- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT05128721
Evaluation of Inactivated Vaccine in Healthy Adults Against Coronavirus Disease of 2019 (COVID-19)
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
Panoramica dello studio
Stato
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
Iscrizione (Anticipato)
Fase
- Fase 1
Contatti e Sedi
Contatto studio
- Nome: Osama Azmy, MD
- Numero di telefono: +201223103084
- Email: osamaazmy@yahoo.com
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:
- Osama Azmy, MD
- Numero di telefono: +201223103084
- Email: osamaazmy@yahoo.com
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Adults with age 18 to 50 years.
- Willingness.
- For married females of childbearing age: Willingness to practice continuous effective contraception for one year from the start of the study.
- Agreement to refrain from blood donation during the study.
- Body temperature is within the normal range (36.5 - 37.5°C).
- General good health as established by medical history, physical and laboratory examinations.
Exclusion Criteria:
- Pregnancy or lactation.
- Inability to provide informed consent.
- Recent receipt of any vaccination within 30 days prior to baseline.
- Planning to receive any vaccination during the course of the study.
- Prior receipt of Adenovirus vaccine, or any other Coronavirus vaccine.
- Recent receipt of any immunoglobulin within 90 days prior to baseline.
- Recent receipt of any blood product within 90 days prior to baseline.
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).
- Currently taking any product (investigational or off-label) for prevention of COVID-19 disease.
- Having any autoimmune disease.
- History of allergic reactions for any of the vaccine components.
- History of angioedema.
- History of anaphylaxis.
- History of cancer.
- History of serious psychiatric conditions that are likely to affect participation in the study.
- Having bleeding disorders.
- Having chronic respiratory diseases.
- Having chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorders, and neurological illness.
- Volunteers with BMI ≥ 40 Kg/m2 or ≤ 18 Kg/m2.
- Current alcohol abuse.
- Drug abuse within 5 years prior to baseline.
- 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.
- Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
- High-risk population (volunteers who work in front-line health facilities or were in close contact with confirmed COVID-19 cases).
- Living in the same household as anyone at high risk of severe COVID-19.
- 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
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:
|
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:
|
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:
|
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
Sponsor
Investigatori
- Investigatore principale: Osama Azmy, MD, Medical Research and Clinical Studies Institute National Research Centre, Dokki, Giza, Egypt.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Infezioni da coronavirus
- Infezioni da Coronaviridae
- Infezioni da Nidovirus
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni delle vie respiratorie
- Malattie delle vie respiratorie
- Polmonite, virale
- Polmonite
- Malattie polmonari
- COVID-19
- Effetti fisiologici delle droghe
- Fattori immunologici
- Vaccini
Altri numeri di identificazione dello studio
- NO-B041
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
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
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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 .
Prove cliniche su COVID-19
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNon ancora reclutamentoSindrome post-COVID-19 | Lungo COVID | Lungo Covid19 | Condizione post COVID-19 | Sindrome post-COVID | Condizione post COVID-19, non specificata | Condizione post-COVIDOlanda
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios...CompletatoSequele post acute di COVID-19 | Condizione post COVID-19 | Lungo-COVID | Sindrome cronica da COVID-19Italia
-
Indonesia UniversityReclutamentoSindrome post-COVID-19 | Lungo COVID | Condizione post COVID-19 | Sindrome post-COVID | Lungo COVID-19Indonesia
-
Yang I. PachankisAttivo, non reclutanteInfezione respiratoria da COVID-19 | Sindrome da stress COVID-19 | Reazione avversa al vaccino COVID-19 | Tromboembolia associata a COVID-19 | Sindrome da terapia post-intensiva COVID-19 | Ictus associato a COVID-19Cina
-
First Affiliated Hospital Xi'an Jiaotong UniversityShangluo Central Hospital; Ankang Central Hospital; Hanzhong Central Hospital; Yulin... e altri collaboratoriReclutamentoCOVID-19 | Sindrome post-COVID-19 | Post-acuto COVID-19 | COVID-19 acutoCina
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaReclutamentoPandemia di covid-19 | Vaccini contro il covid-19 | Malattia da virus COVID-19Indonesia
-
University Hospital, Ioannina1st Division of Internal Medicine, University Hospital of IoanninaReclutamentoPolmonite COVID-19 | Infezione respiratoria da COVID-19 | Pandemia di covid-19 | Sindrome da distress respiratorio acuto COVID-19 | Polmonite associata a COVID-19 | Coagulopatia associata a COVID 19 | COVID-19 (Coronavirus 2019) | Tromboembolia associata a COVID-19Grecia
-
University of Witten/HerdeckeInstitut für Rehabilitationsforschung NorderneyCompletatoSindrome post-COVID-19 | Sindrome da lungo tempo COVID-19Germania
-
Jonathann Kuo, MDAttivo, non reclutanteInfezione da SARS-CoV2 | Sindrome post-COVID-19 | Disautonomia | Sindrome post-acuta da COVID-19 | Lungo COVID | Lungo Covid19 | COVID-19 ricorrente | Post-acuto COVID-19 | Infezione post-acuta da COVID-19 | Sequele post acute di COVID-19 | Disautonomia come disturbo | Disautonomia Sindrome da ipotensione ortostatica e altre condizioniStati Uniti
Prove cliniche su Covi Vax
-
Sorrento Therapeutics, Inc.Ritirato
-
Sorrento Therapeutics, Inc.Ritirato
-
Sorrento Therapeutics, Inc.RitiratoCovid19 | Sindrome da distress respiratorio acutoStati Uniti
-
Chonnam National University HospitalSconosciutoMieloma multiploCorea, Repubblica di
-
Entos Pharmaceuticals Inc.Canadian Institutes of Health Research (CIHR); Aegis Life, Inc.; Clinical Pharma... e altri collaboratoriCompletatoSARS-CoV-2Burkina Faso, Canada, Senegal, Sud Africa
-
Codagenix, IncCompletatoCOVID-19Regno Unito
-
Codagenix, IncCompletatoCOVID-19 | SARS-CoV-2Regno Unito
-
University of PennsylvaniaPhiladelphia Department of Public HealthCompletato
-
Sorrento Therapeutics, Inc.Reclutamento
-
Sorrento Therapeutics, Inc.RitiratoSindrome da distress respiratorio acuto | Sindrome da distress respiratorio acuto