- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Kontakter och platser
Studieorter
-
-
-
Kinshasa, Kongo, Demokratiska republiken
- Médecins Sans Frontières
-
-
-
-
-
Mbarara, Uganda, 1956
- Epicentre
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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)
|
Ring vaccination with vaccination of contacts and contacts of contacts after laboratory confirmation of one Ebola Zaire case
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Cumulative incidence
Tidsram: 84 days after vaccination
|
Occurrence of Ebola Zaire cases amongst contacts and contacts of contacts
|
84 days after vaccination
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Assessment of Adverse and Serious Adverse Events
Tidsram: 84 days after vaccination
|
Safety of a single dose of rVSVΔG-ZEBOV-GP
|
84 days after vaccination
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- V920-01
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Ebolavirussjukdom
-
Menzies School of Health ResearchUniversity of Sydney; Murdoch Childrens Research InstituteHar inte rekryterat ännuRespiratory Syncytial Virus (RSV) | Luftvägsinfektion VirusAustralien
-
U.S. Army Medical Research and Development CommandAvslutad
-
ModernaTX, Inc.AvslutadRespiratoriskt synkytialt virusFörenta staterna
-
Sinocelltech Ltd.RekryteringRespiratoriskt synkytialt virusKina
-
ModernaTX, Inc.Aktiv, inte rekryterandeRespiratoriskt synkytialt virusKanada, Japan, Storbritannien, Förenta staterna, Sydafrika, Chile, Danmark, Panama
-
Merck Sharp & Dohme LLCAvslutadRespiratoriskt synkytialt virusStorbritannien
-
Dalhousie UniversityImmunoVaccine Technologies, Inc. (IMV Inc.)AvslutadRespiratoriskt synkytialt virusKanada
-
ModernaTX, Inc.AvslutadRespiratoriskt synkytialt virusFörenta staterna, Spanien, Taiwan, Korea, Republiken av, Singapore, Kanada, Belgien, Finland, Japan, Storbritannien, Chile, Nya Zeeland, Sydafrika, Australien, Puerto Rico, Argentina, Costa Rica, Polen, Bangladesh, Colombia, Tysk... och mer
-
ModernaTX, Inc.Aktiv, inte rekryterandeRespiratoriskt synkytialt virusFörenta staterna, Kanada, Storbritannien, Puerto Rico
-
ModernaTX, Inc.AvslutadRespiratoriskt synkytialt virusFörenta staterna, Panama
Kliniska prövningar på rVSVΔG-ZEBOV-GP
-
Centers for Disease Control and PreventionDepartment of Health and Human Services; University of Sierra Leone; Ministry... och andra samarbetspartnersAvslutadHemorragisk feber, ebolaSierra Leone
-
Canadian Immunization Research NetworkMerck Sharp & Dohme LLC; University of Ottawa; Dalhousie University; Université... och andra samarbetspartnersAvslutad
-
Universitätsklinikum Hamburg-EppendorfUniversity Hospital, Geneva; Wellcome Trust; KEMRI-Wellcome Trust Collaborative... och andra samarbetspartnersAvslutadHemorragisk feber, ebolaTyskland
-
National Institute of Allergy and Infectious Diseases...Avslutad
-
Universitätsklinikum Hamburg-EppendorfGoethe University; German Federal Ministry of Education and Research; Bernhard... och andra samarbetspartnersHar inte rekryterat ännu
-
Centre de Recherche Médicale de LambarénéMerck Sharp & Dohme LLCAvslutad
-
Tulane UniversityMerck Sharp & Dohme LLC; Kenema Government HospitalRekrytering
-
National Institute of Allergy and Infectious Diseases...London School of Hygiene and Tropical Medicine; Institut National de la... och andra samarbetspartnersAvslutadEbolavirussjukdomGuinea, Liberia, Mali, Sierra Leone
-
Tongji HospitalThe Affiliated Hospital of Yangzhou University; Xunxian People's Hospital; Weifang Hospital of Traditional Chinese Medicine och andra samarbetspartnersHar inte rekryterat ännuHjärtsvikt | Hypertoni | Parkinsons sjukdom | Perifer arteriell ocklusiv sjukdom | Cerebrala arteriella sjukdomar | Kranskärlsstenos | Sköldkörteldysfunktion
-
Krasnoyarsk Regional HospitalOkändPatologiska processer | Hjärtsjukdom | Hjärt-kärlsjukdomar | Lungsjukdomar | Förmaksflimmer | Arytmier, hjärt | Hypertoni, lung