Marburgvirus
Conditions
Interventions
Sponsors
Rwanda Biomedical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. 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. Female participant specific criteria: 1. Negative pregnancy serum test at screening, and negative urine pregnancy test before vaccination, if of reproductive potential. 2. Agrees to use an effective means of birth control from at least 21 days prior to enrollment through 24 weeks after study vaccination if assessed to be woman of childbearing potential UNLESS they fulfill one of the following criteria: o At least 1 year postmenopausal. o Surgically sterile. Male participants must agree: 1. Not to father a child or donate sperm through study end. 2. To use a barrier (condom) means of birth control from vaccination through study end, if assessed to be of reproductive potential.
Exclusion criteria
Exclusion criteria: 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 exposure to MARV or prior diagnosis of MVD, determined from the participant’s reported medical history. However, prior receipt of Ebola or Marburg investigational vaccine are non-exclusionary but will only need to be documented. 4. History of or active status of any of the following clinically significant conditions (not full list): ? Serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain. ? Allergic reaction to excipients in the IP including gentamycin, neomycin or streptomycin or any other aminoglycoside. 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: Any investigational product in the past 28 days, use of immunomodulators or systemic glucocorticoids, receipt of blood products. Currently enrolled or planned to be enrolled in another study. 7. Current anti-tuberculosis prophylaxis or therapy. 8. Abnormality or permanent body art (such as tattoo) 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quantitate antibody titers evolution from Day 1 to Day 29 post-vaccination | — |
Countries
Rwanda
Contacts
Public ContactMichelle Botha
Manager Global Site Activation
Outcome results
None listed