Clinical Evaluation for Batch Consistency of Ad5-nCoV in Chinese Healthy Adults

ABSTRACT

ConditionCOVID-19

InterventionBiological batch 1 of Ad5-nCoV;Biological batch 2 of Ad5-nCoV;Biological batch 3 of Ad5-nCoV

Primary outcome:GMTs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination.

Criteria
Inclusion Criteria

1. healthy participants aged 18 years and above who have not received COVID-19 vaccine.

2. The subjects can provide with informed consent and sign informed consent form (ICF).

4. The subjects are able to and willing to comply with the requirements of the clinical
trial program and could complete the follow-up of the study.

5. Axillary temperature = 37.0?. 6. negative IgM and IgG against SARS-CoV-2 7. with BMI
between18.5 to 30.0 8. No history of epidemiological contact with COVID-2019 9. have not
been to medium or high risk areas in the past 21 days and have no history of departure.

10. be determined to be healthy by medical history, physical examination and clinical
examination and meet the requirements for immunization of this product.

Exclusion criteria

1. Medical history or family history of convulsion, epilepsy, encephalopathy and
psychosis.

2. Allergic to any component of the research vaccines, or a history of hypersensitivity
or serious reactions to vaccination.

3. Women with positive urine pregnancy test, pregnant or breast-feeding, or have a
pregnancy plan in this study.

4. Suffering from acute febrile disease, infectious disease, or SARS infection history

5. Serious cardiovascular disease, such as arrhythmia, conduction block, myocardial
infarction, severe hypertension, which cannot be controlled by medication (systolic
blood pressure =180mmHg, diastolic blood pressure =110mmHg)

6. Have severe chronic diseases or unstable condition ( Grade 3 or higher as defined in
the guidelines for the classification of adverse events in clinical trials for
prophylactic vaccines), Such as diabetes, thyroid disease and so on.

7. Congenital or acquired angioedema / neuroedema.

8. had urticaria one year before this vaccination.

9. Asplenia or functional asplenia.

10. Thrombocytopenia or other clotting disorder (this may contraindicate intramuscular
injection).

11. Faintng during acupuncture treatment

12. Received immunosuppressant therapy, antiallergic therapy, cytotoxic therapy, high dose
inhaled corticosteroid over the past 6 months (excluding corticosteroid spray for
allergic rhinitis, surface corticosteroid for acute non-complicated dermatitis, and
corticosteroid with dose less than 20mg/ day)

13. Received blood products within 4 months before vaccination.

14. Received other investigational drugs within 1 month prior to receiving the
investigational vaccines.

15. Received other live attenuated vaccines within 1 month prior to receiving the
investigational vaccines.

16. Received subunit or inactivated vaccine within 14 days prior to receiving
investigational vaccine.

17. Be receiving anti-tuberculosis treatment

18. Have the history of SARS-CoV-2 infection or COVID-19

19. Any medical, psychological, social or other conditions that, in the investigator's
judgment, are inconsistent with the study protocol or affect the subjects' informed
consent