Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-30 @ 10:49 PM
Study NCT ID:
NCT01623557
Status:
COMPLETED
Last Update Posted:
2015-02-16
First Post:
2012-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Challenge Study to Assess the Protective Efficacy of Two Malaria Vaccine Candidates
Sponsor:
University of Oxford
Organization:
Study Overview
Official Title:
A Phase I/IIa Sporozoite Challenge Study to Assess the Protective Efficacy of Two Prime-Boost Malaria Vaccine Candidates: ChAd63 and MVA Encoding ME-TRAP and the Same Viral Vectors Encoding CS
Status:
COMPLETED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VAC045
Brief Summary:
This study aims to assess the safety and effectiveness of four new candidate malaria vaccines; ChAd63 CS, ChAd63 ME-TRAP, MVA CS \& MVA ME-TRAP. These vaccines consist of viruses (ChAd63 and MVA) which have been genetically modified so (i) they cannot replicate in humans and (ii) they include parts of the malaria parasite; Plasmodium falciparum (CS and ME-TRAP). The hope is that these vaccines will induce immune responses in vaccinees that are able to prevent malaria.
This proposed study will compare how effective ChAd63-MVA CS is at preventing malaria infection in UK volunteers following malaria challenge compared to ChAd63-MVA ME-TRAP.
The study will be conducted at the University of Oxford's Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Oxford, UK and the Wellcome Trust Clinical Research Facility in Southampton, UK. The malaria challenge will take place at the insectary at Imperial College (Infection and Immunity Section) in London, UK.
This proposed study will compare how effective ChAd63-MVA CS is at preventing malaria infection in UK volunteers following malaria challenge compared to ChAd63-MVA ME-TRAP.
The study will be conducted at the University of Oxford's Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Oxford, UK and the Wellcome Trust Clinical Research Facility in Southampton, UK. The malaria challenge will take place at the insectary at Imperial College (Infection and Immunity Section) in London, UK.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: