Tahar Djebbar Khedidja, Allouache Mounia, Kezzal Salim, Benguerguoura Fouzia, TouilBoukoffa Chafia, Zidi Ines, Raache Rachida, Ouzari Hadda-Imene
Laboratoire de Contrôle de Qualité des Vaccins et Sérums, Département de Contrôle des Produits Biologiques, Institut Pasteur d'Algérie, Route du Petit Staouel, Dely-Brahim 16047, Algeria.
Laboratoire de Biologie Cellulaire et Moléculaire-Equipe Cytokines et NO Synthase, Faculté des Sciences Biologiques, Université des Sciences et de la TechnologieHouariBoumedienne (USTHB), Bab Ezzouar 16111, Algeria.
Vaccines (Basel). 2022 Jun 6;10(6):906. doi: 10.3390/vaccines10060906.
In Algeria, vaccination against pertussis is carried out using the whole-cell pertussis vaccine combined with the diphtheria and tetanus toxoids (DTwp). The quality control of vaccines locally produced or imported is carried out before the batch release. The aim of our work was to evaluate the potency of pertussis vaccines. In the present study, five consecutive trials of potency were conducted on samples of the same batch of (DTwp) using the mouse protection test (MPT) against experimental infection of strain 18323, based on the Kendrick test. The virulence of 18-323 was verified by the mortality of mice, with an average LD50 of 338.92, as well as the dose of the lethal test containing a mean number of LD50 of 324.43. The (MPT) test recorded a relative potency of 8.02 IU/human dose, with 95% CL of (3.56-18.05) IU/human dose. The development of the (MPT) at the laboratory of quality control of vaccines and sera at the Pasteur Institute of Algeria was effective in evaluating the potency of whole-cell pertussis vaccines. Interestingly, our study indicates that this potency is necessary for the vaccine quality assurance. Further validation is needed to strengthen the application and routine use of the test.
在阿尔及利亚,使用全细胞百日咳疫苗与白喉和破伤风类毒素联合疫苗(DTwp)进行百日咳疫苗接种。对本地生产或进口的疫苗进行批签发前的质量控制。我们工作的目的是评估百日咳疫苗的效力。在本研究中,基于肯德里克试验,使用小鼠保护试验(MPT)针对18323菌株的实验性感染,对同一批次的(DTwp)样本连续进行了五次效力试验。通过小鼠死亡率验证了18 - 323的毒力,平均半数致死量(LD50)为338.92,以及致死试验剂量中平均含有324.43个LD50。(MPT)试验记录的相对效力为8.02国际单位/人用剂量,95%置信区间为(3.56 - 18.05)国际单位/人用剂量。阿尔及利亚巴斯德研究所疫苗和血清质量控制实验室开展的(MPT)试验有效地评估了全细胞百日咳疫苗的效力。有趣的是,我们的研究表明这种效力对于疫苗质量保证是必要的。需要进一步验证以加强该试验的应用和常规使用。