A Clinical Trial to Evaluate the Recombinant Human Type5 Adenovirus Vector Based Ebola Virus Disease Vaccine
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 in Sierra Leone
1 other identifier
interventional
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2015
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 11, 2015
CompletedFirst Posted
Study publicly available on registry
October 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedSeptember 1, 2016
December 1, 2015
8 months
October 11, 2015
August 30, 2016
Conditions
Outcome Measures
Primary Outcomes (4)
Occurrence of solicited adverse reactions after vaccination
7 days after vaccination
ELISA antigen-specific assays for antibody to GP responses
14 days after vaccination
ELISA antigen-specific assays for antibody to GP responses
28 days after vaccination
ELISA antigen-specific assays for antibody to GP responses
168 days after vaccination
Secondary Outcomes (6)
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
Neutralizing antibody titers response to human Ad5
28 days after vaccination
- +1 more secondary outcomes
Study Arms (3)
Group A
EXPERIMENTAL(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
Group B
EXPERIMENTAL(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 C
PLACEBO COMPARATOR(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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr. Alie H Wurie
Freetown, Sierra Leone
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alie H Wurie
Ministry of Health & Sanitation
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2015
First Posted
October 14, 2015
Study Start
October 1, 2015
Primary Completion
June 1, 2016
Study Completion
July 1, 2016
Last Updated
September 1, 2016
Record last verified: 2015-12