Back to resultsA Study to Assess the Safety and Immunogenicity of a Malaria Vaccine Candidate, R21, Administered With AS01B
Primary Purpose
Malaria
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
R21 with ASO1B
Sponsored by
About this trial
This is an interventional prevention trial for Malaria
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 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
- 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)
- History of clinical malaria (any species)
- Travel to a malaria endemic region during the study period or within the previous six months
- Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
- 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
- Inability of the study team to contact the volunteer's GP to confirm medical history and safety to participate
Sites / Locations
- CCVTM, University of Oxford
- NIHR Wellcome Trust Clinical Research Facility
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
10µg of R21 with AS01B on days 0, 28, and 56.
50µg of R21 with AS01B on days 0, 28, and 56.
Outcomes
Primary Outcome Measures
Safety and tolerability of administration of R21 with adjuvant AS01B. This will be done by recording the number of participants who experience adverse events, and the severity of any adverse events.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02600975
Brief Title
A Study to Assess the Safety and Immunogenicity of a Malaria Vaccine Candidate, R21, Administered With AS01B
Official Title
A Phase I Study to Assess the Safety and Immunogenicity of a Protein Particle Malaria Vaccine Candidate, R21, Administered With AS01B in Healthy UK Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
December 8, 2015 (Actual)
Primary Completion Date
January 19, 2017 (Actual)
Study Completion Date
January 19, 2017 (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 a clinical trial in which healthy volunteers will be administered an experimental malaria vaccine, R21. The R21 vaccine will be administered with the adjuvant AS01B.
All vaccinations will be administered intramuscularly. Each volunteer will receive three vaccinations in total.
There are two different vaccine schedules:
Group 1 will receive R21 10µg with AS01B on days 0, 28, and 56. Group 2 will receive R21 50µg with AS01B on days 0, 28, and 56.
The study will assess the safety of the vaccine, and the immune responses to the vaccination. Immune responses are measured by tests on blood samples.
Healthy adult 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
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
10µg of R21 with AS01B on days 0, 28, and 56.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
50µg of R21 with AS01B on days 0, 28, and 56.
Intervention Type
Biological
Intervention Name(s)
R21 with ASO1B
Intervention Description
R21 with ASO1B
Primary Outcome Measure Information:
Title
Safety and tolerability of administration of R21 with adjuvant AS01B. This will be done by recording the number of participants who experience adverse events, and the severity of any adverse events.
Time Frame
34 weeks
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 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
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)
History of clinical malaria (any species)
Travel to a malaria endemic region during the study period or within the previous six months
Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
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
Inability of the study team to contact the volunteer's GP to confirm medical history and safety to participate
Facility Information:
Facility Name
CCVTM, University of Oxford
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
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Yes when manuscript is published
Learn more about this trial
A Study to Assess the Safety and Immunogenicity of a Malaria Vaccine Candidate, R21, Administered With AS01B
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