COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04568811

Not reported

Not reported

2020-09-29

Completed

nonRCT

Non-randomized

Single group assignment

Open label

single-center

Prevention

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

- 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.

1

Jiangsu Province Centers for Disease Control and Prevention

2

100

China

Healthy volunteers

N/A

89

Occurrence of adverse reactions within 14 days after booster vaccination

None

Phase 1

[{"arm_notes": "1", "treatment_id": 26, "treatment_name": "Ad5-ncov", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]