Malaria, VivaxEarly Phase 1NCT05270265

Safety and Immunogenicity of Pvs25-IMX313/Matrix-M1 Vaccine

A Early Phase 1 study testing Pvs25-IMX313/Matrix-M1 in people with Malaria, Vivax, run by University of Oxford at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is an open-label, single-centre, non-randomised, first-in-human Phase Ia study to assess the safety and immunogenicity of the Pvs25-IMX313 vaccine, administered in Matrix-M1 adjuvant. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Malaria, Vivax
What is being tested?: Pvs25-IMX313/Matrix-M1
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteUnited Kingdom
Study dates: 9 Feb 2022to 31 Jul 2023
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adult aged 18 to 45 years.
Able and willing (in the Investigator's opinion) to comply with all study requirements.
Willing to allow the Investigators to discuss the volunteer's medical history with their GP.
Volunteers with the potential to become pregnant only: must practice continuous effective contraception for the duration of the study. Acceptable forms of contraception for volunteers of child-bearing potential are: Established use of oral, injected or implanted hormonal methods of contraception, Placement of an intrauterine device or intrauterine system, Male sterilization (if the vasectomised partner is the sole partner for the participant), True abstinence from sex with sperm-producing partners, when this is in line with the preferred and usual lifestyle of the participant (periodic abstinence and withdrawal are not acceptable methods of contraception).
Agreement to refrain from blood donation for the duration of the study.
Able and willing to provide written informed consent to participate in the trial.

Who cannot join

History of clinical malaria (any species).
Travel to a clearly malaria endemic locality during the study period or within the preceding six months.
Use of immunoglobulins or blood products (e.g., blood transfusion) in the last three months.
Receipt of any vaccine in the 30 days preceding enrolment, or planned receipt of any other vaccine within 30 days following each study vaccination, with the exception of --COVID-19 vaccines, which should not be received between 14 days before to 7 days after any study vaccination.
Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period.
Concurrent involvement in another clinical trial or planned involvement during the study period.

Show all 30Show fewer

Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data, as assessed by the Investigator.
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 allergic disease or reactions likely to be exacerbated by any component of the -vaccine.
Any history of anaphylaxis in reaction to vaccinations.
Pregnancy, lactation or intention to become pregnant during the study.
History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
History of serious psychiatric condition that may affect participation in the study.
Any other serious chronic illness requiring hospital specialist supervision.
Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 25 standard UK units every week.
Suspected or known injecting drug abuse in the 5 years preceding enrolment.
Hepatitis B surface antigen (HBsAg) detected in serum.
Seropositive for hepatitis C virus (antibodies to HCV) at screening (unless volunteer has taken part in a prior hepatitis C vaccine study with confirmed negative HCV antibodies prior to participation in that study, and negative HCV ribonucleic acid (RNA) PCR at screening for this study).
Volunteers unable to be closely followed for social, geographic or psychological reasons.
Any clinically significant abnormal finding on biochemistry or haematology blood tests, urinalysis or clinical examination. In the event of abnormal test results, confirmatory repeat tests will be requested. Procedures for identifying laboratory values meeting exclusion criteria are shown in SOP VC027.
Any other significant disease, disorder, or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
Inability of the study team to contact the volunteer's GP to confirm medical history and safety to participate.
Vaccination and re-vaccination exclusion criteria:
Absolute contraindications:
Anaphylactic reaction following administration of vaccine
Pregnancy
Contraindications at that point in time (may be rescheduled):
Acute disease (moderate/severe illness with or without fever)
T>37.5C
Current COVID-19 infection, defined as ongoing symptoms with positive COVID-19 PCR swab 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 or rapid antigen test, as long as symptoms are improving or resolved. 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.

United Kingdom1 site

CCVTM, University of Oxford, Churchill Hospital
Oxford, OX3 7LE

Other trials in United Kingdom

About this study

Official title: A Phase Ia Study to Assess Safety and Immunogenicity of the Plasmodium Vivax Malaria Vaccine Candidate Pvs25-IMX313 in Matrix-M1 Adjuvant in Healthy Adults Living in the UK

This is an open-label, single-centre, non-randomised, first-in-human Phase Ia study to assess the safety and immunogenicity of the Pvs25-IMX313 vaccine, administered in Matrix-M1 adjuvant.

Read the detailed description

Volunteers will be recruited into one of three groups (n=8-10 per group) at the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Oxford over approximately 18 months. All volunteers will receive three doses of Pvs25-IMX313 in Matrix-M1, administered intramuscularly and given four weeks apart. Enrolment will be staggered with clinical and safety reviews, follow-up visits and monitoring via a diary card.

Conditions: Malaria, Vivax
Being tested: Pvs25-IMX313/Matrix-M1
Keywords: Pvs25-IMX313, Matrix-M1
Medical subject headings: Malaria, Vivax

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pvs25-IMX313/Matrix-M1Biological
Three doses of Pvs25-IMX313 in Matrix-M1 at different concentrations

Study groups in NCT05270265
Study group	Role	What they receive
Group 1 (low dose)	Experimental	8-10 volunteers receiving three doses of 10 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm Receives: Biological: Pvs25-IMX313/Matrix-M1
Group 2 (standard dose)	Experimental	8-10 volunteers receiving three doses of 50 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm Receives: Biological: Pvs25-IMX313/Matrix-M1
Group 3 (fractional dose)	Experimental	8-10 volunteers receiving two doses of 50 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0 and 28, followed by one dose of 10 µg Pvs25-IMX313 in 50 µg Matrix-M1 on day 56 via intramuscular injection (IM) in the deltoid region of the arm Receives: Biological: Pvs25-IMX313/Matrix-M1

What is being measured

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

Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms
Number of participants in each group who reported solicited local reactogenicity signs and symptoms in the 7 days following each vaccination. Solicited local reactogenicity signs and symptoms are collected through participant-reported e-diaries.
Measured: 7 days following each vaccination
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms.
Number of participants in each group who reported solicited systemic reactogenicity signs and symptoms in the 7 days following each vaccination. Solicited systemic reactogenicity signs and symptoms are collected through participant-reported e-diaries.
Measured: 7 days following each vaccination
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events.
Unsolicited adverse events were collected for 28 days following each vaccination through participant-reported e-diaries.
Measured: 28 days following each vaccination
Safety of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Occurrence of Abnormal Laboratory Test Results
Occurrence of change from baseline laboratory test results
Measured: 28 days following vaccination
Safety and Tolerability of the Pvs25-IMx313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Serious Adverse Events
Number of serious adverse events reported per group throughout the study period.
Measured: Whole duration of the study period (8 months following enrolment)

Secondary outcomes (4)

Humoral Immunogenicity of the Pvs25-IMX313/Matrix-M1 Vaccine When Administered to Healthy Adult Volunteers: Humoral Responses to the Pvs25 Protein
Antibody responses to the Pvs25 protein will be assessed through total IgG isotypes and avidity
Measured: Days 1, 29, 57, 140 and 240.
Cellular Immunogenicity of the Pvs25-IMX313/Matrix-M1 Vaccine When Administered to Healthy Adult Volunteers: Cellular Responses to the Pvs25 Protein.
T cell responses to Pvs25 will be assessed by ex vivo enzyme-linked immunospot assays (ELISpot) and flow cytometry assays.
Measured: Days 1, 29, 57, 140 and 240.
Ex Vivo Efficacy of the Pvs25-IMX313/Matrix-M1 Vaccine When Administered to Healthy Adult Volunteers: Transmission-Reducing Activity
Transmission-reducing activity will be assessed through direct membrane feeding assays (DMFA).
Measured: Days 1, 29, 57, 140 and 240.
Ex Vivo Efficacy of the Pvs25-IMX313/Matrix-M1 Vaccine When Administered to Healthy Adult Volunteers: Transmission-Blocking Activity
Transmission-blocking activity will be assessed through direct membrane feeding assays (DMFA).
Measured: Days 1, 29, 57, 140 and 240.

Timeline

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

9 Feb 202231 Jul 2023

First posted8 Mar 2022
Study start9 Feb 2022
Primary completion31 Jul 2023
Study completion31 Jul 2023

Why it stopped: The study was terminated due to administrative delays in the approval of a substantial amendment to extend the shelf-life of Pvs25-IMX313. Regulatory approval was only received on 11 August 2023, after end of study visits had already been conducted.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Malaria, VivaxStudies 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: Early Phase 1
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05270265
Sponsor's protocol ID: VAC084
Status last verified: Aug 2024
First submitted: 28 Jan 2022
Last updated: 15 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Malaria, Vivax trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ia Study to Assess Safety and Immunogenicity of the Plasmodium Vivax Malaria Vaccine Candidate Pvs25-IMX313 in Matrix-M1 Adjuvant in Healthy Adults Living in the UK
ClinicalTrials.gov ID: NCT05270265
Acronym / sponsor ID: VAC084
Conditions: Malaria, Vivax
Keywords: Pvs25-IMX313, Matrix-M1
Phase: Early Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated due to administrative delays in the approval of a substantial amendment to extend the shelf-life of Pvs25-IMX313. Regulatory approval was only received on 11 August 2023, after end of study visits had already been conducted.
Enrolment: 25 participants (actual)
Lead sponsor: University of OxfordUniversity, hospital or other
Study start: 9 Feb 2022 (actual)
Primary completion: 31 Jul 2023 (actual)
Study completion: 31 Jul 2023 (actual)
First posted: 8 Mar 2022 (actual)
Results: Posted 15 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is an open-label, single-centre, non-randomised, first-in-human Phase Ia study to assess the safety and immunogenicity of the Pvs25-IMX313 vaccine, administered in Matrix-M1 adjuvant.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group 1 (low dose)	Experimental	Biological: Pvs25-IMX313/Matrix-M18-10 volunteers receiving three doses of 10 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm
Group 2 (standard dose)	Experimental	Biological: Pvs25-IMX313/Matrix-M18-10 volunteers receiving three doses of 50 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm
Group 3 (fractional dose)	Experimental	Biological: Pvs25-IMX313/Matrix-M18-10 volunteers receiving two doses of 50 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0 and 28, followed by one dose of 10 µg Pvs25-IMX313 in 50 µg Matrix-M1 on day 56 via intramuscular injection (IM) in the deltoid region of the arm

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Healthy adult aged 18 to 45 years.
Able and willing (in the Investigator's opinion) to comply with all study requirements.
Willing to allow the Investigators to discuss the volunteer's medical history with their GP.
Volunteers with the potential to become pregnant only: must practice continuous effective contraception for the duration of the study. Acceptable forms of contraception for volunteers of child-bearing potential are: Established use of oral, injected or implanted hormonal methods of contraception, Placement of an intrauterine device or intrauterine system, Male sterilization (if the vasectomised partner is the sole partner for the participant), True abstinence from sex with sperm-producing partners, when this is in line with the preferred and usual lifestyle of the participant (periodic abstinence and withdrawal are not acceptable methods of contraception).
Agreement to refrain from blood donation for the duration of the study.

Key exclusion criteria (30 listed)

History of clinical malaria (any species).
Travel to a clearly malaria endemic locality during the study period or within the preceding six months.
Use of immunoglobulins or blood products (e.g., blood transfusion) in the last three months.
Receipt of any vaccine in the 30 days preceding enrolment, or planned receipt of any other vaccine within 30 days following each study vaccination, with the exception of --COVID-19 vaccines, which should not be received between 14 days before to 7 days after any study vaccination.
Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period.

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
Pvs25-IMX313/Matrix-M1Three doses of Pvs25-IMX313 in Matrix-M1 at different concentrations	Biological	Group 1 (low dose), Group 2 (standard dose), Group 3 (fractional dose)

Primary outcome

Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms
Time frame: 7 days following each vaccination
Number of participants in each group who reported solicited local reactogenicity signs and symptoms in the 7 days following each vaccination. Solicited local reactogenicity signs and symptoms are collected through participant-reported e-diaries.
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms.
Time frame: 7 days following each vaccination
Number of participants in each group who reported solicited systemic reactogenicity signs and symptoms in the 7 days following each vaccination. Solicited systemic reactogenicity signs and symptoms are collected through participant-reported e-diaries.
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events.
Time frame: 28 days following each vaccination
Unsolicited adverse events were collected for 28 days following each vaccination through participant-reported e-diaries.
Safety of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Occurrence of Abnormal Laboratory Test Results
Time frame: 28 days following vaccination
Occurrence of change from baseline laboratory test results
Safety and Tolerability of the Pvs25-IMx313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Serious Adverse Events
Time frame: Whole duration of the study period (8 months following enrolment)
Number of serious adverse events reported per group throughout the study period.

4 secondary outcomes

Humoral Immunogenicity of the Pvs25-IMX313/Matrix-M1 Vaccine When Administered to Healthy Adult Volunteers: Humoral Responses to the Pvs25 Protein
Time frame: Days 1, 29, 57, 140 and 240.
Cellular Immunogenicity of the Pvs25-IMX313/Matrix-M1 Vaccine When Administered to Healthy Adult Volunteers: Cellular Responses to the Pvs25 Protein.
Time frame: Days 1, 29, 57, 140 and 240.
Ex Vivo Efficacy of the Pvs25-IMX313/Matrix-M1 Vaccine When Administered to Healthy Adult Volunteers: Transmission-Reducing Activity
Time frame: Days 1, 29, 57, 140 and 240.
Ex Vivo Efficacy of the Pvs25-IMX313/Matrix-M1 Vaccine When Administered to Healthy Adult Volunteers: Transmission-Blocking Activity
Time frame: Days 1, 29, 57, 140 and 240.

Results and safety

Results posted to the registry on 15 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1 (Low Dose)	8	8
Group 2 (Standard Dose)	9	8
Group 3 (Fractional Dose)	8	8

Primary outcome: Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms

Time frame: 7 days following each vaccination. Count of participants. Unit: Participants

Measure	Group 1 (Low Dose) n = 8	Group 2 (Standard Dose) n = 9	Group 3 (Fractional Dose) n = 8
Warmth: Mild	1	3	3
Warmth: Moderate	0	0	0
Warmth: Severe	0	0	0
Redness: Mild	0	0	0
Redness: Moderate	0	0	0
Redness: Severe	0	0	0
Itch: Mild	1	0	0
Itch: Moderate	0	0	0

Population analysed: Percentages are the proportion of participants in each group that reported each symptom after at least one vaccination. Group 1: All participants received three vaccinations Group 2: 9 participants received vaccinations 1 and 2, 7 participants received vaccination 3 Group 3: 8 participants received vaccinations 1 and 2, 6 participants received vaccination 3

Primary outcome: Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms.

Time frame: 7 days following each vaccination. Count of participants. Unit: Participants

Measure	Group 1 (Low Dose) n = 8	Group 2 (Standard Dose) n = 9	Group 3 (Fractional Dose) n = 8
Arthralgia: Mild	1	2	3
Arthralgia: Moderate	0	0	0
Arthralgia: Severe	0	0	0
Fatigue: Mild	7	7	6
Fatigue: Moderate	1	4	2
Fatigue: Severe	0	0	1
Myalgia: Mild	2	4	5
Myalgia: Moderate	1	0	1

Primary outcome: Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events.

Time frame: 28 days following each vaccination. Number. Unit: Number of events

Measure	Group 1 (Low Dose) n = 8	Group 2 (Standard Dose) n = 9	Group 3 (Fractional Dose) n = 8
Total unsolicited adverse events (UAEs)	56	54	53
UAEs - no relationship to investigational vaccine	26	20	14
UAEs - unlikely related to investigational vaccine	22	21	31
UAEs - possibly related to investigational vaccine	5	12	6
UAEs - probably related to investigational vaccine	3	1	2
UAEs - definitely related to investigational vaccine	0	0	0

Primary outcome: Safety of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Occurrence of Abnormal Laboratory Test Results

Time frame: 28 days following vaccination. Number. Unit: Number of abnormal laboratory results

Measure	Group 1 (Low Dose) n = 8	Group 2 (Standard Dose) n = 9	Group 3 (Fractional Dose) n = 8
Grade 1 laboratory abnormalities	47	25	21
Grade 2 laboratory abnormalities	3	5	4
Grade 3 laboratory abnormalities	0	2	1

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: Low Dose	0 of 8 (0%)	8 of 8 (100%)	0 of 8
Group 2: Mid Dose	0 of 9 (0%)	9 of 9 (100%)	0 of 9
Group 3: Fractional Dose	0 of 8 (0%)	8 of 8 (100%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Angela M Minassian, DPhil FRCP principal investigator

Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, United

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Pvs25-IMX313/Matrix-M1 in people with Malaria, Vivax, run by University of Oxford at 1 site in United Kingdom.

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 30 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: stopped early, as of the sponsor's last update on 15 Jan 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 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms (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 NCT05270265.

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 15 Jan 2026.