MalariaPhase 1NCT02532049
A Clinical Trial to Assess the Safety and Immunogenicity of New Malaria Vaccine Candidates ChAd63 Pfs25-IMX313 and MVA Pfs25-IMX313
A Phase 1 study testing ChAd63 Pfs25-IMX313 and MVA Pfs25-IMX313 in people with Malaria, run by University of Oxford at 2 sites in United Kingdom.
Trial summary
This is a clinical trial in which healthy volunteers will be administered one or two experimental malaria vaccines. ChAd Pfs-IMX313 will either be administered alone or with MVA Pfs25-IMX313 in a prime-boost regime. All vaccines will be administered intramuscularly. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- ChAd63 Pfs25-IMX313 and MVA Pfs25-IMX313
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 12 Oct 2015to 25 May 2017
- 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 50 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 adults aged 18 to 50 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
- For females only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening and vaccination
- Agreement to refrain from blood donation during the course of the study
- Provide written informed consent
Who cannot join
- The volunteer may not enter the study if any of the following apply:
- Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
- Prior receipt of an investigational malaria vaccine or any other investigational vaccine likely to impact on interpretation of the trial data.
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- 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.
Show all 15Show fewer
- Any history of anaphylaxis in relation to vaccination
- Pregnancy, lactation or willingness/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 likely to 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 42 units every week
- Suspected or known injecting drug abuse in the 5 years preceding enrolment
- Seropositive for hepatitis B surface antigen (HBsAg)
- Seropositive for hepatitis C virus (antibodies to HCV)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
CCVTM, University of Oxford, Churchill Hospital
Oxford, OX3 7LE
NIHR Wellcome Trust Clinical Research Facility
Southampton, SO16 6YD
About this study
Official title: A Phase Ia Clinical Trial to Assess the Safety, Immunogenicity and Ex-vivo Efficacy of New Plasmodium Falciparum Malaria Vaccine Candidates ChAd63 Pfs-IMX313 Alone and With MVA Pfs25-IMX313
This is a clinical trial in which healthy volunteers will be administered one or two experimental malaria vaccines. ChAd Pfs-IMX313 will either be administered alone or with MVA Pfs25-IMX313 in a prime-boost regime.
All vaccines will be administered intramuscularly.
Read more
Group 1 will receive one dose of ChAd63 Pfs25-IMX313 at 5x10^9 vp.
Group 2A will receive one dose of ChAd63 Pfs-IMX313 at 5x10^10 vp.
Group 2B will receive one dose of ChAd63 Pfs-IMX313 at 5x10^10 vp and one dose of MVA Pfs25-IMX313 at 1x10^8 pfu eight weeks later.
Group 2C will receive one dose of ChAd63 Pfs25-IMX313 at 5x10^10 vp and one dose of MVA Pfs25-IMX313 at 2x10^8 pfu eight weeks later.
The study will assess the safety of the vaccinations, and the immune responses to the vaccination. Immune responses are measured by tests on blood samples.
Healthy volunteers will be recruited in Oxford and Southampton, England.
- Conditions
- Malaria
- Being tested
- ChAd63 Pfs25-IMX313, MVA Pfs25-IMX313
- Keywords
- Malaria, Vaccine, Immune Response
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChAd63 Pfs25-IMX313Biological
MVA Pfs25-IMX313Biological
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | ChAd63 Pfs25-IMX313 (5x10^9 vp) Receives: Biological: ChAd63 Pfs25-IMX313 |
| Group 2A | Active comparator | ChAd63 Pfs25-IMX313 (5x10^10 vp) Receives: Biological: ChAd63 Pfs25-IMX313 |
| Group 2B | Active comparator | ChAd63 Pfs25-IMX313 (5x10^10) and MVA Pfs25-IMX313 (1x10^8 pfu) 8 weeks later Receives: Biological: ChAd63 Pfs25-IMX313; Biological: MVA Pfs25-IMX313 |
| Group 2C | Active comparator | ChAd63 Pfs25-IMX313 (5x10^10) and MVA Pfs25-IMX313 (2x10^8 pfu) 8 weeks later Receives: Biological: ChAd63 Pfs25-IMX313; Biological: MVA Pfs25-IMX313 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events.
Measured: 8 months
Secondary outcomes (2)
Immunogenicity of ChAd63 Pfs25-IMX313 when administered to healthy volunteers alone, and with MVA Pfs25-IMX313 in a prime-boost regime.
Measured: 8 months
Ex-vivo efficacy of ChAd63 Pfs25-IMX313 when administered to healthy volunteers alone, and with MVA Pfs25-IMX313 in a prime-boost regime. The functional activity of the vaccine induced antibodies will be tested using membrane-feeding assays.
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 posted25 Aug 2015 (estimated)
- Study start12 Oct 2015
- Primary completion25 May 2017
- Study completion25 May 2017
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 MalariaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532049
- Sponsor's protocol ID
- VAC062
- Status last verified
- Jul 2017
- First submitted
- 7 Aug 2015
- Last updated
- 17 Jul 2017
- Results posted
- No
Publications
de Graaf H, Payne RO, Taylor I, Miura K, Long CA, Elias SC, Zaric M, Minassian AM, Silk SE, Li L, Poulton ID, Baker M, Draper SJ, Gbesemete D, Brendish NJ, Martins F, Marini A, Mekhaiel D, Edwards NJ, Roberts R, Vekemans J, Moyle S, Faust SN, Berrie E, Lawrie AM, Hill F, Hill AVS, Biswas S. Safety and Immunogenicity of ChAd63/MVA Pfs25-IMX313 in a Phase I First-in-Human Trial. Front Immunol. 2021 Jul 14;12:694759. doi: 10.3389/fimmu.2021.694759. eCollection 2021.
PubMed 34335606
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia Clinical Trial to Assess the Safety, Immunogenicity and Ex-vivo Efficacy of New Plasmodium Falciparum Malaria Vaccine Candidates ChAd63 Pfs-IMX313 Alone and With MVA Pfs25-IMX313
- ClinicalTrials.gov ID
- NCT02532049
- Acronym / sponsor ID
- VAC062
- Conditions
- Malaria
- Keywords
- Malaria, Vaccine, Immune Response
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 12 Oct 2015 (actual)
- Primary completion
- 25 May 2017 (actual)
- Study completion
- 25 May 2017 (actual)
- First posted
- 25 Aug 2015 (estimated)
- 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 clinical trial in which healthy volunteers will be administered one or two experimental malaria vaccines. ChAd Pfs-IMX313 will either be administered alone or with MVA Pfs25-IMX313 in a prime-boost regime.
All vaccines will be administered intramuscularly.
Group 1 will receive one dose of ChAd63 Pfs25-IMX313 at 5x10^9 vp.
Group 2A will receive one dose of ChAd63 Pfs-IMX313 at 5x10^10 vp.
Group 2B will receive one dose of ChAd63 Pfs-IMX313 at 5x10^10 vp and one dose of MVA Pfs25-IMX313 at 1x10^8 pfu eight weeks later.
Group 2C will receive one dose of ChAd63 Pfs25-IMX313 at 5x10^10 vp and one dose of MVA Pfs25-IMX313 at 2x10^8 pfu eight weeks later.
The study will assess the safety of the vaccinations, and the immune responses to the vaccination. Immune responses are measured by tests on blood samples.
Healthy volunteers will be recruited in Oxford and Southampton, England.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Biological: ChAd63 Pfs25-IMX313ChAd63 Pfs25-IMX313 (5x10^9 vp) |
| Group 2A | Active comparator | Biological: ChAd63 Pfs25-IMX313ChAd63 Pfs25-IMX313 (5x10^10 vp) |
| Group 2B | Active comparator | Biological: ChAd63 Pfs25-IMX313, Biological: MVA Pfs25-IMX313ChAd63 Pfs25-IMX313 (5x10^10) and MVA Pfs25-IMX313 (1x10^8 pfu) 8 weeks later |
| Group 2C | Active comparator | Biological: ChAd63 Pfs25-IMX313, Biological: MVA Pfs25-IMX313ChAd63 Pfs25-IMX313 (5x10^10) and MVA Pfs25-IMX313 (2x10^8 pfu) 8 weeks later |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy adults aged 18 to 50 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
- For females only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening and vaccination
- Agreement to refrain from blood donation during the course of the study
Key exclusion criteria (15 listed)
- Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
- Prior receipt of an investigational malaria vaccine or any other investigational vaccine likely to impact on interpretation of the trial data.
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- 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.
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 |
|---|---|---|
| ChAd63 Pfs25-IMX313 | Biological | Group 1, Group 2A, Group 2B, Group 2C |
| MVA Pfs25-IMX313 | Biological | Group 2B, Group 2C |
Primary outcome
Number of Adverse Events
Time frame: 8 months
The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events.
2 secondary outcomes
Immunogenicity of ChAd63 Pfs25-IMX313 when administered to healthy volunteers alone, and with MVA Pfs25-IMX313 in a prime-boost regime.
Time frame: 8 months
Ex-vivo efficacy of ChAd63 Pfs25-IMX313 when administered to healthy volunteers alone, and with MVA Pfs25-IMX313 in a prime-boost regime. The functional activity of the vaccine induced antibodies will be tested using membrane-feeding assays.
Time frame: 8 months
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 17 Jul 2017.
- Derived from this study: PubMed 34335606de Graaf H, Payne RO, Taylor I, Miura K, Long CA, Elias SC, Zaric M, Minassian AM, Silk SE, Li L, Poulton ID, Baker M, Draper SJ, Gbesemete D, Brendish NJ, Martins F, Marini A, Mekhaiel D, Edwards NJ, Roberts R, Vekemans J, Moyle S, Faust SN, Berrie E, Lawrie AM, Hill F, Hill AVS, Biswas S. Safety and Immunogenicity of ChAd63/MVA Pfs25-IMX313 in a Phase I First-in-Human Trial. Front Immunol. 2021 Jul 14;12:694759. doi: 10.3389/fimmu.2021.694759. eCollection 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ChAd63 Pfs25-IMX313 and MVA Pfs25-IMX313 in people with Malaria, run by University of Oxford at 2 sites 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 15 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 17 Jul 2017. 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 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?
Number of 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?
On the ClinicalTrials.gov record for NCT02532049, 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 17 Jul 2017.