a phase i trial to evaluate ad5-ebov in healthy adult africans in china.

Conditions: Ebola Virus Disease

Summary: this is a single center, open, dose-escalation phase 1 clinical trial. this study will determine the safety and side-effect profile, and immunogenicity of an investigational ad5-ebov vaccine in healthy adult africans aged between 18-60 years in china.

this is a single center, open, dose-escalation clinical trial. according to the chinese guidelines for vaccine clinical trial, the sample size of a phase 1 clinical trial should be at least 20. in this study, a total of 60 participants will be included.30 participants will be firstly recruited and assigned to receive the low dose ad5-ebov. after the safety of the low dose vaccination is confirmed, another 30 participants will be recruited and assigned to receive the high dose ad5-ebov. the whole follow-up period for each participant will be 28 days.

Eligibility criteria:
inclusion criteria: * aged between 18 and 60 years. * african in china. * able to understand the content of informed consent and willing to sign the informed consent * able and willing to complete all the secluded study process during the whole study follow-up period (about 1 month). * a body mass index (bmi) 18.5-35.0 kg/m2 * hemoglobin ≥110g/l for female, and ≥120g/l for male. * white blood cells (wbc) 4.0-10.0×109 cells/l * total lymphocyte count 0.8-4.5×109 cells/l * platelets 100-300×109 cells/l * alanine aminotransferase (alt) 0-40u/l * serum creatinine 44-106μmol/l * active partial thromboplastin time (aptt) 20-40 seconds * prothrombin time (pt) 10-14 seconds * negative in hiv diagnostic blood test * axillary temperature ≤37.0°c on the day of enrollment * general good health as established by medical history and physical examination. exclusion criteria: * family history of seizure, epilepsy, brain or mental disease * participant that has a medical history of any of the following: allergic history of any vaccination or drugs, or allergic to any ingredient of the ad5-ebov, such as mannitol. * woman who is pregnant, breast-feeding or positive in β-hcg (human chorionic gonadotropin) pregnancy test (urine) on day of enrollment, or become pregnant during the next 6 months * any acute fever disease or infections in last 7 days * major congenital defects or not well-controlled chronic illness, such as asthma, diabetes, or thyroid disease * hereditary angioneurotic edema or acquired angioneurotic edema * urticaria in last one year * asplenia or functional asplenia * platelet disorder or other bleeding disorder may cause injection contraindication * 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 blood products in last 4 months * prior administration of other research medicines in last 1 month * prior administration of attenuated vaccine in last 1 month * prior administration of inactivated vaccine in last 14 days * current anti-tuberculosis prophylaxis or therapy * any condition that in the opinion of the investigators may interfere with the evaluation of study objectives

Keywords: vaccines ebola virus disease