participants With Related MAAEs From 12 Months up to 24 Months
Time frame: From 12 months up to 24 months
Number of Participants With Any Related AESIs From 12 Months up to 24 Months
Time frame: From 12 months up to 24 months
Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs)
Time frame: Baseline (Day 1), Days 15, 43, 365, 547, and 730
Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs
Time frame: Baseline (Day 1), Days 8, 15, 29, 36, 43, 57, 91, 182, 365, 547, and 730

Results and safety

Results posted to the registry on 19 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CV7202 1 mcg	16	16
CV7202 2 mcg	16	13
CV7202 5 mcg	10	9
Rabipur®	11	10

Primary outcome: Number of Participants Who Experienced a Local Solicited Adverse Event (AE) Post Dose 1 (Day 1)

Time frame: From the first dose of vaccination up to 7 days after vaccination (up to Day 8). Count of participants. Unit: Participants

Measure	CV7202 1 mcg n = 16	CV7202 2 mcg n = 16	CV7202 5 mcg n = 10	Rabipur® n = 11
Value	13	15	10	5

Population analysed: Safety analysis set included all participants who had received at least 1 dose of mRNA vaccine CV7202 or Rabipur and those participants who had any post-Day 1 safety data.

Primary outcome: Number of Participants With Grade 0, 1, 2 and 3 Local Solicited AEs Post Dose 1 (Day 1)

Time frame: From the first dose of vaccination up to 7 days after vaccination (up to Day 8). Count of participants. Unit: Participants

Measure	CV7202 1 mcg n = 16	CV7202 2 mcg n = 16	CV7202 5 mcg n = 10	Rabipur® n = 11
Grade 0 (No AE/Absent)	3	1	0	5
Grade 1 (Mild)	13	13	4	5
Grade 2 (Moderate)	0	1	5	0
Grade 3 (Severe)	0	1	1	0
Not assessed	0	0	0	1

Population analysed: Safety analysis set included all participants who had received at least 1 dose of mRNA vaccine CV7202 or Rabipur and those participants who had any post-Day 1 safety data.

Primary outcome: Number of Participants Who Experienced a Systemic Solicited AE and Related Systemic Solicited AE Post Dose 1 (Day 1)

Time frame: From the first dose of vaccination up to 7 days after vaccination (up to Day 8). Count of participants. Unit: Participants

Measure	CV7202 1 mcg n = 16	CV7202 2 mcg n = 16	CV7202 5 mcg n = 10	Rabipur® n = 11
Participants with Systemic Solicited AE	11	13	9	8
Participants with Related Systemic Solicited AE	8	13	9	5

Population analysed: Safety analysis set included all participants who had received at least 1 dose of mRNA vaccine CV7202 or Rabipur and those participants who had any post-Day 1 safety data.

Primary outcome: Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1)

Time frame: From the first dose of vaccination up to 7 days after vaccination (up to Day 8). Count of participants. Unit: Participants

Measure	CV7202 1 mcg n = 16	CV7202 2 mcg n = 16	CV7202 5 mcg n = 10	Rabipur® n = 11
Participants with Systemic Solicited AEs: Grade 0 (No AE/Absent)	5	3	1	2
Participants with Systemic Solicited AEs: Grade 1 (Mild)	8	4	0	4
Participants with Systemic Solicited AEs: Grade 2 (Moderate)	3	6	3	4
Participants with Systemic Solicited AEs: Grade 3 (Severe)	0	3	6	0
Participants with Systemic Solicited AEs: Not assessed	0	0	0	1
Participants with Related Systemic Solicited AEs: Grade 0 (No AE/Absent)	8	3	1	5
Participants with Related Systemic Solicited AEs: Grade 1 (Mild)	5	4	0	2
Participants with Related Systemic Solicited AEs: Grade 2 (Moderate)	3	6	3	3

Population analysed: Safety analysis set included all participants who had received at least 1 dose of mRNA vaccine CV7202 or Rabipur and those participants who had any post-Day 1 safety data.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the first dose of vaccination up to 24 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CV7202 1 mcg	1 of 16 (6.3%)	14 of 16 (87.5%)	0 of 16
CV7202 2 mcg	0 of 16 (0%)	14 of 16 (87.5%)	0 of 16
CV7202 5 mcg	0 of 10 (0%)	10 of 10 (100%)	0 of 10
Rabipur®	1 of 11 (9.1%)	8 of 11 (72.7%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33487468Aldrich 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rabipur® and Rabies mRNA vaccine CV7202 in people with Rabies, run by CureVac at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experienced a Local Solicited Adverse Event (AE) Post Dose 1 (Day 1) (time frame: From the first dose of vaccination up to 7 days after vaccination (up to Day 8)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03713086, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024; AzTrials last refreshed its copy on 29 Oct 2026.