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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
500
control
Dr. Alie H Wurie
Freetown, Sierra Leone
Occurrence of solicited adverse reactions after vaccination
Time frame: 7 days after vaccination
ELISA antigen-specific assays for antibody to GP responses
Time frame: 14 days after vaccination
ELISA antigen-specific assays for antibody to GP responses
Time frame: 28 days after vaccination
ELISA antigen-specific assays for antibody to GP responses
Time frame: 168 days after vaccination
Occurrence of unsolicited adverse reactions after vaccination
Time frame: 28 days after vaccination
Occurrence of serious adverse reaction during the whole follow-up period
Time frame: 6 months
Post-vaccination Rate of infected with HIV
Time frame: 6 months
Neutralizing antibody titers response to human Ad5
Time frame: 14 days after vaccination
Neutralizing antibody titers response to human Ad5
Time frame: 28 days after vaccination
Neutralizing antibody titers response to human Ad5
Time frame: 168 days after vaccination
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