Safety and Immunogenicity Study of Booster Vaccination With Medium-dosage or High-dosage SARS-CoV-2 Inactivated Vaccine for Prevention of COVID-19
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
Visão geral do estudo
Status
Status
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Tipo de estudo
Inscrição (Antecipado)
Inscrição
Estágio
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
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Jiangsu
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Xinqi, Jiangsu, China, 221400
- Xinqi City Center for Disease Control and Prevention
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Critérios de participação
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Número de braços
Armas e Intervenções
Grupo de Participantes / BraçoGrupo de Participantes / Braço |
Intervenção / TratamentoIntervenção / Tratamento |
|---|---|
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Experimental: Experimental Group
600 participants will receive one dose of booster vaccination with high-dosage inactivated SARS-CoV-2 vaccine .
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SARS-CoV-2 Inactivated Vaccine 1200SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Outros nomes:
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Comparador Ativo: Control Group
600 participants will receive one dose of booster vaccination with medium-dosage inactivated SARS-CoV-2 vaccine .
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SARS-CoV-2 Inactivated Vaccine 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain)
Prazo: Day 28 after booster vaccination
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GMT of neutralizing antibodies(CZ02 strain) 28 days after booster vaccination.
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Day 28 after booster vaccination
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Medidas de resultados secundários
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Immunogenicity index-seropositive rate of neutralizing antibodies(CZ02 strain)
Prazo: Day 28 after booster vaccination
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The seropositive rate of neutralizing antibodies(CZ02 strain) 28 days after booster vaccination
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Day 28 after booster vaccination
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Immunogenicity index-seroconversion rate of neutralizing antibodies(CZ02 strain)
Prazo: Day 28 after booster vaccination
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The seroconversion rate of neutralizing antibodies(CZ02 strain) 28 days after booster vaccination
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Day 28 after booster vaccination
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Immunogenicity index-GMI of neutralizing antibodies(CZ02 strain)
Prazo: Day 28 after booster vaccination
|
GMI of neutralizing antibodies(CZ02 strain) 28 days after booster vaccination
|
Day 28 after booster vaccination
|
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Immunogenicity index-seropositive rate of neutralizing antibodies(Delta Strain)
Prazo: 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)
Prazo: 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)
Prazo: Day 28 after booster vaccination
|
GMI of neutralizing antibodies(Delta Strain) 28 days after booster vaccination
|
Day 28 after booster vaccination
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Immunogenicity index-seroconversion rate of neutralizing antibodies(Omicron Strain)
Prazo: Day 28 after booster vaccination
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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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: Day 28 after booster vaccination
|
GMT of neutralizing antibodies(Delta Strain) 28 days after booster vaccination
|
Day 28 after booster vaccination
|
Outras medidas de resultado
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Immunogenicity index-the seropositive rate of neutralizing antibodies(CZ02 strain,Delta Strain and Omicron Strain)
Prazo: 6 months after the booster vaccination
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The seroconversion rate of neutralizing antibodies(CZ02 strain,Delta Strain and Omicron Strain) 6 months after the booster vaccination
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6 months after the booster vaccination
|
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Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain,Delta Strain and Omicron Strain)
Prazo: 6 months after the booster vaccination
|
GMI of neutralizing antibodies(CZ02 strain,Delta Strain and Omicron Strain) 6 months after the booster vaccination
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6 months after the booster vaccination
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Hongxing Pan, Master, Jiangsu Provincial Center for Disease Prevention and Control
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Início do estudo
Conclusão Primária (Real)
Conclusão Primária
Conclusão do estudo (Antecipado)
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Primeira postagem
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
Outros números de identificação do estudo
- PRO-nCOV-4007
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