The Phase I Clinical Trial of Booster Vaccination of Adenovirus Type-5 Vectored COVID-19 Vaccine

Jiangsu Provincial Center for Disease Control and Prevention

Status and phase

Completed

Phase 1

Conditions

Adenovirus Type-5 Vectored COVID-19 Vaccine

Treatments

Biological: Adenovirus Type-5 Vectored COVID-19 Vaccine

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT04568811

JSVCT100

Details and patient eligibility

About

The 2019 novel-coronavirus (2019-nCov) is the cause of a cluster of unexplained pneumonia that started in Hubei province in China. It has manifest into a global health crisis with escalating confirmed cases and spread across many countries.

In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of diseases caused by COVID-19 can be tough for current treatment.

This study is a phase I clinical trial of booster vaccination of adenovirus type-5 vectored COVID-19 vaccine 6 months after prime vaccination. The investigators intent to evaluate the safety and immunogenicity of booster vaccination of adenovirus type-5 vectored COVID-19 vaccine in healthy adults aged aged 18-60 years.

Full description

In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of diseases caused by COVID-19 can be tough for current treatment.

This is a single-center, open-label phase I clinical trial of booster vaccination in healthy 18 to 60 years of age, inclusive, who has been prime vaccinated with adenovirus type-5 vectored COVID-19 vaccine. This clinical trial is designed to assess the safety and immunogenicity of booted vaccination of adenovirus type-5 vectored COVID-19 vaccine manufactured by Beijing Institute of Biotechnology and CanSino Biologics Inc.

Enrollment

89 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Participants who has received prime vaccination of adenovirus type-5 vectored COVID-19 vaccine
Able to understand the content of informed consent and willing to sign the informed consent
Negative in HIV diagnostic test.
Axillary temperature ≤37.0°C.
General good health as established by medical history and physical examination.
Able to complete 12 months visit

Exclusion criteria

Family history of seizure, epilepsy, brain or mental disease
Subject allergic to any component of the investigational vaccine, or a more severe allergic reaction and history of allergies in the past.
Woman who is pregnant, breast-feeding on day of enrollment, or become pregnant during the next 12 months
Any acute fever disease or infections.
History of SARS
Major congenital defects or not well-controlled chronic illness, such as asthma, diabetes, or thyroid disease.
Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension without controllable drugs, etc.
Hereditary angioneurotic edema or acquired angioneurotic edema
Urticaria in last one year
No spleen or functional spleen.
Platelet disorder or other bleeding disorder may cause injection contraindication
Faint at the sight of 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
According to the judgement of investigator,various medical, psychological, social or other conditions, those could affect the subjects to sign informed consent.