Ebola Disease
Conditions
Brief summary
A Single-Center, Randomized, Blind, Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in Healthy Adults Aged Between 18 and 50 years in Sierra Leone.
Interventions
BIOLOGICALEbola Vaccine
BIOLOGICALPlacebo
control
Sponsors
Beijing Institute of Biotechnology
Tianjin Cansino Biotechnology Inc
Jiangsu Province Centers for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged between 18 and 50 years * Able to understand the content of informed consent and signed the informed consent * Able and willing to complete all the secluded study process during the whole study follow-up period (about 6 months). * Negative in HIV diagnostic blood test on day of enrollment * Axillary temperature ≤37.0°C on the day of enrollment * Non-pregnant females with a negative result in the urine pregnancy test on day of enrollment * General good health as established by medical history and physical examination.
Exclusion criteria
* Infected by Ebola virus (inquiry) * Vaccination with other Ebola vaccine (inquiry) * HIV infection or other serious immunodeficiency disease (inquiry) * Allergic history of any vaccination or drugs, or allergic to any ingredient of the Ad5-EBOV, such as mannitol * Family history of brain or mental disease * Woman who is pregnant or breast-feeding * Any acute fever disease or infections in last 7 days * Major congenital defects or not well-controlled chronic illness * Asplenia or functional asplenia * Platelet disorder or other bleeding disorder * Faint at the sight of blood or needles. * Prior administration of immunodepressant or corticosteroids, antianaphylaxis treatment, cytotoxic treatment in last 6 months * Prior administration of other research medicines in last 1 month * Prior administration of attenuated vaccine(s) in the last one month * Prior administration of inactivated vaccine(s) in the last 14 days * Any condition that in the opinion of the investigators may interfere with the participants' compliance or evaluation of study objectives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of solicited adverse reactions after vaccination | 7 days after vaccination |
| ELISA antigen-specific assays for antibody to GP responses | 14 days after vaccination |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of unsolicited adverse reactions after vaccination | 28 days after vaccination |
| Occurrence of serious adverse reaction during the whole follow-up period | 6 months |
| Post-vaccination Rate of infected with HIV | 6 months |
| Neutralizing antibody titers response to human Ad5 | 14 days after vaccination |
Countries
Sierra Leone
Outcome results
None listed