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- Klinische proef 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
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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Kinshasa, Congo, de Democratische Republiek van de
- Médecins Sans Frontières
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Mbarara, Oeganda, 1956
- Epicentre
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Cumulative incidence
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Assessment of Adverse and Serious Adverse Events
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- V920-01
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Ebola-virusziekte
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National Institute of Allergy and Infectious Diseases...Voltooid
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Merck Sharp & Dohme LLCUnited States Department of Defense; BioProtection Systems CorporationVoltooid
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National Institute of Allergy and Infectious Diseases...US Military HIV Research ProgramVoltooid
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National Institute of Allergy and Infectious Diseases...VoltooidEbola-virusVerenigde Staten, Congo, de Democratische Republiek van de
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Merck Sharp & Dohme LLCDepartment of Health and Human Services; BioProtection Systems CorporationVoltooid
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National Institute of Allergy and Infectious Diseases...VoltooidEbola-virusziekte | Ebola hemorragische koorts | Ebola-virus vaccins | Envelop glycoproteïne, ebolavirus | FilovirusVerenigde Staten
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Institut National de la Santé Et de la Recherche...BeëindigdEbola-virusoverlevendeGuinea
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Merck Sharp & Dohme LLCNational Institute of Allergy and Infectious Diseases (NIAID); BioProtection...Voltooid
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University of OxfordNational Institute of Allergy and Infectious Diseases (NIAID); Wellcome TrustVoltooidEbola | Ebola ZaïreVerenigd Koninkrijk
Klinische onderzoeken op rVSVΔG-ZEBOV-GP
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Universitätsklinikum Hamburg-EppendorfUniversity Hospital, Geneva; Wellcome Trust; KEMRI-Wellcome Trust Collaborative... en andere medewerkersVoltooidHemorragische koorts, EbolaDuitsland
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Universitätsklinikum Hamburg-EppendorfGoethe University; German Federal Ministry of Education and Research; Bernhard... en andere medewerkersNog niet aan het werven
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Cecile TremblayMerck Sharp & Dohme LLC; Dalhousie University; Université de Montréal; Coalition... en andere medewerkersActief, niet wervend
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Emory UniversityWashington University School of Medicine; Merck Sharp & Dohme LLCNog niet aan het werven
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National Institute of Allergy and Infectious Diseases...London School of Hygiene and Tropical Medicine; Institut National de la Santé... en andere medewerkersActief, niet wervendEbola-virusziekteGuinea, Liberia, Mali, Sierra Leone
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Tulane UniversityMerck Sharp & Dohme LLC; Kenema Government HospitalNog niet aan het werven
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Krasnoyarsk Regional HospitalOnbekendPathologische processen | Hartziekten | Hart-en vaatziekten | Longziekten | Boezemfibrilleren | Aritmieën, hart | Hypertensie, pulmonaal
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Fudan UniversityActief, niet wervendDrievoudige negatieve borstkankerChina
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Sun Yat-sen UniversityNog niet aan het werven
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Universitätsklinikum Hamburg-EppendorfWervingHart-en vaatziekte | Diabetes mellitus, type 2 | Borstneoplasmata | Diabetes mellitus, type 1 | Longziekte, chronisch obstructief | Astma | Comorbiditeiten en naast elkaar bestaande aandoeningenDuitsland