A Phase 1 interventional study of Rabipur® and Rabies mRNA vaccine CV7202 in Rabies, sponsored by CureVac. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-19.
Sponsored by CureVac (part of BioNTech SE) · Phase 1, Interventional, and Prevention
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.
114 studies on the registry are indexed under Rabies; 15 are open to participants now.
This study's enrollment of 53 is below the median of 201 across 104 interventional studies indexed under Rabies.
Browse Rabies studies →CureVac is the lead sponsor of 18 studies on the registry; none are open to participants now.
First submitted before CureVac became part of BioNTech SE.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria: Subjects must satisfy the following criteria at trial entry:
Exclusion Criteria Any trial subject who meets any of the following criteria will not qualify for entry into the trial
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations.
Biological: Rabipur®
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.
Biological: Rabies mRNA vaccine CV7202
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.
Biological: Rabies mRNA vaccine CV7202
Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1.
Biological: Rabies mRNA vaccine CV7202
3 doses administered IM at Days 1, 8 and 29 in the deltoid region of the arm
Also known as: Licensed rabies vaccine containing inactivated rabies virus
CV7202 administered IM at Days 1 and 29 in the deltoid region of the arm
CV7202 administered IM at Days 1 and 29 in the deltoid region of the arm
CV7202 administered IM at Days 1 and 29 in the deltoid region of the arm
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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From the first dose of vaccination up to 12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Day 1), Days 8, 15, 29, 36, 43, 57, 91, 182, 365, 547, and 730
The study was conducted at 2 investigative sites in Germany and Belgium between 12 October 2018 and 23 November 2021.
| Milestone | CV7202 1 mcg | CV7202 2 mcg | CV7202 5 mcg | Rabipur® |
|---|---|---|---|---|
| Started | 16 | 16 | 10 | 11 |
| Received dose at day 1 | 16 | 16 | 10 | 11 |
| Received dose at day 8 | 0 | 0 | 0 | 11 |
| Received dose at day 29 | 8 | 8 | 0 | 11 |
| Completed | 16 | 13 | 9 | 10 |
| Not completed | 0 | 3 | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 2 | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 | 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.
| Participants | CV7202 1 mcg | CV7202 2 mcg | CV7202 5 mcg | Rabipur® |
|---|---|---|---|---|
| Number of Participants Who Experienced a Local Solicited Adverse Event (AE) Post Dose 1 (Day 1) | 13 | 15 | 10 | 5 |
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).
| Participants | CV7202 1 mcg | CV7202 2 mcg | CV7202 5 mcg | Rabipur® |
|---|---|---|---|---|
| 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 |
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.
| Participants | CV7202 1 mcg | CV7202 2 mcg | CV7202 5 mcg | Rabipur® |
|---|---|---|---|---|
| Participants with Systemic Solicited AE | 11 | 13 | 9 | 8 |
| Participants with Related Systemic Solicited AE | 8 | 13 | 9 | 5 |
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).
| Participants | CV7202 1 mcg | CV7202 2 mcg | CV7202 5 mcg | Rabipur® |
|---|---|---|---|---|
| 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 |
| Participants with Related Systemic Solicited AEs — Grade 3 (Severe) | 0 | 3 | 6 | 0 |
| Participants with Related Systemic Solicited AEs — Not assessed | 0 | 0 | 0 | 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.
| Days | CV7202 1 mcg | CV7202 2 mcg | CV7202 5 mcg | Rabipur® |
|---|---|---|---|---|
| Pain | 1 (1 to 4) | 2 (1 to 3) | 3 (1 to 6) | 2 (1 to 4) |
| Redness | — | — | 2 (2 to 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.
| Days | CV7202 1 mcg | CV7202 2 mcg | Rabipur® |
|---|---|---|---|
| Pain | 1 (1 to 4) | 2 (1 to 4) | 2 (1 to 4) |
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.
| Days | Rabipur® |
|---|---|
| Pain | 2 (1 to 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, chills, diarrhea, headache, fatigue, myalgia, and arthralgia. All AEs were documented in diary by the participant.
| Days | CV7202 1 mcg | CV7202 2 mcg | CV7202 5 mcg | Rabipur® |
|---|---|---|---|---|
| Temperature | — | 1 (1 to 2) | 1 (1 to 1) | — |
| Headache | 1 (1 to 4) | 2 (1 to 5) | 2 (1 to 4) | 1 (1 to 4) |
| Fatigue | 2 (1 to 2) | 2 (1 to 3) | 2 (1 to 7) | 1 (1 to 5) |
| Chills | — | 1.5 (1 to 2) | 1 (1 to 2) | — |
| Myalgia | 2 (1 to 5) | 3 (1 to 3) | 2 (1 to 5) | 1 (1 to 1) |
| Athralgia | 1 (1 to 3) | 1 (1 to 2) | 2 (1 to 3) | — |
| Nausea/Vomiting | 1 (1 to 1) | 3 (3 to 3) | 1 (1 to 3) | 1 (1 to 1) |
| Diarrhea | 4 (4 to 4) | 1 (1 to 1) | 2 (1 to 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, chills, headache, fatigue, myalgia, and arthralgia. All AEs were documented in diary by the participant.
| Days | CV7202 1 mcg | CV7202 2 mcg | Rabipur® |
|---|---|---|---|
| Temperature | 1 (1 to 1) | 1.5 (1 to 2) | — |
| Headache | 1 (1 to 3) | 2 (1 to 4) | 1.5 (1 to 2) |
| Fatigue | 2 (1 to 2) | 2 (2 to 3) | 2 (1 to 3) |
| Chills | 1.5 (1 to 2) | 1.5 (1 to 2) | — |
| Myalgia | 1.5 (1 to 2) | 1.5 (1 to 2) | — |
| Arthralgia | 1 (1 to 2) | 2 (2 to 2) | — |
| Nausea/Vomiting | — | 2 (2 to 2) | — |
| Diarrhea | — | 2 (2 to 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, headache, fatigue, myalgia, and arthralgia. All AEs were documented in diary by the participant.
| Days | Rabipur® |
|---|---|
| Headache | 1 (1 to 1) |
| Fatigue | 2 (2 to 2) |
| Chills | 1 (1 to 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. 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.
| Participants | CV7202 1 mcg | CV7202 2 mcg | CV7202 5 mcg | Rabipur® |
|---|---|---|---|---|
| Participants with Unsolicited AEs | 10 | 14 | 9 | 6 |
| Participants with Related Unsolicited AEs | 2 | 9 | 7 | 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. 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.
| Participants | CV7202 1 mcg | CV7202 2 mcg | CV7202 5 mcg | Rabipur® |
|---|---|---|---|---|
| Participants with all unsolicited AEs — Grade 1 (Mild) | 3 | 3 | 2 | 2 |
| Participants with all unsolicited AEs — Grade 2 (Moderate) | 4 | 9 | 1 | 3 |
| Participants with all unsolicited AEs — Grade 3 (Severe) | 3 | 2 | 6 | 1 |
| Participants with related unsolicited AEs — Grade 1 (Mild) | 1 | 4 | 1 | 0 |
| Participants with related unsolicited AEs — Grade 2 (Moderate) | 1 | 3 | 1 | 1 |
| Participants with related unsolicited AEs — Grade 3 (Severe) | 0 | 2 | 5 | 0 |
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.
| Participants | CV7202 1 mcg | CV7202 2 mcg | CV7202 5 mcg | Rabipur® |
|---|---|---|---|---|
| Number of Participants With Any Serious Adverse Events (SAEs) up to 12 Months | 1 | 0 | 0 | 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. 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.
| Participants | CV7202 1 mcg | CV7202 2 mcg | CV7202 5 mcg | Rabipur® |
|---|---|---|---|---|
| Number of Participants With Any Medically-attended AEs (MAAEs) up to 12 Months | 6 | 8 | 3 | 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. 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.
| Participants | CV7202 1 mcg | CV7202 2 mcg | CV7202 5 mcg | Rabipur® |
|---|---|---|---|---|
| Participants with AESIs | 0 | 0 | 0 | 0 |
| Participants with related AESIs | 0 | 0 | 0 | 0 |
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.
| Participants | CV7202 1 mcg | CV7202 2 mcg | CV7202 5 mcg | Rabipur® |
|---|---|---|---|---|
| Number of Participants With Related SAEs From 12 Months Post-vaccination up to 24 Months | 0 | 0 | 0 | 0 |
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.
| Participants | CV7202 1 mcg | CV7202 2 mcg | CV7202 5 mcg | Rabipur® |
|---|---|---|---|---|
| Number of Participants With Related MAAEs From 12 Months up to 24 Months | 0 | 0 | 0 | 0 |
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.
| Participants | CV7202 1 mcg | CV7202 2 mcg | CV7202 5 mcg | Rabipur® |
|---|---|---|---|---|
| Number of Participants With Any Related AESIs From 12 Months up to 24 Months | 0 | 0 | 1 | 0 |
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.
| percentage of participants | CV7202 1 mcg | CV7202 2 mcg | CV7202 5 mcg | Rabipur® |
|---|---|---|---|---|
| Baseline (Day 1) | 0.0 (0.0 to 20.6) | 0.0 (0.0 to 20.6) | 0.0 (0.0 to 30.8) | 0.0 (0.0 to 30.8) |
| Day 15 | 0.0 (0.0 to 20.6) | 6.3 (0.2 to 30.2) | 0.0 (0.0 to 30.8) | 100.0 (69.2 to 100.0) |
| Day 43 | 50.0 (24.7 to 75.3) | 62.5 (35.4 to 84.8) | 22.2 (2.8 to 60.0) | 100.0 (69.2 to 100.0) |
| Day 365 | 12.5 (1.6 to 38.3) | 14.3 (1.8 to 42.8) | 11.1 (0.3 to 48.2) | 100.0 (69.2 to 100.0) |
| Day 547 | 22.2 (2.8 to 60.0) | 28.6 (3.7 to 71.0) | 16.7 (0.4 to 64.1) | 90.0 (55.5 to 99.7) |
| Day 730 | 22.2 (2.8 to 60.0) | 42.9 (9.9 to 81.6) | 16.7 (0.4 to 64.1) | 90.0 (55.5 to 99.7) |
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.
| IU/mL | CV7202 1 mcg | CV7202 2 mcg | CV7202 5 mcg | Rabipur® |
|---|---|---|---|---|
| Baseline (Day 1) | 0.050 ± 1.0000 | 0.050 ± 1.0000 | 0.050 ± 1.0000 | 0.050 ± 1.0000 |
| Day 8 | 0.053 ± 1.2698 | 0.053 ± 1.2179 | 0.050 ± 1.0000 | 0.057 ± 1.3394 |
| Day 15 | 0.069 ± 1.8803 | 0.095 ± 2.6702 | 0.062 ± 1.5685 | 7.834 ± 2.7369 |
| Day 29 | 0.092 ± 1.9864 | 0.189 ± 3.8604 | 0.144 ± 2.8064 | 4.478 ± 3.0074 |
| Day 36 | 0.231 ± 3.2958 | 0.433 ± 5.1784 | 0.136 ± 3.1008 | 8.921 ± 2.4253 |
| Day 43 | 0.653 ± 9.3871 | 0.692 ± 8.3640 | 0.122 ± 2.9790 | 9.341 ± 2.2222 |
| Day 57 | 0.540 ± 8.2728 | 0.502 ± 7.6846 | 0.125 ± 2.8786 | 7.849 ± 1.8818 |
| Day 91 | 0.445 ± 5.8568 | 0.275 ± 6.0428 | 0.105 ± 2.9133 | 4.888 ± 1.8755 |
| Day 182 | 0.176 ± 4.6498 | 0.163 ± 3.6199 | 0.074 ± 2.4421 | 1.089 ± 1.9244 |
| Day 365 | 0.095 ± 2.7511 | 0.097 ± 2.8842 | 0.072 ± 2.3457 | 0.816 ± 2.1405 |
| Day 547 | 0.132 ± 2.7428 | 0.149 ± 3.6318 | 0.077 ± 2.9198 | 0.879 ± 1.9594 |
| Day 730 | 0.128 ± 3.9213 | 0.246 ± 4.0963 | 0.073 ± 2.5600 | 0.831 ± 2.0624 |
Collected over From the first dose of vaccination up to 24 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CV7202 1 mcg | 0/16 (0%) | 1/16 (6.3%) | 14/16 (87.5%) |
| CV7202 2 mcg | 0/16 (0%) | 0/16 (0%) | 14/16 (87.5%) |
| CV7202 5 mcg | 0/10 (0%) | 0/10 (0%) | 10/10 (100%) |
| Rabipur® | 0/11 (0%) | 1/11 (9.1%) | 8/11 (72.7%) |
| Event | CV7202 1 mcg | CV7202 2 mcg | CV7202 5 mcg | Rabipur® |
|---|---|---|---|---|
| AppendicitisInfections and infestations | 0/16 | 0/16 | 0/10 | 1/11 |
| Herpes zosterInfections and infestations | 1/16 | 0/16 | 0/10 | 0/11 |
| Event | CV7202 1 mcg | CV7202 2 mcg | CV7202 5 mcg | Rabipur® |
|---|---|---|---|---|
| HeadacheNervous system disorders | 4/16 | 1/16 | 8/10 | 2/11 |
| NasopharyngitisInfections and infestations | 9/16 | 5/16 | 7/10 | 4/11 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/16 | 1/16 | 3/10 | 1/11 |
| PyrexiaGeneral disorders | 2/16 | 1/16 | 3/10 | 0/11 |
| Night sweatsSkin and subcutaneous tissue disorders | 0/16 | 0/16 | 3/10 | 0/11 |
| Decreased appetiteMetabolism and nutrition disorders | 0/16 | 0/16 | 3/10 | 0/11 |
| Upper respiratory tract infectionInfections and infestations | 0/16 | 4/16 | 1/10 | 0/11 |
| TonsillitisInfections and infestations | 0/16 | 0/16 | 2/10 | 0/11 |
| DizzinessNervous system disorders | 0/16 | 1/16 | 2/10 | 1/11 |
| Abdominal painGastrointestinal disorders | 0/16 | 0/16 | 2/10 | 0/11 |
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.
| Age, Continuous(years) | CV7202 1 mcg | CV7202 2 mcg | CV7202 5 mcg | Rabipur® | Total |
|---|---|---|---|---|---|
| Mean | 27.1 ± 5.62 | 28.3 ± 5.81 | 26.1 ± 3.96 | 25.5 ± 4.23 | 26.9 ± 5.11 |
| Sex: Female, Male(Participants) | CV7202 1 mcg | CV7202 2 mcg | CV7202 5 mcg | Rabipur® | Total |
|---|---|---|---|---|---|
| Female | 9 | 12 | 5 | 7 | 33 |
| Male | 7 | 4 | 5 | 4 | 20 |
| Race (NIH/OMB)(Participants) | CV7202 1 mcg | CV7202 2 mcg | CV7202 5 mcg | Rabipur® | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 |
| White | 15 | 16 | 10 | 11 | 52 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 0 | 0 | 1 |
| Region of Enrollment(participants) | CV7202 1 mcg | CV7202 2 mcg | CV7202 5 mcg | Rabipur® | Total |
|---|---|---|---|---|---|
| Belgium | 16 | 8 | 10 | 11 | 45 |
| Germany | 0 | 8 | 0 | 0 | 8 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Oct 2018 to primary completion in Nov 2021, 37 months.
Results were first posted in Dec 2024, 3 years after primary completion.
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