Study on Sequential Immunization of Inactivated COVID-19 Vaccine and Recombinant COVID-19 Vaccine (Ad5 Vector) in Elderly Adults

COVID-19 Clinical Trial

Official title:

Safety and Immunogenicity of Sequential Immunization of Inactivated COVID-19 Vaccine and Recombinant COVID-19 Vaccine (Ad5 Vector) inChinese Healthy Adults Aged 60 and Above: a Randomized, Observer-blind,Parallel-controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04952727
• Other study ID #: JSVCT117
• Status: Completed
• Phase: Phase 4
• Start date: August 26, 2021
• Est. completion date: May 15, 2022

Study information

• Verified date: March 2022
• Source: Jiangsu Province Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, observer-blind, parallel-controlled study, for evaluation of safety and immunogenicity of sequential immunization of a recombinant COVID-19 vaccine (adenovirus type 5 vector) in Chinese healthy adults aged 60 and above after the priming vaccination of inactivated vaccine. 300 healthy subjects aged 60 and above will be recruited in this study. Of them, 200 subjects who have been vaccinated with two dose of inactive SARS-CoV-2 vaccine will be recruited and randomized at a 1:1 ratio to receive a booster dose of inactivated SARS-CoV-2 vaccine or recombinant SARS-CoV-2 Ad5 vectored vaccine at 3~6 months later. Other 100 subjects who have been vaccinated with one dose of inactivated SARS-CoV-2 vaccine will be recruited and randomized at a 1:1 ratio to receive a booster dose of inactivated SARS-CoV-2 vaccine or recombinant SARS-CoV-2 Ad5 vectored vaccine at 1~3 months later. The occurrence of adverse events within 28 days and serious adverse events within 6 months after vaccination will be observed. In addition, blood samples will be collected on day 0 before the boosting with ad5 vectored vaccine and on day 14, 28 and month 6 after the boosting. Serum antibody levels, cellular immune responses and the subgroups or germlines of the specific B cells will be analyzed. Each subject will remain in this study for approximately 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 15, 2022
• Est. primary completion date: November 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Health subjects aged 60 and above, 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 corticosteroidspray 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 variousmedical, psychological, social or other conditions.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• Recombinant SARS-CoV-2 Ad5 vectored vaccine
This vaccine contains 5×10^10 virus particles of recombinant replication defective human type 5 adenovirus expressing SARS-CoV-2 S protein, which is produced by CanSino Biologics Inc. It is a liquid dosage form, 0.5 ml / bottle.
• Inactive SARS-CoV-2 vaccine (Vero cell)
This vaccine contains 600 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research & Development Co., Ltd. 0.5 ml / bottle.

Locations

Country	Name	City	State
China	Jiangsu Provincial Center for Diseases Control and Prevention	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Jiangsu Province Centers for Disease Control and Prevention	CanSino Biologics Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Types of IgG binding to SARS-CoV-2 S protein on day 14, day 28 and month 6 after the booster vaccination.	Types of IgG binding to SARS-CoV-2 S protein on day 14, day 28 and month 6 after the booster vaccination.	on day 14, day 28 and month 6 after the booster vaccination
Other	GMT of neutralizing antibodies against P.1 variants on day 28 after the booster vaccination.	GMT of neutralizing antibodies against P.1 variants on day 28 after the booster vaccination.	on day 28 after the booster vaccination
Other	GMT of neutralizing antibodies against 501Y.V2 variants on day 28 after the booster vaccination.	GMT of neutralizing antibodies against 501Y.V2 variants on day 28 after the booster vaccination.	on day 28 after the booster vaccination
Primary	Incidence of adverse reactions within 28 days after the booster dose.	Incidence of adverse reactions within 28 days after vaccination.	Within 28 days after the booster dose
Primary	GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the booster dose.	GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the vaccination.	On day 14 after the booster dose
Secondary	Incidence of solicited AE within 14 days after the booster dose	Incidence of solicited adverse events (AE) within 14 days after the booster vaccination.	within 14 days after the booster dose
Secondary	Incidence of unsolicited AE within 28 days after the booster dose.	Incidence of unsolicited adverse events (AE) within 28 days after vaccination.	within 28 days after the booster dose
Secondary	Incidence of serious adverse events (SAE) till the 6 months after the booster dose.	Incidence of serious adverse events (SAE) till the 6 months after booster vaccination.	within 6 months after the booster dose
Secondary	GMT of binding antibodies against SARS-CoV-2 S and N protein on day 14, day 28 and month 6 after the booster dose.	GMT of binding antibodies against SARS-CoV-2 S and N protein measured by ELISA on day 14, day 28 and month 6after the booster vaccination.	on day 14, day 28 and month 6 after the booster vaccination
Secondary	GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 and month 6 after the booster dose.	GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 and month 6 after the booster dose.	on day 28 and month 6 after the last dose of vaccination
Secondary	Fold increase of binding antibodies against SARS-CoV-2 S and N protein on day 14, day 28 and month 6 after the booster vaccination.	Fold increase of binding antibodies against SARS-CoV-2 S and N protein measured by ELISA, as compared to baseline, on day 14, day 28 and month 6 after the booster vaccination.	on day 14, day 28 and month 6 after the booster vaccination
Secondary	Fold increase of neutralizing antibodies against live SARS-CoV-2 virus on day 14, day 28 and month 6 after the booster vaccination.	Fold increase of neutralizing antibodies against live SARS-CoV-2 virus, as compared to baseline, on day 14, day 28 and month 6 after the booster vaccination.	on day 14, day 28 and month 6 after the last dose of vaccination
Secondary	Proportion of the participants with at least a four-fold increase of the binding antibodies against SARS-CoV-2 S and N protein on day 14, day 28 and month 6 after the booster vaccination.	Proportion of the participants with at least a four-fold increase of the binding antibodies against SARS-CoV-2 S and N protein on day 14, day 28 and month 6 after the booster vaccination.	on day 14, day 28 and month 6 after the booster vaccination
Secondary	Proportion of the participants with at least a four-fold increase of neutralizing antibodies against live SARS-CoV-2virus on day 14, day 28 and month 6 after the booster vaccination.	Proportion of the participants with at least a four-fold increase of neutralizing antibodies against live SARS-CoV-2virus, as compared to baseline, at Day 14, Day 28 and Month 6 after the booster vaccination.	on day 14, day 28 and month 6 after the booster vaccination
Secondary	Specific T cell responses on day 14 after the booster vaccination.	Specific T cell responses on day 14 after the booster vaccination detected by ELISPOT.	on day 14 after the booster vaccination