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

NCT04892459 | Completed Phase 4 DMC

• 1 other identifier: JSVCT116
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, observer-blind, parallel-controlled study, for evaluation of safety and immunogenicity of sequential immunization of a recombinant SARS-CoV-2 vaccine (adenovirus type 5 vector) in Chinese healthy adults aged 18-59 years after the priming vaccination of inactivated vaccine. 300 healthy subjects aged 18-59 years 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.

Conditions

COVID-19

Keywords

SARS-CoV-2 Vaccine; Sequential immunization; Heterologous prime-boost; Ad5 vectored vaccine

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (10)

• Incidence of solicited AE within 14 days after the booster dose

  within 14 days after the booster dose

• Incidence of unsolicited AE within 28 days after the booster dose.

  within 28 days after the booster dose

• Incidence of serious adverse events (SAE) till the 6 months after the booster dose.

  within 6 months after the booster dose

• GMT of binding antibodies against SARS-CoV-2 S and N protein on day 14, day 28 and month 6 after the booster dose.

  on day 14, day 28 and month 6 after the booster vaccination

• 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

Other Outcomes (3)

• 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

• GMT of neutralizing antibodies against P.1 virants on day 28 after the booster vaccination.

  on day 28 after the booster vaccination

• GMT of neutralizing antibodies against 501Y.V2 virants on day 28 after the booster vaccination.

  on day 28 after the booster vaccination

Study Arms (4)

heterologous boost arm with Ad5 vectored vaccine

EXPERIMENTAL

Subjects who have been primed with two doses of inactive SARS-CoV-2 vaccine will receive a booster of recombinant SARS-CoV-2 Ad5 vectored vaccine after 3\~6 months.

Biological: Recombinant SARS-CoV-2 Ad5 vectored vaccine

homogeneous boost arm with inactive vaccine

ACTIVE COMPARATOR

Subjects who have been primed with two doses of inactive SARS-CoV-2 vaccine will receive a booster dose of inactive SARS-CoV-2 vaccine after 3\~6 months.

Biological: Inactive SARS-CoV-2 vaccine (Vero cell)

heterologous regimen with Ad5 vectored vaccine

EXPERIMENTAL

Subjects who have been primed with one dose of inactive SARS-CoV-2 vaccine will receive one dose of recombinant SARS-CoV-2 Ad5 vectored vaccine after 1\~3 months.

Biological: Recombinant SARS-CoV-2 Ad5 vectored vaccine

homogeneous regimen arm with inactive vaccine

ACTIVE COMPARATOR

Subjects who have been primed with one dose of inactive SARS-CoV-2 vaccine will receive one dose of inactive SARS-CoV-2 vaccine after 1\~3 months.

Biological: Inactive SARS-CoV-2 vaccine (Vero cell)

Interventions

Recombinant SARS-CoV-2 Ad5 vectored vaccine BIOLOGICAL

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.

Also known as: Ad5-nCoV

heterologous boost arm with Ad5 vectored vaccine; heterologous regimen with Ad5 vectored vaccine

Inactive SARS-CoV-2 vaccine (Vero cell) BIOLOGICAL

This vaccine contains 600 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research \& Development Co., Ltd. 0.5 ml / bottle.

Also known as: CoronaVac

homogeneous boost arm with inactive vaccine; homogeneous regimen arm with inactive vaccine

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead
• CanSino Biologics Inc.: collaborator

Study Sites (1)

Jiangsu Provincial Center for Disease Control and Prevention

Nanjing, Jiangsu, 210009, China

Location

Related Publications (1)

• Li J, Hou L, Guo X, Jin P, Wu S, Zhu J, Pan H, Wang X, Song Z, Wan J, Cui L, Li J, Chen Y, Wang X, Jin L, Liu J, Shi F, Xu X, Zhu T, Chen W, Zhu F. Heterologous AD5-nCOV plus CoronaVac versus homologous CoronaVac vaccination: a randomized phase 4 trial. Nat Med. 2022 Feb;28(2):401-409. doi: 10.1038/s41591-021-01677-z. Epub 2022 Jan 27.

  PMID: 35087233 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Ad5-nCoV vaccine; sinovac COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jing-Xin Li, PhD

  Jiangsu Provincial Center for Diseases Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Unblinded staff will responsible for the vaccine administration and management, and other investigators will be kept blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Subjects who have been primed with one dose or two doses of inactive SARS-CoV-2 vaccine will be recruited and randomized at a 1:1 ratio to receive a booster dose of inactive SARS-CoV-2 vaccine or recombinant SARS-CoV-2 Ad5 vectored vaccine

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 19, 2021
• Study Start: May 25, 2021
• Primary Completion: July 25, 2021
• Study Completion: December 25, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

CN (1)