Study on Sequential Immunization of Inactivated SARS-CoV-2 Vaccine and Recombinant SARS-CoV-2 Vaccine (Ad5 Vector)

ABSTRACT

ConditionCOVID-19

InterventionBiological Recombinant SARS-CoV-2 Ad5 vectored vaccine;Biological Inactive SARS-CoV-2 vaccine (Vero cell)

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 14 after the booster dose.

Criteria
Inclusion Criteria

- Health subjects aged 18-59 years, who have been completed two-dose regimen of inactive
SARS-CoV-2 vaccine in the past 3-6 months, or received one dose of inactive SARS-CoV-2
vaccine in the past 1-3 months.

- 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.

- Axillary temperature = 37.0?.

- Individuals who are in good health condition at the time of entry into the trial as
determined by medical history, physical examination and clinical judgment of the
investigator and meet the requirements of immunization.

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, pregnant or breast-feeding, or have a
pregnancy plan within six months.

- have acute febrile diseases and infectious diseases.

- have severe chronic diseases or condition in progress cannot be controlled.

- congenital or acquired angioedema / neuroedema

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

- have asplenia or functional asplenia.

- have thrombocytopenia or other coagulation disorders (which may cause
contraindications for intramuscular injection).

- have needle sickness.

- have the history of immunosuppressive therapy, anti-allergy therapy, cytotoxic therapy
or inhaled corticosteroids (excluding corticosteroid spray therapy for allergic
rhinitis, and acute corticosteroid therapy without dermatitis) over the past 6 months.

- have received blood products within 4 months before injection of investigational
vaccines.

- under anti-tuberculosis treatment.

- not be able to follow the protocol, or not be able to understand the informed consent
according to the researcher's judgment, due to various medical, psychological, social
or other conditions.