A Study to Determine if a New Malaria Vaccine is Safe and Induces Immunity Among Kenyan Adults, Young Children and Infants

NCT03580824 | Completed Phase 1 DMC

• 1 other identifier: VAC073
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

This is a clinical trial to evaluate the safety and immunogenicity of R21/MM in healthy Kenyan participants from the different age groups.Participants will receive 3 vaccinations 4 weeks apart.

Conditions

Malaria,Falciparum

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability of R21 with adjuvant Matrix-M in healthy adults then children and finally infants.

  Solicited and unsolicited adverse event data will be collected at each clinic visit from diary cards, clinical review, clinical examination (including observations) and laboratory results. This AE data will be tabulated and frequency, duration and severity of AEs compared between groups. The following parameters will be assessed for all study groups: * Occurrence of solicited local reactogenicity signs and symptoms for 7 days following the vaccination * Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination * Occurrence of unsolicited adverse events for 28 days following the vaccination * Change from baseline for safety laboratory measures * Occurrence of serious adverse events during the whole study duration

  up to 2 years following vaccination

Secondary Outcomes (1)

• To assess the cellular and humoral immunogenicity of R21 in humans with adjuvant Matrix- M in healthy adults, children and infants.

  up to 2 years following vaccination

Study Arms (3)

Group 1

EXPERIMENTAL

Group 1 adults (n=20) will be administered 10mcg R21/50mcg Matrix-M vaccine through intramuscular route (into the non-dominant arm). A booster dose will be administered at 9-25 months post 3rd dose.

Biological: R21 in Matrix- M adjuvant vaccine

Group 2

EXPERIMENTAL

Group 2A children 1-5 years (n=3) will be receiving 5mcg R21/25mcg Matrix-M vaccine through intramuscular route (into the left deltoid). Group 2B children 1-5 years (n=17) will be receiving 10mcg R21/50mcg Matrix-M vaccine through intramuscular route (into the left deltoid). A booster dose will be administered at 9-25 months post 3rd dose.

Biological: R21 in Matrix- M adjuvant vaccine

Group 3

EXPERIMENTAL

Group 3A infants 5-\<12 months (n=3) will be receiving 5mcg R21/25mcg Matrix-M vaccine through intramuscular route (into the left deltoid). Group 3B infants 5-\<12 months (n=3) will be receiving 10mcg R21/50mcg Matrix-M vaccine through intramuscular route (into the left deltoid). Group 3C infants 5-\<12 months (n=15) will be receiving 5mcg R21/25mcg Matrix-M vaccine through intramuscular route (into the left deltoid). Group 3D infants 5-\<12 months (n=15) will be receiving 10mcg R21/50mcg Matrix-M vaccine through intramuscular route (into the left deltoid). Group 3E infants 5-\<12 months (n=15) will be receiving 5mcg R21/50mcg Matrix-M vaccine through intramuscular route (into the left deltoid). A booster dose will be administered at 9-25 months post 3rd dose.

Biological: R21 in Matrix- M adjuvant vaccine

Interventions

R21 in Matrix- M adjuvant vaccine BIOLOGICAL

R21: Protein particle malaria vaccine candidate in Matrix-M: Saponin based vaccine adjuvant.

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 5 Months - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy adults aged 18 to 45 years (Group 1), Healthy child aged 1-5 years (Group 2), healthy infant aged 5- \<12 months (Group 3)
• Able and willing (in the Investigator's opinion) to comply with all study requirements
• Non-pregnant, non-lactating adult female or adult male
• Agreement to refrain from blood donation during the study
• Use of effective method of contraception for duration of study for female participants.
• For female participants, we will ask them to attend with their family planning records for verification. Effective contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly, in accordance with the product label. Examples of these include: combined oral contraceptives; injectable progestogen; implants of etenogestrel or levonorgestrel; intrauterine device or intrauterine system; male partner sterilisation at least 6 months prior to the female subject's entry into the study, and the relationship is monogamous; male condom combined with a vaginal spermicide (foam, gel, film, cream or suppository); and male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository)
• Adults with a Body Mass Index (BMI) 18 to 30 Kg/m2; or young children and infants with Z-score of weight-for-age within ±2SD
• Provide written informed consent
• Plan to remain resident in the study area for 2 years following last dose of vaccination

You may not qualify if:

• Clinically significant congenital abnormalities as judged by the study clinician.
• 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).
• Sickle cell trait or disease or G6PD deficiency.
• Any history of anaphylaxis in relation to vaccination.
• Clinically significant laboratory abnormality as judged by the study clinician.
• Blood transfusion within one month of enrolment.
• Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
• Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period.
• Seropositive for hepatitis B surface antigen (HBsAg) or hepatitis C (HCV IgG).
• Any significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.

Sponsors & Collaborators

• University of Oxford: lead
• Kenya Medical Research Institute: collaborator
• European and Developing Countries Clinical Trials Partnership (EDCTP): collaborator

Study Sites (1)

KEMRI/Wellcome Trust Programme, Centre for Geographic Medicine Research - Coast

Kilifi, PO Box 230, 80108, Kenya

Location

Related Publications (2)

• Mukhopadhyay ES, Bellamy DG, Tinto H, Hamaluba M, Truby A, Salman AM, Hill AVS. Naturally acquired immune responses to alpha-gal in malaria endemic settings and pre-clinical efficacy testing with R21/MM. Vaccine. 2025 Dec 5;68:127897. doi: 10.1016/j.vaccine.2025.127897. Epub 2025 Nov 1.

  PMID: 41176969 DERIVED

• Sang S, Datoo MS, Otieno E, Muiruri C, Bellamy D, Gathuri E, Ngoto O, Musembi J, Provstgaard-Morys S, Stockdale L, Aboagye J, Woods D, Lawrie A, Roberts R, Keter K, Kimani D, Ndungu F, Kapulu M, Njau I, Orindi B, Ewer KJ, Hill AVS, Bejon P, Hamaluba M. Safety and immunogenicity of varied doses of R21/Matrix-M vaccine at three years follow-up: A phase 1b age de-escalation, dose-escalation trial in adults, children, and infants in Kilifi-Kenya. Wellcome Open Res. 2023 Oct 12;8:450. doi: 10.12688/wellcomeopenres.19795.1. eCollection 2023.

  PMID: 38813551 DERIVED

MeSH Terms

Conditions

Malaria, Falciparum

Condition Hierarchy (Ancestors)

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

Study Officials

• Adrian Hill

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: July 9, 2018
• Study Start: April 30, 2019
• Primary Completion: June 14, 2022
• Study Completion: June 14, 2022
• Last Updated: August 3, 2023

Record last verified: 2022-08

Locations

KE (1)