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

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ClinicalTrials.gov Identifier: NCT01450280
Recruitment Status : Completed
First Posted : October 12, 2011
Last Update Posted : November 29, 2012
Sponsor:
Information provided by (Responsible Party):
University of Oxford

Tracking Information
First Submitted Date  ICMJE October 3, 2011
First Posted Date  ICMJE October 12, 2011
Last Update Posted Date November 29, 2012
Study Start Date  ICMJE December 2011
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2011)		 Safety assessment of new candidate malaria vaccines ChAd63 CS [ Time Frame: Participants will be followed for the duration of the study, an expected average of 12 months ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 7, 2011)		 Safety assessment of new candidate malaria vaccines ChAd63 CS [ Time Frame: Participants will be followed for the duration of the study, an expected average of 18 months ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2011)		 Assessment of immune response induced by vaccination [ Time Frame: Participants will be followed for the duration of the study, an expected average of 12 months ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2011)		 Assessment of immune response induced by vaccination [ Time Frame: Participants will be followed for the duration of the study, an expected average of 18 months ]
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity of New Malaria Vaccine Candidate ChAd63 CS Administered Alone and With MVA CS
Official Title  ICMJE A Phase Ia Study to Assess the Safety and Immunogenicity of New Malaria Vaccine Candidates ChAd63 CS Administered Alone and With MVA CS
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Malaria
Intervention  ICMJE
  • Biological: ChAd63 CS
    ChAd63 CS 5x10^9 vp intra-muscularly Day 0
  • Biological: ChAd63 CS, MVA CS
    ChAd63 CS 5x10^9 vp intra-muscularly Day 0; MVA CS 2x10^8 pfu intra-muscularly Day 56
  • Biological: ChAd63 CS
    ChAd63 CS 5x10^10 vp intra-muscularly Day 0
  • Biological: ChAd63, MVA CS
    ChAd63 CS 5x10^10 vp intra-muscularly Day 0; MVA CS 2x10^8 pfu intra-muscularly Day 56
Study Arms  ICMJE
  • Experimental: Group 1A
    AdCh63 CS 5x10^9 vp
    Intervention: Biological: ChAd63 CS
  • Experimental: Group 1B
    ChAd63 CS 5x10^9 vp Day 0; MVA CS 2x10^8 pfu Day 56
    Intervention: Biological: ChAd63 CS, MVA CS
  • Experimental: Group 2A
    AdCh63 CS 5 x 10^10 vp
    Intervention: Biological: ChAd63 CS
  • Experimental: Group 2B
    ChAd63 CS 5x10^10 vp Day 0; MVA CS 2x10^8 pfu Day 56
    Intervention: Biological: ChAd63, MVA CS
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 7, 2011)		 24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ireland
Removed Location Countries United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT01450280
Other Study ID Numbers  ICMJE VAC038
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of Oxford
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Oxford
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sam McConkey Clinical Research Centre Royal College of Surgeons in Ireland (RCSI)
PRS Account University of Oxford
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP