Malaria,FalciparumPhase 1NCT04130282
VAC077: Safety and Immunogenicity of the Pfs25-IMX313/Matrix-M Vaccine
A Phase 1 study testing Pfs25-IMX313/Matrix-M1 in people with Malaria,Falciparum, run by University of Oxford at 1 site in United Kingdom.
Trial summary
This is an open label, single-site, first-in-human, Phase Ia study to assess safety and immunogenicity of the Plasmodium falciparum malaria vaccine candidate Pfs25-IMX313 in Matrix-M1 adjuvant in healthy adults living in the UK Volunteers will receive 3 doses of vaccine over 2 months and will be followed up for… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria,Falciparum
- What is being tested?
- Pfs25-IMX313/Matrix-M1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Sep 2019to 22 Sep 2020
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The volunteer must satisfy all the following criteria to be eligible for the study:
- 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 General Practitioner.
- Women only: Must practice continuous effective contraception for the duration of the study
- Agreement to refrain from blood donation for the duration of the study
- Written informed consent to participate in the trial.
Who cannot join
- The volunteer may not enter the study if any of the following apply:
- 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) at any time in the past.
- Receipt of any vaccine in the 30 days preceding enrolment, or planned receipt of any other vaccine within 30 days following each vaccination
- Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period.
Show all 23Show fewer
- Concurrent involvement in another clinical trial or planned involvement during the study period
- 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 (e.g. egg products)
- 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 or (unless has taken part in a prior hepatitis C vaccine study with confirmed negative HCV antibodies prior to participation in that study, and negative HCV 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
CCVTM, University of Oxford, Churchill Hospital
Oxford, OX3 7LE
About this study
Official title: A Phase Ia Study to Assess Safety and Immunogenicity of the Plasmodium Falciparum Malaria Vaccine Candidate Pfs25-IMX313 in Matrix-M1 Adjuvant in Healthy Adults Living in the UK
This is an open label, single-site, first-in-human, Phase Ia study to assess safety and immunogenicity of the Plasmodium falciparum malaria vaccine candidate Pfs25-IMX313 in Matrix-M1 adjuvant in healthy adults living in the UK
Volunteers will receive 3 doses of vaccine over 2 months and will be followed up for approximately 8 months.
Read the detailed description
This Phase 1a clinical trial is designed primarily to assess the safety and tolerability of the Pfs25-IMX313/Matrix-M transmission blocking vaccine in healthy adult volunteers. An important secondary objective is to to assess the immune response to the vaccine.
8 volunteers will receive 3 doses of 10µg Pfs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56. Blood samples will be taken for safety testing and to collect information about the immune response. Any symptoms that occur after vaccination will also be recorded.
Healthy volunteers aged 18-45 will be recruited in England at the Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford.
- Conditions
- Malaria,Falciparum
- Being tested
- Pfs25-IMX313/Matrix-M1
- Keywords
- Pfs25
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pfs25-IMX313/Matrix-M1Biological
3 doses of 10µg Pfs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 8 volunteers receiving 3 doses of 10µg Pfs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56 Receives: Biological: Pfs25-IMX313/Matrix-M1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of safety and reactogenicity through collection of data on the frequency, duration and severity of solicited and unsolicited adverse events.
The following parameters will be assessed:
- Frequency, duration and severity of solicited local reactogenicity signs and symptoms for 7 days following each vaccination
- Frequency, duration and severity of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination
- Frequency, duration and severity of unsolicited adverse events for 28 days following the vaccination
- Change from baseline for safety haematological and biochemical laboratory measures, which will presented according to local grading scales, for 28 days following vaccination
- Frequency, duration and severity of serious adverse events during the whole study duration
Measured: 8 months
Secondary outcomes (2)
Humoral and cellular immunogenicity of the Pfs25-IMX313/Matrix-M1 vaccine, when administered to healthy adult volunteers
Pfs25-specific immunogenicity will be assessed by immunological assays, with comparison before and after vaccination. The main outcome measures will be humoral and B cell responses to the Pfs25 protein - total IgG, isotypes and avidity; T cell responses to Pfs25 by ex vivo ELISpot and flow cytometry assays.
Measured: 8 months
Ex-vivo efficacy of the Pfs25-IMX313/Matrix-M1 vaccine, when administered to healthy adult volunteers
Ex vivo functional blocking activity of purified IgG against the P. falciparum NF54 strain will be assessed by standard membrane feeding assay.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start27 Sep 2019
- Primary completion22 Sep 2020
- Study completion22 Sep 2020
Why it stopped: Delays caused by Covid-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria,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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela Minassian, PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130282
- Sponsor's protocol ID
- VAC077
- Status last verified
- Sep 2020
- First submitted
- 8 Oct 2019
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. 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 Falciparum Malaria Vaccine Candidate Pfs25-IMX313 in Matrix-M1 Adjuvant in Healthy Adults Living in the UK
- ClinicalTrials.gov ID
- NCT04130282
- Acronym / sponsor ID
- VAC077
- Conditions
- Malaria,Falciparum
- Keywords
- Pfs25
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Delays caused by Covid-19
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 22 Sep 2020 (actual)
- Study completion
- 22 Sep 2020 (actual)
- First posted
- 17 Oct 2019 (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 an open label, single-site, first-in-human, Phase Ia study to assess safety and immunogenicity of the Plasmodium falciparum malaria vaccine candidate Pfs25-IMX313 in Matrix-M1 adjuvant in healthy adults living in the UK
Volunteers will receive 3 doses of vaccine over 2 months and will be followed up for approximately 8 months.
Detailed description
This Phase 1a clinical trial is designed primarily to assess the safety and tolerability of the Pfs25-IMX313/Matrix-M transmission blocking vaccine in healthy adult volunteers. An important secondary objective is to to assess the immune response to the vaccine.
8 volunteers will receive 3 doses of 10µg Pfs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56. Blood samples will be taken for safety testing and to collect information about the immune response. Any symptoms that occur after vaccination will also be recorded.
Healthy volunteers aged 18-45 will be recruited in England at the Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Pfs25-IMX313/Matrix-M18 volunteers receiving 3 doses of 10µg Pfs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 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 General Practitioner.
- Women only: Must practice continuous effective contraception for the duration of the study
- Agreement to refrain from blood donation for the duration of the study
Key exclusion criteria (23 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) at any time in the past.
- Receipt of any vaccine in the 30 days preceding enrolment, or planned receipt of any other vaccine within 30 days following each 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 |
|---|---|---|
| Pfs25-IMX313/Matrix-M13 doses of 10µg Pfs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56 | Biological | Group 1 |
Primary outcome
Assessment of safety and reactogenicity through collection of data on the frequency, duration and severity of solicited and unsolicited adverse events.
Time frame: 8 months
The following parameters will be assessed: * Frequency, duration and severity of solicited local reactogenicity signs and symptoms for 7 days following each vaccination * Frequency, duration and severity of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination * Frequency, duration and severity of unsolicited adverse events for 28 days following the vaccination * Change from baseline for safety haematological and biochemical laboratory measures, which will presented according to local grading scales, for 28 days following vaccination * Frequency, duration and severity of serious adverse events during the whole study duration
2 secondary outcomes
Humoral and cellular immunogenicity of the Pfs25-IMX313/Matrix-M1 vaccine, when administered to healthy adult volunteers
Time frame: 8 months
Ex-vivo efficacy of the Pfs25-IMX313/Matrix-M1 vaccine, when administered to healthy adult volunteers
Time frame: 8 months
Results and safety
The study was stopped early (reason given: Delays caused by Covid-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
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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 Minassian, PhD principal investigator
University of Oxford
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 Pfs25-IMX313/Matrix-M1 in people with Malaria,Falciparum, 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 7 inclusion and 23 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 29 Sep 2020. 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?
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 was stopped early (reason given: Delays caused by Covid-19). Results are not available in the source record.
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?
Assessment of safety and reactogenicity through collection of data on the frequency, duration and severity of solicited and unsolicited adverse events. (time frame: 8 months). 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 29 Sep 2020.