Trial Outcomes & Findings for A Study to Assess the Safety, Reactogenicity and Immune Response of CureVac's Candidate Rabies mRNA Vaccine in Healthy Adults (NCT NCT03713086)

Last Updated: 2024-12-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

53 participants

Primary outcome timeframe

From the first dose of vaccination up to 7 days after vaccination (up to Day 8)

Results posted on

2024-12-19

Participant Flow

The study was conducted at 2 investigative sites in Germany and Belgium between 12 October 2018 and 23 November 2021.

A total 90 participants were screened, out of which 53 were enrolled and received the treatment.

Participant milestones

Participant milestones
Measure	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.	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.	CV7202 5 mcg Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1.	Rabipur® Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations.
Overall Study STARTED	16	16	10	11
Overall Study Received Dose at Day 1	16	16	10	11
Overall Study Received Dose at Day 8	0	0	0	11
Overall Study Received Dose at Day 29	8	8	0	11
Overall Study COMPLETED	16	13	9	10
Overall Study NOT COMPLETED	0	3	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	CV7202 5 mcg Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1.	Rabipur® Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations.
Overall Study Withdrawal by Subject	0	2	1	0
Overall Study Lost to Follow-up	0	1	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CV7202 1 mcg n=16 Participants Participants received mRNA CV7202 1 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 n=16 Participants 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.	CV7202 5 mcg n=10 Participants Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1.	Rabipur® n=11 Participants Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations.	Total n=53 Participants Total of all reporting groups
Region of Enrollment Belgium	16 participants n=5 Participants	8 participants n=7 Participants	10 participants n=5 Participants	11 participants n=4 Participants	45 participants n=21 Participants
Region of Enrollment Germany	0 participants n=5 Participants	8 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	8 participants n=21 Participants
Age, Continuous	27.1 years STANDARD_DEVIATION 5.62 • n=5 Participants	28.3 years STANDARD_DEVIATION 5.81 • n=7 Participants	26.1 years STANDARD_DEVIATION 3.96 • n=5 Participants	25.5 years STANDARD_DEVIATION 4.23 • n=4 Participants	26.9 years STANDARD_DEVIATION 5.11 • n=21 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	12 Participants n=7 Participants	5 Participants n=5 Participants	7 Participants n=4 Participants	33 Participants n=21 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	20 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	16 Participants n=7 Participants	10 Participants n=5 Participants	11 Participants n=4 Participants	52 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants

PRIMARY outcome

Timeframe: From the first dose of vaccination up to 7 days after vaccination (up to Day 8)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	CV7202 1 mcg n=16 Participants Participants received mRNA CV7202 1 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 n=16 Participants 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.	CV7202 5 mcg n=10 Participants Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1.	Rabipur® n=11 Participants Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations.
Number of Participants Who Experienced a Local Solicited Adverse Event (AE) Post Dose 1 (Day 1)	13 Participants	15 Participants	10 Participants	5 Participants

PRIMARY outcome

Timeframe: From the first dose of vaccination up to 7 days after vaccination (up to Day 8)

Population: 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.

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).

Outcome measures

Outcome measures
Measure	CV7202 1 mcg n=16 Participants Participants received mRNA CV7202 1 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 n=16 Participants 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.	CV7202 5 mcg n=10 Participants Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1.	Rabipur® n=11 Participants Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations.
Number of Participants With Grade 0, 1, 2 and 3 Local Solicited AEs Post Dose 1 (Day 1) Grade 0 (No AE/Absent)	3 Participants	1 Participants	0 Participants	5 Participants
Number of Participants With Grade 0, 1, 2 and 3 Local Solicited AEs Post Dose 1 (Day 1) Grade 1 (Mild)	13 Participants	13 Participants	4 Participants	5 Participants
Number of Participants With Grade 0, 1, 2 and 3 Local Solicited AEs Post Dose 1 (Day 1) Grade 2 (Moderate)	0 Participants	1 Participants	5 Participants	0 Participants
Number of Participants With Grade 0, 1, 2 and 3 Local Solicited AEs Post Dose 1 (Day 1) Grade 3 (Severe)	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Grade 0, 1, 2 and 3 Local Solicited AEs Post Dose 1 (Day 1) Not assessed	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: From the first dose of vaccination up to 7 days after vaccination (up to Day 8)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	CV7202 1 mcg n=16 Participants Participants received mRNA CV7202 1 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 n=16 Participants 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.	CV7202 5 mcg n=10 Participants Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1.	Rabipur® n=11 Participants Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations.
Number of Participants Who Experienced a Systemic Solicited AE and Related Systemic Solicited AE Post Dose 1 (Day 1) Participants with Systemic Solicited AE	11 Participants	13 Participants	9 Participants	8 Participants
Number of Participants Who Experienced a Systemic Solicited AE and Related Systemic Solicited AE Post Dose 1 (Day 1) Participants with Related Systemic Solicited AE	8 Participants	13 Participants	9 Participants	5 Participants

PRIMARY outcome

Timeframe: From the first dose of vaccination up to 7 days after vaccination (up to Day 8)

Population: 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.

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).

Outcome measures

Outcome measures
Measure	CV7202 1 mcg n=16 Participants Participants received mRNA CV7202 1 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 n=16 Participants 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.	CV7202 5 mcg n=10 Participants Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1.	Rabipur® n=11 Participants Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations.
Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) Participants with Systemic Solicited AEs · Grade 0 (No AE/Absent)	5 Participants	3 Participants	1 Participants	2 Participants
Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) Participants with Systemic Solicited AEs · Grade 1 (Mild)	8 Participants	4 Participants	0 Participants	4 Participants
Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) Participants with Systemic Solicited AEs · Grade 2 (Moderate)	3 Participants	6 Participants	3 Participants	4 Participants
Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) Participants with Systemic Solicited AEs · Grade 3 (Severe)	0 Participants	3 Participants	6 Participants	0 Participants
Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) Participants with Systemic Solicited AEs · Not assessed	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) Participants with Related Systemic Solicited AEs · Grade 0 (No AE/Absent)	8 Participants	3 Participants	1 Participants	5 Participants
Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) Participants with Related Systemic Solicited AEs · Grade 1 (Mild)	5 Participants	4 Participants	0 Participants	2 Participants
Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) Participants with Related Systemic Solicited AEs · Grade 2 (Moderate)	3 Participants	6 Participants	3 Participants	3 Participants
Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) Participants with Related Systemic Solicited AEs · Grade 3 (Severe)	0 Participants	3 Participants	6 Participants	0 Participants
Number of Participants With Grade 0, 1, 2, and 3 of Systemic Solicited AEs and Related Systemic Solicited AEs Post Dose 1 (Day 1) Participants with Related Systemic Solicited AEs · Not assessed	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: From Day 1 (post-dose 1) to Day 8

Population: 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. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who had an event in the respective category (pain, redness).

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.

Outcome measures

Outcome measures
Measure	CV7202 1 mcg n=16 Participants Participants received mRNA CV7202 1 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 n=16 Participants 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.	CV7202 5 mcg n=10 Participants Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1.	Rabipur® n=11 Participants Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations.
Number of Days of Local Solicited AEs Post Dose 1 (Day 1) Pain	1 Days Interval 1.0 to 4.0	2 Days Interval 1.0 to 3.0	3 Days Interval 1.0 to 6.0	2 Days Interval 1.0 to 4.0
Number of Days of Local Solicited AEs Post Dose 1 (Day 1) Redness	—	—	2 Days Interval 2.0 to 2.0	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CV7202 1 mcg n=8 Participants Participants received mRNA CV7202 1 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 n=8 Participants 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.	CV7202 5 mcg n=11 Participants Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1.	Rabipur® Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations.
Number of Days of Local Solicited AEs Post Dose 2 Pain	1 Days Interval 1.0 to 4.0	2 Days Interval 1.0 to 4.0	2 Days Interval 1.0 to 4.0	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CV7202 1 mcg n=11 Participants Participants received mRNA CV7202 1 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 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.	CV7202 5 mcg Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1.	Rabipur® Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations.
Number of Days of Local Solicited AEs Post Dose 3 Pain	2 Days Interval 1.0 to 2.0	—	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CV7202 1 mcg n=16 Participants Participants received mRNA CV7202 1 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 n=16 Participants 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.	CV7202 5 mcg n=10 Participants Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1.	Rabipur® n=11 Participants Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations.
Number of Days of Systemic Solicited AEs Post Dose 1 Temperature	—	1 Days Interval 1.0 to 2.0	1 Days Interval 1.0 to 1.0	—
Number of Days of Systemic Solicited AEs Post Dose 1 Headache	1 Days Interval 1.0 to 4.0	2 Days Interval 1.0 to 5.0	2 Days Interval 1.0 to 4.0	1 Days Interval 1.0 to 4.0
Number of Days of Systemic Solicited AEs Post Dose 1 Fatigue	2 Days Interval 1.0 to 2.0	2 Days Interval 1.0 to 3.0	2 Days Interval 1.0 to 7.0	1 Days Interval 1.0 to 5.0
Number of Days of Systemic Solicited AEs Post Dose 1 Chills	—	1.5 Days Interval 1.0 to 2.0	1 Days Interval 1.0 to 2.0	—
Number of Days of Systemic Solicited AEs Post Dose 1 Myalgia	2 Days Interval 1.0 to 5.0	3 Days Interval 1.0 to 3.0	2 Days Interval 1.0 to 5.0	1 Days Interval 1.0 to 1.0
Number of Days of Systemic Solicited AEs Post Dose 1 Athralgia	1 Days Interval 1.0 to 3.0	1 Days Interval 1.0 to 2.0	2 Days Interval 1.0 to 3.0	—
Number of Days of Systemic Solicited AEs Post Dose 1 Nausea/Vomiting	1 Days Interval 1.0 to 1.0	3 Days Interval 3.0 to 3.0	1 Days Interval 1.0 to 3.0	1 Days Interval 1.0 to 1.0
Number of Days of Systemic Solicited AEs Post Dose 1 Diarrhea	4 Days Interval 4.0 to 4.0	1 Days Interval 1.0 to 1.0	2 Days Interval 1.0 to 3.0	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CV7202 1 mcg n=8 Participants Participants received mRNA CV7202 1 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 n=8 Participants 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.	CV7202 5 mcg n=11 Participants Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1.	Rabipur® Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations.
Number of Days of Systemic Solicited AEs Post Dose 2 Temperature	1 Days Interval 1.0 to 1.0	1.5 Days Interval 1.0 to 2.0	—	—
Number of Days of Systemic Solicited AEs Post Dose 2 Headache	1 Days Interval 1.0 to 3.0	2 Days Interval 1.0 to 4.0	1.5 Days Interval 1.0 to 2.0	—
Number of Days of Systemic Solicited AEs Post Dose 2 Fatigue	2 Days Interval 1.0 to 2.0	2 Days Interval 2.0 to 3.0	2 Days Interval 1.0 to 3.0	—
Number of Days of Systemic Solicited AEs Post Dose 2 Chills	1.5 Days Interval 1.0 to 2.0	1.5 Days Interval 1.0 to 2.0	—	—
Number of Days of Systemic Solicited AEs Post Dose 2 Myalgia	1.5 Days Interval 1.0 to 2.0	1.5 Days Interval 1.0 to 2.0	—	—
Number of Days of Systemic Solicited AEs Post Dose 2 Arthralgia	1 Days Interval 1.0 to 2.0	2 Days Interval 2.0 to 2.0	—	—
Number of Days of Systemic Solicited AEs Post Dose 2 Nausea/Vomiting	—	2 Days Interval 2.0 to 2.0	—	—
Number of Days of Systemic Solicited AEs Post Dose 2 Diarrhea	—	2 Days Interval 2.0 to 2.0	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CV7202 1 mcg n=10 Participants Participants received mRNA CV7202 1 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 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.	CV7202 5 mcg Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1.	Rabipur® Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations.
Number of Days of Systemic Solicited AEs Post Dose 3 Headache	1 Days Interval 1.0 to 1.0	—	—	—
Number of Days of Systemic Solicited AEs Post Dose 3 Fatigue	2 Days Interval 2.0 to 2.0	—	—	—
Number of Days of Systemic Solicited AEs Post Dose 3 Chills	1 Days Interval 1.0 to 1.0	—	—	—

PRIMARY outcome

Timeframe: From the first dose of vaccination up to 28 days after vaccination (up to Day 29)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	CV7202 1 mcg n=16 Participants Participants received mRNA CV7202 1 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 n=16 Participants 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.	CV7202 5 mcg n=10 Participants Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1.	Rabipur® n=11 Participants Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations.
Number of Participants Who Experienced Unsolicited and Related Unsolicited AEs Participants with Related Unsolicited AEs	2 Participants	9 Participants	7 Participants	1 Participants
Number of Participants Who Experienced Unsolicited and Related Unsolicited AEs Participants with Unsolicited AEs	10 Participants	14 Participants	9 Participants	6 Participants

PRIMARY outcome

Timeframe: From the first dose of vaccination up to 28 days after vaccination (up to Day 29)

Population: 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. Here overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and number analyzed included those participants who were evaluable for the specified categories for this outcome measure.

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.

Outcome measures

Outcome measures
Measure	CV7202 1 mcg n=16 Participants Participants received mRNA CV7202 1 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 n=16 Participants 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.	CV7202 5 mcg n=10 Participants Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1.	Rabipur® n=11 Participants Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations.
Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs Participants with all unsolicited AEs · Grade 1 (Mild)	3 Participants	3 Participants	2 Participants	2 Participants
Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs Participants with all unsolicited AEs · Grade 2 (Moderate)	4 Participants	9 Participants	1 Participants	3 Participants
Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs Participants with all unsolicited AEs · Grade 3 (Severe)	3 Participants	2 Participants	6 Participants	1 Participants
Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs Participants with related unsolicited AEs · Grade 1 (Mild)	1 Participants	4 Participants	1 Participants	0 Participants
Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs Participants with related unsolicited AEs · Grade 2 (Moderate)	1 Participants	3 Participants	1 Participants	1 Participants
Number of Participants With Grade 1, 2 and 3 Unsolicited and Related Unsolicited AEs Participants with related unsolicited AEs · Grade 3 (Severe)	0 Participants	2 Participants	5 Participants	0 Participants

PRIMARY outcome

Timeframe: From the first dose of vaccination up to 12 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	CV7202 1 mcg n=16 Participants Participants received mRNA CV7202 1 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 n=16 Participants 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.	CV7202 5 mcg n=10 Participants Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1.	Rabipur® n=11 Participants Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations.
Number of Participants With Any Serious Adverse Events (SAEs) up to 12 Months	1 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: From the first dose of vaccination up to 12 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	CV7202 1 mcg n=16 Participants Participants received mRNA CV7202 1 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 n=16 Participants 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.	CV7202 5 mcg n=10 Participants Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1.	Rabipur® n=11 Participants Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations.
Number of Participants With Any Medically-attended AEs (MAAEs) up to 12 Months	6 Participants	8 Participants	3 Participants	3 Participants

PRIMARY outcome

Timeframe: From the first dose of vaccination up to 12 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	CV7202 1 mcg n=16 Participants Participants received mRNA CV7202 1 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 n=16 Participants 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.	CV7202 5 mcg n=10 Participants Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1.	Rabipur® n=11 Participants Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations.
Number of Participants With Any Adverse Events of Special Interest (AESIs) and Related AESI up to 12 Month Participants with AESIs	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Adverse Events of Special Interest (AESIs) and Related AESI up to 12 Month Participants with related AESIs	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From 12 months up to 24 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	CV7202 1 mcg n=16 Participants Participants received mRNA CV7202 1 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 n=16 Participants 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.	CV7202 5 mcg n=10 Participants Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1.	Rabipur® n=10 Participants Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations.
Number of Participants With Related SAEs From 12 Months Post-vaccination up to 24 Months	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From 12 months up to 24 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	CV7202 1 mcg n=16 Participants Participants received mRNA CV7202 1 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 n=16 Participants 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.	CV7202 5 mcg n=10 Participants Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1.	Rabipur® n=10 Participants Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations.
Number of Participants With Related MAAEs From 12 Months up to 24 Months	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From 12 months up to 24 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	CV7202 1 mcg n=16 Participants Participants received mRNA CV7202 1 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 n=16 Participants 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.	CV7202 5 mcg n=10 Participants Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1.	Rabipur® n=10 Participants Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations.
Number of Participants With Any Related AESIs From 12 Months up to 24 Months	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Days 15, 43, 365, 547, and 730

Population: Full analysis set (FAS) is a subset of the safety set with participants who had the baseline sample and at least 1 additional blood sample available for VNT analysis. Here overall number of participants analyzed included those participants who were evaluable for this outcome measure and number analyzed included those participants who were evaluable at specified timepoints for this outcome measure.

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.

Outcome measures

Outcome measures
Measure	CV7202 1 mcg n=16 Participants Participants received mRNA CV7202 1 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 n=16 Participants 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.	CV7202 5 mcg n=10 Participants Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1.	Rabipur® n=10 Participants Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations.
Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs) Baseline (Day 1)	0.0 percentage of participants Interval 0.0 to 20.6	0.0 percentage of participants Interval 0.0 to 20.6	0.0 percentage of participants Interval 0.0 to 30.8	0.0 percentage of participants Interval 0.0 to 30.8
Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs) Day 15	0.0 percentage of participants Interval 0.0 to 20.6	6.3 percentage of participants Interval 0.2 to 30.2	0.0 percentage of participants Interval 0.0 to 30.8	100.0 percentage of participants Interval 69.2 to 100.0
Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs) Day 43	50.0 percentage of participants Interval 24.7 to 75.3	62.5 percentage of participants Interval 35.4 to 84.8	22.2 percentage of participants Interval 2.8 to 60.0	100.0 percentage of participants Interval 69.2 to 100.0
Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs) Day 365	12.5 percentage of participants Interval 1.6 to 38.3	14.3 percentage of participants Interval 1.8 to 42.8	11.1 percentage of participants Interval 0.3 to 48.2	100.0 percentage of participants Interval 69.2 to 100.0
Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs) Day 547	22.2 percentage of participants Interval 2.8 to 60.0	28.6 percentage of participants Interval 3.7 to 71.0	16.7 percentage of participants Interval 0.4 to 64.1	90.0 percentage of participants Interval 55.5 to 99.7
Percentages of Participants With Rabies-specific Serum Virus-neutralizing Antibody Titer (VNTs) Day 730	22.2 percentage of participants Interval 2.8 to 60.0	42.9 percentage of participants Interval 9.9 to 81.6	16.7 percentage of participants Interval 0.4 to 64.1	90.0 percentage of participants Interval 55.5 to 99.7

SECONDARY outcome

Timeframe: Baseline (Day 1), Days 8, 15, 29, 36, 43, 57, 91, 182, 365, 547, and 730

Population: FAS is a subset of the safety set with participants who had the baseline sample and at least 1 additional blood sample available for VNT analysis. Here overall number of participants analyzed included those participants who were evaluable for this outcome measure and number analyzed included those participants who were evaluable at specified timepoints for this outcome measure.

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.

Outcome measures

Outcome measures
Measure	CV7202 1 mcg n=16 Participants Participants received mRNA CV7202 1 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 n=16 Participants 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.	CV7202 5 mcg n=10 Participants Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1.	Rabipur® n=11 Participants Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations.
Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs Baseline (Day 1)	0.050 IU/mL Standard Deviation 1.0000	0.050 IU/mL Standard Deviation 1.0000	0.050 IU/mL Standard Deviation 1.0000	0.050 IU/mL Standard Deviation 1.0000
Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs Day 8	0.053 IU/mL Standard Deviation 1.2698	0.053 IU/mL Standard Deviation 1.2179	0.050 IU/mL Standard Deviation 1.0000	0.057 IU/mL Standard Deviation 1.3394
Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs Day 15	0.069 IU/mL Standard Deviation 1.8803	0.095 IU/mL Standard Deviation 2.6702	0.062 IU/mL Standard Deviation 1.5685	7.834 IU/mL Standard Deviation 2.7369
Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs Day 29	0.092 IU/mL Standard Deviation 1.9864	0.189 IU/mL Standard Deviation 3.8604	0.144 IU/mL Standard Deviation 2.8064	4.478 IU/mL Standard Deviation 3.0074
Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs Day 36	0.231 IU/mL Standard Deviation 3.2958	0.433 IU/mL Standard Deviation 5.1784	0.136 IU/mL Standard Deviation 3.1008	8.921 IU/mL Standard Deviation 2.4253
Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs Day 43	0.653 IU/mL Standard Deviation 9.3871	0.692 IU/mL Standard Deviation 8.3640	0.122 IU/mL Standard Deviation 2.9790	9.341 IU/mL Standard Deviation 2.2222
Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs Day 57	0.540 IU/mL Standard Deviation 8.2728	0.502 IU/mL Standard Deviation 7.6846	0.125 IU/mL Standard Deviation 2.8786	7.849 IU/mL Standard Deviation 1.8818
Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs Day 91	0.445 IU/mL Standard Deviation 5.8568	0.275 IU/mL Standard Deviation 6.0428	0.105 IU/mL Standard Deviation 2.9133	4.888 IU/mL Standard Deviation 1.8755
Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs Day 182	0.176 IU/mL Standard Deviation 4.6498	0.163 IU/mL Standard Deviation 3.6199	0.074 IU/mL Standard Deviation 2.4421	1.089 IU/mL Standard Deviation 1.9244
Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs Day 365	0.095 IU/mL Standard Deviation 2.7511	0.097 IU/mL Standard Deviation 2.8842	0.072 IU/mL Standard Deviation 2.3457	0.816 IU/mL Standard Deviation 2.1405
Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs Day 547	0.132 IU/mL Standard Deviation 2.7428	0.149 IU/mL Standard Deviation 3.6318	0.077 IU/mL Standard Deviation 2.9198	0.879 IU/mL Standard Deviation 1.9594
Serum Geometric Mean Titers (GMTs) of Rabies-specific VNTs Day 730	0.128 IU/mL Standard Deviation 3.9213	0.246 IU/mL Standard Deviation 4.0963	0.073 IU/mL Standard Deviation 2.5600	0.831 IU/mL Standard Deviation 2.0624

Adverse Events

CV7202 1 mcg

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

CV7202 2 mcg

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

CV7202 5 mcg

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Rabipur®

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CV7202 1 mcg n=16 participants at risk Participants received mRNA CV7202 1 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 n=16 participants at risk 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.	CV7202 5 mcg n=10 participants at risk Participants received mRNA CV7202 5 mcg intramuscular injection at Day 1.	Rabipur® n=11 participants at risk Participants received 3 doses of Rabipur® intramuscular injection at Days 1, 8 and 29 according to the manufacturer's recommendations.
Infections and infestations Herpes zoster	6.2% 1/16 • From the first dose of vaccination up to 24 months 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.	0.00% 0/16 • From the first dose of vaccination up to 24 months 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.	0.00% 0/10 • From the first dose of vaccination up to 24 months 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.	0.00% 0/11 • From the first dose of vaccination up to 24 months 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.
Infections and infestations Appendicitis	0.00% 0/16 • From the first dose of vaccination up to 24 months 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.	0.00% 0/16 • From the first dose of vaccination up to 24 months 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.	0.00% 0/10 • From the first dose of vaccination up to 24 months 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.	9.1% 1/11 • From the first dose of vaccination up to 24 months 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.

Other adverse events

Additional Information

CureVac SE

CureVac

Phone: +49 (0) 697680587-0

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
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