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MalariaPhase 1NCT05155579

Assessment of Safety and Immunogenicity of a Single Vial Presentation of R21/Matrix-M and Co-Administration With EPI Vaccines

A Phase 1 study testing R21/Matrix-M - single vial formulation, R21/Matrix-M - two vial formulation and Licensed vaccine - Measles-rubella in people with Malaria, run by University of Oxford at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase Ib trial conducted in Bougouni, Mali to evaluate the safety and immunogenicity of R21/Matrix-M in a single and two vial presentation, with different immunisation schedules, and when co-administered with EPI vaccines in African children. Read more about this study

Who is it for?
Ages 6 weeks to 36 monthsHealthy volunteers can take part
Conditions the study is for
Malaria
What is being tested?
R21/Matrix-M - single vial formulation, R21/Matrix-M - two vial formulation and Licensed vaccine - Measles-rubella
Could I receive a placebo?
No, everyone receives an active treatment
How many people
594 participants
Where
2 sitesin 2 countries
Study dates
14 May 2022to 27 May 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 6 weeks to 36 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Age:
  • Group 1: The child is 5-11 months of age at the time of randomization (i.e. up to the day before of their first birthday).
  • Group 2: The child is 12-23 months of age at the time of randomization (i.e. up to the day before of their second birthday).
  • Group 3: The child is 24-36 months of age at the time of randomization (i.e. up to the day of their third birthday).
  • Group 4: The child is 6-7 months of age at the time of randomization.
  • Group 5: The child is 6 weeks of age at the time of randomization and have not received any dose of the pentavalent vaccine, pneumococcal vaccine, rotavirus vaccine, IPV and only the first dose of the OPV.
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  • Group 6: The child is aged 5-36 months at the time of their first vaccination
  • Signed informed consent/thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child to join the trial.
  • The investigator believes that the parents/guardians can and will comply with the requirements of the protocol if the child is enrolled in the study.
  • The child is a permanent resident of the study area and likely to remain a resident for the duration of the trial.

Who cannot join

  • The child has previously received a malaria vaccine.
  • The child is enrolled in another malaria intervention trial that could interfere with the results of this study.
  • The child has a history of allergic disease or reactions likely to be exacerbated by any component of the study vaccines.
  • The child has a history of allergic reactions, significant IgE-mediated events or anaphylaxis to previous immunisations.
  • The child has major congenital defects.
  • The child has anaemia associated with clinical signs of symptoms of decompensation, or a haemoglobin of ≤7.4 g/dL.
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  • The child has had a blood transfusion within one month of enrolment.
  • The child has been administered immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
  • The child has malnutrition requiring hospital admission.
  • The child has an acute or chronic, clinically significant pulmonary, cardiovascular, gastrointestinal, endocrine, neurological, skin, hepatic or renal functional abnormality, as determined by medical history, physical examination or laboratory tests.
  • Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV or asplenia.
  • The child has received an investigational drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • The child is currently participating in another clinical trial if likely to affect data interpretation of this trial
  • The child has 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.
  • Clinically significant laboratory abnormality as judged by the study clinician
  • For group 5 only: the child has received any dose of the pentavalent vaccine, pneumococcal vaccine, rotavirus vaccine, IPV or has received more than one dose of the OPV.
  • Exclusion criteria during the study (to be checked prior to each vaccination):
  • 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.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Mali1 site

  • Malaria Research & Training Center, Department of Epidemiology of Parasitic Diseases, Faculty of Medicine, Pharmacy and Dentistry, University of Sciences Techniques and Technologies of Bamako

    Bamako

Other trials in Mali

United Kingdom1 site

  • CCVTM, University of Oxford

    Oxford

Other trials in United Kingdom

About this study

Official title: A Phase Ib Trial to Evaluate the Safety and Immunogenicity of R21/Matrix-M in a Single and Two Vial Presentation, With Different Immunisation Schedules, and When Co-Administered With EPI Vaccines in African Children

This is a Phase Ib trial conducted in Bougouni, Mali to evaluate the safety and immunogenicity of R21/Matrix-M in a single and two vial presentation, with different immunisation schedules, and when co-administered with EPI vaccines in African children.

Read the detailed description

This trial has six groups. This will be a double-blind, individually randomised trial, with 1:1 randomisation with the single or two vial presentation of R21/Matrix-M malaria vaccine for study groups 1, 2 and 3. Groups 1, 2 and 3 are to assess the safety and immunogenicity of R21/Matrix-M as a single vial formulation compared with a two-vial formulation, in children aged 5- 36 months, in a malaria endemic area. The age range of 5-36 months has been split into three groups to ensure an even age spread across age groups.

For groups 4 and 5, this is a randomised, open-label study to assess the safety and immunogenicity of R21/Matrix-M when co-administrated with various EPI vaccines at the relevant ages, in a malaria endemic area.

Group 6 is a randomised, open-label study to assess safety and immunogenicity of a delayed, third dose of R21/Matrix-M in 5-36 month old children, in a malaria endemic area.

For groups 1, 2, 3, 5 and 6, participants will be randomised 1:1. For group 4, participants will be randomised 3:3:1.

Approximately 590 children will be recruited across these six study groups.

The primary study objectives are:

Safety

  • To assess the safety and reactogenicity of R21/Matrix-M, as a single- vial formulation in 5-36-month old African children.
  • To assess the safety and reactogenicity of co-administration of R21/Matrix-M with the EPI vaccines given at 9 months, measles-rubella and yellow fever vaccines, in African children.
  • To assess the safety and reactogenicity of co-administration of R21/Matrix-M with the EPI vaccines given at 6, 10 and 14 weeks of age, pentavalent and oral polio vaccine (OPV), in African children.

Immunogenicity

  • To assess the immunogenicity of R21/Matrix-M, as a single- vial formulation in 5-36-month-old African children, compared with the two-vial formulation.
  • To assess the immunogenicity of EPI vaccines given at 9 months, measles-rubella and yellow fever vaccines, when given with and without R21/Matrix-M
  • To assess the immunogenicity of EPI vaccines given at 6, 10 and 14 weeks of age, pentavalent and oral polio vaccines, given as part of EPI at 6, 10 and 14 weeks of age, when given with and without R21/Matrix-M.

The secondary study objectives are:

  • To assess the safety and reactogenicity of R21/Matrix-M, as a single- vial formulation in African children compared with the two-vial formulation.
  • To assess the safety and reactogenicity of a delayed third dose of R21/Matrix-M in 5-36-month-old African children.
  • To assess the immunogenicity of a delayed third dose of R21/Matrix-M in 5-36-month-old African children.

This trial is funded by the Serum Institute of India.

Conditions
Malaria
Being tested
R21/Matrix-M - single vial formulation, R21/Matrix-M - two vial formulation, Licensed vaccine - Measles-rubella, Licensed vaccine - Yellow fever, Licensed vaccine - Pentavalent (diphtheria, tetanus, pertussis, hepatitis B and Hib)
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 - single vial formulationBiological

    Adjuvanted malaria vaccine in a single vial formulation

  • R21/Matrix-M - two vial formulationBiological

    Adjuvanted malaria vaccine in a double vial formulation

  • Licensed vaccine - Measles-rubellaBiological

    Licensed vaccine part of the EPI vaccination schedule

  • Licensed vaccine - Yellow feverBiological

    Licensed vaccine part of the EPI vaccination schedule

  • Licensed vaccine - Pentavalent (diphtheria, tetanus, pertussis, hepatitis B and Hib)Biological

    Licensed vaccine part of the EPI vaccination schedule

  • Licensed vaccine - Oral Polio Vaccine (OPV)Biological

    Licensed vaccine part of the EPI vaccination schedule

  • Licensed vaccine - RotavirusBiological

    Licensed vaccine part of the EPI vaccination schedule

  • Licensed vaccine - Pneumococcal vaccineBiological

    Licensed vaccine part of the EPI vaccination schedule

  • Licensed vaccine - Inactivated Polio Vaccine (IPV)Biological

    Licensed vaccine part of the EPI vaccination schedule

Study groups in NCT05155579
Study groupRoleWhat they receive
Groups 1a, 2a and 3aExperimental60 children, aged 5-36 months, who will receive 4 doses of 5µg R21/50µg Matrix-M as a two vial formulation. The first three doses will be given one month apart, followed by a booster vaccination 12 months after the third dose. The age range of 5-36 months has been split into three groups to ensure an even age spread across age groups. Group 1a is 20 children aged 5-11 months, group 2a is 20 children aged 12-23 months, and group 3a is 20 children aged 24-36 months.
Receives: Biological: R21/Matrix-M - two vial formulation
Group 1b, 2b and 3bExperimental60 children, aged 5-36 months, who will receive 4 doses of 5µg R21/50µg Matrix-M as a single vial formulation. The first three doses will be given one month apart, followed by a booster vaccination 12 months after the third dose. The age range of 5-36 months has been split into three groups to ensure an even age spread across age groups. Group 1b is 20 children aged 5-11 months, group 2b is 20 children aged 12-23 months, and group 3b is 20 children aged 24-36 months.
Receives: Biological: R21/Matrix-M - single vial formulation
Group 4aExperimental150 participants, aged 6-7 months at the time of randomisation (to ensure third vaccination is given at approximately 9 months), who will receive 3 doses of 5µg R21/50µg Matrix-M one month apart. At the time of the third dose they will receive their measles-rubella and yellow fever vaccinations at the same time as R21/Matrix-M.
Receives: Biological: R21/Matrix-M - single vial formulation; Biological: Licensed vaccine - Measles-rubella; Biological: Licensed vaccine - Yellow fever
Group 4bActive comparator150 participants, aged 6-7 months at the time of randomisation, who will receive a measles-rubella and yellow fever vaccination 2 months after randomisation.
Receives: Biological: Licensed vaccine - Measles-rubella; Biological: Licensed vaccine - Yellow fever
Group 4cExperimentalGroup 4c is 50 participants, aged 6-7 months at the time of randomisation, who will receive 3 doses of 5µg R21/50µg Matrix-M one month apart.
Receives: Biological: R21/Matrix-M - single vial formulation
Group 5aExperimental30 children who will receive 3 doses of 5µg R21/50µg Matrix-M, pentavalent, rotavirus, pneumococcal and OPV vaccines at 6, 10 and 14 weeks of age. They will receive IPV two weeks following the third dose.
Receives: Biological: R21/Matrix-M - single vial formulation; Biological: Licensed vaccine - Pentavalent (diphtheria, tetanus, pertussis, hepatitis B and Hib); Biological: Licensed vaccine - Oral Polio Vaccine (OPV); Biological: Licensed vaccine - Rotavirus; Biological: Licensed vaccine - Pneumococcal vaccine; Biological: Licensed vaccine - Inactivated Polio Vaccine (IPV)
Group 5bActive comparator30 children who will receive 3 doses of pentavalent, rotavirus, pneumococcal and OPV vaccines at 6, 10 and 14 weeks of age. They will receive IPV two weeks following the third dose.
Receives: Biological: Licensed vaccine - Pentavalent (diphtheria, tetanus, pertussis, hepatitis B and Hib); Biological: Licensed vaccine - Oral Polio Vaccine (OPV); Biological: Licensed vaccine - Rotavirus; Biological: Licensed vaccine - Pneumococcal vaccine; Biological: Licensed vaccine - Inactivated Polio Vaccine (IPV)
Group 6aExperimental30 children, aged 5-36 months, who will receive 3 doses of 5µg R21/50µg Matrix-M. The first two doses one month apart and the third dose 6 months after the first dose.
Receives: Biological: R21/Matrix-M - single vial formulation
Group 6bExperimental30 children, aged 5-36 months, who will receive 3 doses of 5µg R21/50µg Matrix-M. The first two doses one month apart and the third dose 12 months after the first dose.
Receives: Biological: R21/Matrix-M - single vial formulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety

    Solicited adverse events:

    • 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.

    Unsolicited adverse events

    • Occurrence of unsolicited adverse events for 28 days following the vaccination. Laboratory adverse events
    • Change from baseline for safety laboratory measures thought to be clinically significant.

    Serious adverse events

    • Occurrence of serious adverse events for the whole study duration.

    Measured: 2 years

  2. Immunogenicity

    • To assess the humoral immunogenicity of R21/Matrix-M as a single- vial formulation in 5-36-month-old African children, compared with the two-vial formulation, 0, 30, 180 and 365 days after the administration of the third dose of R21/Matrix-M; and 0, 30, 180 and 365 days after the administration of a booster dose.
    • To assess the humoral immunogenicity of EPI vaccines given at 9 months, measles-rubella and yellow fever vaccines, when given with and without R21/Matrix-M, 0, 30, 180 and 360 days after the administration of the third dose of R21/Matrix-M
    • To assess the humoral immunogenicity of EPI vaccines given at 6, 10 and 14 weeks of age, pentavalent and oral polio vaccines, given as part of EPI at 6, 10 and 14 weeks of age, when given with and without R21/Matrix-M, 0, 30, 180 and 360 days after the administration of the third dose of R21/Matrix-M or the EPI vaccines.

    Measured: 2 years

Secondary outcomes (2)

  1. Safety of a delayed third dose

    Solicited adverse events:

    • 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.

    Unsolicited adverse events

    • Occurrence of unsolicited adverse events for 28 days following the vaccination. Laboratory adverse events
    • Change from baseline for safety laboratory measures thought to be clinically significant.

    Serious adverse events

    • Occurrence of serious adverse events for the whole study duration.

    Measured: 2 years

  2. Immunogenicity of a delayed third dose

    • To assess the humoral immunogenicity of a delayed third dose of R21/Matrix-M in 5-36-month-old African children, at 30 and 180 days after administration of the second dose, and 0, 30, 180 and 360 days after the administration of the third dose of R21/Matrix-M

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2021
  2. Study start14 May 2022
  3. Primary completion27 May 2025
  4. Study completion27 May 2025

Resources

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
Randomised
Intervention model
Parallel groups
Model description
RCT
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
594 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05155579
Sponsor's protocol ID
VAC088
Status last verified
Sep 2025
First submitted
9 Dec 2021
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing R21/Matrix-M - single vial formulation, R21/Matrix-M - two vial formulation and Licensed vaccine - Measles-rubella in people with Malaria, run by University of Oxford at 2 sites in 2 countries.

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 10 inclusion and 18 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 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Mali, United Kingdom. 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?

Safety (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05155579.

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 8 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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