MalariaPhase 1/2NCT00984763
A Study to Assess Safety, Immunogenicity and Parasite Growth Inhibition of an Asexual Blood Stage Vaccine for P. Falciparum Malaria
A Phase 1/2 study testing AMA1-C1/Alhydrogel® + CPG 7909 in people with Malaria, run by University of Oxford at 1 site in United Kingdom.
Trial summary
Malaria is a parasite, infection with which kills over 2 million people each year. It is a major problem for those who live in endemic areas and for travellers. There is a great need for a safe effective malaria vaccine. 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?
- AMA1-C1/Alhydrogel® + CPG 7909
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2010to 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
- Subject is willing and able to give informed consent for participation in the study
- Healthy, non pregnant adult aged 18 - 50 years
- Resident in or near Oxford for the duration of the challenge study
- Seropositive for CMV and EBV
- Female subjects of child bearing potential must be willing to ensure that they practice effective contraception during the study
- Males must be willing to use barrier contraception from day of first vaccination onwards until 3 months after the second vaccination
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- Able (in the Investigator's opinion) and willing to comply with all study requirements
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study
- Agreement to permanently refrain from blood donation.
Who cannot join
- Any deviation from the normal range in biochemistry or haematology blood tests or in urine analysis as defined in Appendix B
- Female patient/subject who is pregnant, lactating or planning pregnancy during the course of the study
- Healthy volunteers who have participated in another research study involving an investigational product in the past 12 weeks
- Subjects who have previously received an investigational malaria vaccine
- History of malaria chemoprophylaxis with chloroquine within 5 months prior to the planned challenge, with Lariam within 6 weeks prior to the challenge, and Riamet® within 2 weeks prior to the challenge
- Travel to a malaria endemic area within the previous 6 months
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- Planned travel to malarious areas during the study period
- Any history of malaria
- Contraindication to both anti-malarial drugs (Riamet® and chloroquine)
- concomitant use of other drugs known to cause QT-interval prolongation, ( e.g. macrolides, quinolones, amiodarone etc)
- An estimated ten year risk of fatal cardiovascular disease of ≥5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system (Conroy 2003)
- Family history of sudden cardiac death
- History of cardiac arrhythmia or prolonged QT syndrome
- Any history of severe allergic reaction or anaphylaxis
- History of a known allergy to nickel
- 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
- 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)
- Seropositive for hepatitis B surface antigen (HBsAg) or antibodies to hepatitis C virus
- Any on-going chronic illness requiring hospital specialist supervision
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- History of or current intravenous drug abuse
- Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or may influence the result of the study, or the subject's ability to participate in the study.
- Investigator assessment of lack of willingness to participate and comply with all requirements of 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, Headington
About this study
Official title: A Phase I/IIa Study of the Safety, Immunogenicity and Parasite Growth Inhibitory Activity of AMA1-C1/Alhydrogel® + CPG 7909, an Asexual Blood Stage Vaccine for Plasmodium Falciparum Malaria
Malaria is a parasite, infection with which kills over 2 million people each year. It is a major problem for those who live in endemic areas and for travellers. There is a great need for a safe effective malaria vaccine. The purpose of this study is to examine a new vaccine designed to provide immunity during the blood stage of the malaria parasite's lifecycle.
The vaccine consists of AMA1-C1 which is a mixture of two recombinant synthetic AMA1 proteins from two Plasmodium falciparum strains, Alhydrogel® which is an aluminium-based adjuvant and CPG 7909 - an oligodeoxynucleotide, which enhances immune response.
Read more
This study will enable the investigators to assess:
- The ability of of a growth inhibition assay to predict the effectiveness of a malaria vaccine.
- The safety of the vaccine in healthy volunteers
- The response of the human immune system to the vaccine
- Conditions
- Malaria
- Being tested
- AMA1-C1/Alhydrogel® + CPG 7909
- Keywords
- Malaria, Vaccine
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMA1-C1/Alhydrogel® + CPG 7909Biological
A 0.55 mL dose of AMA1-C1/Alhydrogel® + CPG 7909 (corresponds to 80 µg of AMA1-C1 and 564 µg of CPG 7909)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | AMA1-C1/Alhydrogel® + CPG 7909 vaccine given twice two months apart followed by malaria parasite challenge Receives: Biological: AMA1-C1/Alhydrogel® + CPG 7909 |
| Group 2 | No intervention | Control: malaria parasite challenge without prior vaccinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate a correlation between in vitro growth inhibition assay and parasite multiplication rate in vivo
Measured: Up to 16 days following blood stage parasite challenge
Secondary outcomes (1)
To detect differences in the multiplication rate responses between unvaccinated control subjects and volunteers vaccinated with AMA1-C1/Alhydrogel® + CPG 7909
Measured: Up to 16 days following blood stage parasite challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startJan 2010
- Primary completionSep 2010
- Study completionSep 2010
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 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 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, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984763
- Sponsor's protocol ID
- VAC035
- Status last verified
- May 2015
- First submitted
- 24 Sep 2009
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Duncan CJ, Sheehy SH, Ewer KJ, Douglas AD, Collins KA, Halstead FD, Elias SC, Lillie PJ, Rausch K, Aebig J, Miura K, Edwards NJ, Poulton ID, Hunt-Cooke A, Porter DW, Thompson FM, Rowland R, Draper SJ, Gilbert SC, Fay MP, Long CA, Zhu D, Wu Y, Martin LB, Anderson CF, Lawrie AM, Hill AV, Ellis RD. Impact on malaria parasite multiplication rates in infected volunteers of the protein-in-adjuvant vaccine AMA1-C1/Alhydrogel+CPG 7909. PLoS One. 2011;6(7):e22271. doi: 10.1371/journal.pone.0022271. Epub 2011 Jul 22.
PubMed 21799809
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Study of the Safety, Immunogenicity and Parasite Growth Inhibitory Activity of AMA1-C1/Alhydrogel® + CPG 7909, an Asexual Blood Stage Vaccine for Plasmodium Falciparum Malaria
- ClinicalTrials.gov ID
- NCT00984763
- Acronym / sponsor ID
- VAC035
- Conditions
- Malaria
- Keywords
- Malaria, Vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jan 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 25 Sep 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.
Malaria is a parasite, infection with which kills over 2 million people each year. It is a major problem for those who live in endemic areas and for travellers. There is a great need for a safe effective malaria vaccine. The purpose of this study is to examine a new vaccine designed to provide immunity during the blood stage of the malaria parasite's lifecycle.
The vaccine consists of AMA1-C1 which is a mixture of two recombinant synthetic AMA1 proteins from two Plasmodium falciparum strains, Alhydrogel® which is an aluminium-based adjuvant and CPG 7909 - an oligodeoxynucleotide, which enhances immune response.
This study will enable the investigators to assess:
- The ability of of a growth inhibition assay to predict the effectiveness of a malaria vaccine.
- The safety of the vaccine in healthy volunteers
- The response of the human immune system to the vaccine
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: AMA1-C1/Alhydrogel® + CPG 7909AMA1-C1/Alhydrogel® + CPG 7909 vaccine given twice two months apart followed by malaria parasite challenge |
| Group 2 | No intervention | –Control: malaria parasite challenge without prior vaccinations |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Subject is willing and able to give informed consent for participation in the study
- Healthy, non pregnant adult aged 18 - 50 years
- Resident in or near Oxford for the duration of the challenge study
- Seropositive for CMV and EBV
- Female subjects of child bearing potential must be willing to ensure that they practice effective contraception during the study
Key exclusion criteria (24 listed)
- Any deviation from the normal range in biochemistry or haematology blood tests or in urine analysis as defined in Appendix B
- Female patient/subject who is pregnant, lactating or planning pregnancy during the course of the study
- Healthy volunteers who have participated in another research study involving an investigational product in the past 12 weeks
- Subjects who have previously received an investigational malaria vaccine
- History of malaria chemoprophylaxis with chloroquine within 5 months prior to the planned challenge, with Lariam within 6 weeks prior to the challenge, and Riamet® within 2 weeks prior to the challenge
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 |
|---|---|---|
| AMA1-C1/Alhydrogel® + CPG 7909A 0.55 mL dose of AMA1-C1/Alhydrogel® + CPG 7909 (corresponds to 80 µg of AMA1-C1 and 564 µg of CPG 7909) | Biological | Group 1 |
Primary outcome
To demonstrate a correlation between in vitro growth inhibition assay and parasite multiplication rate in vivo
Time frame: Up to 16 days following blood stage parasite challenge
1 secondary outcome
To detect differences in the multiplication rate responses between unvaccinated control subjects and volunteers vaccinated with AMA1-C1/Alhydrogel® + CPG 7909
Time frame: Up to 16 days following blood stage parasite challenge
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 May 2015.
- Derived from this study: PubMed 21799809Duncan CJ, Sheehy SH, Ewer KJ, Douglas AD, Collins KA, Halstead FD, Elias SC, Lillie PJ, Rausch K, Aebig J, Miura K, Edwards NJ, Poulton ID, Hunt-Cooke A, Porter DW, Thompson FM, Rowland R, Draper SJ, Gilbert SC, Fay MP, Long CA, Zhu D, Wu Y, Martin LB, Anderson CF, Lawrie AM, Hill AV, Ellis RD. Impact on malaria parasite multiplication rates in infected volunteers of the protein-in-adjuvant vaccine AMA1-C1/Alhydrogel+CPG 7909. PLoS One. 2011;6(7):e22271. doi: 10.1371/journal.pone.0022271. Epub 2011 Jul 22.
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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
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 1/2 study testing AMA1-C1/Alhydrogel® + CPG 7909 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 9 inclusion and 24 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 May 2015. 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?
To demonstrate a correlation between in vitro growth inhibition assay and parasite multiplication rate in vivo (time frame: Up to 16 days following blood stage parasite challenge). 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 NCT00984763, 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 28 May 2015.