MalariaPhase 1NCT02181088
A Phase Ia Clinical Trial to Assess the Safety and Immunogenicity of New Plasmodium Falciparum Malaria Vaccine Candidates ChAd63 RH5 Alone and With MVA RH5
A Phase 1 study testing ChAd63 RH5 low dose, ChAd63 RH5 full dose and MVA RH5 low dose in people with Malaria and Plasmodium Falciparum, run by University of Oxford at 2 sites in United Kingdom.
Trial summary
The purpose of this study is to assess two new malaria vaccines, ChAd63 RH5 and MVA RH5, at different doses and alone or in combination. The study will enable us to assess the safety of the vaccines and the extent of the immune response in healthy volunteers. 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 Falciparum
- What is being tested?
- ChAd63 RH5 low dose, ChAd63 RH5 full dose and MVA RH5 low dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Aug 2014to Oct 2015
- 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 screening and 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 human immunodeficiency virus (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 vaccination
Show all 19Show fewer
- 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)
- 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 general practitioner (GP) to confirm medical history and safety to participate
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford
Oxford, OX3 7LE
Wellcome Trust CRF, Southampton General Hospital, University of Southampton
Southampton
About this study
The purpose of this study is to assess two new malaria vaccines, ChAd63 RH5 and MVA RH5, at different doses and alone or in combination. The study will enable us to assess the safety of the vaccines and the extent of the immune response in healthy volunteers. We will do this by giving volunteers one or two vaccinations, doing blood tests and collecting information about any symptoms that occur after vaccination. This is the first trial to use these vaccines in humans.
- Conditions
- Malaria, Plasmodium Falciparum
- Being tested
- ChAd63 RH5 low dose, ChAd63 RH5 full dose, MVA RH5 low dose, MVA RH5 full dose
- Keywords
- Malaria, Plasmodium falciparum, RH5
- Medical subject headings
- Malaria, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChAd63 RH5 low doseBiological
Also called ChAd63 RH5
ChAd63 RH5 at 5 x 10^9 vp
ChAd63 RH5 full doseBiological
Also called ChAd63 RH5
ChAd63 RH5 at 5 x 10^10 vp
MVA RH5 low doseBiological
Also called MVA RH5
MVA RH5 at 1 x 10^8 pfu
MVA RH5 full doseBiological
Also called MVA RH5
MVA RH5 at 2 x 10^8 pfu
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (ChAd63 RH5 low dose) | Experimental | 1 dose of ChAd63 RH5 5 x 10^9 vp intramuscularly Receives: Biological: ChAd63 RH5 low dose |
| Group 2A (ChAd63 RH5 full dose) | Experimental | 1 dose of ChAd63 RH5 at 5 x 10^10 vp intramuscularly Receives: Biological: ChAd63 RH5 full dose |
| Group 2B (ChAd63 RH5 full dose and MVA RH5 low dose) | Experimental | 1 dose of ChAd63 RH5 at 5 x 10^10 vp intramuscularly and 1 dose MVA RH5 at 1 x 10^8 pfu 8 weeks later intramuscularly Receives: Biological: ChAd63 RH5 full dose; Biological: MVA RH5 low dose |
| Group 2C (ChAd63 RH5 full dose and MVA RH5 full dose) | Experimental | 1 dose of ChAd63 RH5 at 5 x 10^10 vp intramuscularly and 1 dose MVA RH5 at 2 x 10^8 pfu 8 weeks later intramuscularly Receives: Biological: ChAd63 RH5 full dose; Biological: MVA RH5 full dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of ChAd63 RH5 when administered alone and in heterologous prime-boost with MVA RH5
Occurrence of solicited and unsolicited adverse events will be monitored at each clinic visit from diary cards, clinical review, clinical examination (including observations) and laboratory results.
Measured: 240 days
Secondary outcomes (1)
To assess the cellular and humoral immunogenicity of ChAd63 RH5 when administered alone, and in heterologous prime-boost with MVA RH5 in healthy volunteers.
- falciparum RH5-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, functional antibody assays and B cell analyses. Other exploratory immunological assays including cytokine analysis, other 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.
Measured: 240 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2015
- Study completionOct 2015
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
- 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
- Collaborators
- European Commission
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181088
- Sponsor's protocol ID
- VAC057
- Other IDs
- 2013-005458-31
- Status last verified
- Dec 2015
- First submitted
- 1 Jul 2014
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. 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 Falciparum Malaria Vaccine Candidates ChAd63 RH5 Alone and With MVA RH5
- ClinicalTrials.gov ID
- NCT02181088
- Acronym / sponsor ID
- VAC057
- Conditions
- Malaria, Plasmodium Falciparum
- Keywords
- Malaria, Plasmodium falciparum, RH5
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- Aug 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 3 Jul 2014 (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.
The purpose of this study is to assess two new malaria vaccines, ChAd63 RH5 and MVA RH5, at different doses and alone or in combination. The study will enable us to assess the safety of the vaccines and the extent of the immune response in healthy volunteers. We will do this by giving volunteers one or two vaccinations, doing blood tests and collecting information about any symptoms that occur after vaccination. This is the first trial to use these vaccines in humans.
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 (ChAd63 RH5 low dose) | Experimental | Biological: ChAd63 RH5 low dose1 dose of ChAd63 RH5 5 x 10^9 vp intramuscularly |
| Group 2A (ChAd63 RH5 full dose) | Experimental | Biological: ChAd63 RH5 full dose1 dose of ChAd63 RH5 at 5 x 10^10 vp intramuscularly |
| Group 2B (ChAd63 RH5 full dose and MVA RH5 low dose) | Experimental | Biological: ChAd63 RH5 full dose, Biological: MVA RH5 low dose1 dose of ChAd63 RH5 at 5 x 10^10 vp intramuscularly and 1 dose MVA RH5 at 1 x 10^8 pfu 8 weeks later intramuscularly |
| Group 2C (ChAd63 RH5 full dose and MVA RH5 full dose) | Experimental | Biological: ChAd63 RH5 full dose, Biological: MVA RH5 full dose1 dose of ChAd63 RH5 at 5 x 10^10 vp intramuscularly and 1 dose MVA RH5 at 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 screening and vaccination
- Agreement to refrain from blood donation during the course of the study
Key exclusion criteria (19 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 human immunodeficiency virus (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 RH5 low doseAlso: ChAd63 RH5ChAd63 RH5 at 5 x 10^9 vp | Biological | Group 1 (ChAd63 RH5 low dose) |
| ChAd63 RH5 full doseAlso: ChAd63 RH5ChAd63 RH5 at 5 x 10^10 vp | Biological | Group 2A (ChAd63 RH5 full dose), Group 2B (ChAd63 RH5 full dose and MVA RH5 low dose), Group 2C (ChAd63 RH5 full dose and MVA RH5 full dose) |
| MVA RH5 low doseAlso: MVA RH5MVA RH5 at 1 x 10^8 pfu | Biological | Group 2B (ChAd63 RH5 full dose and MVA RH5 low dose) |
| MVA RH5 full doseAlso: MVA RH5MVA RH5 at 2 x 10^8 pfu | Biological | Group 2C (ChAd63 RH5 full dose and MVA RH5 full dose) |
Primary outcome
To assess the safety of ChAd63 RH5 when administered alone and in heterologous prime-boost with MVA RH5
Time frame: 240 days
Occurrence of solicited and unsolicited adverse events will be monitored at each clinic visit from diary cards, clinical review, clinical examination (including observations) and laboratory results.
1 secondary outcome
To assess the cellular and humoral immunogenicity of ChAd63 RH5 when administered alone, and in heterologous prime-boost with MVA RH5 in healthy volunteers.
Time frame: 240 days
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 3 Dec 2015.
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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 RH5 low dose, ChAd63 RH5 full dose and MVA RH5 low dose in people with Malaria and Plasmodium Falciparum, 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 6 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 3 Dec 2015. 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?
To assess the safety of ChAd63 RH5 when administered alone and in heterologous prime-boost with MVA RH5 (time frame: 240 days). 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 3 Dec 2015.