Clinical trial NCT02575456: A Clinical Trial to Evaluate the Recombinant Human Type5 Adenovirus Vector Based Ebola Virus Disease Vaccine
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ebola Disease
Lead sponsor: Jiangsu Province Centers for Disease Control and Prevention
Sponsor class: NETWORK
Collaborators: name: Beijing Institute of Biotechnology
name: Tianjin Cansino Biotechnology Inc
First posted: 2015-10-14
Enrollment: 500
Sex: ALL
Minimum age (years): 8
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of solicited adverse reactions after vaccination
timeFrame: 7 days after vaccination
measure: ELISA antigen-specific assays for antibody to GP responses
timeFrame: 14 days after vaccination
measure: ELISA antigen-specific assays for antibody to GP responses
timeFrame: 28 days after vaccination
measure: ELISA antigen-specific assays for antibody to GP responses
timeFrame: 168 days after vaccination
Secondary outcomes:
measure: Occurrence of unsolicited adverse reactions after vaccination
timeFrame: 28 days after vaccination
measure: Occurrence of serious adverse reaction during the whole follow-up period
timeFrame: 6 months
measure: Post-vaccination Rate of infected with HIV
timeFrame: 6 months
measure: Neutralizing antibody titers response to human Ad5
timeFrame: 14 days after vaccination
measure: Neutralizing antibody titers response to human Ad5
timeFrame: 28 days after vaccination
measure: Neutralizing antibody titers response to human Ad5
timeFrame: 168 days after vaccination
Other outcomes:
Locations:
city: Freetown
country: Sierra Leone
facility: Dr. Alie H Wurie
Study officials:
affiliation: Ministry of Health & Sanitation
name: Alie H Wurie
role: PRINCIPAL_INVESTIGATOR
References: