KHRC Initiates Phase 1 (First-In-Human) Clinical Trial
March 30, 2023 | News | Reading time: 3 min
The Kintampo Health Research Centre (KHRC) has conducted clinical research for over 25 years and has been instrumental in conducting key trials that have led to change in policies both locally and internationally. One of such trial is the pivotal phase 3 trial of the first malaria vaccine (RTS,S), which is being piloted and implemented in some regions in Ghana. Additionally, the centre played a key role in providing the evidence base towards the change in policy from Chloroquine to Artemisinin-based Combination Therapies (ACTs) for the treatment of malaria
Apart from malaria, the centre has conducted several trials in other therapeutic areas including meningitis, sickle cell disease, among others. Currently, the centre is participating in a multi-country phase 3 trial of Sanofi Pasteur’s COVID-19 candidate vaccines. The success of this on-going trial will make more life -saving vaccines available to Ghana and other African countries and help reduce the huge disparities in access to COVID-19 vaccines.
In a first of its kind at KHRC with sponsorship from Emergent Product Development Gaithersburg, Inc., is currently conducting a phase 1 Lassa fever vaccine trial in healthy adults in the Kintampo North Municipality and Kintampo South District.
Over the years, these trials have helped to build up the clinical trial infrastructure and capacity of KHRC staff, turning the centre into one of the best clinical trial centres in Africa.
KHRC has a multi-purpose, state-of-the-art clinical laboratory with capacity for tests such as real time polymerase chain reaction (PCR), high performance liquid chromatography, multiplex ELISA, as well as full clinical chemistry, haematology and coagulation profile.
Seth Owusu-Agyei laboratory at KHRC
High Performance Liquid Chromatography (HPLC) equipment at the KHRC laboratory
Multiplex ELISA platform (Quansys)
Real Time PCR (7500 Fast) and Real Time (AGS)
Haematology analyzer (Sysmex XN-330)
Clinical Chemistry Analyser
Coagulation machine (Sysmex)
The centre is a regional training centre of malaria microscopy and has helped train hundred of microscopists across Ghana. The laboratory has capacity for cold and ultracold storage of biospecimen at -20℃, -80℃, and -150℃. Liquid nitrogen storage is also available. The laboratory consistently participates in external quality assessment programmes offered by providers including the UK National External Quality Assessment Services and the US College of American Pathologists.
The centre has a 12-bed clinical trial unit equipped with consulting/examination rooms, a pharmacy unit, a specimen collection room, a nurse’s area, twelve patient rooms, an office and a kitchen.
Examination room
KHRC clinical trial facility
Vaccine preparation room
Specimen collection room
This set up has emergency equipment including a crash cart with emergency medicines, oxygen cylinders and logistics to provide intranasal oxygen to participants, electric suction machine, ECG machine, defibrillator, and airway management devices including Ambu bag and masks, Guedel and laryngeal mask airways and endotracheal tubes. Other available equipment for managing medical emergencies include BP machines, nebulizers, pulse oximeters. The unit is linked to the emergency unit of the Kintampo Municipal Hospital by a short walkway.
Additional infrastructure include an on-site pharmacy with adequate fridge and freezer space for storage of study medications. Freezer and fridge temperatures are monitored continuously and linked to an alarm system.
The data science department has the capacity to process to large datasets for over 20,000 participants. Well trained data managers have experience with different databases including Oracle InForm, OpenClinica, REDCap, EDC RDC, Oracle RDC, Medidata Rave and Axiom eFusion. Twenty-four hour internet access (both WLAN and Wi-Fi) is available with download speed up to 99mbps.
Data SCience Department
All clinical trials at KHRC are conducted to the highest ethical and regulatory standards. The trial scientists prioritize adherence to the quality standards set out in the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. The centre keeps a highly trained workforce and regularly reviews its Quality Assurance and Quality Control systems to ensure compliance.
The trial documents are reviewed and approved by institutional and central ethics committees and the Ghana Food and Drugs Authority prior to implementation. Close monitoring and scrutiny of trials is routinely conducted by the sponsor’s representatives, the ethics committees and the Ghana FDA while the trial is on-going to ensure safety of trial participants and the accuracy of trial results.