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History of Changes for Study: NCT02532049
A Clinical Trial to Assess the Safety and Immunogenicity of New Malaria Vaccine Candidates ChAd63 Pfs25-IMX313 and MVA Pfs25-IMX313
Latest version (submitted July 14, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 20, 2015 None (earliest Version on record)
2 September 3, 2015 Study Status
3 October 7, 2015 Recruitment Status, Study Status and Contacts/Locations
4 April 13, 2016 Study Status
5 July 19, 2016 Study Status
6 February 13, 2017 Study Status
7 May 5, 2017 Recruitment Status, Study Status, Contacts/Locations and Study Design
8 July 14, 2017 Recruitment Status and Study Status
Comparison Format:

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Study NCT02532049
Submitted Date:  August 20, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: VAC062
Brief Title: A Clinical Trial to Assess the Safety and Immunogenicity of New Malaria Vaccine Candidates ChAd63 Pfs25-IMX313 and MVA Pfs25-IMX313
Official Title: A Phase Ia Clinical Trial to Assess the Safety, Immunogenicity and Ex-vivo Efficacy of New Plasmodium Falciparum Malaria Vaccine Candidates ChAd63 Pfs-IMX313 Alone and With MVA Pfs25-IMX313
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2015
Overall Status: Not yet recruiting
Study Start: August 2015
Primary Completion: November 2016 [Anticipated]
Study Completion: November 2016 [Anticipated]
First Submitted: August 7, 2015
First Submitted that
Met QC Criteria:
August 20, 2015
First Posted: August 25, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 20, 2015
Last Update Posted: August 25, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University of Oxford
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary:

This is a clinical trial in which healthy volunteers will be administered one or two experimental malaria vaccines. ChAd Pfs-IMX313 will either be administered alone or with MVA Pfs25-IMX313 in a prime-boost regime.

All vaccines will be administered intramuscularly.

Group 1 will receive one dose of ChAd63 Pfs25-IMX313 at 5x10^9 vp.

Group 2A will receive one dose of ChAd63 Pfs-IMX313 at 5x10^10 vp.

Group 2B will receive one dose of ChAd63 Pfs-IMX313 at 5x10^10 vp and one dose of MVA Pfs25-IMX313 at 1x10^8 pfu eight weeks later.

Group 2C will receive one dose of ChAd63 Pfs25-IMX313 at 5x10^10 vp and one dose of MVA Pfs25-IMX313 at 2x10^8 pfu eight weeks later.

The study will assess the safety of the vaccinations, and the immune responses to the vaccination. Immune responses are measured by tests on blood samples.

Healthy volunteers will be recruited in Oxford and Southampton, England.

Detailed Description:
Open or close this module Conditions
Conditions: Malaria
Keywords: Malaria
Vaccine
Immune Response
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 4
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 24 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Group 1
ChAd63 Pfs25-IMX313 (5x10^9 vp)
Biological: ChAd63 Pfs25-IMX313
Active Comparator: Group 2A
ChAd63 Pfs25-IMX313 (5x10^10 vp)
Biological: ChAd63 Pfs25-IMX313
Active Comparator: Group 2B
ChAd63 Pfs25-IMX313 (5x10^10) and MVA Pfs25-IMX313 (1x10^8 pfu) 8 weeks later
Biological: ChAd63 Pfs25-IMX313Biological: MVA Pfs25-IMX313
Active Comparator: Group 2C
ChAd63 Pfs25-IMX313 (5x10^10) and MVA Pfs25-IMX313 (2x10^8 pfu) 8 weeks later
Biological: ChAd63 Pfs25-IMX313Biological: MVA Pfs25-IMX313
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Number of Adverse Events
[ Time Frame: 8 months ]

The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events.
Secondary Outcome Measures:
1. Immunogenicity of ChAd63 Pfs25-IMX313 when administered to healthy volunteers alone, and with MVA Pfs25-IMX313 in a prime-boost regime.
[ Time Frame: 8 months ]

2. Ex-vivo efficacy of ChAd63 Pfs25-IMX313 when administered to healthy volunteers alone, and with MVA Pfs25-IMX313 in a prime-boost regime. The functional activity of the vaccine induced antibodies will be tested using membrane-feeding assays.
[ Time Frame: 8 months ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 50 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

The volunteer must satisfy all the following criteria to be eligible for the study:

  • 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
  • For females only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening and vaccination
  • Agreement to refrain from blood donation during the course of the study
  • Provide written informed consent

Exclusion Criteria:

The volunteer may not enter the study if any of the following apply:

  • Participation in another research study involving receipt of 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)
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products.
  • Any history of anaphylaxis in relation to vaccination
  • Pregnancy, lactation or willingness/intention to become pregnant during the study
  • History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
  • History of serious psychiatric condition likely to 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)
Open or close this module Contacts/Locations
Central Contact Person: Volunteer Coordinator
Telephone: 01865 857406
Email: vaccinetrials@ndm.ox.ac.uk
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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