A Phase I Trial to Evaluate Ad5-EBOV in Healthy Adult Africans in China.

Zhejiang University

Status and phase: Completed; Phase 1

Conditions: Ebola Virus Disease

Treatments: Biological: Ad5-EBOV

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02401373

GR2015VCT001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

low dose

Experimental group

Description:

30 participants will be firstly recruited and assigned to receive the low dose of Recombinant Human Type 5 Adenovirus Vector Based Ebola Vaccine (Ad5-EBOV).

Treatment:

Biological: Ad5-EBOV

High dose

Experimental group

Description:

After the safety of the low dose vaccination is confirmed, another 30 participants will be recruited and assigned to receive the high dose of Recombinant Human Type 5 Adenovirus Vector Based Ebola Vaccine (Ad5-EBOV).

Treatment:

Biological: Ad5-EBOV