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

NCT02572388 | Completed Phase 1 Results

• 1 other identifier: VAC053
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

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.

Conditions

Malaria

Outcome Measures

Primary Outcomes (4)

• 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.

  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).

  Assessment of solicited AEs in the first 7 days post vaccination.

• Safety and Tolerability of R21 With and Without the Adjuvant Matrix-M1 Assessed by the Occurrence of Unsolicited Adverse Events.

  Occurrence of unsolicited local and systemic adverse events.

  Unsolicited AEs to be assessed up to 28 days post vaccination.

• Safety and Tolerability of R21 With and Without the Adjuvant Matrix-M1 Assessed by the Occurrence of Serious Adverse Events.

  Occurrence of serious adverse events collected from enrolment until the end of the follow-up period.

  6 months

• Safety and Tolerability of R21 With and Without the Adjuvant Matrix-M1 Assessed by the Occurrence of Laboratory Adverse Events.

  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.

  At Day 0 (baseline), day 7 and day 28 post vaccination

Study Arms (4)

Group 1

ACTIVE COMPARATOR

10µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56.

Biological: R21; Biological: Matrix-M1

Group 2

ACTIVE COMPARATOR

50µg of R21 on days 0, 28, and 56.

Biological: R21

Group 3

ACTIVE COMPARATOR

50µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56.

Biological: R21; Biological: Matrix-M1

Group 4

ACTIVE COMPARATOR

2µg of R21 mixed with 50µg of Matrix-M

Biological: R21; Biological: Matrix-M1

Interventions

R21 BIOLOGICAL

Group 1; Group 2; Group 3; Group 4

Matrix-M1 BIOLOGICAL

Group 1; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (2)

Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

NIHR Wellcome Trust Clinical Research Facility, Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

Related Publications (1)

• Venkatraman N, Tiono AB, Bowyer G, Bellamy DG, Stockdale LK, Powlson J, Collins KA, Coulibaly S, Datoo MS, Silman D, Ouedraogo A, Nebie I, Imoukhuede EB, Brod F, Folegatti P, Dickinson-Craig E, Jamieson S, Bougouma EC, Wright D, Diarra A, Bliss CM, Morter R, Glenn G, Fries LF, Reimer JM, Lovgren-Bengtsson K, Baker M, Poulton I, Moyle S, Berrie E, Green N, Mukhopadhyay E, Viebig NK, Angus B, Lawrie A, Roberts R, Gilbert SC, Lewis DJM, Sirima SB, Ewer KJ, Hill AVS. Evaluation of a novel malaria anti-sporozoite vaccine candidate, R21 in Matrix-M adjuvant, in the UK and Burkina Faso: two phase 1, first-in-human trials. Lancet Microbe. 2025 Mar;6(3):100868. doi: 10.1016/S2666-5247(24)00084-3. Epub 2025 Jan 10.

  PMID: 39805302 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

R21 monoclonal antibody; Matrix-M

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Adrian V Hill, DPhil FRCP
• Organization: University of Oxford

adrian.hill@ndm.ox.ac.uk

+44 1865 617610

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2015
• First Posted: October 8, 2015
• Study Start: October 15, 2015
• Primary Completion: August 29, 2017
• Study Completion: August 29, 2017
• Last Updated: November 12, 2019
• Results First Posted: November 12, 2019

Record last verified: 2018-01

Locations

GB (2)