- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01364883
Safety and Immunogenicity of Novel Vaccination Schedules With Malaria Vaccines AdCh63 ME-TRAP and MVA ME-TRAP
26 juli 2013 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Interventionell
Inskrivning (Faktisk)
39
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Oxford, Storbritannien
- Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 50 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Group 1
AdCh63 ME-TRAP prime D0, AdCh63 ME-TRAP boost W4, AdCh63 ME-TRAP boost W8, MVA ME-TRAP boost W16
|
Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP
|
|
Experimentell: Group 2
AdCh63 ME-TRAP prime D0, AdCh63 ME-TRAP boost W8, MVA ME-TRAP boost W16, MVA ME-TRAP boost W24
|
Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP
|
|
Experimentell: Group 3
AdCh63 ME-TRAP prime D0, AdCh63 ME-TRAP boost W4, MVA ME-TRAP boost W8, MVA ME-TRAP boost W12
|
Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP
|
|
Experimentell: Group 4
AdCh63 ME-TRAP prime D0, MVA ME-TRAP boost W8, MVA ME-TRAP boost W16, MVA ME-TRAP boost W24
|
Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP
|
|
Experimentell: Group 5
AdCh63 ME-TRAP prime D0, MVA ME-TRAP boost W4, AdCh63 ME-TRAP boost W8, MVA ME-TRAP boost W16
|
Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP
|
|
Experimentell: Group 6
AdCh63 ME-TRAP prime D0, MVA ME-TRAP boost W4, AdCh63 ME-TRAP boost W8, MVA ME-TRAP boost W12
|
Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP
|
|
Experimentell: Group 7
AdCh63 ME-TRAP prime D0, MVA ME-TRAP boost W8, AdCh63 ME-TRAP boost W16, MVA ME-TRAP boost W24
|
AdCh63 ME-TRAP prime D0, AdCh63 ME-TRAP boost W8, AdCh63 ME-TRAP boost W16, MVA ME-TRAP boost W24
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Vaccine Safety
Tidsram: Participants will be followed for the duration of the study, an expected average of 21 months
|
To assess the safety 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 21 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Vaccine immunogenicity
Tidsram: Participants will be followed for the duration of the study, an expected average of 21months
|
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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Adrian VS Hill, University of Oxford
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2011
Primärt slutförande (Faktisk)
1 juli 2013
Avslutad studie (Faktisk)
1 juli 2013
Studieregistreringsdatum
Först inskickad
31 maj 2011
Först inskickad som uppfyllde QC-kriterierna
2 juni 2011
Första postat (Uppskatta)
3 juni 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
29 juli 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 juli 2013
Senast verifierad
1 juli 2013
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- VAC043
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 .