Clinical Trial

Background

The first GCP Standard Clinical Trial related activity was initiated at AHRI with WHO/TDR capacity building grantin 2001. Since then AHRI has been engaged in capacity building in many ways including man power and physical facilities.

Achievements thus may include establishment of:

  • Fully dedicated Clinical Trial Unit/Team with qualified staff
  • Data Management Unit
  • Clinical trial site with study ward facilities
  • Dedicated and fully operational Clinical Trial Safety Laboratory

Achievements

The followingsare few of GCP Compliant Clinical Trials that has been conducted and completed at AHRI in collaboration with different international partners:

 

1. A two-arm single-blinded, randomised comparison of four fixed-dose drug combination (4FDCs) (intervention group) versus standard treatment with separate TB drugs (comparator group), Multicentre Trial: Ethiopia and Nigeria.PI: Abraham Aseffa (MD, PhD); Sponsor: WHO-TDR

 

2. A safety and immunogenicity phase I trial with an adjuvanted TB subunit vaccine (Ag85B-ESAT-6 + IC31)administered in different antigen/adjuvant formulations in TST negative and TST positive volunteers at 0 and 2 months( THYB 03). PI: Jemal Hussein (MD, MSc); Sponsor: SSI, Denmark

 

3. Meningococcal trivalent polysaccharide vaccine (GSK) trial.PI: Abraham Aseffa (MD, PhD); Sponsor: WHO-TDR

 

4. Double blinded randomized placebo controlled phase II trial ofShiunko Ointment localapplication twice a day for 4 weeks in Ethiopian patients with localized cutaneous Leishmaniasis. PI: Oumer Ali (MD, MSc); Sponsor: AHRI in collaboration with Nagasaki University

 

5. A randomized double-blind controlled trial to evaluate the safety and immunogenicity of killed bivalent (O1 and O139) whole cell-oral cholera vaccine (WC-OCV) in healthy individuals in Ethiopia.

 

PI: Abraham Aseffa (MD, PhD)& Co-PI: Zenebe Akalu (MD, MSc); Sponsor: International Vaccine Institute (IVI), Seoul, S. Korea

 

Current Projects/Studies/Activities

A. On-going trials

 

1. The Evaluation of a Standardized Treatment Regimen of Anti-Tuberculosis Drugs for Patients with MDR-TB (STREAM), Multicenter Trial (Ethiopia, South Africa, Mongolia & Vietnam).

 

PI: TesfamariamMebrhatu (MD, MPH) - AHRI/ALERT and Dr Daniel Meressa (MD, PGSDip); Sponsor: The International Union Against Tuberculosis and Lung Disease (IUATLD) in collaboration with MRC-CTU-UK

 

Generally, anti-TB therapy including MDR TB is based on experts’ opinion with median treatment success rate of ~60% (WHO 2009). A so-called ‘Bangladesh regimen’, a nine months regimen, achieved relapse free cure rate of 87.9% among MDR-TB patients (Van Deunet al., AJRCCM 2010). STREAM is therefore testing whether this success can be duplicated in a larger controlled trial. STREAM is a multi-country trial involvingseveral clinical sites. ALERT hospital and St Peter’s TB Specialized Hospitalare the two clinical sites in Ethiopia.

 

2. Bioequivalence (BE) Clinical Studies, New Development. PI: MekonnenTeferi (DVM, MSc.) Bioequivalence clinical center at AHRI was established in September 2013 as clinical affiliate to the Regional Bioequivalence Center (RBEC) following the establishment of the latter in 2012. The center aims at having a locally accessible, GCP/GLP compliant and WHO qualified BE testing center in East Africa.

 

Two BE pilot studies have been conducted for the bioavailability of generic products of local manufacturers in comparison with the respective brand products..Both of the pilot studies have been successfully completed with acceptable standards.Currently, study documents are compiled for possible WHO review, inspection and qualification formeeting international standardsduring study conduct as well as facilities at the clinical site and the analytical lab at RBEC. The clinical center at AHRI has a phase I clinical site standard facilities including study screening and admission wards.

 

B. Other activities: study protocol development, quality assurance and GCP training

 

There are few more trials under site preparation for kick-off and others through protocol development. In parallel, the clinical trial team is striving to improve the quality of study conduct and meeting international standards through establishing a dedicated QA unit and accredited clinical laboratory at AHRI. The team at AHRI is also engaged in preparing and providing GCP training to its staff and local collaborators.