MalariaPhase 1NCT01351948
Safety and Immunogenicity of Malaria Vaccines AdCh63 AMA1, MVA AMA1 and AMA1-C1/Alhydrogel®+/- CPG 7909
A Phase 1 study testing AdCh63 AMA1 + MVA AMA1 + AMA1-C1/Alhydrogel®+ CPG 7909, AdCh63 AMA1 + AMA1-C1/Alhydrogel®+ CPG 7909 and AdCh63 AMA1 + AMA1-C1/Alhydrogel® in people with Malaria, run by University of Oxford at 1 site in United Kingdom.
Trial summary
This study aims to compare the safety and immunogenicity of AdCh63 AMA1 and MVA AMA1vaccine candidates administered alone and with adjuvants in various schedules. These vaccines consist of inactivated viruses which have been modified, so they cannot reproduce in humans, and also to include genetic material for malaria… 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 AMA1 + MVA AMA1 + AMA1-C1/Alhydrogel®+ CPG 7909, AdCh63 AMA1 + AMA1-C1/Alhydrogel®+ CPG 7909 and AdCh63 AMA1 + AMA1-C1/Alhydrogel®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2011to Mar 2013
- 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.
- Men only: Must use barrier contraception from day of any vaccination with CPG 7909, for 3 months.
- 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 21Show fewer
- 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.
- History of clinically significant contact dermatitis.
- History of a known allergy to nickel (volunteers may be enrolled in group 5 if they have an allergy to nickel)
- 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).
- History or evidence of pre-existing autoimmune or antibody mediated disease or laboratory evidence of possible autoimmune disease, defined as anti-dsDNA ≥ 25 IU/mL or a positive antinuclear antibody (ANA) result at screening.
- 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.
United Kingdom1 site
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Old Road, Headington
Oxford, OX3 7LJ
About this study
Official title: A Phase Ia Study to Assess the Safety and Immunogenicity of Novel Schedules for Vaccination With the Candidate Malaria Vaccines; AdCh63 AMA1, MVA AMA1 & AMA1-C1/Alhydrogel® +/- CPG 7909
This study aims to compare the safety and immunogenicity of AdCh63 AMA1 and MVA AMA1vaccine candidates administered alone and with adjuvants in various schedules. These vaccines consist of inactivated viruses which have been modified, so they cannot reproduce in humans, and also to include genetic material for malaria protein AMA1 which is expressed by the malaria parasite during blood stage infection. The vaccines are designed to stimulate an immune response to this malaria protein and thus provide protection against malaria infection. Adjuvants are a crucial component of modern vaccine regimens, increasing the immunogenicity and potency of protein vaccines. In this study we will assess whether virus vectored vaccines combined with protein in adjuvant AMA1-C1/Alhydrogel® and CPG 7909 adjuvant (emulsion containing TLR agonist) can induce stronger and more durable immune response.
- Conditions
- Malaria
- Being tested
- AdCh63 AMA1 + MVA AMA1 + AMA1-C1/Alhydrogel®+ CPG 7909, AdCh63 AMA1 + AMA1-C1/Alhydrogel®+ CPG 7909, AdCh63 AMA1 + AMA1-C1/Alhydrogel®, AdCh63 AMA1 AMA1-C1/Alhydrogel®+ CPG 7909, AdCh63 AMA1 + MVA AMA1
- Keywords
- Immune response
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdCh63 AMA1 + MVA AMA1 + AMA1-C1/Alhydrogel®+ CPG 7909Biological
5x10^10 vp AdCh63 AMA1 Day 0, 1.25x10^8 pfu MVA AMA1 Day 56, AMA1-C1/Alhydrogel®+ CPG 7909 (80ug, 800ug, 564ug respectively) Day 112. IM injections
AdCh63 AMA1 + AMA1-C1/Alhydrogel®+ CPG 7909Biological
5x10^10 vp AdCh63 AMA1 Day 0,AMA1-C1/Alhydrogel®+ CPG 7909 (80ug, 800ug, 564ug respectively) Day 56. IM injections
AdCh63 AMA1 + AMA1-C1/Alhydrogel®Biological
5x10^10 vp AdCh63 AMA1 Day 0, AMA1-C1/Alhydrogel® (80ug, 800ug respectively) Day 56. IM injections
AdCh63 AMA1 AMA1-C1/Alhydrogel®+ CPG 7909Biological
5x10^10 vp AdCh63 AMA1 Day 0, AMA1-C1/Alhydrogel®+ CPG 7909 (80ug, 800ug, 564ug respectively) Day 112. IM injections
AdCh63 AMA1 + MVA AMA1Biological
5x10^10 vp AdCh63 AMA1 Day 0, 1.25x10^8 pfu MVA AMA1 Day 112. IM injections
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | AdCh63 AMA1 + MVA AMA1 + AMA1-C1/Alhydrogel®+ CPG 7909 Receives: Biological: AdCh63 AMA1 + MVA AMA1 + AMA1-C1/Alhydrogel®+ CPG 7909 |
| Group 2 | Experimental | AdCh63 AMA1 + AMA1-C1/Alhydrogel®+ CPG 7909 Receives: Biological: AdCh63 AMA1 + AMA1-C1/Alhydrogel®+ CPG 7909 |
| Group 3 | Experimental | AdCh63 AMA1 + AMA1-C1/Alhydrogel® Receives: Biological: AdCh63 AMA1 + AMA1-C1/Alhydrogel® |
| Group 4 | Experimental | AdCh63 AMA1 AMA1-C1/Alhydrogel®+ CPG 7909 Receives: Biological: AdCh63 AMA1 AMA1-C1/Alhydrogel®+ CPG 7909 |
| Group 5 | Experimental | AdCh63 AMA1 + MVA AMA1 Receives: Biological: AdCh63 AMA1 + MVA AMA1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of vaccination
To assess the safety of vaccination of healthy adults with AdCh63 AMA1, MVA AMA1 \& AMA1-C1/Alhydrogel® +/- CPG 7909 administered in various schedules using actively and passively collected data on adverse events
Measured: Expected average of 12 months
Secondary outcomes (1)
Immunogenicity of vaccination
To assess the immunogenicity of vaccination of healthy adults with AdCh63 AMA1, MVA AMA1 \& AMA1-C1/Alhydrogel® +/- CPG 7909 administered in various schedules by measuring T cell responses (IFN-γ ELISPOT, flow cytometry), B cell responses and antibody responses to AMA1. Further immunological assessments may be undertaken as necessary
Measured: 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 posted11 May 2011 (estimated)
- Study startJun 2011
- Primary completionMar 2013
- Study completionMar 2013
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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrian VS Hill, D.Phil, FRCP, Principal investigator, The Jenner Institute, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351948
- Sponsor's protocol ID
- VAC044
- Status last verified
- Mar 2013
- First submitted
- 9 May 2011
- Last updated
- 14 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2013. 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 Novel Schedules for Vaccination With the Candidate Malaria Vaccines; AdCh63 AMA1, MVA AMA1 & AMA1-C1/Alhydrogel® +/- CPG 7909
- ClinicalTrials.gov ID
- NCT01351948
- Acronym / sponsor ID
- VAC044
- Conditions
- Malaria
- Keywords
- Immune response
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jun 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 11 May 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 study aims to compare the safety and immunogenicity of AdCh63 AMA1 and MVA AMA1vaccine candidates administered alone and with adjuvants in various schedules. These vaccines consist of inactivated viruses which have been modified, so they cannot reproduce in humans, and also to include genetic material for malaria protein AMA1 which is expressed by the malaria parasite during blood stage infection. The vaccines are designed to stimulate an immune response to this malaria protein and thus provide protection against malaria infection. Adjuvants are a crucial component of modern vaccine regimens, increasing the immunogenicity and potency of protein vaccines. In this study we will assess whether virus vectored vaccines combined with protein in adjuvant AMA1-C1/Alhydrogel® and CPG 7909 adjuvant (emulsion containing TLR agonist) can induce stronger and more durable immune response.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: AdCh63 AMA1 + MVA AMA1 + AMA1-C1/Alhydrogel®+ CPG 7909AdCh63 AMA1 + MVA AMA1 + AMA1-C1/Alhydrogel®+ CPG 7909 |
| Group 2 | Experimental | Biological: AdCh63 AMA1 + AMA1-C1/Alhydrogel®+ CPG 7909AdCh63 AMA1 + AMA1-C1/Alhydrogel®+ CPG 7909 |
| Group 3 | Experimental | Biological: AdCh63 AMA1 + AMA1-C1/Alhydrogel®AdCh63 AMA1 + AMA1-C1/Alhydrogel® |
| Group 4 | Experimental | Biological: AdCh63 AMA1 AMA1-C1/Alhydrogel®+ CPG 7909AdCh63 AMA1 AMA1-C1/Alhydrogel®+ CPG 7909 |
| Group 5 | Experimental | Biological: AdCh63 AMA1 + MVA AMA1AdCh63 AMA1 + MVA AMA1 |
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
- Women only: Must practice continuous effective contraception for the duration of the study.
- Men only: Must use barrier contraception from day of any vaccination with CPG 7909, for 3 months.
Key exclusion criteria (21 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 |
|---|---|---|
| AdCh63 AMA1 + MVA AMA1 + AMA1-C1/Alhydrogel®+ CPG 79095x10^10 vp AdCh63 AMA1 Day 0, 1.25x10^8 pfu MVA AMA1 Day 56, AMA1-C1/Alhydrogel®+ CPG 7909 (80ug, 800ug, 564ug respectively) Day 112. IM injections | Biological | Group 1 |
| AdCh63 AMA1 + AMA1-C1/Alhydrogel®+ CPG 79095x10^10 vp AdCh63 AMA1 Day 0,AMA1-C1/Alhydrogel®+ CPG 7909 (80ug, 800ug, 564ug respectively) Day 56. IM injections | Biological | Group 2 |
| AdCh63 AMA1 + AMA1-C1/Alhydrogel®5x10^10 vp AdCh63 AMA1 Day 0, AMA1-C1/Alhydrogel® (80ug, 800ug respectively) Day 56. IM injections | Biological | Group 3 |
| AdCh63 AMA1 AMA1-C1/Alhydrogel®+ CPG 79095x10^10 vp AdCh63 AMA1 Day 0, AMA1-C1/Alhydrogel®+ CPG 7909 (80ug, 800ug, 564ug respectively) Day 112. IM injections | Biological | Group 4 |
| AdCh63 AMA1 + MVA AMA15x10^10 vp AdCh63 AMA1 Day 0, 1.25x10^8 pfu MVA AMA1 Day 112. IM injections | Biological | Group 5 |
Primary outcome
Safety of vaccination
Time frame: Expected average of 12 months
To assess the safety of vaccination of healthy adults with AdCh63 AMA1, MVA AMA1 \& AMA1-C1/Alhydrogel® +/- CPG 7909 administered in various schedules using actively and passively collected data on adverse events
1 secondary outcome
Immunogenicity of vaccination
Time frame: 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 14 Mar 2013.
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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 VS Hill, D.Phil, FRCP principal investigator
The Jenner Institute, 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 AdCh63 AMA1 + MVA AMA1 + AMA1-C1/Alhydrogel®+ CPG 7909, AdCh63 AMA1 + AMA1-C1/Alhydrogel®+ CPG 7909 and AdCh63 AMA1 + AMA1-C1/Alhydrogel® 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 21 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 14 Mar 2013. 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?
Safety of vaccination (time frame: 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?
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 14 Mar 2013.