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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 februari 2022 uppdaterad av: 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.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Detaljerad beskrivning

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 .

Studietyp

Interventionell

Inskrivning (Förväntat)

1200

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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
Andra namn:
  • 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
Andra namn:
  • CoronaVac

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain)
Tidsram: Day 28 after booster vaccination
GMT of neutralizing antibodies(CZ02 strain) 28 days after booster vaccination.
Day 28 after booster vaccination

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Immunogenicity index-seropositive rate of neutralizing antibodies(CZ02 strain)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: Day 28 after booster vaccination
GMT of neutralizing antibodies(Delta Strain) 28 days after booster vaccination
Day 28 after booster vaccination

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Immunogenicity index-the seropositive rate of neutralizing antibodies(CZ02 strain,Delta Strain and Omicron Strain)
Tidsram: 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)
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

17 december 2021

Primärt slutförande (Faktisk)

21 december 2021

Avslutad studie (Förväntat)

1 juni 2022

Studieregistreringsdatum

Först inskickad

14 oktober 2021

Först inskickad som uppfyllde QC-kriterierna

14 oktober 2021

Första postat (Faktisk)

15 oktober 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

2 mars 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

13 februari 2022

Senast verifierad

1 oktober 2021

Mer information

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Nej

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