MalariaPhase 1NCT05385510
Assessment of Safety and Immunogenicity of R21/Matrix-M™ in African Children Living With HIV
A Phase 1 study testing R21/Matrix-M™ in people with Malaria, run by University of Oxford at 1 site in Uganda.
Trial summary
A Phase Ib trial to evaluate the safety and immunogenicity of R21/Matrix-M™ in African children living with HIV Read more about this study
- Who is it for?
- Ages 5 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- R21/Matrix-M™
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteUganda
- Study dates
- 10 Jan 2023to 3 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
- Affect the participant's ability to participate in the trial
- These may include: diseases or disorders of the pulmonary, cardiovascular, gastrointestinal, endocrine, neurological, skin, hepatic or renal systems, cancer, bleeding disorders, abnormalities of screening laboratory tests or examinations
- Receipt of an investigational drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Current participation in another clinical trial if likely to affect data interpretation of this trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ib Trial to Evaluate the Safety and Immunogenicity of R21/Matrix-M™ in African Children Living With HIV
A Phase Ib trial to evaluate the safety and immunogenicity of R21/Matrix-M™ in African children living with HIV
Read the detailed description
This is a Phase Ib, open-label, non-randomised, controlled trial to evaluate the safety and immunogenicity of R21/Matrix-M™ in 5-36 month old African children living with HIV.
The study will be conducted in Uganda at the MRC/UVRI and LSHTM Uganda research unit with recruitment taking place in Kampala, Wakiso and Entebbe.
Children aged 5-36 months will be recruited to the trial. 100 children with confirmed HIV infection will be recruited to group 1. 20 children without HIV infection will be recruited to group 2. Up to 10% variation for each group will be permitted to accommodate variation in the rate of recruitment and retention.
HIV positive children will be recruited from Paediatric HIV care centres within Kampala and Wakiso districts. HIV negative children will be recruited from Entebbe hospital and primary health care centres that provide immunisation and growth monitoring services.
All participants will receive 3 vaccinations of 5µg R21/50µg Matrix-M™. Participants will receive their first dose at 0 months, second dose at 1 month and third dose at 2 months. Participants will receive a booster at 14 months (12 months after their third dose). Participants will be followed up for 12 months following the primary vaccination series and 12 months following the booster dose.
Primary objective:
To assess the safety and reactogenicity profile of the malaria vaccine candidate R21/Matrix-M™ in 5-36-month old African children living with HIV
Secondary objectives:
- To assess the humoral immunogenicity of R21/Matrix-M™ in 5-36-month-old African children, comparing children living with HIV with HIV negative children
- To assess the impact of vaccination on HIV reservoir
- To assess whether increasing age and nadir CD4 count are associated with immunogenicity of R21/Matrix-M™ in 5-36-month-old African children living with HIV
Tertiary objective:
To assess the immunogenicity profile of R21/Matrix-M™ in 5-36-month-old African children, comparing children living with HIV with HIV negative children
This trial is funded by the Serum Institute of India Pvt Ltd.
- Conditions
- Malaria
- Being tested
- R21/Matrix-M™
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R21/Matrix-M™Biological
Adjuvanted malaria vaccine
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - children with HIV | Experimental | 100 5-36 month old children with confirmed HIV infection. Receives: Biological: R21/Matrix-M™ |
| Group 2 - children without HIV | Experimental | 20 5-36 month old children without HIV infection. Receives: Biological: R21/Matrix-M™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Solicited local signs and symptoms
Occurrence of solicited local signs and symptoms
Measured: 7 days following receipt of each dose
Solicited systemic signs and symptoms
Occurrence of solicited systemic signs and symptoms
Measured: 7 days following receipt of each dose
SAEs
Occurrence of SAEs
Measured: Through study completion - on average for 15 months
Unsolicited AEs
Occurrence of unsolicited adverse events
Measured: 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
Measured: Through study completion - on average for 15 months
Secondary outcomes (3)
Antibody responses to CSP and HBsAb
Antibody responses to CSP (total anti-IgG responses to NANP and C-term region of CSP) and HBsAb
Measured: 1 and 6 months following third dose, and 1 and 12 months following booster dose
HIV viral load
Change in total HIV DNA copies per million CD4+ T cells
Measured: 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
CD4+ count, age at enrolment and vaccine immune response
Measured: 1 week after doses 1 and booster, 1 and 6 months after dose 3, and 1 and 12 months after the booster dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start10 Jan 2023
- Primary completion3 Sep 2025
- Study completion3 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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™
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- MRC/UVRI and LSHTM Uganda Research Unit
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385510
- Sponsor's protocol ID
- VAC092
- Status last verified
- Feb 2026
- First submitted
- 3 May 2022
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Trial to Evaluate the Safety and Immunogenicity of R21/Matrix-M™ in African Children Living With HIV
- ClinicalTrials.gov ID
- NCT05385510
- Acronym / sponsor ID
- VAC092
- Conditions
- Malaria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- MRC/UVRI and LSHTM Uganda Research Unit
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 3 Sep 2025 (actual)
- Study completion
- 3 Sep 2025 (actual)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase Ib trial to evaluate the safety and immunogenicity of R21/Matrix-M™ in African children living with HIV
Detailed description
This is a Phase Ib, open-label, non-randomised, controlled trial to evaluate the safety and immunogenicity of R21/Matrix-M™ in 5-36 month old African children living with HIV.
The study will be conducted in Uganda at the MRC/UVRI and LSHTM Uganda research unit with recruitment taking place in Kampala, Wakiso and Entebbe.
Children aged 5-36 months will be recruited to the trial. 100 children with confirmed HIV infection will be recruited to group 1. 20 children without HIV infection will be recruited to group 2. Up to 10% variation for each group will be permitted to accommodate variation in the rate of recruitment and retention.
HIV positive children will be recruited from Paediatric HIV care centres within Kampala and Wakiso districts. HIV negative children will be recruited from Entebbe hospital and primary health care centres that provide immunisation and growth monitoring services.
All participants will receive 3 vaccinations of 5µg R21/50µg Matrix-M™. Participants will receive their first dose at 0 months, second dose at 1 month and third dose at 2 months. Participants will receive a booster at 14 months (12 months after their third dose). Participants will be followed up for 12 months following the primary vaccination series and 12 months following the booster dose.
Primary objective:
To assess the safety and reactogenicity profile of the malaria vaccine candidate R21/Matrix-M™ in 5-36-month old African children living with HIV
Secondary objectives:
- To assess the humoral immunogenicity of R21/Matrix-M™ in 5-36-month-old African children, comparing children living with HIV with HIV negative children
- To assess the impact of vaccination on HIV reservoir
- To assess whether increasing age and nadir CD4 count are associated with immunogenicity of R21/Matrix-M™ in 5-36-month-old African children living with HIV
Tertiary objective:
To assess the immunogenicity profile of R21/Matrix-M™ in 5-36-month-old African children, comparing children living with HIV with HIV negative children
This trial is funded by the Serum Institute of India Pvt Ltd.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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™
| Arm | Type | Receives |
|---|---|---|
| Group 1 - children with HIV | Experimental | Biological: R21/Matrix-M™100 5-36 month old children with confirmed HIV infection. |
| Group 2 - children without HIV | Experimental | Biological: R21/Matrix-M™20 5-36 month old children without HIV infection. |
Who may qualify
- Ages
- 5 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (19 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| R21/Matrix-M™Adjuvanted malaria vaccine | Biological | Group 1 - children with HIV, Group 2 - children without HIV |
Primary outcome
Solicited local signs and symptoms
Time frame: 7 days following receipt of each dose
Occurrence of solicited local signs and symptoms
Solicited systemic signs and symptoms
Time frame: 7 days following receipt of each dose
Occurrence of solicited systemic signs and symptoms
SAEs
Time frame: Through study completion - on average for 15 months
Occurrence of SAEs
Unsolicited AEs
Time frame: 30 days following receipt of each dose
Occurrence of unsolicited adverse events
Clinically significant change from baseline for safety laboratory measures
Time frame: Through study completion - on average for 15 months
Clinically significant change from baseline for safety laboratory measures
3 secondary outcomes
Antibody responses to CSP and HBsAb
Time frame: 1 and 6 months following third dose, and 1 and 12 months following booster dose
HIV viral load
Time frame: 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
Time frame: 1 week after doses 1 and booster, 1 and 6 months after dose 3, and 1 and 12 months after the booster dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing R21/Matrix-M™ in people with Malaria, run by University of Oxford at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Solicited local signs and symptoms (time frame: 7 days following receipt of each dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.