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

Purpose

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.

Condition	Intervention	Phase
Malaria	Biological: AdCh63 ME-TRAP, MVA ME-TRAP Biological: HDCRV	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
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

Resource links provided by NLM:

Genetics Home Reference related topics: tumor necrosis factor receptor-associated periodic syndrome

MedlinePlus related topics: Malaria

U.S. FDA Resources

Further study details as provided by University of Oxford:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
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

Secondary Outcome Measures:

Immunogenicity 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 ] [ Designated as safety issue: No ]
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.

Enrollment:	52
Study Start Date:	June 2010
Study Completion Date:	December 2011
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group 1A Adults (18-50 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP	Biological: AdCh63 ME-TRAP, MVA ME-TRAP AdCh63 ME-TRAP 1 x 10^10vp IM followed by MVA ME-TRAP 2 x 10^8 pfu IM 8 weeks later
Experimental: Group 1B Adults (18-50 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME TRAP	Biological: AdCh63 ME-TRAP, MVA ME-TRAP AdCh63 ME-TRAP 5 x 10^10vp IM followed by MVA ME-TRAP 2 x 10^8 pfu IM 8 weeks later
Experimental: Group 2A Children (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP	Biological: AdCh63 ME-TRAP, MVA ME-TRAP AdCh63 ME-TRAP 1 x 10^10vp IM followed by MVA ME-TRAP 1 x 10^8 pfu IM 8 weeks later
Experimental: Group 2B Children (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP	Biological: AdCh63 ME-TRAP, MVA ME-TRAP AdCh63 ME-TRAP 1 x 10^10vp IM followed by MVA ME-TRAP 2 x 10^8 pfu IM 8 weeks later
Active Comparator: Group 2C Children (2-6 years old) vaccinated with human diploid cell rabies vaccine	Biological: HDCRV HDCRV 1ml IM followed by HDCRV 1ml IM 8 weeks later
Experimental: Group 3A Children (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP	Biological: AdCh63 ME-TRAP, MVA ME-TRAP AdCh63 ME-TRAP 5 x 10^10vp IM followed by MVA ME-TRAP 1 x 10^8 pfu IM 8 weeks later
Experimental: Group 3B Children (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP	Biological: AdCh63 ME-TRAP, MVA ME-TRAP AdCh63 ME-TRAP 5 x 10^10vp IM followed by MVA ME-TRAP 2 x 10^8 pfu IM 8 weeks later
Active Comparator: Group 3C Children (2-6 years old) vaccinated with human diploid cell rabies vaccine	Biological: HDCRV HDCRV 1ml IM followed by HDCRV 1ml IM 8 weeks later

Eligibility

Ages Eligible for Study:	2 Years to 50 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Consenting adult males aged 18-50 years in good health and healthy children aged 2-6 years.with consenting parents.

Exclusion Criteria:

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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01373879

Locations

Gambia
Dr Kalifa Bojang
Banjul, Gambia

Sponsors and Collaborators

University of Oxford

European and Developing Countries Clinical Trials Partnership (EDCTP)

Investigators

Principal Investigator:

Kalifa Bojang

Medical Research Council PO Box 273, Banjul The Gambia

More Information

No publications provided by University of Oxford

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	University of Oxford
ClinicalTrials.gov Identifier:	NCT01373879 History of Changes
Other Study ID Numbers:	VAC041
Study First Received:	June 14, 2011
Last Updated:	March 13, 2013
Health Authority:	Gambia: MRC Ethics Committee

Keywords provided by University of Oxford:

Vaccine
Immune response

Additional relevant MeSH terms:

Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on May 19, 2013