A Phase II Clinical Trial to Evaluate the Recombinant Human Type 5 Adenovirus Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV)
- Conditions
- EbolaEbola Virus Disease
- Registration Number
- PACTR201509001259869
- Lead Sponsor
- Ministry of Health & Sanitation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 500
1. Aged between 18 and 50 years
2. Able to understand the content of informed consent and signed the informed consent
3. Able and willing to complete all the secluded study process during the whole study follow-up period (about 6 months).
4. Negative in HIV diagnostic blood test on the day of enrollment
5. Axillaty temperature ?37.0°C on the day of enrollment
6. Non-pregnant females with a negative result in the urine pregnancy test on day of enrollment
7. General good health as established by medical history and physical examination.
1. Infected by Ebola virus (inquiry)
2. Vaccination with other Ebola vaccine (inquiry)
3. HIV infection or other serious immunodeficiency disease (inquiry)
4. Allergic history of any vaccination or drugs, or allergic to any ingredient of the Ad5-EBOV, such as mannitol
5. Family history of brain or mental disease
6.Woman who is pregnant or breast-feeding
7. Any acute fever disease or infections in last 7 days
8. Major congenital defects or not well-controlled chronic illness
9. Asplenia or functional asplenia
10. Platelet disorder or other bleeding disorder
11. Faint at the sight of blood or needles.
12. Prior administration of immunodepressant or corticosteroids, antianaphylaxis treatment, cytotoxic treatment in last 6 months
13. Prior administration of other research medicines in last 1 month
14. 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
- Not specified
- Primary Outcome Measures
Name Time Method Safety: Occurrence of solicited adverse reactions within 7 days after vaccination;Immunogenicity: ELISA antigen-specific assays for antibody responses
- Secondary Outcome Measures
Name Time Method Safety: Occurrence of unsolicited adverse reactions;Safety: Occurrence of serious adverse reactions during whole follow-up period;Safety: Infection rate of HIV during the whole follow-up period;Immunogenicity: Neutralizing antibody tiers response to human Ad5