Clinical trial NCT04568811: The Phase I Clinical Trial of Booster Vaccination of Adenovirus Type-5 Vectored COVID-19 Vaccine
Official title: The Single-center, Open-label Phase I Clinical Trial of Booster Vaccination of Adenovirus Type-5 Vectored COVID-19 Vaccine in Healthy Adults Aged 18-60 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Adenovirus Type-5 Vectored COVID-19 Vaccine
Lead sponsor: Jiangsu Province Centers for Disease Control and Prevention
Sponsor class: NETWORK
First posted: 2020-09-29
Enrollment: 89
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Occurrence of adverse reactions within 14 days after booster vaccination
timeFrame: 0-14 days post-vaccination
Secondary outcomes:
measure: Occurrence of adverse events within 14 days after booster vaccination
timeFrame: 0-14 days post-vaccination
measure: Occurrence of adverse events within 28 days after booster vaccination
timeFrame: 0-28 days post-vaccination
measure: Occurrence of serious adverse events within 28 days after booster vaccination
timeFrame: 0-28 days post-vaccination
measure: Occurrence of serious adverse events within 6 months after booster vaccination
timeFrame: 6 months post-vaccination
measure: Occurrence of serious adverse events within 12 months after booster vaccination
timeFrame: 12 months post-vaccination
measure: Changes in laboratory test indicators before and 1 day after vaccination
timeFrame: 1 day post-vaccination
measure: Antibody of S-RBD at day 14, day 28, month 6 and month 12 after booster vaccination
timeFrame: 14 days, 28 days, 6 months and 12 months post-vaccination
measure: Cellular immunity at day 14 after booster vaccination
timeFrame: 14 days post-vaccination
Other outcomes:
Locations:
city: Wuhan
country: China
facility: A rehabilitation centre in Wuhan
state: Hubei
Study officials:
References: