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Safety and Immunogenicity of New Malaria Vaccine Candidate ChAd63 CS Administered Alone and With MVA CS

Primary Purpose

Malaria

Status
Completed
Phase
Phase 1
Locations
Ireland
Study Type
Interventional
Intervention
ChAd63 CS
ChAd63 CS, MVA CS
ChAd63 CS
ChAd63, MVA CS
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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 the volunteer"s medical history with their General Practitioner
  • Women only: Must practice continuous effective contraception for the duration of the study
  • Agreement to refrain from blood donation during the course of the study and for 6 months after the end of their involvement in the study.
  • Written informed consent

Exclusion Criteria:

  • History of clinical P. falciparum malaria
  • Travel to a malaria endemic region during the study period or within the preceding six months with a significant risk of malaria exposure.
  • 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, breast feeding 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 post vaccination.
  • History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
  • 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 5 years preceding enrolment.
  • Seropositive for hepatitis B surface antigen (HBsAg).
  • Seropositive for hepatitis C virus (antibodies to HCV).
  • Any clinically significant abnormal finding on biochemistry or haematology blood tests, urinalysis or clinical examination.
  • 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 the study data.

Sites / Locations

  • Clinical Research Centre Royal College of Surgeons in Ireland (RCSI), Beaumont Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1A

Group 1B

Group 2A

Group 2B

Arm Description

AdCh63 CS 5x10^9 vp

ChAd63 CS 5x10^9 vp Day 0; MVA CS 2x10^8 pfu Day 56

AdCh63 CS 5 x 10^10 vp

ChAd63 CS 5x10^10 vp Day 0; MVA CS 2x10^8 pfu Day 56

Outcomes

Primary Outcome Measures

Safety assessment of new candidate malaria vaccines ChAd63 CS
To assess the safety of new candidate malaria vaccines ChAd63 CS administered alone and with MVA CS in a prime-boost regime to healthy volunteers by recording local and systemic solicited and unsolicited adverse events.

Secondary Outcome Measures

Assessment of immune response induced by vaccination
To assess the humoral and cellular immune responses generated by ChAd63 CS when administered to healthy volunteers alone and with MVA CS by assessing induced antibody and T cell response to the vaccine insert.

Full Information

First Posted
October 3, 2011
Last Updated
November 28, 2012
Sponsor
University of Oxford
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1. Study Identification

Unique Protocol Identification Number
NCT01450280
Brief Title
Safety and Immunogenicity of New Malaria Vaccine Candidate ChAd63 CS Administered Alone and With MVA CS
Official Title
A Phase Ia Study to Assess the Safety and Immunogenicity of New Malaria Vaccine Candidates ChAd63 CS Administered Alone and With MVA CS
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is an open label phase I study, to assess the safety of a novel malaria vaccine, AdCh63 CS, simian adenovirus encoding Plasmodium falciparum liver stage antigen, Circumsporozoite protein. All volunteers recruited will be healthy adults. They will be primed with various doses of AdCh63 CS administered intramuscularly. Some of the volunteers will receive a booster vaccination with MVA CS administered via intramuscular route. Safety data will be collected for each vaccination regimen. Secondary aim of this study will be to assess the immune responses generated by vaccination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1A
Arm Type
Experimental
Arm Description
AdCh63 CS 5x10^9 vp
Arm Title
Group 1B
Arm Type
Experimental
Arm Description
ChAd63 CS 5x10^9 vp Day 0; MVA CS 2x10^8 pfu Day 56
Arm Title
Group 2A
Arm Type
Experimental
Arm Description
AdCh63 CS 5 x 10^10 vp
Arm Title
Group 2B
Arm Type
Experimental
Arm Description
ChAd63 CS 5x10^10 vp Day 0; MVA CS 2x10^8 pfu Day 56
Intervention Type
Biological
Intervention Name(s)
ChAd63 CS
Intervention Description
ChAd63 CS 5x10^9 vp intra-muscularly Day 0
Intervention Type
Biological
Intervention Name(s)
ChAd63 CS, MVA CS
Intervention Description
ChAd63 CS 5x10^9 vp intra-muscularly Day 0; MVA CS 2x10^8 pfu intra-muscularly Day 56
Intervention Type
Biological
Intervention Name(s)
ChAd63 CS
Intervention Description
ChAd63 CS 5x10^10 vp intra-muscularly Day 0
Intervention Type
Biological
Intervention Name(s)
ChAd63, MVA CS
Intervention Description
ChAd63 CS 5x10^10 vp intra-muscularly Day 0; MVA CS 2x10^8 pfu intra-muscularly Day 56
Primary Outcome Measure Information:
Title
Safety assessment of new candidate malaria vaccines ChAd63 CS
Description
To assess the safety of new candidate malaria vaccines ChAd63 CS administered alone and with MVA CS in a prime-boost regime to healthy volunteers by recording local and systemic solicited and unsolicited adverse events.
Time Frame
Participants will be followed for the duration of the study, an expected average of 12 months
Secondary Outcome Measure Information:
Title
Assessment of immune response induced by vaccination
Description
To assess the humoral and cellular immune responses generated by ChAd63 CS when administered to healthy volunteers alone and with MVA CS by assessing induced antibody and T cell response to the vaccine insert.
Time Frame
Participants will be followed for the duration of the study, an expected average of 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 the volunteer"s medical history with their General Practitioner Women only: Must practice continuous effective contraception for the duration of the study Agreement to refrain from blood donation during the course of the study and for 6 months after the end of their involvement in the study. Written informed consent Exclusion Criteria: History of clinical P. falciparum malaria Travel to a malaria endemic region during the study period or within the preceding six months with a significant risk of malaria exposure. 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, breast feeding 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 post vaccination. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ). 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 5 years preceding enrolment. Seropositive for hepatitis B surface antigen (HBsAg). Seropositive for hepatitis C virus (antibodies to HCV). Any clinically significant abnormal finding on biochemistry or haematology blood tests, urinalysis or clinical examination. 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 the study data.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sam McConkey
Organizational Affiliation
Clinical Research Centre Royal College of Surgeons in Ireland (RCSI)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Centre Royal College of Surgeons in Ireland (RCSI), Beaumont Hospital
City
Dublin
Country
Ireland

12. IPD Sharing Statement

Citations:
PubMed Identifier
25522180
Citation
de Barra E, Hodgson SH, Ewer KJ, Bliss CM, Hennigan K, Collins A, Berrie E, Lawrie AM, Gilbert SC, Nicosia A, McConkey SJ, Hill AV. A phase Ia study to assess the safety and immunogenicity of new malaria vaccine candidates ChAd63 CS administered alone and with MVA CS. PLoS One. 2014 Dec 18;9(12):e115161. doi: 10.1371/journal.pone.0115161. eCollection 2014.
Results Reference
derived

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Safety and Immunogenicity of New Malaria Vaccine Candidate ChAd63 CS Administered Alone and With MVA CS

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