MalariaPhase 1NCT01450280
Safety and Immunogenicity of New Malaria Vaccine Candidate ChAd63 CS Administered Alone and With MVA CS
A Phase 1 study testing ChAd63 CS, ChAd63 CS, MVA CS and ChAd63, MVA CS in people with Malaria, run by University of Oxford at 1 site in Ireland.
Trial summary
This is an open label phase I study, to assess the safety of a novel malaria vaccine, AdCh63 CS, simian adenovirus encoding Plasmodium falciparum liver stage antigen, Circumsporozoite protein. All volunteers recruited will be healthy adults. 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 CS, ChAd63 CS, MVA CS and ChAd63, MVA CS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIreland
- Study dates
- Dec 2011to Oct 2012
- 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
- Women only: Must practice continuous effective contraception for the duration of the study
- 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
- History of clinical P. falciparum malaria
- Travel to a malaria endemic region during the study period or within the preceding six months with a significant risk of malaria exposure.
- 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 within the past 6 months (inhaled and topical steroids are allowed)
Show all 19Show fewer
- Pregnancy, breast feeding 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.
- History of clinically significant contact dermatitis.
- Any history of anaphylaxis post vaccination.
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
- 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 5 years preceding enrolment.
- Seropositive for hepatitis B surface antigen (HBsAg).
- Seropositive for hepatitis C virus (antibodies to HCV).
- Any clinically significant abnormal finding on biochemistry or haematology blood tests, urinalysis or clinical examination.
- 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.
Trial locations and contacts
1 site in 1 country.
Ireland1 site
Clinical Research Centre Royal College of Surgeons in Ireland (RCSI), Beaumont Hospital
Dublin
About this study
Official title: A Phase Ia Study to Assess the Safety and Immunogenicity of New Malaria Vaccine Candidates ChAd63 CS Administered Alone and With MVA CS
This is an open label phase I study, to assess the safety of a novel malaria vaccine, AdCh63 CS, simian adenovirus encoding Plasmodium falciparum liver stage antigen, Circumsporozoite protein. All volunteers recruited will be healthy adults. They will be primed with various doses of AdCh63 CS administered intramuscularly. Some of the volunteers will receive a booster vaccination with MVA CS administered via intramuscular route. Safety data will be collected for each vaccination regimen. Secondary aim of this study will be to assess the immune responses generated by vaccination.
- Conditions
- Malaria
- Being tested
- ChAd63 CS, ChAd63 CS, MVA CS, ChAd63, MVA CS
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChAd63 CSBiological
ChAd63 CS 5x10^9 vp intra-muscularly Day 0
ChAd63 CS, MVA CSBiological
ChAd63 CS 5x10^9 vp intra-muscularly Day 0; MVA CS 2x10^8 pfu intra-muscularly Day 56
ChAd63 CSBiological
ChAd63 CS 5x10^10 vp intra-muscularly Day 0
ChAd63, MVA CSBiological
ChAd63 CS 5x10^10 vp intra-muscularly Day 0; MVA CS 2x10^8 pfu intra-muscularly Day 56
| Study group | Role | What they receive |
|---|---|---|
| Group 1A | Experimental | AdCh63 CS 5x10^9 vp Receives: Biological: ChAd63 CS |
| Group 1B | Experimental | ChAd63 CS 5x10^9 vp Day 0; MVA CS 2x10^8 pfu Day 56 Receives: Biological: ChAd63 CS, MVA CS |
| Group 2A | Experimental | AdCh63 CS 5 x 10^10 vp Receives: Biological: ChAd63 CS |
| Group 2B | Experimental | ChAd63 CS 5x10^10 vp Day 0; MVA CS 2x10^8 pfu Day 56 Receives: Biological: ChAd63, MVA CS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessment of new candidate malaria vaccines ChAd63 CS
To assess the safety of new candidate malaria vaccines ChAd63 CS administered alone and with MVA CS in a prime-boost regime to healthy volunteers by recording local and systemic solicited and unsolicited adverse events.
Measured: Participants will be followed for the duration of the study, an expected average of 12 months
Secondary outcomes (1)
Assessment of immune response induced by vaccination
To assess the humoral and cellular immune responses generated by ChAd63 CS when administered to healthy volunteers alone and with MVA CS by assessing induced antibody and T cell response to the vaccine insert.
Measured: Participants will be followed for the duration of the study, an expected average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startDec 2011
- Primary completionOct 2012
- Study completionOct 2012
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
- Sam McConkey, Principal investigator, Clinical Research Centre Royal College of Surgeons in Ireland (RCSI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450280
- Sponsor's protocol ID
- VAC038
- Status last verified
- Nov 2012
- First submitted
- 3 Oct 2011
- Last updated
- 29 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
de Barra E, Hodgson SH, Ewer KJ, Bliss CM, Hennigan K, Collins A, Berrie E, Lawrie AM, Gilbert SC, Nicosia A, McConkey SJ, Hill AV. A phase Ia study to assess the safety and immunogenicity of new malaria vaccine candidates ChAd63 CS administered alone and with MVA CS. PLoS One. 2014 Dec 18;9(12):e115161. doi: 10.1371/journal.pone.0115161. eCollection 2014.
PubMed 25522180
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia Study to Assess the Safety and Immunogenicity of New Malaria Vaccine Candidates ChAd63 CS Administered Alone and With MVA CS
- ClinicalTrials.gov ID
- NCT01450280
- Acronym / sponsor ID
- VAC038
- Conditions
- Malaria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 12 Oct 2011 (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 I study, to assess the safety of a novel malaria vaccine, AdCh63 CS, simian adenovirus encoding Plasmodium falciparum liver stage antigen, Circumsporozoite protein. All volunteers recruited will be healthy adults. They will be primed with various doses of AdCh63 CS administered intramuscularly. Some of the volunteers will receive a booster vaccination with MVA CS administered via intramuscular route. Safety data will be collected for each vaccination regimen. Secondary aim of this study will be to assess the immune responses generated by vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1A | Experimental | Biological: ChAd63 CSAdCh63 CS 5x10^9 vp |
| Group 1B | Experimental | Biological: ChAd63 CS, MVA CSChAd63 CS 5x10^9 vp Day 0; MVA CS 2x10^8 pfu Day 56 |
| Group 2A | Experimental | Biological: ChAd63 CSAdCh63 CS 5 x 10^10 vp |
| Group 2B | Experimental | Biological: ChAd63, MVA CSChAd63 CS 5x10^10 vp Day 0; MVA CS 2x10^8 pfu Day 56 |
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
- Women only: Must practice continuous effective contraception for the duration of the study
- 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.
Key exclusion criteria (19 listed)
- History of clinical P. falciparum malaria
- Travel to a malaria endemic region during the study period or within the preceding six months with a significant risk of malaria exposure.
- 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.
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 CSChAd63 CS 5x10^9 vp intra-muscularly Day 0 | Biological | Group 1A |
| ChAd63 CS, MVA CSChAd63 CS 5x10^9 vp intra-muscularly Day 0; MVA CS 2x10^8 pfu intra-muscularly Day 56 | Biological | Group 1B |
| ChAd63 CSChAd63 CS 5x10^10 vp intra-muscularly Day 0 | Biological | Group 2A |
| ChAd63, MVA CSChAd63 CS 5x10^10 vp intra-muscularly Day 0; MVA CS 2x10^8 pfu intra-muscularly Day 56 | Biological | Group 2B |
Primary outcome
Safety assessment of new candidate malaria vaccines ChAd63 CS
Time frame: Participants will be followed for the duration of the study, an expected average of 12 months
To assess the safety of new candidate malaria vaccines ChAd63 CS administered alone and with MVA CS in a prime-boost regime to healthy volunteers by recording local and systemic solicited and unsolicited adverse events.
1 secondary outcome
Assessment of immune response induced by vaccination
Time frame: Participants will be followed for the duration of the study, an expected average of 12 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 29 Nov 2012.
- Derived from this study: PubMed 25522180de Barra E, Hodgson SH, Ewer KJ, Bliss CM, Hennigan K, Collins A, Berrie E, Lawrie AM, Gilbert SC, Nicosia A, McConkey SJ, Hill AV. A phase Ia study to assess the safety and immunogenicity of new malaria vaccine candidates ChAd63 CS administered alone and with MVA CS. PLoS One. 2014 Dec 18;9(12):e115161. doi: 10.1371/journal.pone.0115161. eCollection 2014.
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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.
Sam McConkey principal investigator
Clinical Research Centre Royal College of Surgeons in Ireland (RCSI)
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 CS, ChAd63 CS, MVA CS and ChAd63, MVA CS in people with Malaria, run by University of Oxford at 1 site in Ireland.
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 29 Nov 2012. 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 Ireland. 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?
Safety assessment of new candidate malaria vaccines ChAd63 CS (time frame: Participants will be followed for the duration of the study, an expected average of 12 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 NCT01450280, 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 29 Nov 2012.