Safety, Tolerability and Immunogenicity of Vaccine Candidate MVA-MERS-S

• Sponsor: Marylyn Addo (Other)
• Overall Status: Completed
• CT.gov ID: NCT03615911
• Collaborator: Philipps University Marburg Medical Center (Other), Ludwig-Maximilians - University of Munich (Other), Charite University, Berlin, Germany (Other), Bernhard Nocht Institute for Tropical Medicine (Other), University of Cologne (Other)
• Enrollment: 26
• Location: 1
• Arms: 2
• Actual Duration (Months): 17.3
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

The Middle East Respiratory Syndrome Coronavirus (MERS-CoV) is a potentially fatal disease with a reported lethality of up to 40% that is under tight epidemiologic control by the World Health Organization (WHO) and currently without registered prevention or treatment option.

In this phase I first-in-human clinical trial, healthy volunteers in two different dose cohorts will be vaccinated twice with the candidate vaccine MVA-MERS-S. A subgroup will additionally receive a late booster vaccination.

The aim of the study is to assess the safety and tolerability of the candidate vaccine and to characterize its immunogenicity.

Condition or Disease	Intervention/Treatment	Phase
MERS (Middle East Respiratory Syndrome)	Biological: vaccine candidate MVA-MERS-S	Phase 1

Detailed Description

The vaccine contains a Modified Vaccinia Virus Ankara (MVA) vector expressing the MERS-CoV spike glycoprotein (S). A total of 24 participants will receive the following vaccine regime:

12 participants will receive 10^7 plaque-forming units (PFU) of MVA-MERS-S on days 0 and 28.

12 participants will receive 10^8 PFU of MVA-MERS-S on days 0 and 28.

Safety and immunogenicity data will be collected throughout the study, which concludes at day 180.

Update March 2019: A subgroup of participants from both dose cohorts will receive a late booster immunization of 10^8 PFU MVA-MERS-S 12 months (+/- 4 months) after prime immunization.

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: An Open, Single Center Phase I Trial to Assess the Safety, Tolerability and Immunogenicity of Two Ascending Doses of the Candidate Vaccine MVA-MERS-S
• Actual Study Start Date: Nov 28, 2017
• Actual Primary Completion Date: Apr 15, 2019
• Actual Study Completion Date: May 10, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Biological: vaccine candidate MVA-MERS-S; vaccination with MVA-MERS-S in two escalating dose regimes
Experimental: 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.	Biological: vaccine candidate MVA-MERS-S; vaccination with MVA-MERS-S in two escalating dose regimes

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Experiencing Solicited Local or Systemic Reactogenicity as Defined by the Study Protocol [14 days after each vaccination]

   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.

2. Percentage of Participants Who Experienced an Unsolicited Adverse Event [28 days after each vaccination]

   The 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.

3. 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) [Throughout the study up to conclusion]

   The safety laboratory measures include: - Clinical Chemistry: CRP in miligrams per liter [mg/l]

4. 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) [Throughout the study up to conclusion]

   The safety laboratory measures include Hematology: WBC count in billions per liter [billion cells/L]

5. Percentage of Participants Experiencing a Serious Adverse Event up to Day 180 (Study Completion) [Throughout the study up to conclusion]

   Serious 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.

Secondary Outcome Measures

1. Immunogenicity: Number of Participants Who Seroconverted Throughout the Study (up to Study Completion at Day 180) [Throughout the study up to conclusion]

   Humoral immunity: The magnitude of MVA-MERS-S antibody responses as assessed by neutralization assay and ELISA.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

The participant must not be enrolled before all inclusion criteria (including test results) are confirmed. Subjects meeting all of the criteria listed below will be included in the study:

1. Ability to understand the subject information and to personally sign and date the informed consent to participate in the study, before completing any study related procedures.

2. Provided written informed consent.

3. Healthy male and female participants aged 18 - 55 years inclusive at the time of consent. The date of signing informed consent is defined as the beginning of the screening period. This inclusion criterion will only be assessed at the first screening visit.

4. No clinically significant health problems as determined during medical history and physical examination at screening visit.

5. Body weight in defined relation to height. Body mass index 18.5 - 30.0 kg/m2 and weight >50 kg at screening.

6. Females of child-bearing potential who agree to apply effective contraception methods (defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly ) from at least 7 days prior to vaccination until the end of the study or females who are permanently sterilized (at least 6 weeks post-sterilization).

7. Males who agree to apply effective contraception methods from day 0 through day 56.

8. Be willing to refrain from blood donation during the course of the study.

9. The subject is co-operative and available for the entire study.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria are met at screening or at day -1:

1. Prior receipt of a MERS vaccine or MVA immunizations.

2. Receipt of any vaccine in the 2 weeks prior to 1st trial vaccination (4 weeks for live vaccines) or planned receipt of any vaccine in the 3 weeks following the 2nd trial vaccination.

3. Known allergy to the components of the MVA-MERS-S vaccine product as eggs, chicken proteins, and gentamycin or history of life-threatening reactions to vaccine containing the same substances.

4. Participation in a clinical trial or use of an investigational product within 30 days or five times the half-life of the investigational drug -whichever is longer- prior to receiving the first dose within this study.

5. Evidence in the subject's medical history or in the medical examination that might influence either the safety of the subject or the absorption, distribution, metabolism or excretion of the investigational product under investigation.

6. Any positive result for human immunodeficiency virus (HIV)1/2 antibody, hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg) testing.

7. Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years, and/or diabetes.

8. Participants with inflammatory, infectious and neuroinflammatory underlying disease which could cause an expected impairment of the blood brain barrier such as meningitis, multiple sclerosis, epilepsy, or Alzheimer's disease.

9. Any chronic or active neurologic disorder, including migraines, seizures, and epilepsy, excluding a single febrile seizure as a child.

10. Known history of Guillain-Barré Syndrome.

11. Active malignancy or history of metastatic or hematologic malignancy.

12. Suspected or known alcohol and/or illicit drug abuse within the past 5 years.

13. Moderate or severe illness and/or fever >38°C within 1 week prior to vaccination.

14. Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period.

15. History of blood donation within 60 days of enrollment or plans to donate within the treatment phase (until the 2nd vaccination).

16. Receipt of chronic (defined as more than 14 days) immune suppressants or other immune-modifying drugs within 6 months of study inclusion (screening).

• For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day.

• Intranasal and topical steroids are allowed.

1. Participants with skin lesions close to the injection site or active oral lesions will be excluded.

2. Thrombocytopenia, contraindicating intramuscular vaccination based on investigator's judgment.

3. Participants with a significant infection or known inflammation.

4. History of relevant cardiovascular disorders or evidence of hyper- (sitting blood pressure systolic >140 or diastolic >90 mmHg) or hypotension (sitting blood pressure systolic <90 or diastolic <40 mmHg) at screening.

5. Subjects who are known or suspected not to comply with the study directives.

6. Any other significant finding that in the opinion of the investigator would increase the risk of the individual having an adverse outcome from participating in this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CTC North GmbH & Co. KG at the University Medical Center Hamburg-Eppendorf	Hamburg		Germany	20251

Sponsors and Collaborators

• Marylyn Addo
• Philipps University Marburg Medical Center
• Ludwig-Maximilians - University of Munich
• Charite University, Berlin, Germany
• Bernhard Nocht Institute for Tropical Medicine
• University of Cologne

Investigators

• Principal Investigator: Marylyn M Addo, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf

Study Documents (Full-Text)

• Study Protocol - Nov 27, 2018
• Statistical Analysis Plan - May 28, 2019

More Information

Additional Information:

• Middle East respiratory syndrome coronavirus situation updates

Publications

• Agnihothram S, Gopal R, Yount BL Jr, Donaldson EF, Menachery VD, Graham RL, Scobey TD, Gralinski LE, Denison MR, Zambon M, Baric RS. Evaluation of serologic and antigenic relationships between middle eastern respiratory syndrome coronavirus and other coronaviruses to develop vaccine platforms for the rapid response to emerging coronaviruses. J Infect Dis. 2014 Apr 1;209(7):995-1006. doi: 10.1093/infdis/jit609. Epub 2013 Nov 18.
• Haagmans BL, van den Brand JM, Raj VS, Volz A, Wohlsein P, Smits SL, Schipper D, Bestebroer TM, Okba N, Fux R, Bensaid A, Solanes Foz D, Kuiken T, Baumgärtner W, Segalés J, Sutter G, Osterhaus AD. An orthopoxvirus-based vaccine reduces virus excretion after MERS-CoV infection in dromedary camels. Science. 2016 Jan 1;351(6268):77-81. doi: 10.1126/science.aad1283. Epub 2015 Dec 17.
• Memish ZA, Zumla AI, Al-Hakeem RF, Al-Rabeeah AA, Stephens GM. Family cluster of Middle East respiratory syndrome coronavirus infections. N Engl J Med. 2013 Jun 27;368(26):2487-94. doi: 10.1056/NEJMoa1303729. Epub 2013 May 29. Erratum in: N Engl J Med. 2013 Aug 8;369(6):587.
• Song F, Fux R, Provacia LB, Volz A, Eickmann M, Becker S, Osterhaus AD, Haagmans BL, Sutter G. Middle East respiratory syndrome coronavirus spike protein delivered by modified vaccinia virus Ankara efficiently induces virus-neutralizing antibodies. J Virol. 2013 Nov;87(21):11950-4. doi: 10.1128/JVI.01672-13. Epub 2013 Aug 28.
• Sutter G, Moss B. Nonreplicating vaccinia vector efficiently expresses recombinant genes. Proc Natl Acad Sci U S A. 1992 Nov 15;89(22):10847-51.
• van Boheemen S, de Graaf M, Lauber C, Bestebroer TM, Raj VS, Zaki AM, Osterhaus AD, Haagmans BL, Gorbalenya AE, Snijder EJ, Fouchier RA. Genomic characterization of a newly discovered coronavirus associated with acute respiratory distress syndrome in humans. mBio. 2012 Nov 20;3(6). pii: e00473-12. doi: 10.1128/mBio.00473-12.
• Zaki AM, van Boheemen S, Bestebroer TM, Osterhaus AD, Fouchier RA. Isolation of a novel coronavirus from a man with pneumonia in Saudi Arabia. N Engl J Med. 2012 Nov 8;367(19):1814-20. doi: 10.1056/NEJMoa1211721. Epub 2012 Oct 17. Erratum in: N Engl J Med. 2013 Jul 25;369(4):394.

• Responsible Party: Marylyn Addo, Prof. Dr. med. Marylyn M. Addo, Principal Investigator, Head of the Department of Infectious Diseases, Universitätsklinikum Hamburg-Eppendorf
• ClinicalTrials.gov Identifier: NCT03615911
• Other Study ID Numbers: UKE-DZIF1-MVA-MERS-S
• First Posted: Aug 6, 2018
• Last Update Posted: Oct 6, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Marylyn Addo, Prof. Dr. med. Marylyn M. Addo, Principal Investigator, Head of the Department of Infectious Diseases, Universitätsklinikum Hamburg-Eppendorf: vaccine; clinical phase 1; modified vaccinia Ankara vector; MERS-CoV
• Additional relevant MeSH terms: Coronavirus Infections

Study Results

Participant Flow

Arm/Group Title	Vaccination With 10^7 PFU MVA-MERS-S	Vaccination With 10^8 PFU MVA-MERS-S
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	14	12
Received Late Booster Immunization	3	7
COMPLETED	12	11
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Vaccination With 10^7 PFU MVA-MERS-S	Vaccination With 10^8 PFU MVA-MERS-S	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	14	12	26
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	14 100%	12 100%	26 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	10 71.4%	10 83.3%	20 76.9%
Male	4 28.6%	2 16.7%	6 23.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 7.1%	1 8.3%	2 7.7%
Not Hispanic or Latino	13 92.9%	11 91.7%	24 92.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Germany	14 100%	12 100%	26 100%
BMI (kg/m2) (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	23.6 (2.5)	23.5 (3.7)	23.6 (3.0)

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Experiencing Solicited Local or Systemic Reactogenicity as Defined by the Study Protocol
Description	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.
Time Frame	14 days after each vaccination

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vaccination With 10^7 PFU MVA-MERS-S	Vaccination With 10^8 PFU MVA-MERS-S
Arm/Group Description	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.	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.
Measure Participants	14	12
Count of Participants [Participants]	10 71.4%	10 83.3%

2. Primary Outcome

Title	Percentage of Participants Who Experienced an Unsolicited Adverse Event
Description	The 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.
Time Frame	28 days after each vaccination

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vaccination With 10^7 PFU MVA-MERS-S	Vaccination With 10^8 PFU MVA-MERS-S
Arm/Group Description	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.	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.
Measure Participants	14	12
Count of Participants [Participants]	5 35.7%	8 66.7%

3. Primary Outcome

Title	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)
Description	The safety laboratory measures include: - Clinical Chemistry: CRP in miligrams per liter [mg/l]
Time Frame	Throughout the study up to conclusion

Outcome Measure Data

Analysis Population Description

All participants were included in the safety analysis.

Arm/Group Title	Vaccination With 10^7 PFU MVA-MERS-S	Vaccination With 10^8 PFU MVA-MERS-S
Arm/Group Description	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.	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.
Measure Participants	14	12
Mean (Standard Deviation) [mg/l]	0 (0.3)	-1 (3)

4. Primary Outcome

Title	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)
Description	The safety laboratory measures include Hematology: WBC count in billions per liter [billion cells/L]
Time Frame	Throughout the study up to conclusion

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vaccination With 10^7 PFU MVA-MERS-S	Vaccination With 10^8 PFU MVA-MERS-S
Arm/Group Description	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.	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.
Measure Participants	14	12
Mean (Standard Deviation) [Billion Cells/L]	-1.8 (1.44)	-1.0 (1.92)

5. Primary Outcome

Title	Percentage of Participants Experiencing a Serious Adverse Event up to Day 180 (Study Completion)
Description	Serious 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.
Time Frame	Throughout the study up to conclusion

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vaccination With 10^7 PFU MVA-MERS-S	Vaccination With 10^8 PFU MVA-MERS-S
Arm/Group Description	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.	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.
Measure Participants	14	12
Count of Participants [Participants]	0 0%	0 0%

6. Secondary Outcome

Title	Immunogenicity: Number of Participants Who Seroconverted Throughout the Study (up to Study Completion at Day 180)
Description	Humoral immunity: The magnitude of MVA-MERS-S antibody responses as assessed by neutralization assay and ELISA.
Time Frame	Throughout the study up to conclusion

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vaccination With 10^7 PFU MVA-MERS-S	Vaccination With 10^8 PFU MVA-MERS-S
Arm/Group Description	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.	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.
Measure Participants	12	11
Count of Participants [Participants]	8 57.1%	10 83.3%

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	Participants filled out a participant diary, which was assessed on study visits (Day 1, 3, 7, 14, 28 after vaccination).
Arm/Group Title	Vaccination With 10^7 PFU MVA-MERS-S		Vaccination With 10^8 PFU MVA-MERS-S
Arm/Group Description	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.		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.
All Cause Mortality
	Vaccination With 10^7 PFU MVA-MERS-S		Vaccination With 10^8 PFU MVA-MERS-S
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/12 (0%)
Serious Adverse Events
	Vaccination With 10^7 PFU MVA-MERS-S		Vaccination With 10^8 PFU MVA-MERS-S
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Vaccination With 10^7 PFU MVA-MERS-S		Vaccination With 10^8 PFU MVA-MERS-S
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/14 (71.4%)		10/12 (83.3%)
Gastrointestinal disorders
Gastrointestinal Symptoms	5/14 (35.7%)		5/12 (41.7%)
General disorders
Fatigue and Malaise	10/14 (71.4%)		7/12 (58.3%)
Other systemic unsolicited	1/14 (7.1%)		1/12 (8.3%)
Immune system disorders
Fever/Chills	0/14 (0%)		2/12 (16.7%)
Musculoskeletal and connective tissue disorders
Arthralgia	3/14 (21.4%)		1/12 (8.3%)
Myalgia	1/14 (7.1%)		4/12 (33.3%)
Nervous system disorders
Headache	7/14 (50%)		9/12 (75%)
Skin and subcutaneous tissue disorders
Local reactogenicity	8/14 (57.1%)		10/12 (83.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.