A Clinical Trial to Evaluate the Recombinant Human Type5 Adenovirus Vector Based Ebola Virus Disease Vaccine
Phase 2
Completed
- Conditions
- Ebola Disease
- Interventions
- Biological: PlaceboBiological: Ebola Vaccine
- Registration Number
- NCT02575456
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group C Placebo (0 vp/ vial, 2 vials):1 ml sterilization injection water per dose to dilute 1 vial, total dose of 0 vp. The inoculation site was the central lateral deltoid in the upper arm, and inoculation route was intramuscular injection Group B Ebola Vaccine (4×10\^10vp/vial, 2 vials): 1 ml sterilization injection water per dose to dilute 1 vial (4×10\^10vp/vial), total dose of 8×10\^10vp, one shot in each arm. The inoculation site was the central lateral deltoid in the upper arm, and inoculation route was intramuscular injection Group A Ebola Vaccine (4×10\^10vp/vial, 4 vials): 1 ml sterilization injection water per dose to dilute 2 vials (4×10\^10 vp/vial), one shot in each arm, total dose of 1.6×10\^11vp. The inoculation site was the central lateral deltoid in the upper arm, and inoculation route was intramuscular injection
- Primary Outcome Measures
Name Time Method Occurrence of solicited adverse reactions after vaccination 7 days after vaccination ELISA antigen-specific assays for antibody to GP responses 168 days after vaccination
- Secondary Outcome Measures
Name Time Method Occurrence of serious adverse reaction during the whole follow-up period 6 months Neutralizing antibody titers response to human Ad5 168 days after vaccination Occurrence of unsolicited adverse reactions after vaccination 28 days after vaccination Post-vaccination Rate of infected with HIV 6 months
Trial Locations
- Locations (1)
Dr. Alie H Wurie
🇸🇱Freetown, Sierra Leone