MalariaPhase 1NCT01450293
AdCh63 ME-TRAP and MVA ME-TRAP Malaria Vaccines Evaluation in Healthy Children in a Malaria Endemic Area
A Phase 1 study testing AdCh63 ME-TRAP, MVA ME-TRAP in people with Malaria, run by University of Oxford at 1 site in The Gambia.
Trial summary
Infants in malaria-endemic regions of Africa are an important target for vaccination against malaria in view of the enormous disease burden of malaria in this population. The purpose of this trial is to assess the safety and immunogenicity of MVA ME-TRAP and AdCH63 ME-TRAP candidate vaccines in healthy children in a… Read more about this study
- Who is it for?
- Ages 10 weeks to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- AdCh63 ME-TRAP, MVA ME-TRAP
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteThe Gambia
- Study dates
- Oct 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 10 weeks to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants aged 10 weeks and 5-12 months at the time of enrollment with consenting parents.
Who cannot join
- Clinically significant history of skin disorder (psoriasis, contact dermatitis etc.), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness.
- Severe malnutrition.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, betapropiolactone.
- History of splenectomy Haemoglobin less than 8.0 g/dL, where judged to be clinically significant in the opinion of the investigator
- Serum Creatinine concentration greater than 70 mol/L, where judged to be clinically significant in the opinion of the investigator
- Serum ALT concentration greater than 45 U/L, where judged to be clinically significant in the opinion of the investigator
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- Blood transfusion within one month of enrollment.
- History of vaccination with previous experimental malaria vaccines. -Administration of any other vaccine or immunoglobulin less than two weeks before vaccination with the IMPs Current participation in another clinical trial, or within 12 weeks of this study.
- Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial.
- Likelihood of travel away from the study area
- Maternal HIV infection Positive malaria antigen test at screening
- Failure to have received, prior to enrollment, the routine EPI vaccinations due according to the Gambian EPI schedule.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Immunogenicity of Heterologous Prime-boost Vaccination With the Candidate Malaria Vaccines AdCh63 ME-TRAP and MVA ME-TRAP in Healthy Infants in a Malaria- Endemic Area
Infants in malaria-endemic regions of Africa are an important target for vaccination against malaria in view of the enormous disease burden of malaria in this population. The purpose of this trial is to assess the safety and immunogenicity of MVA ME-TRAP and AdCH63 ME-TRAP candidate vaccines in healthy children in a malaria endemic region. The regimen proposed here has protected non-immune volunteers in Oxford against sporozoite challenge, and so may be protective against naturally acquired infection in the Gambia. Administration of AdCh63 ME-TRAP and MVA ME-TRAP to infants in this study will occur at intervals of at least two weeks from the administration of routine infant immunisations, given according to the Gambian EPI.
- Conditions
- Malaria
- Being tested
- AdCh63 ME-TRAP, MVA ME-TRAP
- 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 ME-TRAP, MVA ME-TRAPBiological
1x10^10 vp AdCH63 ME-TRAP followed by 1x10^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh.
AdCH63 ME-TRAP, MVA ME-TRAPBiological
5x10^10 vp AdCH63 ME-TRAP followed by 1x10^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 5 to 12 months old infants; AdCh63 ME-TRAP, MVA ME-TRAP Receives: Biological: AdCh63 ME-TRAP, MVA ME-TRAP |
| Group B | Experimental | 5 to 12 months old infants; AdCh63 ME-TRAP, MVA ME-TRAP Receives: Biological: AdCH63 ME-TRAP, MVA ME-TRAP |
| Group C | No intervention | 5 to 12 months old infants; no vaccination |
| Group D | Experimental | 10 week old babies; AdCh63 ME-TRAP, MVA ME-TRAP Receives: Biological: AdCh63 ME-TRAP, MVA ME-TRAP |
| Group E | Experimental | 10 week old babies; AdCh63 ME-TRAP, MVA ME-TRAP Receives: Biological: AdCH63 ME-TRAP, MVA ME-TRAP |
| Group F | No intervention | 10 week old babies; no vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of heterologous prime-boost vaccination with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP
To assess the safety of heterologous prime-boost vaccination of healthy infants in a malaria-endemic area with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP 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 16 months
Secondary outcomes (1)
Immunogenicity of heterologous prime-boost vaccination with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP
To assess the immunogenicity of heterologous prime-boost vaccination of healthy infants in a malaria-endemic area with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP 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 16 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 startOct 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP)
- Responsible party
- Sponsor
- Investigators
- Kalifa Bojang, Principal investigator, Medical Research Council PO Box 273, Banjul The Gambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450293
- Sponsor's protocol ID
- VAC042
- Status last verified
- Dec 2013
- First submitted
- 3 Oct 2011
- Last updated
- 12 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Heterologous Prime-boost Vaccination With the Candidate Malaria Vaccines AdCh63 ME-TRAP and MVA ME-TRAP in Healthy Infants in a Malaria- Endemic Area
- ClinicalTrials.gov ID
- NCT01450293
- Acronym / sponsor ID
- VAC042
- Conditions
- Malaria
- Keywords
- Immune response
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP)
- Study start
- Oct 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (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.
Infants in malaria-endemic regions of Africa are an important target for vaccination against malaria in view of the enormous disease burden of malaria in this population. The purpose of this trial is to assess the safety and immunogenicity of MVA ME-TRAP and AdCH63 ME-TRAP candidate vaccines in healthy children in a malaria endemic region. The regimen proposed here has protected non-immune volunteers in Oxford against sporozoite challenge, and so may be protective against naturally acquired infection in the Gambia. Administration of AdCh63 ME-TRAP and MVA ME-TRAP to infants in this study will occur at intervals of at least two weeks from the administration of routine infant immunisations, given according to the Gambian EPI.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: AdCh63 ME-TRAP, MVA ME-TRAP5 to 12 months old infants; AdCh63 ME-TRAP, MVA ME-TRAP |
| Group B | Experimental | Biological: AdCH63 ME-TRAP, MVA ME-TRAP5 to 12 months old infants; AdCh63 ME-TRAP, MVA ME-TRAP |
| Group C | No intervention | –5 to 12 months old infants; no vaccination |
| Group D | Experimental | Biological: AdCh63 ME-TRAP, MVA ME-TRAP10 week old babies; AdCh63 ME-TRAP, MVA ME-TRAP |
| Group E | Experimental | Biological: AdCH63 ME-TRAP, MVA ME-TRAP10 week old babies; AdCh63 ME-TRAP, MVA ME-TRAP |
| Group F | No intervention | –10 week old babies; no vaccination |
Who may qualify
- Ages
- 10 weeks to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy infants aged 10 weeks and 5-12 months at the time of enrollment with consenting parents.
Key exclusion criteria (12 listed)
- Clinically significant history of skin disorder (psoriasis, contact dermatitis etc.), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness.
- Severe malnutrition.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, betapropiolactone.
- History of splenectomy Haemoglobin less than 8.0 g/dL, where judged to be clinically significant in the opinion of the investigator
- Serum Creatinine concentration greater than 70 mol/L, where judged to be clinically significant in the opinion of the investigator
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 ME-TRAP, MVA ME-TRAP1x10^10 vp AdCH63 ME-TRAP followed by 1x10^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh. | Biological | Group A, Group D |
| AdCH63 ME-TRAP, MVA ME-TRAP5x10^10 vp AdCH63 ME-TRAP followed by 1x10^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh. | Biological | Group B, Group E |
Primary outcome
Safety of heterologous prime-boost vaccination with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP
Time frame: Participants will be followed for the duration of the study, an expected average of 16 months
To assess the safety of heterologous prime-boost vaccination of healthy infants in a malaria-endemic area with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP by recording local and systemic solicited and unsolicited adverse events
1 secondary outcome
Immunogenicity of heterologous prime-boost vaccination with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP
Time frame: Participants will be followed for the duration of the study, an expected average of 16 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 12 Dec 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.
Kalifa Bojang principal investigator
Medical Research Council PO Box 273, Banjul The Gambia
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 ME-TRAP, MVA ME-TRAP in people with Malaria, run by University of Oxford at 1 site in The Gambia.
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 1 inclusion and 12 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 12 Dec 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 The Gambia. 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 heterologous prime-boost vaccination with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP (time frame: Participants will be followed for the duration of the study, an expected average of 16 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 12 Dec 2013; AzTrials last refreshed its copy on 6 Nov 2026.