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Safety and Immunogenicity of Novel Vaccination Schedules With Malaria Vaccines AdCh63 ME-TRAP and MVA ME-TRAP

NCT01364883 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2013-07-29

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

Vaccination Schedule One

Intramuscular injection of 5x10\^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10\^8 pfu of MVA ME-TRAP

BIOLOGICAL

Vaccination Schedule Two

Intramuscular injection of 5x10\^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10\^8 pfu of MVA ME-TRAP

BIOLOGICAL

Vaccination Schedule Three

Intramuscular injection of 5x10\^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10\^8 pfu of MVA ME-TRAP

BIOLOGICAL

Vaccination Schedule Four

Intramuscular injection of 5x10\^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10\^8 pfu of MVA ME-TRAP

BIOLOGICAL

Vaccination Schedule Five

Intramuscular injection of 5x10\^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10\^8 pfu of MVA ME-TRAP

BIOLOGICAL

Vaccination Schedule Six

Intramuscular injection of 5x10\^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10\^8 pfu of MVA ME-TRAP

BIOLOGICAL

Vaccination Schedule Seven

AdCh63 ME-TRAP prime D0, AdCh63 ME-TRAP boost W8, AdCh63 ME-TRAP boost W16, MVA ME-TRAP boost W24

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • Adrian VS Hill · University of Oxford

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01364883 on ClinicalTrials.gov