An open-label, non-randomised, dose escalation, first-in-human, single centre, phase I clinical trial to determine the safety and immunogenicity of a bivalent ChAdOx1 vectored vaccine against Zaire and Sudan Ebola virus species in healthy adult volunteers.
This is a first-in-human, open-label, dose escalation, phase I clinical trial to assess the safety and immunogenicity of the candidate ChAdOx1 biEBOV vaccine in healthy UK volunteers aged 18-55. The vaccine will be administered intramuscularly (IM). Volunteers will be recruited and vaccinated at the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Oxford. There will be 3 study groups and it is anticipated that a total of 26 volunteers will be enrolled. Dose escalation and sentinel participant procedures will be implemented. Volunteers will be first recruited into Group 1 and subsequently into Groups 2 and 3 following interim clinical safety reviews. Volunteers will be sequentially allocated to a study group by selecting eligible volunteers for enrolment following screening. Sequential allocation will occur based on the order in which volunteers are enrolled.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
26
ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital
Oxford, United Kingdom
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms
Occurrence of solicited local and systemic reactogenicity signs and symptoms. Data shown are number (and percentage) of participants reporting each event. The maximum severity of any local and any systemic solicited symptoms reported by individual participants is also shown.
Time frame: 7 days following vaccination
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms
Occurrence of unsolicited adverse events (AEs)
Time frame: 28 days following vaccination
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Serious Adverse Events
Occurrence of serious adverse events (SAEs) and adverse interests of special interest (AESIs)
Time frame: Duration of the study (6 months)
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities
Abnormal results were graded according to a pre-specified laboratory adverse events severity grading scale - a full breakdown of the levels of severity of the reported events per study timepoint is available in the publication.
Time frame: 28 days following vaccination
Immunogenicity of ChAdOx1 biEBOV in Healthy Adult Volunteers: Measure of Humoral Immunogenicity
ELISA to quantify antibodies to filovirus glycoprotein (specific serological response). Peak antibody responses to both Ebola and Sudan viruses occurred 28 days post vaccination (or post-boost, in the participants who received a booster) across all groups.
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Time frame: At day 28
Immunogenicity of ChAdOx1 biEBOV in Healthy Adult Volunteers: Measure of Cellular Immunogenicity
Intracellular cytokine staining (ICS) by flow cytometry was carried out at baseline as well as at 14 days after vaccination/boost to assess T-cell responses to Ebola virus glycoprotein and Sudan virus glycoprotein.
Time frame: 14 days post final vaccine for each group