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

Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01379430
• Other study ID #: VAC040
• Status: Completed
• Phase: Phase 1
• First received: June 10, 2011
• Last updated: October 2, 2012
• Start date: June 2010
• Est. completion date: May 2011

Study information

• Verified date: October 2012
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kenya: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria

Intervention

Biological:
• AdCh63 ME-TRAP followed by MVA ME-TRAP
AdCh63 ME-TRAP 1x10^10 vp intramuscularly, MVA ME-TRAP 2x10^8 pfu intramuscularly
• AdCh63 ME-TRAP followed by MVA ME-TRAP
AdCh63 ME-TRAP 5x10^10 vp intramuscularly, MVA ME-TRAP 2x10^8 pfu intradermal

Locations

Country	Name	City	State
Kenya	KEMRI/Wellcome Trust Programme, Centre for Geographic Medicine Research - Coast	Kilifi

Sponsors (3)

Lead Sponsor	Collaborator
University of Oxford	European and Developing Countries Clinical Trials Partnership (EDCTP), Kenya Medical Research Institute

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and reactogenicity of AdCh63 ME-TRAP followed by MVA ME-TRAP in adults in Kenya.	To assess safety and reactogenicity of AdCh63 ME-TRAP followed by MVA ME-TRAP in adults in Kenya by recording local and systemic solicited and unsolicited adverse events	Participants will be followed for the duration of the study, an expected average of 12 months	Yes
Secondary	Immunogenicity of vaccines	To evaluate the immunogenicity of AdCh63 ME-TRAP followed by MVA ME-TRAP in adults in Kenya by assessing induced antibody and T cell response to the vaccine insert.	Participants will be followed for the duration of the study, an expected average of 12 months	No
Secondary	Immunogenicity of Vaccines	To compare the use of intra-muscular and intra-dermal MVA ME-TRAP	Participants will be followed for the duration of the study, an expected average of 12 months	No