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

ABSTRACT

ConditionAdenovirus Type-5 Vectored COVID-19 Vaccine

InterventionBiological Adenovirus Type-5 Vectored COVID-19 Vaccine

Primary outcome:Occurrence of adverse reactions within 14 days after booster vaccination

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.