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

18 novembre 2021 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Anticipato)

72

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

  • Nome: Clinical Trial Unit Clinical Trial Unit National Research Centre, MD
  • Numero di telefono: +20237623009
  • Email: ctu.mrce@nrc.sci.eg

Luoghi di studio

    • Giza
      • Cairo, Giza, Egitto, 12622
        • Reclutamento
        • Medical Research Centre of Excellence National Research Centre
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 50 anni (Adulto)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Altri nomi:
  • NRC-VACC-101 vaccine
  • Egyptian Inactivated SARS-CoV-2 Vaccine
  • NRC Inactivated SARS-CoV-2 Vaccine
Comparatore attivo: 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.
Altri nomi:
  • NRC-VACC-101 vaccine
  • Egyptian Inactivated SARS-CoV-2 Vaccine
  • NRC Inactivated SARS-CoV-2 Vaccine
Comparatore placebo: 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.
Altri nomi:
  • NRC-VACC-101 vaccine
  • Egyptian Inactivated SARS-CoV-2 Vaccine
  • NRC Inactivated SARS-CoV-2 Vaccine

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The safety of NRC-VACC-101 Vaccine
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The seroconversion rate of neutralizing antibodies
Lasso di tempo: 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.
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

14 novembre 2021

Completamento primario (Anticipato)

23 febbraio 2023

Completamento dello studio (Anticipato)

23 maggio 2023

Date di iscrizione allo studio

Primo inviato

12 novembre 2021

Primo inviato che soddisfa i criteri di controllo qualità

18 novembre 2021

Primo Inserito (Effettivo)

22 novembre 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 novembre 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 novembre 2021

Ultimo verificato

1 novembre 2021

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Descrizione del piano IPD

Data will be shared upon individual request.

Periodo di condivisione IPD

About one year after completion of the trial

Criteri di accesso alla condivisione IPD

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

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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