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Safety and Immunogenicity of AdCh63 ME-TRAP and MVA ME-TRAP Vaccines in Malaria Endemic Areas

NCT ID: NCT01379430

Last Updated: 2012-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-05-31

Brief Summary

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The purpose of this trial is to assess the safety and immunogenicity of AdCh63 ME-TRAP and MVA ME-TRAP candidate vaccines in healthy adult volunteers in a malaria endemic region. The regime proposed in this trial has protected non-immune volunteers against sporozoite challenge in clinical trials performed by Oxford, and so may be protective against naturally acquired infection in Kenya.The study population will comprise 30 healthy adult males aged 18-50.

The investigators do not propose to include a placebo group. At this stage the investigators objective is to describe the safety profile in a small number of individuals, and the confidence intervals for the proportion of individuals with a particular event would be too wide for meaningful comparison with a placebo group. Immunogenicity will be judged by comparison with baseline.

Detailed Description

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Conditions

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Malaria

Keywords

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Vaccine Immune response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group 1

Intramuscular arm

Group Type EXPERIMENTAL

AdCh63 ME-TRAP followed by MVA ME-TRAP

Intervention Type BIOLOGICAL

AdCh63 ME-TRAP 1x10\^10 vp intramuscularly, MVA ME-TRAP 2x10\^8 pfu intramuscularly

Group 2

Intradermal arm

Group Type EXPERIMENTAL

AdCh63 ME-TRAP followed by MVA ME-TRAP

Intervention Type BIOLOGICAL

AdCh63 ME-TRAP 5x10\^10 vp intramuscularly, MVA ME-TRAP 2x10\^8 pfu intradermal

Interventions

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AdCh63 ME-TRAP followed by MVA ME-TRAP

AdCh63 ME-TRAP 1x10\^10 vp intramuscularly, MVA ME-TRAP 2x10\^8 pfu intramuscularly

Intervention Type BIOLOGICAL

AdCh63 ME-TRAP followed by MVA ME-TRAP

AdCh63 ME-TRAP 5x10\^10 vp intramuscularly, MVA ME-TRAP 2x10\^8 pfu intradermal

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Consenting adult males aged 18-50 years in good health.
* Will remain resident in the study area for the study duration

Exclusion Criteria

* Clinically significant history of the following conditions; skin disorder (eczema, etc.), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness.
* History of splenectomy
* Haemoglobin less than 9.0 g/dl
* Clinically significant abnormalities of laboratory screening tests (full blood count, ALT, creatinine levels, urine dipstick examination for blood and protein).
* Blood transfusion within one month of the beginning of the study
* 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.
* History of contact dermatitis (due to the use of a potentially irritant disinfectant that may be present in trace amounts in the AdCh63 ME-TRAP vaccine, see the investigators brochure for details, attached)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kenya Medical Research Institute

OTHER

Sponsor Role collaborator

European and Developing Countries Clinical Trials Partnership (EDCTP)

OTHER_GOV

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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KEMRI/Wellcome Trust Programme, Centre for Geographic Medicine Research - Coast

Kilifi, , Kenya

Site Status

Countries

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Kenya

References

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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.

Reference Type DERIVED
PMID: 23526949 (View on PubMed)

Other Identifiers

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VAC040

Identifier Type: -

Identifier Source: org_study_id