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Evaluation of Inactivated Vaccine in Healthy Adults Against Coronavirus Disease of 2019 (COVID-19)

18 de noviembre de 2021 actualizado por: National Research Centre, Egypt

A Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of Inactivated Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Vaccine Against COVID-19 in Healthy Adults

In this phase 1 study, the inactivated virus vaccine National Research Centre (NRC) Vaccine-101 (VACC-101) will be investigated for its safety and immunogenicity in healthy volunteers with the aim of providing effective and safe protection against COVID-19.

Descripción general del estudio

Estado

Reclutamiento

Intervención / Tratamiento

Descripción detallada

This is a Phase I, Randomized, Open-Labeled Clinical trial. Eligible volunteers will be randomized in a 1:1:1 allocation ratio, into one of the three study arms using the Interactive Web Response Technology (IWRS).

Unscheduled visits can occur at any time during the study period outside the initially planned study visits, all the extra visits will be documented in the subjects' files. Volunteers will be randomized into one of the following arms to receive different doses of the Inactivated

SARS-COV-2 Vaccine "NRC-VACC-101" as an intramuscular (IM) Injection or Placebo:

Arm One:

Volunteers will receive two IM doses of the vaccine, concentrations of 3 mcg, 28 days apart.

Arm Two:

Volunteers will receive two IM doses of the vaccine, concentrations of 6 mcg, 28 days apart.

Arm Three (Control arm):

Volunteers will receive two IM doses of the placebo, 28 days apart. The first 9 subjects will be initially vaccinated with their first dose, as per their assigned study arm determined by the randomization procedures and will be followed up until day 14 (visit 03). At this point in the study, the Data Safety and Monitoring Board (DSMB) will review safety data before proceeding with vaccinating the rest of the recruited subjects

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

72

Fase

  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Osama Azmy, MD
  • Número de teléfono: +201223103084
  • Correo electrónico: osamaazmy@yahoo.com

Copia de seguridad de contactos de estudio

  • Nombre: Clinical Trial Unit Clinical Trial Unit National Research Centre, MD
  • Número de teléfono: +20237623009
  • Correo electrónico: ctu.mrce@nrc.sci.eg

Ubicaciones de estudio

    • Giza
      • Cairo, Giza, Egipto, 12622
        • Reclutamiento
        • Medical Research Centre of Excellence National Research Centre
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 50 años (Adulto)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Adults with age 18 to 50 years.
  2. Willingness.
  3. For married females of childbearing age: Willingness to practice continuous effective contraception for one year from the start of the study.
  4. Agreement to refrain from blood donation during the study.
  5. Body temperature is within the normal range (36.5 - 37.5°C).
  6. General good health as established by medical history, physical and laboratory examinations.

Exclusion Criteria:

  1. Pregnancy or lactation.
  2. Inability to provide informed consent.
  3. Recent receipt of any vaccination within 30 days prior to baseline.
  4. Planning to receive any vaccination during the course of the study.
  5. Prior receipt of Adenovirus vaccine, or any other Coronavirus vaccine.
  6. Recent receipt of any immunoglobulin within 90 days prior to baseline.
  7. Recent receipt of any blood product within 90 days prior to baseline.
  8. Volunteers who are immunosuppressed or receiving immunosuppressive medications, including:

    HIV infection, asplenia, recurrent severe infections, and the use of immunosuppressive medications within the past 6 months, except for topical steroids or short-term oral steroids (course lasting < 14 days).

  9. Currently taking any product (investigational or off-label) for prevention of COVID-19 disease.
  10. Having any autoimmune disease.
  11. History of allergic reactions for any of the vaccine components.
  12. History of angioedema.
  13. History of anaphylaxis.
  14. History of cancer.
  15. History of serious psychiatric conditions that are likely to affect participation in the study.
  16. Having bleeding disorders.
  17. Having chronic respiratory diseases.
  18. Having chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorders, and neurological illness.
  19. Volunteers with BMI ≥ 40 Kg/m2 or ≤ 18 Kg/m2.
  20. Current alcohol abuse.
  21. Drug abuse within 5 years prior to baseline.
  22. History of laboratory-confirmed COVID-19 or seropositivity for SARS-CoV-2 or positive serum immunoglobulin M (IgM) and immunoglobulin G (IgG) to the SARS CoV-2 or abnormal chest CT-Scan (COVID-19 image) or positive pharyngeal/sputum swabs for SARS-CoV-2.
  23. Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
  24. High-risk population (volunteers who work in front-line health facilities or were in close contact with confirmed COVID-19 cases).
  25. Living in the same household as anyone at high risk of severe COVID-19.
  26. Any condition, according to the judgment of the investigator, that would interfere with the subject's ability to comply with all study requirements or that would place the subject at unacceptable risk by his/her participation in the study or impair the interpretation of the study data.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: NRC-VACC-101 vaccine 3 microgram
Volunteers will receive two IM doses of the vaccine, concentrations of 3 mcg, 28 days apart.
Inactivated SARS-COV-2 Vaccine/alum adjuvant preparation in addition to excipients (NRC-VACC- 101) administered as an IM Injection. NRC-VACC-101 is provided as a single dose of inactivated vaccine of opaque white liquid free from visible particles filled in injection vial (2R) glass vials. Each Dose of Covi Vax Vaccine contains 6 mcg antigen of A human coronavirus (hCoV)-19/Egypt/NRC-03/2020 SARS-CoV-2 strain.
Otros nombres:
  • NRC-VACC-101 vaccine
  • Egyptian Inactivated SARS-CoV-2 Vaccine
  • NRC Inactivated SARS-CoV-2 Vaccine
Comparador activo: NRC-VACC-101 vaccine 6 microgram
Volunteers will receive two IM doses of the vaccine, concentrations of 6 mcg, 28 days apart.
Inactivated SARS-COV-2 Vaccine/alum adjuvant preparation in addition to excipients (NRC-VACC- 101) administered as an IM Injection. NRC-VACC-101 is provided as a single dose of inactivated vaccine of opaque white liquid free from visible particles filled in injection vial (2R) glass vials. Each Dose of Covi Vax Vaccine contains 6 mcg antigen of A human coronavirus (hCoV)-19/Egypt/NRC-03/2020 SARS-CoV-2 strain.
Otros nombres:
  • NRC-VACC-101 vaccine
  • Egyptian Inactivated SARS-CoV-2 Vaccine
  • NRC Inactivated SARS-CoV-2 Vaccine
Comparador de placebos: Control arm
Volunteers will receive two IM doses of the placebo (excipients only), 28 days apart.
Inactivated SARS-COV-2 Vaccine/alum adjuvant preparation in addition to excipients (NRC-VACC- 101) administered as an IM Injection. NRC-VACC-101 is provided as a single dose of inactivated vaccine of opaque white liquid free from visible particles filled in injection vial (2R) glass vials. Each Dose of Covi Vax Vaccine contains 6 mcg antigen of A human coronavirus (hCoV)-19/Egypt/NRC-03/2020 SARS-CoV-2 strain.
Otros nombres:
  • NRC-VACC-101 vaccine
  • Egyptian Inactivated SARS-CoV-2 Vaccine
  • NRC Inactivated SARS-CoV-2 Vaccine

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The safety of NRC-VACC-101 Vaccine
Periodo de tiempo: Follow up for any solicited adverse event(AE) reported within 7 days
To evaluate the safety of the proposed regimens of NRC-VACC-101
Follow up for any solicited adverse event(AE) reported within 7 days
The tolerability of NRC-VACC-101 Vaccine
Periodo de tiempo: Follow up for any AE within 28 days of each dose
To evaluate the tolerability of the proposed regimens of NRC-VACC-101 Vaccine in the healthy population
Follow up for any AE within 28 days of each dose

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The seroconversion rate of neutralizing antibodies
Periodo de tiempo: The evaluation of the antibody will be measured up to one month of each dose
To evaluate the seroconversion rate of neutralizing antibodies resulting from the NRC-VACC-101 Vaccine
The evaluation of the antibody will be measured up to one month of each dose
To recommend the dose level of NRC-VACC-101 Vaccine for the phase II trial.
Periodo de tiempo: The evaluation of the Microneutralization Assay will be assessed up to one month of each dose
The evaluation of the Microneutralization Assay curve will give an overview of the dose possible suggested dose of NRC-VACC-101 Vaccine for the phase II trial
The evaluation of the Microneutralization Assay will be assessed up to one month of each dose

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Osama Azmy, MD, Medical Research and Clinical Studies Institute National Research Centre, Dokki, Giza, Egypt.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

14 de noviembre de 2021

Finalización primaria (Anticipado)

23 de febrero de 2023

Finalización del estudio (Anticipado)

23 de mayo de 2023

Fechas de registro del estudio

Enviado por primera vez

12 de noviembre de 2021

Primero enviado que cumplió con los criterios de control de calidad

18 de noviembre de 2021

Publicado por primera vez (Actual)

22 de noviembre de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de noviembre de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

18 de noviembre de 2021

Última verificación

1 de noviembre de 2021

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Descripción del plan IPD

Data will be shared upon individual request.

Marco de tiempo para compartir IPD

About one year after completion of the trial

Criterios de acceso compartido de IPD

Data will be shared upon individual request by contacting the sponsor of the trial.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • CIF

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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