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A Study to Assess the Safety and Immunogenicity of the Malaria Vaccine, R21, Administered With and Without Matrix-M1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02572388
Recruitment Status : Completed
First Posted : October 8, 2015
Results First Posted : November 12, 2019
Last Update Posted : November 12, 2019
Sponsor:
Information provided by (Responsible Party):
University of Oxford

Brief Summary:

This is a clinical trial in which healthy volunteers will be administered one or two experimental malaria vaccines. The vaccine R21 will either be administered alone or in combination with the adjuvant vaccine Matrix-M1.

All vaccinations will be administered intramuscularly. Each volunteer will receive three vaccinations in total.

There are three different vaccine schedules:

Group 1 will receive 10µg of R21 mixed with 50µg of Matrix-M1 on days 0, 28, and 56.

Group 2 will receive 50µg of R21 on days 0, 28, and 56. .

Group 3 will receive 50µg of R21 mixed with 50µg of Matrix-M1 on days 0, 28, and 56.

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

Healthy adult volunteers will be recruited in Oxford and London, England.


Condition or disease Intervention/treatment Phase
Malaria Biological: R21 Biological: Matrix-M1 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of a Protein Particle Malaria Vaccine Candidate, R21, Administered With and Without Matrix-M1 in Healthy UK Volunteers
Actual Study Start Date : October 15, 2015
Actual Primary Completion Date : August 29, 2017
Actual Study Completion Date : August 29, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Active Comparator: Group 1
10µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56.
Biological: R21
Biological: Matrix-M1
Active Comparator: Group 2
50µg of R21 on days 0, 28, and 56.
Biological: R21
Active Comparator: Group 3
50µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56.
Biological: R21
Biological: Matrix-M1
Active Comparator: Group 4
2µg of R21 mixed with 50µg of Matrix-M
Biological: R21
Biological: Matrix-M1



Primary Outcome Measures :
  1. Safety and Tolerability of Administration of R21 With and Without the Adjuvant Matrix-M1 Assessed by the Occurrence of Solicited Local and Systemic Adverse Events. [ Time Frame: Assessment of solicited AEs in the first 7 days post vaccination. ]
    Occurrence of solicited local and systemic adverse events (i.e: pain, redness, swelling and pruritus at injection site and temperature, feverishness, myalgia, arthralgia, malaise, headache and nausea).

  2. Safety and Tolerability of R21 With and Without the Adjuvant Matrix-M1 Assessed by the Occurrence of Unsolicited Adverse Events. [ Time Frame: Unsolicited AEs to be assessed up to 28 days post vaccination. ]
    Occurrence of unsolicited local and systemic adverse events.

  3. Safety and Tolerability of R21 With and Without the Adjuvant Matrix-M1 Assessed by the Occurrence of Serious Adverse Events. [ Time Frame: 6 months ]
    Occurrence of serious adverse events collected from enrolment until the end of the follow-up period.

  4. Safety and Tolerability of R21 With and Without the Adjuvant Matrix-M1 Assessed by the Occurrence of Laboratory Adverse Events. [ Time Frame: At Day 0 (baseline), day 7 and day 28 post vaccination ]
    Occurrence of laboratory adverse events defined as clinically significant changes from baseline. Haematology (Full Blood Count) and Biochemistry (Kidney and Liver Function Tests) will be assessed.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572388


Locations
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United Kingdom
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital
Oxford, Oxfordshire, United Kingdom, OX3 7LE
NIHR Wellcome Trust Clinical Research Facility, Hammersmith Hospital
London, United Kingdom, W12 0HS
Sponsors and Collaborators
University of Oxford
  Study Documents (Full-Text)

Documents provided by University of Oxford:
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02572388    
Other Study ID Numbers: VAC053
First Posted: October 8, 2015    Key Record Dates
Results First Posted: November 12, 2019
Last Update Posted: November 12, 2019
Last Verified: January 2018
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases