Official Title
A Phase 1 Study to Assess the Safety and Immunogenicity of R21/Matrix-M™ Administered in an Escalating Dose, Multi-prime Vaccination Schedule in Healthy Adults
Brief Summary

This is a phase I clinical study that aims to assess the safety and immunogenicity of anovel, escalating dose regimen of R21/Matrix-M™ in healthy, malaria-naïve adults.

Detailed Description

This is a study to assess safety and immunogenicity of a novel dosing regimen for R21/
Matrix-M™, a leading Plasmodium falciparum malaria vaccine, in healthy, malaria-naïve
adults. Participants in the study will receive either 6 escalating doses (groups 1 and 2)
or 2 standard doses (group 3) of R21/ Matrix-M™, all delivered in the same arm. Up to 36
volunteers will be enrolled and followed up for 12-24 months after their first vaccine.

In addition to blood sampling throughout the follow-up period, participants will undergo
fine needle aspiration of axillary lymph nodes twice during the study, to allow further
characterisation of immune responses to this novel vaccine regimen.

Recruiting
Malaria,Falciparum

Biological: R21/Matrix M™ (Group 1)

- 0.50 mcg R21 in 2.75 mcg Matrix-M™ (D0)

- 0.75 mcg R21 in 3.5 mcg Matrix-M™ (D3)

- 1.25 mcg R21 in 6.25 mcg Matrix-M™ (D7)

- 2.5 mcg R21 in 12.5 mcg Matrix-M™ (D10)

- 5 mcg R21 in 25 mcg Matrix-M™ (D14)

- 10 mcg R21 in 50 mcg Matrix-M™ (D56)

Biological: R21/Matrix M™ (Group 2)

- 0.50 mcg R21 in 2.75 mcg Matrix-M™ (D0)

- 0.75 mcg R21 in 3.5 mcg Matrix-M™ (D3)

- 1.25 mcg R21 in 6.25 mcg Matrix-M™ (D7)

- 2.5 mcg R21 in 12.5 mcg Matrix-M™ (D10)

- 5 mcg R21 in 25 mcg Matrix-M™ (D14)

- 10 mcg R21 in 50 mcg Matrix-M™(D168)

Biological: R21/Matrix M™ (Group 3)

- 10 mcg R21 in 50 mcg Matrix-M™ (D0)

- 10 mcg R21 in 50 mcg Matrix-M™ (D56)

Procedure: Fine needle aspiration (FNA)

Participants in all groups will undergo fine needle aspiration (FNA) of axillary lymph
nodes draining vaccination site on Day 77 and Day 105 after initial vaccination.

Eligibility Criteria

Inclusion Criteria:

- Healthy adult aged 18 to 50 years.

- Able and willing (in the Investigator's opinion) to comply with all study
requirements.

- Participants of childbearing potential only: must practice continuous effective
contraception until the last study visit.

- Agreement to refrain from blood donation for the duration of the study.

- Able and willing to provide written informed consent to participate in the trial.

Exclusion Criteria:

- History of clinical malaria (any species) or previous participation in any malaria
vaccine trial or controlled human malaria infection trial.

- Travel to a clearly malaria endemic locality during the study period or within the
preceding six months, as per the CDC website:
https://www.cdc.gov/malaria/travelers/country_table/a.html

- Participation in another research study involving receipt of an investigational
medicinal product (IMP) in the 30 days preceding enrolment or 5 half-lives of the
investigational medicinal product, whichever is longer, or planned participation
during the study period.

- Prior receipt of an IMP likely to impact interpretation of the trial data, as
assessed by the Investigator.

- Receipt of any vaccine within 30 days of a study vaccine, with the exception of
COVID-19 vaccination.

- Receipt of oral or systemic immunosuppressant medication for more than 14 days in
the six months preceding enrolment.

- Receipt of immunoglobulins or blood products (e.g. blood transfusion) in the three
months preceding enrolment.

- History of anaphylaxis to vaccination, or allergy likely to be exacerbated by any
component of the vaccine or study procedures, including allergy to lidocaine

- Pregnancy, lactation or intention to become pregnant during the study.

- Clinically significant history of chronic disease, including cancer (except basal
cell carcinoma or cervical carcinoma in situ), immunodeficiency (including HIV),
autoimmune conditions (except mild psoriasis, well-controlled autoimmune thyroid
disease, vitiligo or stable coeliac disease), psychiatric disorder, drug or alcohol
abuse

- Positive Hepatitis B surface antigen (HBsAg), HIV antibodies or Hepatitis C (HCV)
antibodies (except previous HCV vaccine study participants)

- HEMStop score > or = to 2(30) with abnormal coagulation screen or clinical concern
regarding bleeding risk.

- Use of medications that increase the risk of bleeding, as assessed by the clinician,
including: warfarin, oral antithrombin agents (e.g. Apixaban), low molecular weight
heparin

- Any clinically significant abnormality of screening examination, blood or urine
tests

- Any other significant disease, disorder, or finding, which, in the opinion of the
Investigator, may put the volunteer at risk, affect the volunteer's ability to
participate in the study or impair interpretation of the study data

- Participants unable to be closely followed for social, geographic or psychological
reasons.

- Investigator inability to corroborate a participant's medical history via access to
NHS electronic records and/or their GP.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 50 Years
Countries
United Kingdom
Locations

Centre for Clinical Vaccinology and Tropical Meducine, Churchill Hospital, University of Oxford
Oxford, Oxfordshire, United Kingdom

University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, United Kingdom

Contacts

Volunteer Co-ordinators
01865611386
vaccinetrials@ndm.ox.ac.uk

University of Oxford
NCT Number
MeSH Terms
Malaria, Falciparum