A Clinical Trial to Assess the Safety and Immunogenicity of New Malaria Vaccine Candidates ChAd63 Pfs25-IMX313 and MVA Pfs25-IMX313
Primary Purpose
Malaria
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
ChAd63 Pfs25-IMX313
MVA Pfs25-IMX313
Sponsored by
About this trial
This is an interventional prevention trial for Malaria focused on measuring Malaria, Vaccine, Immune Response
Eligibility 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)
Sites / Locations
- CCVTM, University of Oxford, Churchill Hospital
- NIHR Wellcome Trust Clinical Research Facility
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2A
Group 2B
Group 2C
Arm Description
ChAd63 Pfs25-IMX313 (5x10^9 vp)
ChAd63 Pfs25-IMX313 (5x10^10 vp)
ChAd63 Pfs25-IMX313 (5x10^10) and MVA Pfs25-IMX313 (1x10^8 pfu) 8 weeks later
ChAd63 Pfs25-IMX313 (5x10^10) and MVA Pfs25-IMX313 (2x10^8 pfu) 8 weeks later
Outcomes
Primary Outcome Measures
Number of Adverse Events
The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events.
Secondary Outcome Measures
Immunogenicity of ChAd63 Pfs25-IMX313 when administered to healthy volunteers alone, and with MVA Pfs25-IMX313 in a prime-boost regime.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02532049
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 12, 2015 (Actual)
Primary Completion Date
May 25, 2017 (Actual)
Study Completion Date
May 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
Malaria, Vaccine, Immune Response
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
ChAd63 Pfs25-IMX313 (5x10^9 vp)
Arm Title
Group 2A
Arm Type
Active Comparator
Arm Description
ChAd63 Pfs25-IMX313 (5x10^10 vp)
Arm Title
Group 2B
Arm Type
Active Comparator
Arm Description
ChAd63 Pfs25-IMX313 (5x10^10) and MVA Pfs25-IMX313 (1x10^8 pfu) 8 weeks later
Arm Title
Group 2C
Arm Type
Active Comparator
Arm Description
ChAd63 Pfs25-IMX313 (5x10^10) and MVA Pfs25-IMX313 (2x10^8 pfu) 8 weeks later
Intervention Type
Biological
Intervention Name(s)
ChAd63 Pfs25-IMX313
Intervention Type
Biological
Intervention Name(s)
MVA Pfs25-IMX313
Primary Outcome Measure Information:
Title
Number of Adverse Events
Description
The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events.
Time Frame
8 months
Secondary Outcome Measure Information:
Title
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
Title
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
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:
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)
Facility Information:
Facility Name
CCVTM, University of Oxford, Churchill Hospital
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
NIHR Wellcome Trust Clinical Research Facility
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
34335606
Citation
de Graaf H, Payne RO, Taylor I, Miura K, Long CA, Elias SC, Zaric M, Minassian AM, Silk SE, Li L, Poulton ID, Baker M, Draper SJ, Gbesemete D, Brendish NJ, Martins F, Marini A, Mekhaiel D, Edwards NJ, Roberts R, Vekemans J, Moyle S, Faust SN, Berrie E, Lawrie AM, Hill F, Hill AVS, Biswas S. Safety and Immunogenicity of ChAd63/MVA Pfs25-IMX313 in a Phase I First-in-Human Trial. Front Immunol. 2021 Jul 14;12:694759. doi: 10.3389/fimmu.2021.694759. eCollection 2021.
Results Reference
derived
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A Clinical Trial to Assess the Safety and Immunogenicity of New Malaria Vaccine Candidates ChAd63 Pfs25-IMX313 and MVA Pfs25-IMX313
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