MERS (Middle East Respiratory Syndrome)Phase 1NCT03615911
Safety, Tolerability and Immunogenicity of Vaccine Candidate MVA-MERS-S
A Phase 1 study testing vaccine candidate MVA-MERS-S in people with MERS (Middle East Respiratory Syndrome), run by Marylyn Addo at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- MERS (Middle East Respiratory Syndrome)
- What is being tested?
- vaccine candidate MVA-MERS-S
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteGermany
- Study dates
- 28 Nov 2017to 10 May 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
- 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.
- Provided written informed consent.
- 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.
- No clinically significant health problems as determined during medical history and physical examination at screening visit.
- Body weight in defined relation to height. Body mass index 18.5 - 30.0 kg/m2 and weight >50 kg at screening.
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- 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).
- Males who agree to apply effective contraception methods from day 0 through day 56.
- Be willing to refrain from blood donation during the course of the study.
- The subject is co-operative and available for the entire study.
Who cannot join
- Participants are excluded from the study if any of the following criteria are met at screening or at day -1:
- Prior receipt of a MERS vaccine or MVA immunizations.
- 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.
- 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.
- 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.
- 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.
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- Any positive result for human immunodeficiency virus (HIV)1/2 antibody, hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg) testing.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years, and/or diabetes.
- 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.
- Any chronic or active neurologic disorder, including migraines, seizures, and epilepsy, excluding a single febrile seizure as a child.
- Known history of Guillain-Barré Syndrome.
- Active malignancy or history of metastatic or hematologic malignancy.
- Suspected or known alcohol and/or illicit drug abuse within the past 5 years.
- Moderate or severe illness and/or fever >38°C within 1 week prior to vaccination.
- Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period.
- History of blood donation within 60 days of enrollment or plans to donate within the treatment phase (until the 2nd vaccination).
- 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.
- Participants with skin lesions close to the injection site or active oral lesions will be excluded.
- Thrombocytopenia, contraindicating intramuscular vaccination based on investigator's judgment.
- Participants with a significant infection or known inflammation.
- 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.
- Subjects who are known or suspected not to comply with the study directives.
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
CTC North GmbH & Co. KG at the University Medical Center Hamburg-Eppendorf
Hamburg, 20251
About this study
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
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.
Read the 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.
- Conditions
- MERS (Middle East Respiratory Syndrome)
- Being tested
- vaccine candidate MVA-MERS-S
- Keywords
- vaccine, clinical phase 1, modified vaccinia Ankara vector, MERS-CoV
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaccine candidate MVA-MERS-SBiological
vaccination with MVA-MERS-S in two escalating dose regimes
| Study group | Role | What they receive |
|---|---|---|
| Vaccination with 10^7 PFU MVA-MERS-S | Experimental | 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. Receives: Biological: vaccine candidate MVA-MERS-S |
| Vaccination with 10^8 PFU MVA-MERS-S | Experimental | 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. Receives: Biological: vaccine candidate MVA-MERS-S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Experiencing Solicited Local or Systemic Reactogenicity as Defined by the Study Protocol
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.
Measured: 14 days after each vaccination
Percentage of Participants Who Experienced an Unsolicited Adverse Event
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.
Measured: 28 days after each vaccination
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)
The safety laboratory measures include:
- Clinical Chemistry: CRP in miligrams per liter [mg/l]
Measured: Throughout the study up to conclusion
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)
The safety laboratory measures include Hematology: WBC count in billions per liter [billion cells/L]
Measured: Throughout the study up to conclusion
Percentage of Participants Experiencing a Serious Adverse Event up to Day 180 (Study Completion)
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.
Measured: Throughout the study up to conclusion
Secondary outcomes (1)
Immunogenicity: Number of Participants Who Seroconverted Throughout the Study (up to Study Completion at Day 180)
Humoral immunity: The magnitude of MVA-MERS-S antibody responses as assessed by neutralization assay and ELISA.
Measured: Throughout the study up to conclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start28 Nov 2017
- Primary completion15 Apr 2019
- Study completion10 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for MERS (Middle East Respiratory Syndrome)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marylyn Addo
- Sponsor type
- University, hospital or other
- Collaborators
- Philipps University Marburg, Ludwig-Maximilians - University of Munich, Charite University, Berlin, Germany, Bernhard Nocht Institute for Tropical Medicine, University of Cologne
- Responsible party
- Sponsor-investigator, Marylyn Addo, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Marylyn M Addo, Prof. Dr., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615911
- Sponsor's protocol ID
- UKE-DZIF1-MVA-MERS-S
- Status last verified
- Oct 2020
- First submitted
- 20 Jul 2018
- Last updated
- 6 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23075143Memish 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.
PubMed 23718156van 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):e00473-12. doi: 10.1128/mBio.00473-12.
PubMed 23170002Agnihothram 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.
PubMed 24253287Song 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.
PubMed 23986586Sutter G, Moss B. Nonreplicating vaccinia vector efficiently expresses recombinant genes. Proc Natl Acad Sci U S A. 1992 Nov 15;89(22):10847-51. doi: 10.1073/pnas.89.22.10847.
PubMed 1438287Haagmans 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, Baumgartner W, Segales 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.
PubMed 26678878Weskamm LM, Fathi A, Raadsen MP, Mykytyn AZ, Koch T, Spohn M, Friedrich M; MVA-MERS-S Study Group; Haagmans BL, Becker S, Sutter G, Dahlke C, Addo MM. Persistence of MERS-CoV-spike-specific B cells and antibodies after late third immunization with the MVA-MERS-S vaccine. Cell Rep Med. 2022 Jul 19;3(7):100685. doi: 10.1016/j.xcrm.2022.100685.
PubMed 35858586Fathi A, Dahlke C, Krahling V, Kupke A, Okba NMA, Raadsen MP, Heidepriem J, Muller MA, Paris G, Lassen S, Kluver M, Volz A, Koch T, Ly ML, Friedrich M, Fux R, Tscherne A, Kalodimou G, Schmiedel S, Corman VM, Hesterkamp T, Drosten C, Loeffler FF, Haagmans BL, Sutter G, Becker S, Addo MM. Increased neutralization and IgG epitope identification after MVA-MERS-S booster vaccination against Middle East respiratory syndrome. Nat Commun. 2022 Jul 19;13(1):4182. doi: 10.1038/s41467-022-31557-0.
PubMed 35853863Koch T, Dahlke C, Fathi A, Kupke A, Krahling V, Okba NMA, Halwe S, Rohde C, Eickmann M, Volz A, Hesterkamp T, Jambrecina A, Borregaard S, Ly ML, Zinser ME, Bartels E, Poetsch JSH, Neumann R, Fux R, Schmiedel S, Lohse AW, Haagmans BL, Sutter G, Becker S, Addo MM. Safety and immunogenicity of a modified vaccinia virus Ankara vector vaccine candidate for Middle East respiratory syndrome: an open-label, phase 1 trial. Lancet Infect Dis. 2020 Jul;20(7):827-838. doi: 10.1016/S1473-3099(20)30248-6. Epub 2020 Apr 21.
PubMed 32325037
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03615911
- Acronym / sponsor ID
- UKE-DZIF1-MVA-MERS-S
- Conditions
- MERS (Middle East Respiratory Syndrome)
- Keywords
- vaccine, clinical phase 1, modified vaccinia Ankara vector, MERS-CoV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Marylyn AddoUniversity, hospital or other
- Collaborators
- Philipps University Marburg, Ludwig-Maximilians - University of Munich, Charite University, Berlin, Germany, Bernhard Nocht Institute for Tropical Medicine, University of Cologne
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 10 May 2019 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Posted 6 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccination with 10^7 PFU MVA-MERS-S | Experimental | Biological: vaccine candidate MVA-MERS-SVaccinations 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 | Experimental | Biological: vaccine candidate MVA-MERS-SVaccinations 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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:
- 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.
- Provided written informed consent.
- 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.
- No clinically significant health problems as determined during medical history and physical examination at screening visit.
Key exclusion criteria (25 listed)
- Participants are excluded from the study if any of the following criteria are met at screening or at day -1:
- Prior receipt of a MERS vaccine or MVA immunizations.
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vaccine candidate MVA-MERS-Svaccination with MVA-MERS-S in two escalating dose regimes | Biological | Vaccination with 10^7 PFU MVA-MERS-S, Vaccination with 10^8 PFU MVA-MERS-S |
Primary outcome
Percentage of Participants Experiencing Solicited Local or Systemic Reactogenicity as Defined by the Study Protocol
Time frame: 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.
Percentage of Participants Who Experienced an Unsolicited Adverse Event
Time frame: 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.
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)
Time frame: Throughout the study up to conclusion
The safety laboratory measures include: - Clinical Chemistry: CRP in miligrams per liter [mg/l]
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)
Time frame: Throughout the study up to conclusion
The safety laboratory measures include Hematology: WBC count in billions per liter [billion cells/L]
Percentage of Participants Experiencing a Serious Adverse Event up to Day 180 (Study Completion)
Time frame: 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.
1 secondary outcome
Immunogenicity: Number of Participants Who Seroconverted Throughout the Study (up to Study Completion at Day 180)
Time frame: Throughout the study up to conclusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23075143Zaki 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.
- Background: PubMed 23718156Memish 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.
- Background: PubMed 23170002van 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):e00473-12. doi: 10.1128/mBio.00473-12.
- Background: PubMed 24253287Agnihothram 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.
- Background: PubMed 23986586Song 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.
- Background: PubMed 1438287Sutter G, Moss B. Nonreplicating vaccinia vector efficiently expresses recombinant genes. Proc Natl Acad Sci U S A. 1992 Nov 15;89(22):10847-51. doi: 10.1073/pnas.89.22.10847.
- Background: PubMed 26678878Haagmans 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, Baumgartner W, Segales 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.
- Derived from this study: PubMed 35858586Weskamm LM, Fathi A, Raadsen MP, Mykytyn AZ, Koch T, Spohn M, Friedrich M; MVA-MERS-S Study Group; Haagmans BL, Becker S, Sutter G, Dahlke C, Addo MM. Persistence of MERS-CoV-spike-specific B cells and antibodies after late third immunization with the MVA-MERS-S vaccine. Cell Rep Med. 2022 Jul 19;3(7):100685. doi: 10.1016/j.xcrm.2022.100685.
- Derived from this study: PubMed 35853863Fathi A, Dahlke C, Krahling V, Kupke A, Okba NMA, Raadsen MP, Heidepriem J, Muller MA, Paris G, Lassen S, Kluver M, Volz A, Koch T, Ly ML, Friedrich M, Fux R, Tscherne A, Kalodimou G, Schmiedel S, Corman VM, Hesterkamp T, Drosten C, Loeffler FF, Haagmans BL, Sutter G, Becker S, Addo MM. Increased neutralization and IgG epitope identification after MVA-MERS-S booster vaccination against Middle East respiratory syndrome. Nat Commun. 2022 Jul 19;13(1):4182. doi: 10.1038/s41467-022-31557-0.
- Derived from this study: PubMed 32325037Koch T, Dahlke C, Fathi A, Kupke A, Krahling V, Okba NMA, Halwe S, Rohde C, Eickmann M, Volz A, Hesterkamp T, Jambrecina A, Borregaard S, Ly ML, Zinser ME, Bartels E, Poetsch JSH, Neumann R, Fux R, Schmiedel S, Lohse AW, Haagmans BL, Sutter G, Becker S, Addo MM. Safety and immunogenicity of a modified vaccinia virus Ankara vector vaccine candidate for Middle East respiratory syndrome: an open-label, phase 1 trial. Lancet Infect Dis. 2020 Jul;20(7):827-838. doi: 10.1016/S1473-3099(20)30248-6. Epub 2020 Apr 21.
- Middle East respiratory syndrome coronavirus situation updatesLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marylyn M Addo, Prof. Dr. principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing vaccine candidate MVA-MERS-S in people with MERS (Middle East Respiratory Syndrome), run by Marylyn Addo at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Experiencing Solicited Local or Systemic Reactogenicity as Defined by the Study Protocol (time frame: 14 days after each vaccination). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03615911, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020.