- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03161366
Providing Additional Information on the Safety and Effectiveness of an Ebola Vaccine
An Open-label, Single Arm Study to Provide Additional Information on Safety and Effectiveness of rVSVΔG-ZEBOV-GP
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Ebola Virus Disease remains ill-known by populations, creating fear and mistrust, is highly contagious, requiring strict isolation measures and with only supportive therapy available that has limited impact on case-fatality which remains high (30 -80%).1 Among vaccines in development, the rVSVΔG-ZEBOV-GP vaccine has given the most promising results in terms of efficacy and safety having been evaluated now in more than 10,000 individuals.
Ring vaccination is a known strategy to control epidemics with specific transmission chains and has been successfully implemented to eradicate smallpox. Ring vaccination enhances standard public health measures of contact tracing, isolation, and community engagement and could be effective when such measures are in place. Building on the interim results of the Ebola ça Suffit trial, there is a need for continued access to a vaccine of which available results suggest that it is safe and likely efficacious against EVD. Although only isolated cases have been reported in Guinea, Sierra Leone and Liberia in 2016, 10 the risk of resurgence or of continued isolated cases in West Africa remains. Moreover, a new outbreak with Ebola Zaïre could start any moment in any of the countries where previous outbreaks occurred as in for example Democratic Republic of Congo and Uganda.
However, the unusual design of the ring trial and the decision to abandon the control group because of strong evidence that the vaccine prevented disease means there may not be enough data to ensure approval from regulatory agencies. Therefore, additional information is still required to consolidate knowledge on the rVSVΔG-ZEBOV-GP vaccine to support regulatory approval and licensure for future access. Additional information is also needed on ring vaccination and contextual adaptations to this approach to ensure its feasibility and effectiveness in the control of Ebola outbreaks in potentially diverse contexts.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Kinshasa, Congo, Repubblica Democratica del
- Médecins Sans Frontières
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Mbarara, Uganda, 1956
- Epicentre
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Individuals aged 6 years or older will be enrolled in the study if they are a contact or contact of contact of a laboratory-confirmed Ebola virus disease case. Children aged between 1 and 6 years may also be enrolled in the study in case there is a confirmed contact with a laboratory-confirmed Ebola patient
- willing to accept weekly visits
- intending to remain in the study area for three months
- providing informed consent, and where applicable, assent
Exclusion Criteria:
- history of EVD (self-report or laboratory confirmed)
- history of having received other investigational research agents in the previous 28 days
- history of anaphylaxis to a vaccine or vaccine component (self-report)
- severe illness that makes the person bed-bound or requiring hospitalization at the time of the vaccination
- severe immunocompromised status
- history of having received immunosuppressant therapies that would substantially interfere with the mode of action of the Ebola vaccine in the previous 6 months
- unwilling to accept weekly visits
- not intending to remain in the study area for three months
- informed consent or assent not provided
- any other condition in which, in the judgment of the investigator, would interfere with or serve as a contraindication to protocol adherence, or impair the subject or caregiver's ability to give informed consent, and where applicable, assent.
- fever above 38°C
- previous receipt of rVSVΔG-ZEBOV-GP in the last 3 years or at being part of another Ebola vaccine clinical trial.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Single arm
Vaccination of contacts and contacts of contacts of a confirmed Ebola Zaire case with one dose of rVSVΔG-ZEBOV-GP (≥ 2x10^7 PFU)
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Ring vaccination with vaccination of contacts and contacts of contacts after laboratory confirmation of one Ebola Zaire case
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Cumulative incidence
Lasso di tempo: 84 days after vaccination
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Occurrence of Ebola Zaire cases amongst contacts and contacts of contacts
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84 days after vaccination
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Assessment of Adverse and Serious Adverse Events
Lasso di tempo: 84 days after vaccination
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Safety of a single dose of rVSVΔG-ZEBOV-GP
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84 days after vaccination
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Collaboratori e investigatori
Sponsor
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
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
Altri numeri di identificazione dello studio
- V920-01
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
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 Malattia da virus Ebola
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National Institute of Allergy and Infectious Diseases...CompletatoMalattia da virus Ebola | Ebola febbre emorragica | Vaccini contro il virus Ebola | Busta Glicoproteina, Virus Ebola | FilovirusStati Uniti
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National Institute of Allergy and Infectious Diseases...CompletatoMalattia da virus Ebola | Vaccini Ebola | Malattia da virus di Marburgo | Virus di Marburgo | Virus EbolaStati Uniti
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National Institute of Allergy and Infectious Diseases...Completato
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Institut National de la Santé Et de la Recherche...TerminatoSopravvissuto al virus EbolaGuinea
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National Institute of Allergy and Infectious Diseases...CompletatoVirus EbolaStati Uniti, Congo, Repubblica Democratica del
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National Institute of Allergy and Infectious Diseases...US Military HIV Research ProgramCompletato
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Merck Sharp & Dohme LLCUnited States Department of Defense; BioProtection Systems CorporationCompletato
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Dalhousie UniversityCanadian Institutes of Health Research (CIHR); NewLink Genetics CorporationCompletato
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Cerus CorporationTerminatoMalattia acuta da virus EbolaStati Uniti
Prove cliniche su rVSVΔG-ZEBOV-GP
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Centers for Disease Control and PreventionDepartment of Health and Human Services; University of Sierra Leone; Ministry of... e altri collaboratoriCompletatoFebbre emorragica, EbolaSierra Leone
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National Institute of Allergy and Infectious Diseases...London School of Hygiene and Tropical Medicine; Institut National de la Santé... e altri collaboratoriCompletatoMalattia da virus EbolaGuinea, Liberia, Mali, Sierra Leone
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Universitätsklinikum Hamburg-EppendorfUniversity Hospital, Geneva; Wellcome Trust; KEMRI-Wellcome Trust Collaborative... e altri collaboratoriCompletatoFebbre emorragica, EbolaGermania
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National Institute of Allergy and Infectious Diseases...Completato
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Canadian Immunization Research NetworkMerck Sharp & Dohme LLC; University of Ottawa; Dalhousie University; Université de... e altri collaboratoriCompletato
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Universitätsklinikum Hamburg-EppendorfGoethe University; German Federal Ministry of Education and Research; Bernhard... e altri collaboratoriRitirato
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Centre de Recherche Médicale de LambarénéMerck Sharp & Dohme LLCCompletato
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Tulane UniversityMerck Sharp & Dohme LLC; Kenema Government HospitalAttivo, non reclutante
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Tongji HospitalThe Affiliated Hospital of Yangzhou University; Xunxian People's Hospital; Weifang... e altri collaboratoriNon ancora reclutamentoArresto cardiaco | Ipertensione | Morbo di Parkinson | Malattia occlusiva arteriosa periferica | Malattie arteriose cerebrali | Stenosi coronarica | Disfunzione tiroidea
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Krasnoyarsk Regional HospitalSconosciutoProcessi patologici | Malattie cardiache | Malattia cardiovascolare | Malattie polmonari | Fibrillazione atriale | Aritmie, cardiache | Ipertensione, polmonare