- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01364883
Safety and Immunogenicity of Novel Vaccination Schedules With Malaria Vaccines AdCh63 ME-TRAP and MVA ME-TRAP
26. juli 2013 oppdatert av: University of Oxford
A Phase I Study to Assess the Safety and Immunogenicity of Novel Schedules for Vaccination With the Candidate Malaria Vaccines AdCh63 ME-TRAP and MVA ME-TRAP
This is an open label phase I study, to assess the safety and immunogenicity of novel schedules for vaccination with the candidate malaria vaccines AdCh63 ME-TRAP and MVA ME-TRAP.
These vaccines have been evaluated previously in a number of clinical trials proved to be safe and capable of inducing protective cellular immune response following challenge with the parasite.
All volunteers recruited will be healthy adults.
They will be primed with AdCh63 ME-TRAP administered intramuscularly and boosted several times with AdCh63 ME-TRAP and MVA ME-TRAP according to various schedules.. Safety data will be collected for each of the seven regimens.
Secondary aims of this study will be to assess the immune responses generated by each of these regimes.
Studieoversikt
Status
Fullført
Forhold
Studietype
Intervensjonell
Registrering (Faktiske)
39
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Oxford, Storbritannia
- Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 50 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Healthy adults aged 18 to 50 years
- Able and willing (in the Investigator's opinion) to comply with all study requirements
- Willing to allow the investigators to discuss their medical history with their General Practitioner
- For female volunteers, willingness to practice continuous effective contraception during the study
- Agreement to refrain from blood donation during the course of the study
- Written informed consent
Exclusion Criteria:
- Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period
- Prior receipt of an investigational malaria vaccine or any other investigational vaccine likely to impact on interpretation of the trial data
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
- Pregnancy, lactation, or intention to become pregnant during the study
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products, Kathon History of clinically significant contact dermatitis
- Any history of anaphylaxis in relation to vaccination
- Any history of malaria Travel to a malaria endemic region during the study period or within the six months preceding enrolment in the study
- History of serious psychiatric condition that may affect participation in the study
- Any other serious chronic illness requiring hospital specialist supervision -Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
- Suspected or known injecting drug abuse in the five years preceding enrolment -Seropositive for hepatitis B surface antigen (HBsAg)
- Seropositive for hepatitis C virus (antibodies to HCV)
- Any relevant history of cancer (excludes basal cell carcinoma of the skin and cervical carcinoma in situ)
- Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
- Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of study data
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Group 1
AdCh63 ME-TRAP prime D0, AdCh63 ME-TRAP boost W4, AdCh63 ME-TRAP boost W8, MVA ME-TRAP boost W16
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Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP
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Eksperimentell: Group 2
AdCh63 ME-TRAP prime D0, AdCh63 ME-TRAP boost W8, MVA ME-TRAP boost W16, MVA ME-TRAP boost W24
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Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP
|
Eksperimentell: Group 3
AdCh63 ME-TRAP prime D0, AdCh63 ME-TRAP boost W4, MVA ME-TRAP boost W8, MVA ME-TRAP boost W12
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Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP
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Eksperimentell: Group 4
AdCh63 ME-TRAP prime D0, MVA ME-TRAP boost W8, MVA ME-TRAP boost W16, MVA ME-TRAP boost W24
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Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP
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Eksperimentell: Group 5
AdCh63 ME-TRAP prime D0, MVA ME-TRAP boost W4, AdCh63 ME-TRAP boost W8, MVA ME-TRAP boost W16
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Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP
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Eksperimentell: Group 6
AdCh63 ME-TRAP prime D0, MVA ME-TRAP boost W4, AdCh63 ME-TRAP boost W8, MVA ME-TRAP boost W12
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Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP
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Eksperimentell: Group 7
AdCh63 ME-TRAP prime D0, MVA ME-TRAP boost W8, AdCh63 ME-TRAP boost W16, MVA ME-TRAP boost W24
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AdCh63 ME-TRAP prime D0, AdCh63 ME-TRAP boost W8, AdCh63 ME-TRAP boost W16, MVA ME-TRAP boost W24
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Vaccine Safety
Tidsramme: Participants will be followed for the duration of the study, an expected average of 21 months
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To assess the safety of vaccination of healthy adults with AdCh63 ME-TRAP and MVA ME-TRAP according to vaccination schedules 1 to 7
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Participants will be followed for the duration of the study, an expected average of 21 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Vaccine immunogenicity
Tidsramme: Participants will be followed for the duration of the study, an expected average of 21months
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To assess the immunogenicity of vaccination of healthy adults with AdCh63 ME-TRAP and MVA ME-TRAP according to vaccination schedules 1 to 7
|
Participants will be followed for the duration of the study, an expected average of 21months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Adrian VS Hill, University of Oxford
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juli 2011
Primær fullføring (Faktiske)
1. juli 2013
Studiet fullført (Faktiske)
1. juli 2013
Datoer for studieregistrering
Først innsendt
31. mai 2011
Først innsendt som oppfylte QC-kriteriene
2. juni 2011
Først lagt ut (Anslag)
3. juni 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
29. juli 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. juli 2013
Sist bekreftet
1. juli 2013
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- VAC043
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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