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 range18 Years – 55 Years

SexALL

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).
✓. 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.

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 range18 Years – 55 Years

SexALL

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).
✓. 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.

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

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria