Skip to main content
OpenTrials
Completed

NCT Number: NCT04952727

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Jiangsu Provincial Center for Diseases Control and Prevention

Nanjing, Jiangsu, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Ad5-nCoV

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.

Other names: CoronaVac

Primary outcomes

  1. Incidence of adverse reactions within 28 days after the booster dose.

    Time frame: Within 28 days after the booster dose

    Incidence of adverse reactions within 28 days after vaccination.

  2. GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the booster dose.

    Time frame: On day 14 after the booster dose

    GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the vaccination.

Secondary outcomes

  1. Incidence of solicited AE within 14 days after the booster dose

    Time frame: within 14 days after the booster dose

    Incidence of solicited adverse events (AE) within 14 days after the booster vaccination.

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

    Time frame: within 28 days after the booster dose

    Incidence of unsolicited adverse events (AE) within 28 days after vaccination.

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

    Time frame: within 6 months after the booster dose

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

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

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

    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.

  5. GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 and month 6 after the booster dose.

    Time frame: on day 28 and month 6 after the last dose of vaccination

    GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 and month 6 after the booster dose.

  6. 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.

    Time frame: 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.

  7. Fold increase of neutralizing antibodies against live SARS-CoV-2 virus on day 14, day 28 and month 6 after the booster vaccination.

    Time frame: on day 14, day 28 and month 6 after the last dose of 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.

  8. 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.

    Time frame: 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.

  9. 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.

    Time frame: 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.

  10. Specific T cell responses on day 14 after the booster vaccination.

    Time frame: on day 14 after the booster vaccination

    Specific T cell responses on day 14 after the booster vaccination detected by ELISPOT.

Other outcomes

  1. Types of IgG binding to SARS-CoV-2 S protein on day 14, day 28 and month 6 after the booster vaccination.

    Time frame: 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.

  2. GMT of neutralizing antibodies against P.1 variants on day 28 after the booster vaccination.

    Time frame: on day 28 after the booster vaccination

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

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

    Time frame: on day 28 after the booster vaccination

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

Sponsors and collaborators

Lead sponsor

Jiangsu Province Centers for Disease Control and Prevention

Network

Collaborators

  • CanSino Biologics Inc.

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jul 7, 2021
Registry last updated
Aug 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.