Malaria, Plasmodium FalciparumPhase 1NCT05357560
A Study to Assess the Experimental Malaria Vaccines RH5.2-VLP and R21
A Phase 1 study testing Matrix-M with RH5.2 VLP and/or R21 in people with Malaria, Plasmodium Falciparum, run by University of Oxford at 1 site in The Gambia.
Trial summary
This is a Phase Ib multi-stage Plasmodium falciparum malaria vaccine study to assess the safety and immunogenicity of the blood-stage vaccine candidate RH5.2 virus-like particle (VLP) in Matrix-MTM and the pre-erythrocytic stage vaccine candidate R21 in Matrix-MTM, both alone and in combination, in adults and infants… Read more about this study
- Who is it for?
- Ages 5 months to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Plasmodium Falciparum
- What is being tested?
- Matrix-M with RH5.2 VLP and/or R21
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteThe Gambia
- Study dates
- 10 Jul 2023to 11 Dec 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 months to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Groups 1, 2 and 6-9: Healthy male or female infants aged 5-17 months at the time of enrolment with signed consent obtained from parents or guardians.
- Groups 3-5: Healthy male or female adults aged 18-45 years at the time of enrolment with signed consent.
- Groups 3-5 (Female participants only): Must be non-pregnant (as demonstrated by a negative urine pregnancy test), and practice continuous effective contraception for the 24 to 30 month duration of the study (see section 9.9).
- Planned long-term (at least 24 months from the date of recruitment) or permanent residence in the study area.
- Adults with a Body Mass Index (BMI) 18 to 30 Kg/m2; or infants with Z-score of weight-for-age within ±2SD.
Who cannot join
- Clinically significant congenital abnormalities as judged by the PI or other delegated individual
- Clinically significant history of skin disorder (psoriasis, contact dermatitis etc.), allergy, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease and neurological illness as judged by the PI or other delegated individual.
- 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).
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g., Kathon, neomycin, betapropiolactone.
- Any history of anaphylaxis in relation to vaccination.
Show all 27Show fewer
- Clinically significant laboratory abnormality at grade 2 or above as judged by the PI or other delegated individual.
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
- Receipt of any vaccine in the 30 days preceding enrolment, or planned receipt of any other vaccine within 30 days following each study vaccination. This excludes COVID-19 vaccines, which should not be received between 14 days before to 7 days after any study vaccination, and EPI vaccines (for infants), which should not be received between 14 days before to 28 days after any study vaccination.
- History of vaccination with previous malaria vaccines
- Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment in adults or at any time for infants, or planned use during the study period.
- Suspected or known current alcohol abuse.
- Suspected or known injecting drug abuse in the 5 years preceding enrolment.
- Seropositive for hepatitis B surface antigen (HBsAg), hepatitis C (HCV IgG) or HIV. For infants, any history of vertical exposure to HIV infection.
- Any other finding which in the opinion of the PI or other delegated individual would increase the risk of an adverse outcome from participation in the trial.
- Positive malaria by PCR screening.
- Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
- Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
- Any other 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.
- Vaccination and re-vaccination exclusion criteria
- The following events associated with vaccine immunisation constitute absolute contraindications to further administration of vaccine. If any of these events occur during the study, the participant must be withdrawn and followed until resolution of the event, as with any adverse event:
- Anaphylactic reaction following administration of vaccine.
- Pregnancy. The following adverse events constitute contraindications to administration of vaccine at that point in time; if any one of these adverse events occurs at the time scheduled for vaccination, the participant may be vaccinated at a later date, or withdrawn at the discretion of the Investigator.
- The participant must be followed until resolution of the event as with any adverse event:
- Acute disease at the time of administration of the IP (acute disease is defined as the presence of a moderate or severe illness with or without fever or symptoms suggestive of possible COVID-19 disease). All vaccines can be administered to persons with a minor illness such as diarrhoea or mild upper respiratory infection without fever, i.e. axillary temperature < 37.5°C.
- Temperature of >37.5°C (99.5°F) at the time of vaccination.
- Confirmed current COVID-19 infection, defined as ongoing symptoms with positive COVID-19 PCR swab or rapid antigen test taken during current illness or positive COVID-19 PCR swab or rapid antigen test within preceding 7 days without symptoms. Vaccinations will be delayed by a minimum of 7 days from the date of the first positive COVID-19 PCR swab, as long as symptoms are improving or resolved and there is no fever. It will be at the discretion of the Investigator to withdraw a participant if they develop severe COVID-19 disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ib Multi-stage Plasmodium Falciparum Malaria Vaccine Study to Assess the Safety and Immunogenicity of the Blood-stage Vaccine Candidate RH5.2 Virus-like Particle (VLP) in Matrix-M and the Pre-erythrocytic Stage Vaccine Candidate R21 in Matrix-M, Both Alone and in Combination, in Adults and Infants in the Gambia
This is a Phase Ib multi-stage Plasmodium falciparum malaria vaccine study to assess the safety and immunogenicity of the blood-stage vaccine candidate RH5.2 virus-like particle (VLP) in Matrix-MTM and the pre-erythrocytic stage vaccine candidate R21 in Matrix-MTM, both alone and in combination, in adults and infants in the Gambia
Read the detailed description
A total of 96 volunteers will be enrolled. Adults (18-45 years) will be enrolled into groups 3 -5. Infants (5 -17 months) will be enrolled into groups 1-2 and groups 6-9. All volunteers will be given 3 doses 50 µg of Matrix-M in combination with RH5.2 VLP and/or R21 via intramuscular (IM) injection in the deltoid region of the non-dominant arm for adults and anterolateral thigh for infants. The first 2 doses will be given at months 0 and 1. Groups 2-6 and group 8 will be given the third dose at month 2, and groups 1, 7 and 9 will be given the third dose at month 6.
- Conditions
- Malaria, Plasmodium Falciparum
- Being tested
- Matrix-M with RH5.2 VLP and/or R21
- Keywords
- RH5.2 virus-like particle (VLP), Matrix-M, R21
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Matrix-M with RH5.2 VLP and/or R21Biological
3 doses of 50 µg of Matrix-M in combination with RH5.2 VLP and/or R21 at different doses and at different timepoints
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Infants R21 delayed 3rd dose | Experimental | 11 volunteers (infant 5-17 months) given 50 µg of Matrix-M in combination with 5µg R21 at months 0, 1 and 6 via intramuscular (IM) injection in the anterolateral thigh Receives: Biological: Matrix-M with RH5.2 VLP and/or R21 |
| Group 2 - Infants R21 standard regimen | Experimental | 11 volunteers (infant 5-17 months) given 50 µg of Matrix-M in combination with 5µg R21 at months 0, 1 and 2 via intramuscular (IM) injection in the anterolateral thigh Receives: Biological: Matrix-M with RH5.2 VLP and/or R21 |
| Group 3 - Adults RH5.2 low dose, standard regimen | Experimental | 10 volunteers (adult 18-45 years) given 50 µg of Matrix-M in combination with 10µg RH5.2 VLP at months 0, 1 and 2 via intramuscular (IM) injection in the deltoid region of the non-dominant arm Receives: Biological: Matrix-M with RH5.2 VLP and/or R21 |
| Group 4 - Adults RH5.2 high dose, standard regimen | Experimental | 10 volunteers (adult 18-45 years) given 50 µg of Matrix-M in combination with 50µg RH5.2 VLP at months 0, 1 and 2 via intramuscular (IM) injection in the deltoid region of the non-dominant arm Receives: Biological: Matrix-M with RH5.2 VLP and/or R21 |
| Group 5 - Adults RH5.2 and R21 low dose, standard regimen | Experimental | 10 volunteers (adult 18-45 years) given 50 µg of Matrix-M in combination with 10µg RH5.2 VLP and 10µg R21 at months 0, 1 and 2 via intramuscular (IM) injection in the deltoid region of the non-dominant arm Receives: Biological: Matrix-M with RH5.2 VLP and/or R21 |
| Group 6 - Infants RH5.2 standard regimen | Experimental | 11 volunteers (infant 5-17 months) given 50µg of Matrix-M in combination with 5µg RH5.2 VLP at months 0, 1 and 2 via intramuscular (IM) injection in the anterolateral thigh Receives: Biological: Matrix-M with RH5.2 VLP and/or R21 |
| Group 7 - Infants RH5.2, delayed 3rd dose | Experimental | 11 volunteers (infant 5-17 months) given 50µg of Matrix-M in combination with 5µg RH5.2 VLP at months 0, 1 and 6 via intramuscular (IM) injection in the anterolateral thigh Receives: Biological: Matrix-M with RH5.2 VLP and/or R21 |
| Group 8 - Infants RH5.2 and R21, standard regimen | Experimental | 11 volunteers (infant 5-17 months) given 50µg of Matrix-M in combination with 5µg RH5.2 VLP and 5µg R21 at months 0, 1 and 2 via intramuscular (IM) injection in the anterolateral thigh Receives: Biological: Matrix-M with RH5.2 VLP and/or R21 |
| Group 9 - Infants RH5.2 and R21, delayed 3rd dose | Experimental | 11 volunteers (infant 5-17 months) given 50µg of Matrix-M in combination with 5µg RH5.2 VLP and 5µg R21 at months 0, 1 and 6 via intramuscular (IM) injection in the anterolateral thigh Receives: Biological: Matrix-M with RH5.2 VLP and/or R21 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine safety and tolerability of RH5.2-VLP with Matrix-M and R21 with Matrix-M, in healthy adults and infants by assessing the occurrence of solicited local reactogenicity signs and symptoms via clinic and home visits
Occurrence of solicited local reactogenicity signs and symptoms via clinic and home visits
Measured: 7 days following each vaccination
To determine safety and tolerability of RH5.2-VLP with Matrix-M and R21 with Matrix-M, in healthy adults and infants by assessing the occurrence of solicited systemic reactogenicity signs and symptoms via clinic and home visits
Occurrence of solicited systemic reactogenicity signs and symptoms via clinic and home visits
Measured: 7 days following each vaccination
To determine safety and tolerability of RH5.2-VLP with Matrix-M and R21 with Matrix-M, in healthy adults and infants by assessing occurrence of unsolicited adverse events
Occurrence of unsolicited adverse events via clinical review, clinical examination (including observations) and laboratory results
Measured: 28 days following the vaccination
Safety of the RH5.2-VLP with Matrix-M and R21 with Matrix-M vaccine, assessed through the number of participants with abnormal laboratory test results
Occurrence of change from baseline laboratory test results
Measured: 28 days following the vaccination
Assessment of safety and tolerability of RH5.2-VLP with Matrix-M and R21 with Matrix-M, in healthy adults and infants assessed through the number of participants with serious adverse events
Occurrence of serious adverse events including grading of causality
Measured: Whole duration of the study (24-30 months following initial trial vaccination)
Secondary outcomes (14)
To assess the humoral and cellular immunogenicity of RH5.2-VLP with Matrix-M as assessed by magnitude assessment at various timepoint
RH5 serology (participants vaccinated with RH5.2-VLP only), blood samples taken at a number of key timepoints including baseline and post vaccination of V+7 (adults only), V+14, V+28 to allow for magnitude assessment, late timepoints used to assess longevity of response
Measured: From a number of key timepoints, baseline up to day 912 (dependant on group)
To assess the humoral and cellular immunogenicity of RH5.2-VLP with Matrix-M as assessed by antibody kinetics at various timepoints
RH5 serology (participants vaccinated with RH5.2-VLP only), blood samples taken at a number of key timepoints including baseline and post vaccination of V+7 (adults only), V+14, V+28 to allow for antibody kinetics, late timepoints used to assess longevity of response
Measured: From a number of key timepoints, baseline up to day 912 (dependant on group)
To assess the humoral and cellular immunogenicity of RH5.2-VLP with Matrix-M, performing ELISA at various timepoints
RH5 serology (participants vaccinated with RH5.2-VLP only), blood samples taken at a number of key timepoints performing ELISA at specified timepoints
Measured: From a number of key timepoints, baseline up to day 912 (dependant on group)
To assess the humoral and cellular immunogenicity of R21 with Matrix-M performing ELISA at various timepoints
R21 serology (participants vaccinated with R21 only), blood samples taken at a number of key timepoints performing ELISA at specified timepoints
Measured: From a number of key timepoints, baseline up to day 912 (dependant on group)
To assess the humoral and cellular immunogenicity of R21 with Matrix-M as assessed by antibody kinetics at various timepoints
R21 serology (participants vaccinated with R21 only), blood samples taken at a number of key timepoints including baseline and post vaccination of V+7 (adults only), V+14, V+28 to allow for antibody kinetics, late timepoints used to assess longevity of response
Measured: From a number of key timepoints, baseline up to day 912 (dependant on group)
To assess the humoral and cellular immunogenicity of R21 with Matrix-M as assessed by magnitude assessment at various timepoint
R21 serology (participants vaccinated with R21 only), blood samples taken at a number of key timepoints including baseline and post vaccination of V+7 (adults only), V+14, V+28 to allow for magnitude assessment, late timepoints used to assess longevity of response
Measured: From a number of key timepoints, baseline up to day 912 (dependant on group)
To assess the humoral and cellular immunogenicity of RH5.2-VLP and R21 with Matrix-M as assessed by antibody kinetics at various timepoints
Hepatitis B serology, blood samples taken at a number of key timepoints including baseline and post vaccination of V+7 (adults only), V+14, V+28 to allow for antibody kinetics, late timepoints used to assess longevity of response
Measured: From a number of key timepoints, baseline up to day 912 (dependant on group)
To assess the humoral and cellular immunogenicity of RH5.2-VLP and R21 with Matrix-M as assessed by magnitude assessment at various timepoints
Hepatitis B serology, blood samples taken at a number of key timepoints including baseline and post vaccination of V+7 (adults only), V+14, V+28 to allow for magnitude assessment, and late timepoints to assess longevity of response
Measured: From a number of key timepoints, baseline up to day 912 (dependant on group)
To assess the humoral and cellular immunogenicity of RH5.2-VLP and R21 with Matrix-M, performing ELISA at various timepoints
Hepatitis B serology, blood samples taken at a number of key timepoints performing ELISA at specified timepoints
Measured: From a number of key timepoints, baseline up to day 912 (dependant on group)
To assess the humoral and cellular immunogenicity of RH5.2-VLP with Matrix-M when administered to healthy volunteers at different doses and combinations and used in various regimens
Growth Inhibition Activity (GIA) (participants vaccinated with RH5.2-VLP only) performed at peak of response after the third vaccination, based on previous work this is likely to be at V3+14 or V3+28
Measured: Likely at V3+14 or V3+28
To assess the humoral and cellular immunogenicity of RH5.2-VLP and R21 with Matrix-M as assessed by antibody kinetics at various timepoints
Serum total IgG concentration determination, blood samples taken at a number of key timepoints including baseline and post vaccination of V+7 (adults only), V+14, V+28 to allow for antibody kinetics, late timepoints to assess longevity of response
Measured: From a number of key timepoints, baseline up to day 912 (dependant on group)
To assess the humoral and cellular immunogenicity of RH5.2-VLP and R21 with Matrix-M as assessed by magnitude assessment at various timepoints
Serum total IgG concentration determination, blood samples taken at a number of key timepoints including baseline and post vaccination of V+7 (adults only), V+14, V+28 to allow for magnitude assessment, late timepoints to assess longevity of response
Measured: From a number of key timepoints, baseline up to day 912 (dependant on group)
To assess the humoral and cellular immunogenicity of RH5.2-VLP and R21 with Matrix-M, performing ELISA at various timepoints
Serum total IgG concentration determination, blood samples taken at a number of key timepoints performing ELISA at specified timepoints
Measured: From a number of key timepoints, baseline up to day 912 (dependant on group)
To assess the humoral and cellular immunogenicity of R21 with Matrix-M when administered to healthy volunteers at different doses and combinations and used in various regimens
Inhibition of sporozoite invasion assay (ISI) (participants vaccinated with R21 only), blood samples taken at a number of key timepoints including baseline and post vaccination of V+7 (adults only), V+14, V+28 to allow for antibody kinetics and magnitude assessment, and late timepoints to assess longevity of response, performing ELISA at every timepoint where 'immunology serum' is required
Measured: From a number of key timepoints, base line up to day 912 (dependant on group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start10 Jul 2023
- Primary completion11 Dec 2025
- Study completion11 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malaria, Plasmodium FalciparumStudies 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
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP), Medical Research Council Unit, The Gambia
- Responsible party
- Sponsor
- Investigators
- Umberto D'Alessandro, Principal investigator, Medical Research Council Unit, The Gambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357560
- Sponsor's protocol ID
- VAC086
- Status last verified
- May 2026
- First submitted
- 13 Apr 2022
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mo AX, McGugan G, Pesce JT. Meeting report: Expert consultation on late arresting replication competent (LARC) malaria sporozoite vaccine research & development. Vaccine. 2025 Apr 30;54:127009. doi: 10.1016/j.vaccine.2025.127009. Epub 2025 Apr 16.
PubMed 40245769
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Multi-stage Plasmodium Falciparum Malaria Vaccine Study to Assess the Safety and Immunogenicity of the Blood-stage Vaccine Candidate RH5.2 Virus-like Particle (VLP) in Matrix-M and the Pre-erythrocytic Stage Vaccine Candidate R21 in Matrix-M, Both Alone and in Combination, in Adults and Infants in the Gambia
- ClinicalTrials.gov ID
- NCT05357560
- Acronym / sponsor ID
- VAC086
- Conditions
- Malaria, Plasmodium Falciparum
- Keywords
- RH5.2 virus-like particle (VLP), Matrix-M, R21
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP), Medical Research Council Unit, The Gambia
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 11 Dec 2025 (actual)
- Study completion
- 11 Dec 2025 (actual)
- First posted
- 3 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.
This is a Phase Ib multi-stage Plasmodium falciparum malaria vaccine study to assess the safety and immunogenicity of the blood-stage vaccine candidate RH5.2 virus-like particle (VLP) in Matrix-MTM and the pre-erythrocytic stage vaccine candidate R21 in Matrix-MTM, both alone and in combination, in adults and infants in the Gambia
Detailed description
A total of 96 volunteers will be enrolled. Adults (18-45 years) will be enrolled into groups 3 -5. Infants (5 -17 months) will be enrolled into groups 1-2 and groups 6-9. All volunteers will be given 3 doses 50 µg of Matrix-M in combination with RH5.2 VLP and/or R21 via intramuscular (IM) injection in the deltoid region of the non-dominant arm for adults and anterolateral thigh for infants. The first 2 doses will be given at months 0 and 1. Groups 2-6 and group 8 will be given the third dose at month 2, and groups 1, 7 and 9 will be given the third dose at month 6.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Infants R21 delayed 3rd dose | Experimental | Biological: Matrix-M with RH5.2 VLP and/or R2111 volunteers (infant 5-17 months) given 50 µg of Matrix-M in combination with 5µg R21 at months 0, 1 and 6 via intramuscular (IM) injection in the anterolateral thigh |
| Group 2 - Infants R21 standard regimen | Experimental | Biological: Matrix-M with RH5.2 VLP and/or R2111 volunteers (infant 5-17 months) given 50 µg of Matrix-M in combination with 5µg R21 at months 0, 1 and 2 via intramuscular (IM) injection in the anterolateral thigh |
| Group 3 - Adults RH5.2 low dose, standard regimen | Experimental | Biological: Matrix-M with RH5.2 VLP and/or R2110 volunteers (adult 18-45 years) given 50 µg of Matrix-M in combination with 10µg RH5.2 VLP at months 0, 1 and 2 via intramuscular (IM) injection in the deltoid region of the non-dominant arm |
| Group 4 - Adults RH5.2 high dose, standard regimen | Experimental | Biological: Matrix-M with RH5.2 VLP and/or R2110 volunteers (adult 18-45 years) given 50 µg of Matrix-M in combination with 50µg RH5.2 VLP at months 0, 1 and 2 via intramuscular (IM) injection in the deltoid region of the non-dominant arm |
| Group 5 - Adults RH5.2 and R21 low dose, standard regimen | Experimental | Biological: Matrix-M with RH5.2 VLP and/or R2110 volunteers (adult 18-45 years) given 50 µg of Matrix-M in combination with 10µg RH5.2 VLP and 10µg R21 at months 0, 1 and 2 via intramuscular (IM) injection in the deltoid region of the non-dominant arm |
| Group 6 - Infants RH5.2 standard regimen | Experimental | Biological: Matrix-M with RH5.2 VLP and/or R2111 volunteers (infant 5-17 months) given 50µg of Matrix-M in combination with 5µg RH5.2 VLP at months 0, 1 and 2 via intramuscular (IM) injection in the anterolateral thigh |
| Group 7 - Infants RH5.2, delayed 3rd dose | Experimental | Biological: Matrix-M with RH5.2 VLP and/or R2111 volunteers (infant 5-17 months) given 50µg of Matrix-M in combination with 5µg RH5.2 VLP at months 0, 1 and 6 via intramuscular (IM) injection in the anterolateral thigh |
| Group 8 - Infants RH5.2 and R21, standard regimen | Experimental | Biological: Matrix-M with RH5.2 VLP and/or R2111 volunteers (infant 5-17 months) given 50µg of Matrix-M in combination with 5µg RH5.2 VLP and 5µg R21 at months 0, 1 and 2 via intramuscular (IM) injection in the anterolateral thigh |
| Group 9 - Infants RH5.2 and R21, delayed 3rd dose | Experimental | Biological: Matrix-M with RH5.2 VLP and/or R2111 volunteers (infant 5-17 months) given 50µg of Matrix-M in combination with 5µg RH5.2 VLP and 5µg R21 at months 0, 1 and 6 via intramuscular (IM) injection in the anterolateral thigh |
Who may qualify
- Ages
- 5 months to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Groups 1, 2 and 6-9: Healthy male or female infants aged 5-17 months at the time of enrolment with signed consent obtained from parents or guardians.
- Groups 3-5: Healthy male or female adults aged 18-45 years at the time of enrolment with signed consent.
- Groups 3-5 (Female participants only): Must be non-pregnant (as demonstrated by a negative urine pregnancy test), and practice continuous effective contraception for the 24 to 30 month duration of the study (see section 9.9).
- Planned long-term (at least 24 months from the date of recruitment) or permanent residence in the study area.
- Adults with a Body Mass Index (BMI) 18 to 30 Kg/m2; or infants with Z-score of weight-for-age within ±2SD.
Key exclusion criteria (27 listed)
- Clinically significant congenital abnormalities as judged by the PI or other delegated individual
- Clinically significant history of skin disorder (psoriasis, contact dermatitis etc.), allergy, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease and neurological illness as judged by the PI or other delegated individual.
- 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).
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g., Kathon, neomycin, betapropiolactone.
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 |
|---|---|---|
| Matrix-M with RH5.2 VLP and/or R213 doses of 50 µg of Matrix-M in combination with RH5.2 VLP and/or R21 at different doses and at different timepoints | Biological | Group 1 - Infants R21 delayed 3rd dose, Group 2 - Infants R21 standard regimen, Group 3 - Adults RH5.2 low dose, standard regimen, Group 4 - Adults RH5.2 high dose, standard regimen, Group 5 - Adults RH5.2 and R21 low dose, standard regimen, Group 6 - Infants RH5.2 standard regimen, Group 7 - Infants RH5.2, delayed 3rd dose, Group 8 - Infants RH5.2 and R21, standard regimen, Group 9 - Infants RH5.2 and R21, delayed 3rd dose |
Primary outcome
To determine safety and tolerability of RH5.2-VLP with Matrix-M and R21 with Matrix-M, in healthy adults and infants by assessing the occurrence of solicited local reactogenicity signs and symptoms via clinic and home visits
Time frame: 7 days following each vaccination
Occurrence of solicited local reactogenicity signs and symptoms via clinic and home visits
To determine safety and tolerability of RH5.2-VLP with Matrix-M and R21 with Matrix-M, in healthy adults and infants by assessing the occurrence of solicited systemic reactogenicity signs and symptoms via clinic and home visits
Time frame: 7 days following each vaccination
Occurrence of solicited systemic reactogenicity signs and symptoms via clinic and home visits
To determine safety and tolerability of RH5.2-VLP with Matrix-M and R21 with Matrix-M, in healthy adults and infants by assessing occurrence of unsolicited adverse events
Time frame: 28 days following the vaccination
Occurrence of unsolicited adverse events via clinical review, clinical examination (including observations) and laboratory results
Safety of the RH5.2-VLP with Matrix-M and R21 with Matrix-M vaccine, assessed through the number of participants with abnormal laboratory test results
Time frame: 28 days following the vaccination
Occurrence of change from baseline laboratory test results
Assessment of safety and tolerability of RH5.2-VLP with Matrix-M and R21 with Matrix-M, in healthy adults and infants assessed through the number of participants with serious adverse events
Time frame: Whole duration of the study (24-30 months following initial trial vaccination)
Occurrence of serious adverse events including grading of causality
14 secondary outcomes
To assess the humoral and cellular immunogenicity of RH5.2-VLP with Matrix-M as assessed by magnitude assessment at various timepoint
Time frame: From a number of key timepoints, baseline up to day 912 (dependant on group)
To assess the humoral and cellular immunogenicity of RH5.2-VLP with Matrix-M as assessed by antibody kinetics at various timepoints
Time frame: From a number of key timepoints, baseline up to day 912 (dependant on group)
To assess the humoral and cellular immunogenicity of RH5.2-VLP with Matrix-M, performing ELISA at various timepoints
Time frame: From a number of key timepoints, baseline up to day 912 (dependant on group)
To assess the humoral and cellular immunogenicity of R21 with Matrix-M performing ELISA at various timepoints
Time frame: From a number of key timepoints, baseline up to day 912 (dependant on group)
To assess the humoral and cellular immunogenicity of R21 with Matrix-M as assessed by antibody kinetics at various timepoints
Time frame: From a number of key timepoints, baseline up to day 912 (dependant on group)
To assess the humoral and cellular immunogenicity of R21 with Matrix-M as assessed by magnitude assessment at various timepoint
Time frame: From a number of key timepoints, baseline up to day 912 (dependant on group)
To assess the humoral and cellular immunogenicity of RH5.2-VLP and R21 with Matrix-M as assessed by antibody kinetics at various timepoints
Time frame: From a number of key timepoints, baseline up to day 912 (dependant on group)
To assess the humoral and cellular immunogenicity of RH5.2-VLP and R21 with Matrix-M as assessed by magnitude assessment at various timepoints
Time frame: From a number of key timepoints, baseline up to day 912 (dependant on group)
To assess the humoral and cellular immunogenicity of RH5.2-VLP and R21 with Matrix-M, performing ELISA at various timepoints
Time frame: From a number of key timepoints, baseline up to day 912 (dependant on group)
To assess the humoral and cellular immunogenicity of RH5.2-VLP with Matrix-M when administered to healthy volunteers at different doses and combinations and used in various regimens
Time frame: Likely at V3+14 or V3+28
To assess the humoral and cellular immunogenicity of RH5.2-VLP and R21 with Matrix-M as assessed by antibody kinetics at various timepoints
Time frame: From a number of key timepoints, baseline up to day 912 (dependant on group)
To assess the humoral and cellular immunogenicity of RH5.2-VLP and R21 with Matrix-M as assessed by magnitude assessment at various timepoints
Time frame: From a number of key timepoints, baseline up to day 912 (dependant on group)
To assess the humoral and cellular immunogenicity of RH5.2-VLP and R21 with Matrix-M, performing ELISA at various timepoints
Time frame: From a number of key timepoints, baseline up to day 912 (dependant on group)
To assess the humoral and cellular immunogenicity of R21 with Matrix-M when administered to healthy volunteers at different doses and combinations and used in various regimens
Time frame: From a number of key timepoints, base line up to day 912 (dependant on group)
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 12 May 2026.
- Derived from this study: PubMed 40245769Mo AX, McGugan G, Pesce JT. Meeting report: Expert consultation on late arresting replication competent (LARC) malaria sporozoite vaccine research & development. Vaccine. 2025 Apr 30;54:127009. doi: 10.1016/j.vaccine.2025.127009. Epub 2025 Apr 16.
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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.
Umberto D'Alessandro principal investigator
Medical Research Council Unit, The Gambia
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 Matrix-M with RH5.2 VLP and/or R21 in people with Malaria, Plasmodium Falciparum, run by University of Oxford at 1 site in The Gambia.
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 5 inclusion and 27 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 12 May 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 The Gambia. 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?
To determine safety and tolerability of RH5.2-VLP with Matrix-M and R21 with Matrix-M, in healthy adults and infants by assessing the occurrence of solicited local reactogenicity signs and symptoms via clinic and home visits (time frame: 7 days following each vaccination). 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?
On the ClinicalTrials.gov record for NCT05357560, which also lists 1 linked publication.
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 12 May 2026.