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Safety and Immunogenicity Study of Booster Vaccination With Medium-dosage or High-dosage SARS-CoV-2 Inactivated Vaccine for Prevention of COVID-19

13. februar 2022 opdateret af: Sinovac Biotech Co., Ltd

A Randomized, Double-Blinded Clinical Trial to Evaluate Additional Dose of Medium-dosage or High-dosage SARS-CoV-2 Inactivated Vaccine in Healthy Individuals Previously Vaccinated With CoronaVac

This is a randomized, double-blinded, phase ⅠV clinical trial of SARS-CoV-2 inactivated vaccine manufactured by manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination with high-dosage SARS-CoV-2 vaccine in populations who have received two-dose Coronavac with 2nd dose vaccinated more than 6 month.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Detaljeret beskrivelse

This study a randomized, double-blinded, phase ⅠV clinical trial of SARS-CoV-2 inactivated vaccine .The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination with high-dosage SARS-CoV-2 vaccine in populations who have received two-dose Coronavac with 2nd dose vaccinated more than 6 month.A total of 1200 subjects who have received two-dose Coronavac with 2nd dose vaccinated more than 6 month will be enrolled.All of subjects will be randomly divided into two groups in a 1:1 ratio .Subjects in experimental group will receive high-dosage SARS-CoV-2 inactivated vaccine.Subjects in control group will receive medium-dosage SARS-CoV-2 inactivated vaccine .

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

1200

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Jiangsu
      • Xinqi, Jiangsu, Kina, 221400
        • Xinqi City Center for Disease Control and Prevention

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Adults aged 18-59;
  • Proven legal identity;
  • The subjects can understand and voluntarily sign the informed consent form and be willing to complete the study in accordance with the study plan;
  • Have received two doses of inactivated SARS-CoV-2 vaccine(CoronaVac) manufactured by Sinovac Research & Development Co., Ltd at an interval of 21 to 35 days and is currently 6-8 months (180 to 240 days) after the second dose.

Exclusion Criteria:

  • History of SARS-CoV-2 infection(laboratory confirmed);
  • Have received three and more doses of inactivated SARS-CoV-2 vaccine;
  • Severe adverse reactions, such as urticaria, dyspnea, and angioneurotic edema , occurred during the primary immunization;
  • Autoimmune disease such as systemic lupus erythematosus or immunodeficiency / immunosuppression such as AIDS, post-transplant;
  • Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc;
  • Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
  • Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
  • Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
  • History of alcohol or drug abuse;
  • Receipt of blood products within in the past 3 months;
  • Receipt of other investigational drugs in the past 30 days;
  • Receipt of attenuated live vaccines in the past 14 days;
  • Acute diseases or acute exacerbation of chronic diseases within 7 days prior to booster vaccination;
  • Axillary temperature >37.0°C;
  • Already pregnant or are breastfeeding, planning to get pregnant within 1months (according to subjects' self-report and urine pregnancy test results);
  • Participated in other clinical trials prior to enrollment and during the follow-up period, or planned to participate in other clinical trials during the clinical trial period;
  • According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Experimental Group
600 participants will receive one dose of booster vaccination with high-dosage inactivated SARS-CoV-2 vaccine .
SARS-CoV-2 Inactivated Vaccine 1200SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Andre navne:
  • CoronaVac
Aktiv komparator: Control Group
600 participants will receive one dose of booster vaccination with medium-dosage inactivated SARS-CoV-2 vaccine .
SARS-CoV-2 Inactivated Vaccine 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Andre navne:
  • CoronaVac

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain)
Tidsramme: Day 28 after booster vaccination
GMT of neutralizing antibodies(CZ02 strain) 28 days after booster vaccination.
Day 28 after booster vaccination

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Immunogenicity index-seropositive rate of neutralizing antibodies(CZ02 strain)
Tidsramme: Day 28 after booster vaccination
The seropositive rate of neutralizing antibodies(CZ02 strain) 28 days after booster vaccination
Day 28 after booster vaccination
Immunogenicity index-seroconversion rate of neutralizing antibodies(CZ02 strain)
Tidsramme: Day 28 after booster vaccination
The seroconversion rate of neutralizing antibodies(CZ02 strain) 28 days after booster vaccination
Day 28 after booster vaccination
Immunogenicity index-GMI of neutralizing antibodies(CZ02 strain)
Tidsramme: Day 28 after booster vaccination
GMI of neutralizing antibodies(CZ02 strain) 28 days after booster vaccination
Day 28 after booster vaccination
Immunogenicity index-seropositive rate of neutralizing antibodies(Delta Strain)
Tidsramme: Day 28 after booster vaccination
The seropositive rate of neutralizing antibodies(Delta Strain) 28 days after booster vaccination
Day 28 after booster vaccination
Immunogenicity index-seroconversion rate of neutralizing antibodies(Delta Strain)
Tidsramme: Day 28 after booster vaccination
The seroconversion rate of neutralizing antibodies(Delta Strain) 28 days after booster vaccination
Day 28 after booster vaccination
Immunogenicity index-GMI of neutralizing antibodies(Delta Strain)
Tidsramme: Day 28 after booster vaccination
GMI of neutralizing antibodies(Delta Strain) 28 days after booster vaccination
Day 28 after booster vaccination
Immunogenicity index-seroconversion rate of neutralizing antibodies(Omicron Strain)
Tidsramme: Day 28 after booster vaccination
The seroconversion rate of neutralizing antibodies(Omicron Strain) 28 days after booster vaccination
Day 28 after booster vaccination
Immunogenicity index-seropositive rate of neutralizing antibodies(Omicron Strain)
Tidsramme: Day 28 after booster vaccination
The seropositive rate of neutralizing antibodies(Omicron Strain) 28 days after booster vaccination
Day 28 after booster vaccination
Immunogenicity index-GMI of neutralizing antibodies(Omicron Strain)
Tidsramme: Day 28 after booster vaccination
GMI of neutralizing antibodies(Omicron Strain) 28 days after booster vaccination
Day 28 after booster vaccination
Immunogenicity index-GMT of neutralizing antibodies(Omicron Strain)
Tidsramme: Day 28 after booster vaccination
GMT of neutralizing antibodies(Omicron Strain) 28 days after booster vaccination
Day 28 after booster vaccination
Immunogenicity index-GMT of neutralizing antibodies(Delta Strain)
Tidsramme: Day 28 after booster vaccination
GMT of neutralizing antibodies(Delta Strain) 28 days after booster vaccination
Day 28 after booster vaccination

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Immunogenicity index-the seropositive rate of neutralizing antibodies(CZ02 strain,Delta Strain and Omicron Strain)
Tidsramme: 6 months after the booster vaccination
The seroconversion rate of neutralizing antibodies(CZ02 strain,Delta Strain and Omicron Strain) 6 months after the booster vaccination
6 months after the booster vaccination
Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain,Delta Strain and Omicron Strain)
Tidsramme: 6 months after the booster vaccination
GMI of neutralizing antibodies(CZ02 strain,Delta Strain and Omicron Strain) 6 months after the booster vaccination
6 months after the booster vaccination

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Hongxing Pan, Master, Jiangsu Provincial Center for Disease Prevention and Control

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

17. december 2021

Primær færdiggørelse (Faktiske)

21. december 2021

Studieafslutning (Forventet)

1. juni 2022

Datoer for studieregistrering

Først indsendt

14. oktober 2021

Først indsendt, der opfyldte QC-kriterier

14. oktober 2021

Først opslået (Faktiske)

15. oktober 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. marts 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. februar 2022

Sidst verificeret

1. oktober 2021

Mere information

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