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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01450280
First received: October 3, 2011
Last updated: November 28, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Malaria
Biological: ChAd63 CS
Biological: ChAd63 CS, MVA CS
Biological: ChAd63, MVA CS
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Participants will be followed for the duration of the study, an expected average of 12 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 24
Study Start Date: December 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1A
AdCh63 CS 5x10^9 vp
Biological: ChAd63 CS
ChAd63 CS 5x10^9 vp intra-muscularly Day 0
Experimental: Group 1B
ChAd63 CS 5x10^9 vp Day 0; MVA CS 2x10^8 pfu Day 56
Biological: ChAd63 CS, MVA CS
ChAd63 CS 5x10^9 vp intra-muscularly Day 0; MVA CS 2x10^8 pfu intra-muscularly Day 56
Experimental: Group 2A
AdCh63 CS 5 x 10^10 vp
Biological: ChAd63 CS
ChAd63 CS 5x10^10 vp intra-muscularly Day 0
Experimental: Group 2B
ChAd63 CS 5x10^10 vp Day 0; MVA CS 2x10^8 pfu Day 56
Biological: ChAd63, MVA CS
ChAd63 CS 5x10^10 vp intra-muscularly Day 0; MVA CS 2x10^8 pfu intra-muscularly Day 56

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450280

Locations
Ireland
Clinical Research Centre Royal College of Surgeons in Ireland (RCSI), Beaumont Hospital
Dublin, Ireland
Sponsors and Collaborators
University of Oxford
Investigators
Principal Investigator: Sam McConkey Clinical Research Centre Royal College of Surgeons in Ireland (RCSI)
  More Information

No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01450280     History of Changes
Other Study ID Numbers: VAC038
Study First Received: October 3, 2011
Last Updated: November 28, 2012
Health Authority: Ireland: Irish Medicines Board

Additional relevant MeSH terms:
Malaria
Parasitic Diseases
Protozoan Infections

ClinicalTrials.gov processed this record on October 29, 2014