Marburg Virus Disease
Conditions
Interventions
Not applicable
Sponsors
Ethiopian Ministry of Health
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each participant must meet all of the following criteria to be enrolled in this study: 1. Male and non-pregnant female participants =18 years who are able and willing to complete and provide written informed consent prior to any study procedure. Note: Participants can be enrolled even if they do not provide optional consent for retention of blood samples for potential future testing and assay development. 2. Is capable of understanding and agrees to comply with planned study procedures and to be available for all clinic follow-up for all planned study visits. 3. Able to provide proof of identity to the satisfaction of the study clinician, completing the enrollment process. 4. Has a means to be contacted and to contact the investigator during the study. 5. Agree not to receive any vaccine within 28 days from study vaccination (prior and after) 6. Agree not to donate bone marrow, blood, or blood products until 3 months after the study vaccination. 7. In good general health without clinically significant medical conditions, based on medical history, physical examination, vital signs, and clinical laboratory results as deemed acceptable by the principal investigator.
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will be excluded from the study: 1. Pregnant or lactating female or plans to become pregnant or breastfeed 2. Has any medical disease or condition that, in the opinion of the investigator, precludes study participation. 3. Known prior diagnosis of MVD, including active Marburg infection, determined from the participant’s reported medical history. 4. History of or active status of any of the following clinically significant conditions: • Serious adverse reactions to vaccines • Allergic reaction to excipients in the IP • History of Diabetes mellitus Type I or Type II • Active Tuberculosis. • Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema. • Idiopathic urticaria within the last year • Bleeding disorder diagnosed by a doctor or use of anticoagulant medications • Major thrombotic event or heparin-induced thrombocytopenia or vaccine-induced thrombotic thrombocytopenia (VITT) • History of malignancy of any organ system, treated or untreated, within the past 5 years from screening. 5. Has a clinically significant acute illness (this does not include minor illnesses) or temperature =38.0°Celsius (=100.4°Fahrenheit) within 24 hours of the planned dose of IP 6. Receipt of any of the following substances: • Received an investigational vaccine or drug 28 days before, during and after the planned administration of the first dose of IP. • Receipt of remdesivir within 6 days prior to receipt of IP • Use of immunomodulators or systemic glucocorticoids in daily doses of glucocorticoid equivalence >20 mg of prednisolone in the last 90 days, and for periods exceeding 10 days. Nonsteroidal anti-inflammatory drugs are permitted. • Receipt of blood products within 3 months prior to enrollment. 7. Current anti-tuberculosis prophylaxis or therapy. 8. Abnormality or permanent body art in deltoid region that would interfere with ability to observe or assess injection site reactions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Count and percentage of vaccinated participants who develop: •SAEs, •solicited AEs, •unsolicited AEs, •AESI, •MAAE, •AE at each intensity level Count and percentage of vaccinated participants who would develop SAEs, solicited AEs, unsolicited AEs, AESI, MAAE, and AE at each intensity level will be described for the cohort. A treatment policy strategy is used for assessing safety irrespective of a current (or prior) infection at time of the vaccination. Infections and death (if they meet the AE and time window criteria) are included in the endpoint (composite strategy). | — |
Secondary
| Measure | Time frame |
|---|---|
| New cases of MVD are ascertained through active surveillance and case detection reports through the national MVD surveillance system.;All Cohort B participants will contribute to efficacy analysis assessed between Study Day 10 to Day 22, group receiving cAd3-Marburg on Study Day 1 will be compared to group receiving cAd3-Marburg on Study Day 22. Select Cohort A participants may be described in efficacy analysis as appropriate.;Quantitate antibody titers evolution from Study Day 1 to Day 29 to Day 91 (anti-Marburg antibodies) in Cohort A participants;New cases of MVD are ascertained through active surveillance and case detection reports through the national MVD surveillance system.;All Cohort B participants will contribute to efficacy analysis assessed between Study Day 10 to Day 22, group receiving cAd3-Marburg on Study Day 1 will be compared to group receiving cAd3-Marburg on Study Day 22. Select Cohort A participants may be described in efficacy analysis as appropriate. | — |
Countries
Ethiopia
Contacts
Public ContactEthiopian;Armauer Hansen Ministry of Health;Research Institute
Sponsor ;Site
Outcome results
None listed