Trial Outcomes & Findings for Safety, Tolerability and Immunogenicity of Vaccine Candidate MVA-MERS-S (NCT NCT03615911)
NCT ID: NCT03615911
Last Updated: 2020-10-06
Results Overview
The solicited local adverse events for this study include: Swelling, erythema, induration, hematoma and pain at site of injection The solicited systemic adverse events for this study include: * Fever * Chills * Myalgia (described to the subject as generalized muscle aches) * Arthralgia (described to the subject as generalized joint aches) * Fatigue/Malaise * Headache * Gastrointestinal symptoms The reactogenicity (adverse events) will be assessed via a trained physician taking into account a patient diary. The severity of the adverse event will be measured as specified in the study protocol (grade 0=none, grade 1=mild, grade 2=moderate, grade 3=severe). The adverse event will furthermore be categorized in related vs. not related.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
14 days after each vaccination
Results posted on
2020-10-06
Participant Flow
Participant milestones
| Measure |
Vaccination With 10^7 PFU MVA-MERS-S
Vaccinations occur on days 0 and 28
A subgroup will additionally receive a late booster immunization with 10\^8 PFU MVA-MERS-S 12 months (+/- 4 months) after prime immunization.
vaccine candidate MVA-MERS-S: vaccination with MVA-MERS-S in two escalating dose regimes
|
Vaccination With 10^8 PFU MVA-MERS-S
Vaccinations occur on days 0 and 28
A subgroup will additionally receive a late booster immunization with 10\^8 PFU MVA-MERS-S 12 months (+/- 4 months) after prime immunization.
vaccine candidate MVA-MERS-S: vaccination with MVA-MERS-S in two escalating dose regimes
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
12
|
|
Overall Study
Received Late Booster Immunization
|
3
|
7
|
|
Overall Study
COMPLETED
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability and Immunogenicity of Vaccine Candidate MVA-MERS-S
Baseline characteristics by cohort
| Measure |
Vaccination With 10^7 PFU MVA-MERS-S
n=14 Participants
Vaccinations occur on days 0 and 28
A subgroup will additionally receive a late booster immunization with 10\^8 PFU MVA-MERS-S 12 months (+/- 4 months) after prime immunization.
vaccine candidate MVA-MERS-S: vaccination with MVA-MERS-S in two escalating dose regimes
|
Vaccination With 10^8 PFU MVA-MERS-S
n=12 Participants
Vaccinations occur on days 0 and 28
A subgroup will additionally receive a late booster immunization with 10\^8 PFU MVA-MERS-S 12 months (+/- 4 months) after prime immunization.
vaccine candidate MVA-MERS-S: vaccination with MVA-MERS-S in two escalating dose regimes
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
14 participants
n=5 Participants
|
12 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
BMI (kg/m2)
|
23.6 kg/m2
STANDARD_DEVIATION 2.5 • n=5 Participants
|
23.5 kg/m2
STANDARD_DEVIATION 3.7 • n=7 Participants
|
23.6 kg/m2
STANDARD_DEVIATION 3.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: 14 days after each vaccinationThe solicited local adverse events for this study include: Swelling, erythema, induration, hematoma and pain at site of injection The solicited systemic adverse events for this study include: * Fever * Chills * Myalgia (described to the subject as generalized muscle aches) * Arthralgia (described to the subject as generalized joint aches) * Fatigue/Malaise * Headache * Gastrointestinal symptoms The reactogenicity (adverse events) will be assessed via a trained physician taking into account a patient diary. The severity of the adverse event will be measured as specified in the study protocol (grade 0=none, grade 1=mild, grade 2=moderate, grade 3=severe). The adverse event will furthermore be categorized in related vs. not related.
Outcome measures
| Measure |
Vaccination With 10^7 PFU MVA-MERS-S
n=14 Participants
Vaccinations occur on days 0 and 28.
A subgroup will additionally receive a late booster immunization with 10\^8 PFU MVA-MERS-S 12 months (+/- 4 months) after prime immunization.
|
Vaccination With 10^8 PFU MVA-MERS-S
n=12 Participants
Vaccinations occur on days 0 and 28.
A subgroup will additionally receive a late booster immunization with 10\^8 PFU MVA-MERS-S 12 months (+/- 4 months) after prime immunization.
|
|---|---|---|
|
Percentage of Participants Experiencing Solicited Local or Systemic Reactogenicity as Defined by the Study Protocol
|
10 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: 28 days after each vaccinationThe unsolicited adverse events will be assessed via a trained physician taking into account a patient diary. The severity of the adverse event will be measured as specified in the study protocol (grade 0=none, grade 1=mild, grade 2=moderate, grade 3=severe). The adverse event will furthermore be categorized in related vs. not related.
Outcome measures
| Measure |
Vaccination With 10^7 PFU MVA-MERS-S
n=14 Participants
Vaccinations occur on days 0 and 28.
A subgroup will additionally receive a late booster immunization with 10\^8 PFU MVA-MERS-S 12 months (+/- 4 months) after prime immunization.
|
Vaccination With 10^8 PFU MVA-MERS-S
n=12 Participants
Vaccinations occur on days 0 and 28.
A subgroup will additionally receive a late booster immunization with 10\^8 PFU MVA-MERS-S 12 months (+/- 4 months) after prime immunization.
|
|---|---|---|
|
Percentage of Participants Who Experienced an Unsolicited Adverse Event
|
5 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Throughout the study up to conclusionPopulation: All participants were included in the safety analysis.
The safety laboratory measures include: \- Clinical Chemistry: CRP in miligrams per liter \[mg/l\]
Outcome measures
| Measure |
Vaccination With 10^7 PFU MVA-MERS-S
n=14 Participants
Vaccinations occur on days 0 and 28.
A subgroup will additionally receive a late booster immunization with 10\^8 PFU MVA-MERS-S 12 months (+/- 4 months) after prime immunization.
|
Vaccination With 10^8 PFU MVA-MERS-S
n=12 Participants
Vaccinations occur on days 0 and 28.
A subgroup will additionally receive a late booster immunization with 10\^8 PFU MVA-MERS-S 12 months (+/- 4 months) after prime immunization.
|
|---|---|---|
|
Change of Mean C-reactive Protein (CRP) Levels (Measured in [mg/l]) From Baseline (Day -1 ) as Compared to the End of the Study (D180)
|
0 mg/l
Standard Deviation 0.3
|
-1 mg/l
Standard Deviation 3
|
PRIMARY outcome
Timeframe: Throughout the study up to conclusionThe safety laboratory measures include Hematology: WBC count in billions per liter \[billion cells/L\]
Outcome measures
| Measure |
Vaccination With 10^7 PFU MVA-MERS-S
n=14 Participants
Vaccinations occur on days 0 and 28.
A subgroup will additionally receive a late booster immunization with 10\^8 PFU MVA-MERS-S 12 months (+/- 4 months) after prime immunization.
|
Vaccination With 10^8 PFU MVA-MERS-S
n=12 Participants
Vaccinations occur on days 0 and 28.
A subgroup will additionally receive a late booster immunization with 10\^8 PFU MVA-MERS-S 12 months (+/- 4 months) after prime immunization.
|
|---|---|---|
|
Change of Mean White Blood Cell (WBC) Counts (Measured in [Billion Cells/L]) From Baseline (Day -1) as Compared to the End of the Study (D180)
|
-1.8 Billion Cells/L
Standard Deviation 1.44
|
-1.0 Billion Cells/L
Standard Deviation 1.92
|
PRIMARY outcome
Timeframe: Throughout the study up to conclusionSerious adverse events are defined as any untoward medical occurrence (whether considered to be related to investigational medicinal product or not) that at any dose: * results in death * is life-threatening * requires inpatient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * is a congenital abnormality/birth defect * is an Important Medical Event, i.e., an event that may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Outcome measures
| Measure |
Vaccination With 10^7 PFU MVA-MERS-S
n=14 Participants
Vaccinations occur on days 0 and 28.
A subgroup will additionally receive a late booster immunization with 10\^8 PFU MVA-MERS-S 12 months (+/- 4 months) after prime immunization.
|
Vaccination With 10^8 PFU MVA-MERS-S
n=12 Participants
Vaccinations occur on days 0 and 28.
A subgroup will additionally receive a late booster immunization with 10\^8 PFU MVA-MERS-S 12 months (+/- 4 months) after prime immunization.
|
|---|---|---|
|
Percentage of Participants Experiencing a Serious Adverse Event up to Day 180 (Study Completion)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Throughout the study up to conclusionHumoral immunity: The magnitude of MVA-MERS-S antibody responses as assessed by neutralization assay and ELISA.
Outcome measures
| Measure |
Vaccination With 10^7 PFU MVA-MERS-S
n=12 Participants
Vaccinations occur on days 0 and 28.
A subgroup will additionally receive a late booster immunization with 10\^8 PFU MVA-MERS-S 12 months (+/- 4 months) after prime immunization.
|
Vaccination With 10^8 PFU MVA-MERS-S
n=11 Participants
Vaccinations occur on days 0 and 28.
A subgroup will additionally receive a late booster immunization with 10\^8 PFU MVA-MERS-S 12 months (+/- 4 months) after prime immunization.
|
|---|---|---|
|
Immunogenicity: Number of Participants Who Seroconverted Throughout the Study (up to Study Completion at Day 180)
|
8 Participants
|
10 Participants
|
Adverse Events
Vaccination With 10^7 PFU MVA-MERS-S
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Vaccination With 10^8 PFU MVA-MERS-S
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vaccination With 10^7 PFU MVA-MERS-S
n=14 participants at risk
Vaccinations occur on days 0 and 28.
A subgroup will additionally receive a late booster immunization with 10\^8 PFU MVA-MERS-S 12 months (+/- 4 months) after prime immunization.
|
Vaccination With 10^8 PFU MVA-MERS-S
n=12 participants at risk
Vaccinations occur on days 0 and 28.
A subgroup will additionally receive a late booster immunization with 10\^8 PFU MVA-MERS-S 12 months (+/- 4 months) after prime immunization.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Local reactogenicity
|
57.1%
8/14 • Solicited AE: 14 days after each vaccination Unsolicited AE: 28 days after each vaccination SAE: Throughout the study (180 days). In case of participation in the follow-up booster immunization 12 months (+/-4 months after prime vaccination) additional 28-day follow-up time after booster vaccination.
Participants filled out a participant diary, which was assessed on study visits (Day 1, 3, 7, 14, 28 after vaccination).
|
83.3%
10/12 • Solicited AE: 14 days after each vaccination Unsolicited AE: 28 days after each vaccination SAE: Throughout the study (180 days). In case of participation in the follow-up booster immunization 12 months (+/-4 months after prime vaccination) additional 28-day follow-up time after booster vaccination.
Participants filled out a participant diary, which was assessed on study visits (Day 1, 3, 7, 14, 28 after vaccination).
|
|
General disorders
Fatigue and Malaise
|
71.4%
10/14 • Solicited AE: 14 days after each vaccination Unsolicited AE: 28 days after each vaccination SAE: Throughout the study (180 days). In case of participation in the follow-up booster immunization 12 months (+/-4 months after prime vaccination) additional 28-day follow-up time after booster vaccination.
Participants filled out a participant diary, which was assessed on study visits (Day 1, 3, 7, 14, 28 after vaccination).
|
58.3%
7/12 • Solicited AE: 14 days after each vaccination Unsolicited AE: 28 days after each vaccination SAE: Throughout the study (180 days). In case of participation in the follow-up booster immunization 12 months (+/-4 months after prime vaccination) additional 28-day follow-up time after booster vaccination.
Participants filled out a participant diary, which was assessed on study visits (Day 1, 3, 7, 14, 28 after vaccination).
|
|
Gastrointestinal disorders
Gastrointestinal Symptoms
|
35.7%
5/14 • Solicited AE: 14 days after each vaccination Unsolicited AE: 28 days after each vaccination SAE: Throughout the study (180 days). In case of participation in the follow-up booster immunization 12 months (+/-4 months after prime vaccination) additional 28-day follow-up time after booster vaccination.
Participants filled out a participant diary, which was assessed on study visits (Day 1, 3, 7, 14, 28 after vaccination).
|
41.7%
5/12 • Solicited AE: 14 days after each vaccination Unsolicited AE: 28 days after each vaccination SAE: Throughout the study (180 days). In case of participation in the follow-up booster immunization 12 months (+/-4 months after prime vaccination) additional 28-day follow-up time after booster vaccination.
Participants filled out a participant diary, which was assessed on study visits (Day 1, 3, 7, 14, 28 after vaccination).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.4%
3/14 • Solicited AE: 14 days after each vaccination Unsolicited AE: 28 days after each vaccination SAE: Throughout the study (180 days). In case of participation in the follow-up booster immunization 12 months (+/-4 months after prime vaccination) additional 28-day follow-up time after booster vaccination.
Participants filled out a participant diary, which was assessed on study visits (Day 1, 3, 7, 14, 28 after vaccination).
|
8.3%
1/12 • Solicited AE: 14 days after each vaccination Unsolicited AE: 28 days after each vaccination SAE: Throughout the study (180 days). In case of participation in the follow-up booster immunization 12 months (+/-4 months after prime vaccination) additional 28-day follow-up time after booster vaccination.
Participants filled out a participant diary, which was assessed on study visits (Day 1, 3, 7, 14, 28 after vaccination).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
1/14 • Solicited AE: 14 days after each vaccination Unsolicited AE: 28 days after each vaccination SAE: Throughout the study (180 days). In case of participation in the follow-up booster immunization 12 months (+/-4 months after prime vaccination) additional 28-day follow-up time after booster vaccination.
Participants filled out a participant diary, which was assessed on study visits (Day 1, 3, 7, 14, 28 after vaccination).
|
33.3%
4/12 • Solicited AE: 14 days after each vaccination Unsolicited AE: 28 days after each vaccination SAE: Throughout the study (180 days). In case of participation in the follow-up booster immunization 12 months (+/-4 months after prime vaccination) additional 28-day follow-up time after booster vaccination.
Participants filled out a participant diary, which was assessed on study visits (Day 1, 3, 7, 14, 28 after vaccination).
|
|
Nervous system disorders
Headache
|
50.0%
7/14 • Solicited AE: 14 days after each vaccination Unsolicited AE: 28 days after each vaccination SAE: Throughout the study (180 days). In case of participation in the follow-up booster immunization 12 months (+/-4 months after prime vaccination) additional 28-day follow-up time after booster vaccination.
Participants filled out a participant diary, which was assessed on study visits (Day 1, 3, 7, 14, 28 after vaccination).
|
75.0%
9/12 • Solicited AE: 14 days after each vaccination Unsolicited AE: 28 days after each vaccination SAE: Throughout the study (180 days). In case of participation in the follow-up booster immunization 12 months (+/-4 months after prime vaccination) additional 28-day follow-up time after booster vaccination.
Participants filled out a participant diary, which was assessed on study visits (Day 1, 3, 7, 14, 28 after vaccination).
|
|
General disorders
Other systemic unsolicited
|
7.1%
1/14 • Solicited AE: 14 days after each vaccination Unsolicited AE: 28 days after each vaccination SAE: Throughout the study (180 days). In case of participation in the follow-up booster immunization 12 months (+/-4 months after prime vaccination) additional 28-day follow-up time after booster vaccination.
Participants filled out a participant diary, which was assessed on study visits (Day 1, 3, 7, 14, 28 after vaccination).
|
8.3%
1/12 • Solicited AE: 14 days after each vaccination Unsolicited AE: 28 days after each vaccination SAE: Throughout the study (180 days). In case of participation in the follow-up booster immunization 12 months (+/-4 months after prime vaccination) additional 28-day follow-up time after booster vaccination.
Participants filled out a participant diary, which was assessed on study visits (Day 1, 3, 7, 14, 28 after vaccination).
|
|
Immune system disorders
Fever/Chills
|
0.00%
0/14 • Solicited AE: 14 days after each vaccination Unsolicited AE: 28 days after each vaccination SAE: Throughout the study (180 days). In case of participation in the follow-up booster immunization 12 months (+/-4 months after prime vaccination) additional 28-day follow-up time after booster vaccination.
Participants filled out a participant diary, which was assessed on study visits (Day 1, 3, 7, 14, 28 after vaccination).
|
16.7%
2/12 • Solicited AE: 14 days after each vaccination Unsolicited AE: 28 days after each vaccination SAE: Throughout the study (180 days). In case of participation in the follow-up booster immunization 12 months (+/-4 months after prime vaccination) additional 28-day follow-up time after booster vaccination.
Participants filled out a participant diary, which was assessed on study visits (Day 1, 3, 7, 14, 28 after vaccination).
|
Additional Information
Prof. Marylyn M. Addo
University Medical Center Hamburg-Eppendorf
Phone: +49 40 7410
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place