The Immunogenicity, Safety, and Effectiveness of the COVID-19 Inactivated Vaccine
The Immunogenicity, Safety, and Effectiveness of the SARS-CoV-2 Vaccine (Vero Cell) Inactivated in Adult Population Aged 18 Years Old and Above in Indonesia
To fast respond the coronavirus disease of 2019 (COVID-19) pandemic, the Indonesian government has launched "Vaksinasi Gotong Royong" (a mutual cooperation vaccination program) in which any company/legal entity/business entity may purchase vaccines to be given free of charge to their employees and families of employees (The Indonesian Ministry of Health, 2021). Vaccines provided for this program include the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) inactivated vaccines produced by Sinopharm.
The Indonesian National Agency of Drug and Food Control (NADFC) has issued an Emergency Use Authorization (EUA) for several COVID-19 vaccines, including the SARS-CoV-2 vaccine (Vero cell) inactivated produced by Sinopharm (NADFC, 2021). Following EUA, Kimia Farma Indonesia as the holder of EUA has the obligation to monitor the safety and effectiveness in Indonesian population.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Bandung, Indonésia
- Laboratorium Klinik Kimia Farma Diponegoro Bandung
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Jakarta, Indonésia
- Laboratorium Klinik Kimia Farma Cikini
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Medan, Indonésia
- Laboratorium Klinik Kimia Farma Medan
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Semarang, Indonésia
- Laboratorium Klinik Kimia Farma Sutomo Semarang
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
Male or female subjects aged 18 years old and above; Will receive the SARS-CoV-2 vaccine (Vero cell) inactivated produced by Sinopharm; Obtain informed consent to participate this study
Exclusion Criteria:
Previous SARS-CoV-2 vaccination, except for drop out after the first vaccine dose of more than 6 months ago; History of SARS-CoV-2 infection within the last 3 months
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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Immunogenicity
Group 1 constitutes the immunogenicity group which will be evaluated regarding immunogenicity, safety, and effectiveness of the SARS-CoV-2 vaccine (Vero cell) inactivated produced by Sinopharm
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Two doses of 0.5 mL intramuscular injection containing 4 mcg (6.5 Unit) antigens with an interval of 21-28 days in accordance with "Vaksinasi Gotong Royong" (mutual cooperation vaccination program)
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Non-Immunogenicity
Group 2 that constitutes the non-immunogenicity group which will be evaluated regarding only safety and effectiveness of the aforementioned vaccine
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Two doses of 0.5 mL intramuscular injection containing 4 mcg (6.5 Unit) antigens with an interval of 21-28 days in accordance with "Vaksinasi Gotong Royong" (mutual cooperation vaccination program)
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The percent inhibition of SARS-CoV-2 surrogate Virus Neutralization Test neutralizing antibody (sVNT NAb)
Prazo: At 14 days, 3 months, and 6 months after 2 doses of vaccination
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To evaluate the percent inhibition of SARS-CoV-2 sVNT NAb following the SARS-CoV-2 vaccine (Vero cell) inactivated administration at 14 days, 3 months, and 6 months after 2 doses of vaccination
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At 14 days, 3 months, and 6 months after 2 doses of vaccination
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The geometric mean titer (GMT) of anti-spike protein receptor binding domain (sRBD) immunoglobulin G (IgG) antibody and the proportion of seropositivity of anti-nucleocapsid antibody
Prazo: At 14 days, 3 months, and 6 months after 2 doses of vaccination
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To evaluate the GMT of anti-sRBD IgG antibody and the proportion of seropositivity of anti-nucleocapsid antibody following the SARS-CoV-2 vaccine (Vero cell) inactivated administration at 14 days, 3 months, and 6 months after 2 doses of vaccination
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At 14 days, 3 months, and 6 months after 2 doses of vaccination
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The proportion of adverse event following immunization
Prazo: Within 28 days after 2 doses of vaccination
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To evaluate the proportion of adverse event following immunization (AEFI) following the SARS-CoV-2 vaccine (Vero cell) inactivated administration after the first dose until 28 days after the second dose of vaccination
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Within 28 days after 2 doses of vaccination
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The proportion of serious adverse event
Prazo: Within 6 months after 2 doses of vaccination
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To evaluate the proportion of serious adverse event following the SARS-CoV-2 vaccine (Vero cell) inactivated administration after the first dose until 6 months after the second dose of vaccination
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Within 6 months after 2 doses of vaccination
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The proportion of symptomatic and PCR-confirmed SARS-CoV-2 infection
Prazo: Within 6 months after 2 doses of vaccination
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To evaluate the proportion of symptomatic and PCR-confirmed SARS-CoV-2 infection following the SARS-CoV-2 vaccine (Vero cell) inactivated administration within 6 months after second dose of vaccination
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Within 6 months after 2 doses of vaccination
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Sinopharm21
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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