Establishing competency based internship program through participatory action research in a private pharmacy college in the Eastern Province of Saudi Arabia.

Objectives: To use Participatory Action Research (PAR) methodology to develop a competency-based training (CBT) program for Bachelor of Pharmacy interns at Mohammed Al-Mana College for Medical Sciences (MACHS), Dammam, Saudi Arabia, based on the International Pharmaceutical Federation (FIP) Global Competency Framework. Methods: The MACHS Pharmacy Department Training Unit developed a competency-based training (CBT) framework over 6 cohorts of interns based on the FIP Global Competency Framework using the Participatory Action Research (PAR) methodology. Assignments were set throughout the training period to support competency development. Assessment methods used for the evaluation included student portfolio, site preceptor evaluation and the college-based assessments. End of training and baseline results were compared to determine the effectiveness of CBT in terms of improvement of skills. Problems were identified and action plans developed, to be implemented on the following cohort. Successful completion of CBT required a total score of 80%. The students who could not pass the assessment were given a chance to improve their weak competencies and retake the assessment. Results: Since its implementation, five cohorts have been trained through CBT. Only 12% of interns passed the training in first attempt in the first cohort. This passing percentage dramatically increased to 75-100% in the consecutive cohorts where students scored better in the portfolio, and site preceptor evaluation as compared to the college-based assessment. Students' feedback towards the assignments was positive. Conclusion: Participatory Action Research was found to be an effective approach towards developing a competency-based training program for Pharmacy interns. More FIP competencies and evaluation strategies will be added to the internship program in the future. Furthermore, a national approach towards implementation of CBT should be used to ensure the uniformity of competency of pharmacists across the kingdom.

Conserved peptides within the E2 region of Hepatitis C virus induce humoral and cellular responses in goats.

The reason(s) why human antibodies raised against hepatitis C virus (HCV) E2 epitopes do not offer protection against multiple viral infections may be related to either genetic variations among viral strains particularly within the hypervariable region-1 (HVR-1), low titers of anti E2 antibodies or interference of non neutralizing antibodies with the function of neutralizing antibodies. This study was designed to assess the immunogenic properties of genetically conserved peptides derived from the C-terminal region of HVR-1 as potential therapeutic and/or prophylactic vaccines against HCV infection. Goats immunized with E2-conserved synthetic peptides termed p36 (a.a 430-446), p37(a.a 517-531) and p38 (a.a 412-419) generated high titers of anti-p36, anti-p37 and anti-P38 antibody responses of which only anti- p37 and anti- p38 were neutralizing to HCV particles in sera from patients infected predominantly with genotype 4a. On the other hand anti-p36 exhibited weak viral neutralization capacity on the same samples. Animals super-immunized with single epitopes generated 2 to 4.5 fold higher titers than similar antibodies produced in chronic HCV patients. Also the studied peptides elicited approximately 3 fold increase in cell proliferation of specific antibody-secreting peripheral blood mononuclear cells (PBMC) from immunized goats. These results indicate that, besides E1 derived peptide p35 (a.a 315-323) described previously by this laboratory, E2 conserved peptides p37 and p38 represent essential components of a candidate peptide vaccine against HCV infection.

Murine neutralizing antibody response and toxicity to synthetic peptides derived from E1 and E2 proteins of hepatitis C virus.

INTRODUCTION: The highest estimated prevalence of HCV infection has been reported in Egypt, nearly 12% mostly type 4. Currently, a commercial vaccine to protect this high risk population as well as global HCV infected patients is not available. OBJECTIVES: In the present study, we aim at: (1) examining the viral binding capacities of purified monospecific polyclonal murine antibodies raised against genetically conserved viral protein sequences, i.e. synthetic peptides derived from those sequences located within envelope proteins and (2) assessment of immunogenic properties and safety parameters of those peptides individually and in a vaccine format in mice. METHODS: Purified IgG Abs from immunized mice were used in immunocapture RT-PCR experiments to test viral neutralization by Abs raised against each of 4 peptides termed p35 (E1), p36 (E2), p37 (E2) and p38 (E2). Swiss mice were immunized with each of the 3 peptides (p35, p37 and p38) which generated neutralizing antibodies in immunocapture experiments. Antibody responses to corresponding peptides were determined using different routes of administration, different adjuvants, different doses and at different time points post-injection. To explore the dose range for future pharmacological studies, three doses namely 50 ng, 10 µg and 50 µg/25 gm mouse body weight were tested for biochemical and histopathological changes in several organs. RESULTS: Murine Abs against p35, p37 and p38 but not p36 showed HCV neutralization in immunocapture experiments. Subcutaneous injection of peptides elicited higher responses than i.m. and i.p. Immunization with Multiple Antigenic Peptide (MAP) form or coupled to Al PO4 elicited the highest Ab responses. Peptide doses of 50 ng/25 gm body weight or less were effective and safe, however dose assessment still requires further study. Histopathological changes were observed in animals that received doses ∼1000 times higher than the potential therapeutic dose. CONCLUSION: Exploration of humoral immunogenicity, neutralization capacity and safety suggested that the peptides presented herein are candidate vaccine components for further preclinical assessment.