RESUMEN
INTRODUCTION: Vaccines are biological products and their efficacy is affected by storage conditions. They are vital in promoting public health. Failures in immunization programmes often times are blamed on disruption in vaccine cold-chain. This study assessed the immunogenicity/potency of the measles vaccines utilized in childhood immunization in South-East, Nigeria and indirectly assessed the effectiveness of the cold-chain technology in the region. METHODS: This was an experimental study carried out between December 2011 and June 2013. Antibody induction method was used to evaluate the immunogenicity/potency of the measles vaccines sourced from the central cold chain facilities in South-east, Nigeria and indirectly, the effectiveness of the cold chain technology in the zone in maintaining vaccine potency. The neutralizing antibodies in a control group (administered with measles vaccines stored at 37°C for 12 months) and in immunized group were determined after 30 days of immunization using ELISA. RESULTS: The mean storage temperature of the vaccines at the states vaccines central cold chain facilities was -2.4°C and before storage at study site, it was 5.8°C but at the study site it was -4.54°C. Mean ±Standard Error in the Mean (SEM) IgG titers for the measles vaccines sourced from "Open Market", Ebonyi, Enugu, Imo, Anambra and Abia States were 0.793±0.051, 1.621±0.015, 1.621±0.015, 1.715±0.081, 1.793±0.051 and 1.683±0.078 respectively while the mean ±Standard Error in the Mean (SEM) IgM titres were 0.857±0.037, 1.400±0.030, 1.391±0.032, 1.339±0.037, 1.405±0.066 and 1.279±0.025 respectively. One way analysis of variance shows that there is statistical difference in the IgG and IgM antibodies titers produced by the control compared to the vaccines (P value < 0.0001). Also, Bartlett's test for equal variances showed that there was statistical difference (P value < 0.0001 for IgG and = 0.036 for IgM). The antibodies elicited by the vaccines from the states were enough to confer protection but the vaccine samples from "Open Market" (control) could not evoke enough antibodies. CONCLUSION: The cold-chain technology in the region was judged to be optimal as at the time of vaccine sampling since all the measles vaccines had good immunogenicity profile. However, efforts are still needed to maintain these facilities in good condition in order to ensure effective immunization program in the region.
Asunto(s)
Anticuerpos Neutralizantes/inmunología , Vacuna Antisarampión/inmunología , Refrigeración , Vacunación , Animales , Almacenaje de Medicamentos , Ensayo de Inmunoadsorción Enzimática , Programas de Inmunización , Inmunoglobulina G/inmunología , Inmunoglobulina M/inmunología , Vacuna Antisarampión/provisión & distribución , Ratones , Nigeria , Temperatura , Factores de TiempoRESUMEN
This study examined the potential usefulness of cultured human nasal epithelium as a model to investigate nasal absorption enhancement strategies for therapeutic peptides. The transport of leucine enkephalin (Leu-Enk) in the presence of bestatin and puromycin, respectively and various combinations of these protease inhibitors with absorption enhancers capable of inhibiting proteases or protecting peptides against protease degradation (glycocholate, dimethyl-beta-cyclodextrin (DM beta CD)) was studied. Epithelial membrane perturbation, protein leakage, bestatin/puromycin absorption and rebound aminopeptidase activity were used as toxicological end-points. The combination of puromycin with glycocholate or DM beta CD resulted in a higher absorption enhancement of Leu-Enk (9-14%) than when the absorption enhancers were combined with bestatin (1-3%) or when the inhibitors were used alone (2-4%). The higher absorption enhancement resulting from the combination of protease inhibitors with absorption enhancers caused a significant reduction of epithelial resistance and increased sodium fluorescein transport. Although only puromycin permeated the human nasal epithelium, both protease inhibitors induced a significant rebound aminopeptidase activity (25-61%), which can be associated with protein leakage (21-46%). This study highlighted (i) the potential usefulness of cultured human nasal epithelium as a model to study nasal absorption enhancement of therapeutic peptides; (ii) further studies using in vivo nasal models are required to ascertain whether the membrane perturbation and cytotoxicity observed with various combinations of the protease inhibitors and absorption enhancers really raise safety concerns.