Heterologous Boost Immunization With an Aerosolised Ad5-nCoV After Two-dose Priming With an Inactivated SARS-CoV-2 Vaccine

ABSTRACT

ConditionCOVID-19

InterventionBiological Aerosolized Ad5-nCoV;Biological Inactivated SARS-CoV-2 vaccine

Primary outcome:Incidence of adverse reactions within 28 days after the booster dose.;GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose in immunogenicity cohort.

Criteria
Inclusion Criteria

- Health subjects aged =18 years.

- Have received two-dose inactivated SARS-CoV-2 vaccine before 6 months or more.

- The subject can provide with informed consent and sign informed consent form (ICF).

- The subjects are able to and willing to comply with the requirements of the clinical
trial program and could complete the 6-month follow-up of the study.

Exclusion Criteria

- Have the medical history or family history of convulsion, epilepsy, encephalopathy and
psychosis.

- Be allergic to any component of the research vaccines, or used to have a history of
hypersensitivity or serious reactions to vaccination.

- Women with positive urine pregnancy test.

- Have acute febrile diseases and infectious diseases.

- Axillary temperature>37.0?.

- Have serious cardiovascular disease, such as arrhythmia, conduction block, myocardial
infarction, severe hypertension that cannot be controlled by medication (systolic
blood pressure =180mmHg and/or diastolic blood pressure =110mmHg when measured in the
field).

- Have severe chronic diseases or condition in progress cannot be smoothly controlled,
such as asthma, diabetes, thyroid disease.

- Congenital or acquired angioedema / neuroedema.

- Have the history of urticaria 1 year before receiving the investigational vaccine.

- Have asplenia or functional asplenia.

- Patients with chronic obstructive pulmonary disease, pulmonary fibrosis and other
pulmonary abnormalities.

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

- Have symptoms of upper respiratory tract infection.

- Have traveled to medium or high risk areas or traveled abroad in the past 21 days, and
epidemiologically contacted with SARS-CoV-2.

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