MalariaPhase 1NCT01816113
Phase Ia Study of ChAd63/MVA PvDBP
A Phase 1 study testing ChAd63 PvDBP 5 x 10^9, ChAd63 PvDBP 5 x 10^10 and MVA PvDBP 1 x 10^8 in people with Malaria and Plasmodium Vivax, run by University of Oxford at 1 site in United Kingdom.
Trial summary
This is an open label phase Ia study, to assess the safety of two novel malaria vaccines, ChAd63 PvDBP, with or without MVA PvDBP. Heterologous prime-boost with ChAd63-MVA is, to our knowledge, one of the most potent T cell-inducing subunit vaccine regimens which can importantly also induce antibodies. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Plasmodium Vivax
- What is being tested?
- ChAd63 PvDBP 5 x 10^9, ChAd63 PvDBP 5 x 10^10 and MVA PvDBP 1 x 10^8
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2013to Jul 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 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 during the study and a negative pregnancy test on the day(s) of vaccination.
- Agreement to refrain from blood donation during the course of the study.
- -Provide written informed consent.
Who cannot join
- 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, Kathon.
- History of clinically significant contact dermatitis.
Show all 20Show fewer
- Any history of anaphylaxis in reaction 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.
- 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) with positive PCR for hepatitis C at screening.
- History of clinical malaria (any species).
- Travel to a malaria endemic region during the study period or within the previous six months.
- 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 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
Centre for Clinical Vaccinology and Tropical Medicine
Oxford, Oxfordshire, OX3 7LE
About this study
Official title: A Phase Ia Clinical Trial to Assess the Safety and Immunogenicity of New Plasmodium Vivax Malaria Vaccine Candidates ChAd63 PvDBP Alone and With MVA PvDBP
This is an open label phase Ia study, to assess the safety of two novel malaria vaccines, ChAd63 PvDBP, with or without MVA PvDBP. Heterologous prime-boost with ChAd63-MVA is, to our knowledge, one of the most potent T cell-inducing subunit vaccine regimens which can importantly also induce antibodies. Previous clinical trials using this regimen expressing ME-TRAP, AMA1 \& MSP1, have shown that administering ChAd63 as a prime followed 8 weeks later by MVA as a boost is a very immunogenic schedule (32-34). For this reason, and to provide comparability with previous ChAd63-MVA trials, we propose to use a similar administration schedule.
- Conditions
- Malaria, Plasmodium Vivax
- Being tested
- ChAd63 PvDBP 5 x 10^9, ChAd63 PvDBP 5 x 10^10, MVA PvDBP 1 x 10^8, MVA PvDBP 2 x 10^8
- Keywords
- PvDBP, Malaria, Plasmodium vivax
- Medical subject headings
- Malaria, Malaria, Vivax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChAd63 PvDBP 5 x 10^9Biological
1 dose of ChAd63 PvDBP 5 x 10^9 vp intramuscularly
ChAd63 PvDBP 5 x 10^10Biological
1 dose of ChAd63 PvDBP 5 x 10^10 vp intramuscularly
MVA PvDBP 1 x 10^8Biological
1 dose MVA PvDBP 1 x 108 pfu 8 weeks later intramuscularly
MVA PvDBP 2 x 10^8Biological
1 dose MVA PvDBP 2 x 108 pfu 8 weeks later intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 4 volunteers; 1 dose of ChAd63 PvDBP 5 x 10^9 vp intramuscularly Receives: Biological: ChAd63 PvDBP 5 x 10^9 |
| Group 2A | Experimental | 4 volunteers; 1 dose of ChAd63 PvDBP 5 x 10^10 vp intramuscularly Receives: Biological: ChAd63 PvDBP 5 x 10^10 |
| Group 2B | Experimental | 8 volunteers; 1 dose of ChAd63 PvDBP 5 x 10^10 vp intramuscularly and 1 dose MVA PvDBP 1 x 10^8 pfu 8 weeks later intramuscularly Receives: Biological: ChAd63 PvDBP 5 x 10^10; Biological: MVA PvDBP 1 x 10^8 |
| Group 2C | Experimental | 8 volunteers; 1 dose of ChAd63 PvDBP 5 x 10^10 vp intramuscularly and 1 dose MVA PvDBP 2 x 10^8 pfu 8 weeks later intramuscularly Receives: Biological: ChAd63 PvDBP 5 x 10^10; Biological: MVA PvDBP 2 x 10^8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety in healthy volunteers of two new candidate malaria vaccines, ChAd63 PvDBP administered alone, and with MVA PvDBP, in a prime-boost regime.
To assess the safety of ChAd63 PvDBP when administered alone and in heterologous prime-boost with MVA PvDBP. Safety will be assessed by the frequency, incidence and nature of adverse events and serious adverse events arising during the study as well as abnormalities in Hematology and Biochemistry lab tests.
Measured: Up to 20 weeks post first vaccination
Secondary outcomes (1)
The humoral and cellular immunogenicity of ChAd63 PvDBP, when administered to healthy volunteers alone and with MVA PvDBP.
PvDBP_RII-specific immunogenicity will be assessed by a variety of immunological assays. These may include ex vivo ELISpot assays for interferon gamma and flow cytometry assays, as well as antibody ELISAs. Other exploratory immunological assays including cytokine analysis, antibody assays, anti-adenovirus antibodies, DNA analysis of genetic polymorphisms potentially relevant to vaccine immunogenicity and gene expression studies amongst others may be performed at the discretion of the investigators.
Other exploratory immunology may be carried out in collaboration with other specialist labs, including labs outside of Europe. This would involve transfer of serum/plasma, but samples will be anonymised. Volunteers will be consented beforehand.
Measured: U to 20 weeks post 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 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2014
- Study completionJul 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrian V S Hill, MD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816113
- Sponsor's protocol ID
- VAC051
- Status last verified
- May 2017
- First submitted
- 13 Mar 2013
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Payne RO, Silk SE, Elias SC, Milne KH, Rawlinson TA, Llewellyn D, Shakri AR, Jin J, Labbe GM, Edwards NJ, Poulton ID, Roberts R, Farid R, Jorgensen T, Alanine DG, de Cassan SC, Higgins MK, Otto TD, McCarthy JS, de Jongh WA, Nicosia A, Moyle S, Hill AV, Berrie E, Chitnis CE, Lawrie AM, Draper SJ. Human vaccination against Plasmodium vivax Duffy-binding protein induces strain-transcending antibodies. JCI Insight. 2017 Jun 15;2(12):e93683. doi: 10.1172/jci.insight.93683. eCollection 2017 Jun 15.
PubMed 28614791
Study at a glance
From the registry record, last updated by the sponsor on 8 May 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 and Immunogenicity of New Plasmodium Vivax Malaria Vaccine Candidates ChAd63 PvDBP Alone and With MVA PvDBP
- ClinicalTrials.gov ID
- NCT01816113
- Acronym / sponsor ID
- VAC051
- Conditions
- Malaria, Plasmodium Vivax
- Keywords
- PvDBP, Malaria, Plasmodium vivax
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 21 Mar 2013 (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 an open label phase Ia study, to assess the safety of two novel malaria vaccines, ChAd63 PvDBP, with or without MVA PvDBP. Heterologous prime-boost with ChAd63-MVA is, to our knowledge, one of the most potent T cell-inducing subunit vaccine regimens which can importantly also induce antibodies. Previous clinical trials using this regimen expressing ME-TRAP, AMA1 \& MSP1, have shown that administering ChAd63 as a prime followed 8 weeks later by MVA as a boost is a very immunogenic schedule (32-34). For this reason, and to provide comparability with previous ChAd63-MVA trials, we propose to use a similar administration schedule.
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 | Experimental | Biological: ChAd63 PvDBP 5 x 10^94 volunteers; 1 dose of ChAd63 PvDBP 5 x 10^9 vp intramuscularly |
| Group 2A | Experimental | Biological: ChAd63 PvDBP 5 x 10^104 volunteers; 1 dose of ChAd63 PvDBP 5 x 10^10 vp intramuscularly |
| Group 2B | Experimental | Biological: ChAd63 PvDBP 5 x 10^10, Biological: MVA PvDBP 1 x 10^88 volunteers; 1 dose of ChAd63 PvDBP 5 x 10^10 vp intramuscularly and 1 dose MVA PvDBP 1 x 10^8 pfu 8 weeks later intramuscularly |
| Group 2C | Experimental | Biological: ChAd63 PvDBP 5 x 10^10, Biological: MVA PvDBP 2 x 10^88 volunteers; 1 dose of ChAd63 PvDBP 5 x 10^10 vp intramuscularly and 1 dose MVA PvDBP 2 x 10^8 pfu 8 weeks later intramuscularly |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 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 during the study and a negative pregnancy test on the day(s) of vaccination.
- Agreement to refrain from blood donation during the course of the study.
Key exclusion criteria (20 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, Kathon.
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 PvDBP 5 x 10^91 dose of ChAd63 PvDBP 5 x 10^9 vp intramuscularly | Biological | Group 1 |
| ChAd63 PvDBP 5 x 10^101 dose of ChAd63 PvDBP 5 x 10^10 vp intramuscularly | Biological | Group 2A, Group 2B, Group 2C |
| MVA PvDBP 1 x 10^81 dose MVA PvDBP 1 x 108 pfu 8 weeks later intramuscularly | Biological | Group 2B |
| MVA PvDBP 2 x 10^81 dose MVA PvDBP 2 x 108 pfu 8 weeks later intramuscularly | Biological | Group 2C |
Primary outcome
The safety in healthy volunteers of two new candidate malaria vaccines, ChAd63 PvDBP administered alone, and with MVA PvDBP, in a prime-boost regime.
Time frame: Up to 20 weeks post first vaccination
To assess the safety of ChAd63 PvDBP when administered alone and in heterologous prime-boost with MVA PvDBP. Safety will be assessed by the frequency, incidence and nature of adverse events and serious adverse events arising during the study as well as abnormalities in Hematology and Biochemistry lab tests.
1 secondary outcome
The humoral and cellular immunogenicity of ChAd63 PvDBP, when administered to healthy volunteers alone and with MVA PvDBP.
Time frame: U to 20 weeks post 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 8 May 2017.
- Derived from this study: PubMed 28614791Payne RO, Silk SE, Elias SC, Milne KH, Rawlinson TA, Llewellyn D, Shakri AR, Jin J, Labbe GM, Edwards NJ, Poulton ID, Roberts R, Farid R, Jorgensen T, Alanine DG, de Cassan SC, Higgins MK, Otto TD, McCarthy JS, de Jongh WA, Nicosia A, Moyle S, Hill AV, Berrie E, Chitnis CE, Lawrie AM, Draper SJ. Human vaccination against Plasmodium vivax Duffy-binding protein induces strain-transcending antibodies. JCI Insight. 2017 Jun 15;2(12):e93683. doi: 10.1172/jci.insight.93683. eCollection 2017 Jun 15.
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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 V S 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 ChAd63 PvDBP 5 x 10^9, ChAd63 PvDBP 5 x 10^10 and MVA PvDBP 1 x 10^8 in people with Malaria and Plasmodium 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 20 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 8 May 2017. 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?
The safety in healthy volunteers of two new candidate malaria vaccines, ChAd63 PvDBP administered alone, and with MVA PvDBP, in a prime-boost regime. (time frame: Up to 20 weeks post 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 NCT01816113, 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 8 May 2017.