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

NCT ID: NCT03580824

Last Updated: 2023-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-30
• Study Completion Date: 2022-06-14

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.

Detailed Description

The study includes three age groups:

Group 1: healthy adults (18-45 years) Group 2: young children (aged 1-5 years) Group 3: infants (aged 5- <12 months of age) Each group will receive 3 vaccine doses which will be 4-weeks apart. A booster dose will be administered at 9-25 months post 3rd dose.

The trial is funded by The European & Developing Countries Clinical Trials Partnership (EDCTP), European Union, ref: RIA2016V-1649 MMVC

Conditions

Malaria,Falciparum

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

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.

Group Type: EXPERIMENTAL

R21 in Matrix- M adjuvant vaccine

Intervention Type: BIOLOGICAL

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

Group 2

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.

Group Type: EXPERIMENTAL

R21 in Matrix- M adjuvant vaccine

Intervention Type: BIOLOGICAL

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

Group 3

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.

Group Type: EXPERIMENTAL

R21 in Matrix- M adjuvant vaccine

Intervention Type: BIOLOGICAL

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

Interventions

R21 in Matrix- M adjuvant vaccine

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 5 Months
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kenya Medical Research Institute

OTHER

Sponsor Role: collaborator

European and Developing Countries Clinical Trials Partnership (EDCTP)

OTHER_GOV

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adrian Hill

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

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

Kilifi, , Kenya

Countries

Kenya

References

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.

Reference Type: DERIVED

PMID: 38813551 (View on PubMed)

Other Identifiers

VAC073

Identifier Type: -

Identifier Source: org_study_id