NCT01364883

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 3, 2011

Completed
28 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 29, 2013

Status Verified

July 1, 2013

Enrollment Period

2 years

First QC Date

May 31, 2011

Last Update Submit

July 26, 2013

Conditions

Malaria

Keywords

VaccineImmune response

Outcome Measures

Primary Outcomes (1)

  • Vaccine Safety

    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

Secondary Outcomes (1)

  • Vaccine immunogenicity

    Participants will be followed for the duration of the study, an expected average of 21months

Study Arms (7)

Group 1

EXPERIMENTAL

AdCh63 ME-TRAP prime D0, AdCh63 ME-TRAP boost W4, AdCh63 ME-TRAP boost W8, MVA ME-TRAP boost W16

Biological: Vaccination Schedule One

Group 2

EXPERIMENTAL

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

Biological: Vaccination Schedule Two

Group 3

EXPERIMENTAL

AdCh63 ME-TRAP prime D0, AdCh63 ME-TRAP boost W4, MVA ME-TRAP boost W8, MVA ME-TRAP boost W12

Biological: Vaccination Schedule Three

Group 4

EXPERIMENTAL

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

Biological: Vaccination Schedule Four

Group 5

EXPERIMENTAL

AdCh63 ME-TRAP prime D0, MVA ME-TRAP boost W4, AdCh63 ME-TRAP boost W8, MVA ME-TRAP boost W16

Biological: Vaccination Schedule Five

Group 6

EXPERIMENTAL

AdCh63 ME-TRAP prime D0, MVA ME-TRAP boost W4, AdCh63 ME-TRAP boost W8, MVA ME-TRAP boost W12

Biological: Vaccination Schedule Six

Group 7

EXPERIMENTAL

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

Biological: Vaccination Schedule Seven

Interventions

Vaccination Schedule OneBIOLOGICAL

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

Group 1
Vaccination Schedule TwoBIOLOGICAL

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

Group 2
Vaccination Schedule ThreeBIOLOGICAL

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

Group 3
Vaccination Schedule FourBIOLOGICAL

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

Group 4
Vaccination Schedule FiveBIOLOGICAL

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

Group 5
Vaccination Schedule SixBIOLOGICAL

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

Group 6
Vaccination Schedule SevenBIOLOGICAL

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

Group 7

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford

Oxford, United Kingdom

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Adrian VS Hill

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2011

First Posted

June 3, 2011

Study Start

July 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

July 29, 2013

Record last verified: 2013-07

Locations

GB(1)