AzTrials
AzTrials

MalariaPhase 1NCT01373879

AdCh63 ME-TRAP and MVA ME-TRAP Malaria Vaccines Evaluation in Healthy Adults and Children in a Malaria Endemic Area

A Phase 1 study testing AdCh63 ME-TRAP, MVA ME-TRAP and HDCRV in people with Malaria, run by University of Oxford at 1 site in The Gambia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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 and adult volunteers in a malaria endemic region. Read more about this study

Who is it for?
Ages 2 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Malaria
What is being tested?
AdCh63 ME-TRAP, MVA ME-TRAP and HDCRV
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteThe Gambia
Study dates
Jun 2010to Dec 2011
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 2 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Consenting adult males aged 18-50 years in good health and healthy children aged 2-6 years.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.
  • Hypersensitivity to HDCRV.
  • 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 9.0 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
Show all 15Show fewer
  • Serum ALT concentration greater than 45 U/L, where judged to be clinically significant in the opinion of the investigator
  • Blood transfusion within one month of enrolment.
  • History of vaccination with previous experimental malaria vaccines.
  • Administration of any other vaccine or immunoglobulin within two weeks before vaccination.
  • 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.
  • HIV positive.
  • Positive malaria antigen test

Trial locations and contacts

1 site in 1 country.

The Gambia1 site

  • Dr Kalifa Bojang

    Banjul

Other trials in The Gambia

About this study

Official title: Safety and Immunogenicity of Heterologous Prime-boost With the Candidate Malaria Vaccines AdCh63 ME-TRAP and MVA ME-TRAP in Healthy Adults and Children in a Malaria Endemic Area

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 and adult volunteers 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.

Conditions
Malaria
Being tested
AdCh63 ME-TRAP, MVA ME-TRAP, HDCRV
Keywords
Vaccine, 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

    AdCh63 ME-TRAP 1 x 10^10vp IM followed by MVA ME-TRAP 2 x 10^8 pfu IM 8 weeks later

  • AdCh63 ME-TRAP, MVA ME-TRAPBiological

    AdCh63 ME-TRAP 5 x 10^10vp IM followed by MVA ME-TRAP 2 x 10^8 pfu IM 8 weeks later

  • AdCh63 ME-TRAP, MVA ME-TRAPBiological

    AdCh63 ME-TRAP 1 x 10^10vp IM followed by MVA ME-TRAP 1 x 10^8 pfu IM 8 weeks later

  • AdCh63 ME-TRAP, MVA ME-TRAPBiological

    AdCh63 ME-TRAP 1 x 10^10vp IM followed by MVA ME-TRAP 2 x 10^8 pfu IM 8 weeks later

  • HDCRVBiological

    HDCRV 1ml IM followed by HDCRV 1ml IM 8 weeks later

  • AdCh63 ME-TRAP, MVA ME-TRAPBiological

    AdCh63 ME-TRAP 5 x 10^10vp IM followed by MVA ME-TRAP 1 x 10^8 pfu IM 8 weeks later

  • AdCh63 ME-TRAP, MVA ME-TRAPBiological

    AdCh63 ME-TRAP 5 x 10^10vp IM followed by MVA ME-TRAP 2 x 10^8 pfu IM 8 weeks later

  • HDCRVBiological

    HDCRV 1ml IM followed by HDCRV 1ml IM 8 weeks later

Study groups in NCT01373879
Study groupRoleWhat they receive
Group 1AExperimentalAdults (18-50 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP
Receives: Biological: AdCh63 ME-TRAP, MVA ME-TRAP
Group 1BExperimentalAdults (18-50 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME TRAP
Receives: Biological: AdCh63 ME-TRAP, MVA ME-TRAP
Group 2AExperimentalChildren (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP
Receives: Biological: AdCh63 ME-TRAP, MVA ME-TRAP
Group 2BExperimentalChildren (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP
Receives: Biological: AdCh63 ME-TRAP, MVA ME-TRAP
Group 2CActive comparatorChildren (2-6 years old) vaccinated with human diploid cell rabies vaccine
Receives: Biological: HDCRV
Group 3AExperimentalChildren (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP
Receives: Biological: AdCh63 ME-TRAP, MVA ME-TRAP
Group 3BExperimentalChildren (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP
Receives: Biological: AdCh63 ME-TRAP, MVA ME-TRAP
Group 3CActive comparatorChildren (2-6 years old) vaccinated with human diploid cell rabies vaccine
Receives: Biological: HDCRV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP

    To assess the safety of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP in healthy adults and children in The Gambia 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)

  1. Immunogenicity of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP

    To assess the immunogenicity of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP in healthy adults and children in The Gambia 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.

  1. First posted15 Jun 2011 (estimated)
  2. Study startJun 2010
  3. Primary completionDec 2011
  4. Study completionDec 2011

Resources

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
Participant
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01373879
Sponsor's protocol ID
VAC041
Status last verified
Mar 2013
First submitted
14 Jun 2011
Last updated
14 Mar 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Ogwang C, Afolabi M, Kimani D, Jagne YJ, Sheehy SH, Bliss CM, Duncan CJ, Collins KA, Garcia Knight MA, Kimani E, Anagnostou NA, Berrie E, Moyle S, Gilbert SC, Spencer AJ, Soipei P, Mueller J, Okebe J, Colloca S, Cortese R, Viebig NK, Roberts R, Gantlett K, Lawrie AM, Nicosia A, Imoukhuede EB, Bejon P, Urban BC, Flanagan KL, Ewer KJ, Chilengi R, Hill AV, Bojang K. Safety and immunogenicity of heterologous prime-boost immunisation with Plasmodium falciparum malaria candidate vaccines, ChAd63 ME-TRAP and MVA ME-TRAP, in healthy Gambian and Kenyan adults. PLoS One. 2013;8(3):e57726. doi: 10.1371/journal.pone.0057726. Epub 2013 Mar 19.

    PubMed 23526949

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AdCh63 ME-TRAP, MVA ME-TRAP and HDCRV 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 15 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 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 a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP (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 NCT01373879, 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 14 Mar 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in