MalariaPhase 1/2NCT01003314
A Study of the Safety and Effectiveness of Two New Malaria Vaccines
A Phase 1/2 study testing AdCh63-MSP1 (lower dose) vaccine and MVA-MSP1 vaccine and AdCh63-MSP1 vaccine (higher dose) and MVA-MSP1 vaccine followed by challenge in people with Malaria, run by University of Oxford at 1 site in United Kingdom.
Trial summary
This study aims to test the safety of two new malaria vaccines AdCh63 MSP1 and MVA MSP1. These vaccines consist of inactivated viruses which have been modified - so they cannot reproduce (replicate) in humans, and also to include genetic material (genes) for malaria proteins which are expressed by the malaria parasite… 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?
- AdCh63-MSP1 (lower dose) vaccine and MVA-MSP1 vaccine and AdCh63-MSP1 vaccine (higher dose) and MVA-MSP1 vaccine followed by challenge
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2009to Sep 2010
- Phase
- Phase 1/2
- 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 and/or challenge
- For males only, willingness to use barrier contraception until 3 months after last vaccination
- Agreement to refrain from blood donation during the course of the study
- Written informed consent
Who cannot join
- Significant concern raised by GP in relation to participation
- 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 a recombinant adenoviral and/or MVA-vectored vaccine
- 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
Show all 26Show fewer
- History of clinically significant contact dermatitis
- A predicted ten year risk of fatal cardiovascular disease of =>5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system [59]
- History of arrhythmia or congenital QT interval prolongation
- Family history of sudden cardiac death
- Contraindication to both anti-malarial drugs (Riamet and chloroquine)
- o concomitant use with other drugs known to cause QT-interval prolongation, (e.g. macrolides, quinolones, amiodarone etc)
- 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
- Seropositive for hepatitis B surface antigen (HBsAg)
- Seropositive for hepatitis C virus (antibodies to HCV)
- Any other significant disease, disorder or finding, which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or may influence the result of the study, or the volunteer's ability to participate in the study
- Any history of malaria
- 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 finding which in the opinion of the investigators would significantly increase the risk of having an adverse outcome from participating in the protocol.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford
Oxford
About this study
Official title: A Phase I/IIa Study to Assess the Safety and Immunogenicity of New Malaria Vaccine Candidates AdCh63 MSP1 Alone and With MVA MSP1
This study aims to test the safety of two new malaria vaccines AdCh63 MSP1 and MVA MSP1. These vaccines consist of inactivated viruses which have been modified - so they cannot reproduce (replicate) in humans, and also to include genetic material (genes) for malaria proteins which are expressed by the malaria parasite during blood stage infection. The vaccines are designed to stimulate an immune response to these malaria proteins (immunogenicity describes the nature and magnitude of this immune response), to provide protection against malaria infection. This protection has been demonstrated in nonhuman studies. Although these vaccines have not been given to humans before, similar vaccines using the same viruses with different malaria genes have been given to humans before. In these studies, the vaccines have been shown to be safe. They have also provided evidence from laboratory tests of immunogenicity. In this study the investigators main aim is to ensure these new vaccines given alone and in combination are safe. The investigators will increase the dose of the first vaccine (AdCh63 MSP1) given to volunteers if the initial dose is safe. The investigators also wish to ensure that challenging a small number of volunteers who have received both vaccines with malaria infection from the bites of infected mosquitos(sporozoite challenge) is safe. Sporozoite challenge has been widely used in humans to test the effectiveness of malaria vaccines and is considered a well established, reliable, predictable and safe system.In the study the investigators will also look for evidence of immunogenicity of these new vaccines, and whether there is any delay to developing malaria following sporozoite challenge. The study will be conducted at the University of Oxfords Centre for Clinical Vaccinology and Tropical Medicine (CCVTM). The challenge part of the study will take place at the insectary at Imperial College, (Infection and Immunity Section)in London.
- Conditions
- Malaria
- Being tested
- AdCh63-MSP1 (lower dose) vaccine and MVA-MSP1 vaccine, AdCh63-MSP1 vaccine (higher dose) and MVA-MSP1 vaccine followed by challenge
- Keywords
- Vaccine, Safety, Immunogenicity, Protection, Sporozoite challenge
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdCh63-MSP1 (lower dose) vaccine and MVA-MSP1 vaccineBiological
Group 1A: single dose of AdCh63-MSP1 vaccine 5 x 10^9 vp administered IM. Group 1B: single dose of AdCh63-MSP1 vaccine 5 x 10^9 vp administered IM followed by a single dose of MVA-MSP1 vaccine 5 x 10^8 vp administered IM 8 weeks later
AdCh63-MSP1 vaccine (higher dose) and MVA-MSP1 vaccine followed by challengeBiological
Group 2A: single dose of AdCh63-MSP1 vaccine 5 x 10^10 vp administered IM. Group 2B: single dose of AdCh63-MSP1 vaccine 5 x 10^10 vp administered IM followed by a single dose of MVA-MSP1 vaccine 5 x 10^8 vp administered IM 8 weeks later. Group 2C: single dose of AdCh63-MSP1 vaccine 5 x 10^10 vp administered IM followed by a single dose of MVA-MSP1 vaccine 5 x 10^8 vp administered IM 8 weeks later and subsequent sporozoite malaria challenge 12-28 days post second vaccination
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Biological: AdCh63-MSP1 (lower dose) vaccine and MVA-MSP1 vaccine |
| Group 2 | Experimental | Not described Receives: Biological: AdCh63-MSP1 vaccine (higher dose) and MVA-MSP1 vaccine followed by challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of new candidate malaria vaccines AdCh63 MSP1 administered alone, and with MVA MSP1 in a prime-boost regime, to healthy volunteers. and safety of the prime-boost vaccine strategy following malaria sporozoite challenge.
Measured: Up to 6 months post enrollment into the study
Secondary outcomes (1)
Humoral and cellular immune responses generated by AdCh63 MSP1, when administered to healthy volunteers alone, with MVA MSP1, and following sporozoite challenge. Efficacy of AdCh63 MSP1 and MVA MSP1 against malaria sporozoite challenge
Measured: Up to 6 months post enrollment into the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Investigators
- Adrian VS Hill, D.Phil, FRCP, Principal investigator, Univeristy of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003314
- Sponsor's protocol ID
- VAC037
- Status last verified
- Mar 2011
- First submitted
- 27 Oct 2009
- Last updated
- 28 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Study to Assess the Safety and Immunogenicity of New Malaria Vaccine Candidates AdCh63 MSP1 Alone and With MVA MSP1
- ClinicalTrials.gov ID
- NCT01003314
- Acronym / sponsor ID
- VAC037
- Conditions
- Malaria
- Keywords
- Vaccine, Safety, Immunogenicity, Protection, Sporozoite challenge
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 28 Oct 2009 (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 study aims to test the safety of two new malaria vaccines AdCh63 MSP1 and MVA MSP1. These vaccines consist of inactivated viruses which have been modified - so they cannot reproduce (replicate) in humans, and also to include genetic material (genes) for malaria proteins which are expressed by the malaria parasite during blood stage infection. The vaccines are designed to stimulate an immune response to these malaria proteins (immunogenicity describes the nature and magnitude of this immune response), to provide protection against malaria infection. This protection has been demonstrated in nonhuman studies. Although these vaccines have not been given to humans before, similar vaccines using the same viruses with different malaria genes have been given to humans before. In these studies, the vaccines have been shown to be safe. They have also provided evidence from laboratory tests of immunogenicity. In this study the investigators main aim is to ensure these new vaccines given alone and in combination are safe. The investigators will increase the dose of the first vaccine (AdCh63 MSP1) given to volunteers if the initial dose is safe. The investigators also wish to ensure that challenging a small number of volunteers who have received both vaccines with malaria infection from the bites of infected mosquitos(sporozoite challenge) is safe. Sporozoite challenge has been widely used in humans to test the effectiveness of malaria vaccines and is considered a well established, reliable, predictable and safe system.In the study the investigators will also look for evidence of immunogenicity of these new vaccines, and whether there is any delay to developing malaria following sporozoite challenge. The study will be conducted at the University of Oxfords Centre for Clinical Vaccinology and Tropical Medicine (CCVTM). The challenge part of the study will take place at the insectary at Imperial College, (Infection and Immunity Section)in London.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: AdCh63-MSP1 (lower dose) vaccine and MVA-MSP1 vaccine |
| Group 2 | Experimental | Biological: AdCh63-MSP1 vaccine (higher dose) and MVA-MSP1 vaccine followed by challenge |
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 during the study and a negative pregnancy test on the day(s) of vaccination and/or challenge
- For males only, willingness to use barrier contraception until 3 months after last vaccination
Key exclusion criteria (26 listed)
- Significant concern raised by GP in relation to participation
- 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 a recombinant adenoviral and/or MVA-vectored vaccine
- 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)
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 |
|---|---|---|
| AdCh63-MSP1 (lower dose) vaccine and MVA-MSP1 vaccineGroup 1A: single dose of AdCh63-MSP1 vaccine 5 x 10^9 vp administered IM. Group 1B: single dose of AdCh63-MSP1 vaccine 5 x 10^9 vp administered IM followed by a single dose of MVA-MSP1 vaccine 5 x 10^8 vp administered IM 8 weeks later | Biological | Group 1 |
| AdCh63-MSP1 vaccine (higher dose) and MVA-MSP1 vaccine followed by challengeGroup 2A: single dose of AdCh63-MSP1 vaccine 5 x 10^10 vp administered IM. Group 2B: single dose of AdCh63-MSP1 vaccine 5 x 10^10 vp administered IM followed by a single dose of MVA-MSP1 vaccine 5 x 10^8 vp administered IM 8 weeks later. Group 2C: single dose of AdCh63-MSP1 vaccine 5 x 10^10 vp administered IM followed by a single dose of MVA-MSP1 vaccine 5 x 10^8 vp administered IM 8 weeks later and subsequent sporozoite malaria challenge 12-28 days post second vaccination | Biological | Group 2 |
Primary outcome
Safety of new candidate malaria vaccines AdCh63 MSP1 administered alone, and with MVA MSP1 in a prime-boost regime, to healthy volunteers. and safety of the prime-boost vaccine strategy following malaria sporozoite challenge.
Time frame: Up to 6 months post enrollment into the study
1 secondary outcome
Humoral and cellular immune responses generated by AdCh63 MSP1, when administered to healthy volunteers alone, with MVA MSP1, and following sporozoite challenge. Efficacy of AdCh63 MSP1 and MVA MSP1 against malaria sporozoite challenge
Time frame: Up to 6 months post enrollment into the study
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 28 Mar 2011.
Related trials for Malaria
Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
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 VS Hill, D.Phil, FRCP principal investigator
Univeristy 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 1/2 study testing AdCh63-MSP1 (lower dose) vaccine and MVA-MSP1 vaccine and AdCh63-MSP1 vaccine (higher dose) and MVA-MSP1 vaccine followed by challenge in people with Malaria, 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 26 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 28 Mar 2011. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety of new candidate malaria vaccines AdCh63 MSP1 administered alone, and with MVA MSP1 in a prime-boost regime, to healthy volunteers. and safety of the prime-boost vaccine strategy following malaria sporozoite challenge. (time frame: Up to 6 months post enrollment into the study). 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 28 Mar 2011.