CompletedPhase 1

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

Germany26 participantsStarted 2017-11-28

Plain-language 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.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. 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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants Experiencing Solicited Local or Systemic Reactogenicity as Defined by the Study Protocol

Timeframe: 14 days after each vaccination

Percentage of Participants Who Experienced an Unsolicited Adverse Event

Timeframe: 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)

Timeframe: 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)

Timeframe: Throughout the study up to conclusion

Percentage of Participants Experiencing a Serious Adverse Event up to Day 180 (Study Completion)

Timeframe: Throughout the study up to conclusion

Trial details

NCT IDNCT03615911

SponsorMarylyn Addo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-04-15

Results submitted2020-04-28

View on ClinicalTrials.gov More MERS (Middle East Respiratory Syndrome) trials

Plain-language summary

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. 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).

What they're measuring

Percentage of Participants Experiencing Solicited Local or Systemic Reactogenicity as Defined by the Study Protocol

Timeframe: 14 days after each vaccination

Percentage of Participants Who Experienced an Unsolicited Adverse Event

Timeframe: 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)

Timeframe: 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)

Timeframe: Throughout the study up to conclusion

Percentage of Participants Experiencing a Serious Adverse Event up to Day 180 (Study Completion)

Timeframe: Throughout the study up to conclusion

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria