Assessment of Safety and Immunogenicity of R21/Matrix-M™ in African Children Living With HIV

NCT05385510 | Completed Phase 1 DMC

• 1 other identifier: VAC092
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase Ib trial to evaluate the safety and immunogenicity of R21/Matrix-M™ in African children living with HIV

Conditions

Malaria

Outcome Measures

Primary Outcomes (5)

• Solicited local signs and symptoms

  Occurrence of solicited local signs and symptoms

  7 days following receipt of each dose

• Solicited systemic signs and symptoms

  Occurrence of solicited systemic signs and symptoms

  7 days following receipt of each dose

• SAEs

  Occurrence of SAEs

  Through study completion - on average for 15 months

• Unsolicited AEs

  Occurrence of unsolicited adverse events

  30 days following receipt of each dose

• Clinically significant change from baseline for safety laboratory measures

  Clinically significant change from baseline for safety laboratory measures

  Through study completion - on average for 15 months

Secondary Outcomes (3)

• Antibody responses to CSP and HBsAb

  1 and 6 months following third dose, and 1 and 12 months following booster dose

• HIV viral load

  7 days post doses 1 and 2, 30 days post dose 3, and 7, 30 and 365 days post booster

• CD4+ count, age at enrolment and vaccine immune response

  1 week after doses 1 and booster, 1 and 6 months after dose 3, and 1 and 12 months after the booster dose

Other Outcomes (1)

• Tertiary - Characterisation of the magnitude and functionality of the cellular and humoral response

  Through study completion - on average for 15 months

Study Arms (2)

Group 1 - children with HIV

EXPERIMENTAL

100 5-36 month old children with confirmed HIV infection.

Biological: R21/Matrix-M™

Group 2 - children without HIV

EXPERIMENTAL

20 5-36 month old children without HIV infection.

Biological: R21/Matrix-M™

Interventions

R21/Matrix-M™ BIOLOGICAL

Adjuvanted malaria vaccine

Group 1 - children with HIV; Group 2 - children without HIV

Eligibility Criteria

• Age: 5 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The child must be 5-36 months of age at enrolment (i.e. up to the day of their third birthday).
• Group 1: The child must have HIV infection (documented positive DNA PCR) with WHO stage 1 or 2 HIV disease, whether or not they are receiving ART.
• Group 2: The child must not have HIV infection (absence of HIV infection must be confirmed by documented negative DNA PCR at screening).
• Witnessed, signed/thumb-printed informed consent, obtained from the parent(s)/guardian(s) of the child
• Parents/guardians of the child are able and willing to comply with the requirements of the protocol, in the opinion of the investigator
• The child must be a permanent resident of the study area and likely to remain resident for the duration of the trial.

You may not qualify if:

• Previous receipt of a malaria vaccine.
• Enrolment in another malaria intervention trial that could interfere with the results of this study.
• History of severe allergic disease or reactions, including anaphylaxis or angioedema
• History of allergic disease or reactions likely to be exacerbated by any component of the study vaccines, or history of allergic reactions to previous vaccinations
• Clinically significant laboratory abnormality as judged by the study clinician including haemoglobin of ≤8.0 g/dL .
• Major congenital defects.
• Receipt of blood transfusion, immunoglobulins and/or any blood products within the three months preceding enrolment
• Malnutrition requiring hospital admission at the time of enrolment.
• HIV disease of stage 3 or 4, as defined by the WHO clinical staging \[23\]
• Confirmed or suspected immunosuppressive or immunodeficient state (other than due to HIV infection).
• o This may include asplenia, use of immunosuppressant medication within the past 6 months (except for topical steroids or short-term oral steroids (course lasting \<14 days).
• Autoimmune conditions (except mild psoriasis, well-controlled autoimmune thyroid disease, vitiligo or stable coeliac disease)
• Any other clinically significant disease or disorder, or social situation, elicited in medical history, physical examination or laboratory tests that, in the opinion of the study clinician, may:
• Put the participants at risk because of participation in the trial, or
• Influence the result of the trial, or

Sponsors & Collaborators

• MRC/UVRI and LSHTM Uganda Research Unit: collaborator
• University of Oxford: lead

Study Sites (1)

MRC/UVRI & LSHTM Uganda Research Unit

Entebbe, Uganda

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

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

Study Design

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

Model Details: This is a Phase Ib, open-label, non-randomised, controlled trial. 100 children with confirmed HIV infection will be recruited to group 1. 20 children without HIV infection will be recruited to group 2. All children will receive R21/Matrix-M™

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 23, 2022
• Study Start: January 10, 2023
• Primary Completion: September 3, 2025
• Study Completion: September 3, 2025
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

UG (1)