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NCT Number: NCT02572388

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

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.

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Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, Oxfordshire, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

R21

Biological

Matrix-M1

Biological

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study title

Safety and Immunogenicity of a Protein Particle Malaria Vaccine Candidate, R21, Administered With and Without Matrix-M1 in Healthy UK Volunteers

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 8, 2015
Registry last updated
Nov 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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