MalariaPhase 1NCT01669512
Adjuvanting Viral Vectored Malaria Vaccines With Matrix M
A Phase 1 study testing Low Dose Matrix M Regimen and Standard Dose Matrix M Regimen in people with Malaria and Matrix M, run by University of Oxford at 1 site in United Kingdom.
Trial summary
ChAd63 METRAP and MVA METRAP are investigational vaccines for malaria which have been studied in clinical trials for 4 years, and 10 years, respectively. These vaccines are inactivated viruses which have been modified so that they cannot reproduce in humans. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- What is being tested?
- Low Dose Matrix M Regimen and Standard Dose Matrix M Regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2012to Dec 2014
- 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
- Healthy adult 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 their medical history with their General Practitioner
- For female volunteers, willingness to practice continuous effective contraception during the study
- For male volunteers, must use barrier contraception for 3 months from the day of any administration of Matrix M™
- Agreement to refrain from blood donation during the course of the study and for 6 months after the end of their involvement in the study
- Written informed consent
Who cannot join
- Participation in another research study involving 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 use within the past 6 months (inhaled and topical steroids are allowed)
- Pregnancy, lactation, or intention to become pregnant during the study
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products, Kathon
Show all 19Show fewer
- History of clinically significant contact dermatitis Any history of anaphylaxis or hypersensitivity in relation to vaccination
- History or evidence of pre-existing autoimmune or antibody-mediated disease or laboratory evidence of possible autoimmune disease, defined as a positive antinuclear antibody (ANA) result at screening.
- Any history of malaria
- Travel to a malaria endemic region during the study period or within the six months preceding enrolment in the study with significant risk of malaria infection
- 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 42 units every week
- Suspected or known injecting drug abuse in the five years preceding enrolment
- Seropositive for hepatitis B surface antigen (HBsAg)
- Seropositive for hepatitis C virus (antibodies to HCV)
- Any relevant history of cancer (excludes basal cell carcinoma of the skin and cervical carcinoma in situ)
- Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
- 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 study data
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Clinical Vaccinology and Tropical Medicine
Oxford, Oxfordshire, OX3 7LE
About this study
Official title: Safety and Immunogenicity of ChAd63 ME-TRAP / MVA ME-TRAP Heterologous Prime Boost Malaria Vaccination Adjuvanted With Matrix M™
ChAd63 METRAP and MVA METRAP are investigational vaccines for malaria which have been studied in clinical trials for 4 years, and 10 years, respectively. These vaccines are inactivated viruses which have been modified so that they cannot reproduce in humans. Genetic information has been added to make them express proteins of the malaria parasite so that they stimulate an immune response against malaria. This trial examines whether a compound called Matrix M™ can be used in efforts to improve on how well the vaccines work at preventing malaria.
Matrix M™ is a vaccine adjuvant, a compound used to improve the immune responses to vaccines. In this trial, Matrix M™ will be combined with each of the vaccines. The objectives are to assess the safety of the vaccines when combined with Matrix M™, and to determine what effect Matrix M™ has on the immune responses to the vaccines.
We will assess the safety of the vaccines (ChAd63 METRAP combined with Matrix M™; and MVA METRAP combined with Matrix M™) by administering them to healthy volunteers and monitoring them for 6 months in total. Eight volunteers will receive the vaccines with the low dose of Matrix M™, eight will receive the vaccines with the standard dose of Matrix M™, and six volunteers will receive the vaccines alone as a comparison group. We will also look at what effect Matrix M™ has on the immune responses to the vaccines, as measured from blood tests. Volunteers will have study visits to the Clinical Centre for Vaccinology and Tropical Medicine on the Churchill Hospital site, Oxford, where they will have vaccinations, have blood taken to monitor safety and measure immune responses to vaccination, and be monitored for symptoms/side effects from vaccination.
- Being tested
- Control Regimen, Low Dose Matrix M Regimen, Standard Dose Matrix M Regimen
- Keywords
- Malaria vaccine, Matrix M
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control RegimenBiological
ChAd63 ME-TRAP 5 x 1010 vp on Day 0 and MVA ME-TRAP 2 x 108 pfu on Day 56
Low Dose Matrix M RegimenBiological
ChAd63 ME-TRAP 5 x 1010 vp mixed with Matrix M-1 25μg on Day 0 and MVA ME-TRAP 2 x 108 pfu mixed with Matrix M-1 25μg on Day 56
Standard Dose Matrix M RegimenBiological
ChAd63 ME-TRAP 5 x 1010 vp mixed with Matrix M-1 50μg on Day 0 and MVA ME-TRAP 2 x 108 pfu mixed with Matrix M-1 50μg on Day 56
| Study group | Role | What they receive |
|---|---|---|
| Control Regimen | Active comparator | ChAd63 ME-TRAP 5 x 1010 vp on Day 0 and MVA ME-TRAP 2 x 108 pfu on Day 56 6 Volunteers Receives: Biological: Control Regimen |
| Low Dose Matrix M Regimen | Experimental | ChAd63 ME-TRAP 5 x 1010 vp mixed with Matrix M-1 25μg on Day 0 and MVA ME-TRAP 2 x 108 pfu mixed with Matrix M-1 25μg on Day 56 8 Volunteers Receives: Biological: Low Dose Matrix M Regimen |
| Standard Dose Matrix M Regimen | Experimental | ChAd63 ME-TRAP 5 x 1010 vp mixed with Matrix M-1 50μg on Day 0 and MVA ME-TRAP 2 x 108 pfu mixed with Matrix M-1 50μg on Day 56 8 Volunteers Receives: Biological: Standard Dose Matrix M Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of ChAd63 ME-TRAP / MVA ME-TRAP heterologous prime boost vaccination adjuvanted with Matrix M™
Analysis of all solicited and unsolicited local and general vaccine-linked adverse events (AEs) occurring in Low Dose Matrix M™ and Standard Dose Matrix M™ Group volunteers.
Measured: 24 weeks from first vaccination
Secondary outcomes (1)
Assess the effects of Matrix M™ on the immunogenicity of ChAd63 ME-TRAP / MVA ME-TRAP heterologous prime boost vaccination
Comparison of immunogenicity of the Matrix M™ - adjuvanted vaccination regimens, versus the Control regimen.
Measured: 24 weeks from first vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2014
- Study completionDec 2014
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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrian Hill, MD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669512
- Sponsor's protocol ID
- VAC048
- Status last verified
- Jan 2015
- First submitted
- 14 Aug 2012
- Last updated
- 7 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Venkatraman N, Anagnostou N, Bliss C, Bowyer G, Wright D, Lovgren-Bengtsson K, Roberts R, Poulton I, Lawrie A, Ewer K, V S Hill A. Safety and immunogenicity of heterologous prime-boost immunization with viral-vectored malaria vaccines adjuvanted with Matrix-M. Vaccine. 2017 Oct 27;35(45):6208-6217. doi: 10.1016/j.vaccine.2017.09.028. Epub 2017 Sep 21.
PubMed 28941620
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of ChAd63 ME-TRAP / MVA ME-TRAP Heterologous Prime Boost Malaria Vaccination Adjuvanted With Matrix M™
- ClinicalTrials.gov ID
- NCT01669512
- Acronym / sponsor ID
- VAC048
- Keywords
- Malaria vaccine, Matrix M
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Aug 2012 (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.
ChAd63 METRAP and MVA METRAP are investigational vaccines for malaria which have been studied in clinical trials for 4 years, and 10 years, respectively. These vaccines are inactivated viruses which have been modified so that they cannot reproduce in humans. Genetic information has been added to make them express proteins of the malaria parasite so that they stimulate an immune response against malaria. This trial examines whether a compound called Matrix M™ can be used in efforts to improve on how well the vaccines work at preventing malaria.
Matrix M™ is a vaccine adjuvant, a compound used to improve the immune responses to vaccines. In this trial, Matrix M™ will be combined with each of the vaccines. The objectives are to assess the safety of the vaccines when combined with Matrix M™, and to determine what effect Matrix M™ has on the immune responses to the vaccines.
We will assess the safety of the vaccines (ChAd63 METRAP combined with Matrix M™; and MVA METRAP combined with Matrix M™) by administering them to healthy volunteers and monitoring them for 6 months in total. Eight volunteers will receive the vaccines with the low dose of Matrix M™, eight will receive the vaccines with the standard dose of Matrix M™, and six volunteers will receive the vaccines alone as a comparison group. We will also look at what effect Matrix M™ has on the immune responses to the vaccines, as measured from blood tests. Volunteers will have study visits to the Clinical Centre for Vaccinology and Tropical Medicine on the Churchill Hospital site, Oxford, where they will have vaccinations, have blood taken to monitor safety and measure immune responses to vaccination, and be monitored for symptoms/side effects from vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Regimen | Active comparator | Biological: Control RegimenChAd63 ME-TRAP 5 x 1010 vp on Day 0 and MVA ME-TRAP 2 x 108 pfu on Day 56 6 Volunteers |
| Low Dose Matrix M Regimen | Experimental | Biological: Low Dose Matrix M RegimenChAd63 ME-TRAP 5 x 1010 vp mixed with Matrix M-1 25μg on Day 0 and MVA ME-TRAP 2 x 108 pfu mixed with Matrix M-1 25μg on Day 56 8 Volunteers |
| Standard Dose Matrix M Regimen | Experimental | Biological: Standard Dose Matrix M RegimenChAd63 ME-TRAP 5 x 1010 vp mixed with Matrix M-1 50μg on Day 0 and MVA ME-TRAP 2 x 108 pfu mixed with Matrix M-1 50μg on Day 56 8 Volunteers |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy adult 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 their medical history with their General Practitioner
- For female volunteers, willingness to practice continuous effective contraception during the study
- For male volunteers, must use barrier contraception for 3 months from the day of any administration of Matrix M™
Key exclusion criteria (19 listed)
- Participation in another research study involving 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 use within the past 6 months (inhaled and topical steroids are allowed)
- Pregnancy, lactation, or intention to become pregnant during the study
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 |
|---|---|---|
| Control RegimenChAd63 ME-TRAP 5 x 1010 vp on Day 0 and MVA ME-TRAP 2 x 108 pfu on Day 56 | Biological | Control Regimen |
| Low Dose Matrix M RegimenChAd63 ME-TRAP 5 x 1010 vp mixed with Matrix M-1 25μg on Day 0 and MVA ME-TRAP 2 x 108 pfu mixed with Matrix M-1 25μg on Day 56 | Biological | Low Dose Matrix M Regimen |
| Standard Dose Matrix M RegimenChAd63 ME-TRAP 5 x 1010 vp mixed with Matrix M-1 50μg on Day 0 and MVA ME-TRAP 2 x 108 pfu mixed with Matrix M-1 50μg on Day 56 | Biological | Standard Dose Matrix M Regimen |
Primary outcome
To assess the safety of ChAd63 ME-TRAP / MVA ME-TRAP heterologous prime boost vaccination adjuvanted with Matrix M™
Time frame: 24 weeks from first vaccination
Analysis of all solicited and unsolicited local and general vaccine-linked adverse events (AEs) occurring in Low Dose Matrix M™ and Standard Dose Matrix M™ Group volunteers.
1 secondary outcome
Assess the effects of Matrix M™ on the immunogenicity of ChAd63 ME-TRAP / MVA ME-TRAP heterologous prime boost vaccination
Time frame: 24 weeks from first vaccination
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 7 Jan 2015.
- Derived from this study: PubMed 28941620Venkatraman N, Anagnostou N, Bliss C, Bowyer G, Wright D, Lovgren-Bengtsson K, Roberts R, Poulton I, Lawrie A, Ewer K, V S Hill A. Safety and immunogenicity of heterologous prime-boost immunization with viral-vectored malaria vaccines adjuvanted with Matrix-M. Vaccine. 2017 Oct 27;35(45):6208-6217. doi: 10.1016/j.vaccine.2017.09.028. Epub 2017 Sep 21.
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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.
Adrian Hill, MD 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 Low Dose Matrix M Regimen and Standard Dose Matrix M Regimen in people with Malaria and Matrix M, 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 19 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 7 Jan 2015. 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 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 assess the safety of ChAd63 ME-TRAP / MVA ME-TRAP heterologous prime boost vaccination adjuvanted with Matrix M™ (time frame: 24 weeks from first vaccination). 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 NCT01669512, 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 7 Jan 2015.