8th Cuban Congress on Microbiology and Parasitology, 5th National Congress on Tropical Medicine and 5th International Symposium on HIV/aids infection in Cuba

Title

Development of Streptococcus pneumoniae conjugate vaccine with the most prevalent serotypes in Latin America.

Authors

Vicente Verez Bencomo , Y. Valdés Balbin , D. Santana Medero , D. García Rivera , A. Villar Aneiros , D. González Díaz , B. Paredes Moreno , L. Rodríguez Noda , U. Ramírez González , J. Chang Calderón , J. Lora García

Abstract


The development of a conjugate vaccine against multiple serotypes of S. pneumonia  is a complex task with numerous challenges. Several years ago, the Center for Biomolecular Chemistry launched a research project for developing a heptavalent vaccine containing the seven serotypes of S. pneumoniae more frequently associated with infection in Cuba and Latin America. As a result we designed a candidate vaccine containing 2µg of each capsular polysaccharide 1, 5, 14, 18C, 19F and 23F as well 4µg for 6B - all of them conjugated to tetanus toxoid- and aluminum phosphate as adjuvant. After several years of research and development, the technology was established for the production of the seven active pharmaceutical ingredients and of the combined vaccine. Several batches have been produced with the aim to assess their physico-chemical properties and to perform the preclinical and toxicological studies, guaranteed by a Quality Assurance System. Cuban pneumococal conjugate vaccine, name QUIMI-ViO, has completed the preclinical and toxicological evaluation and is produced under GMP conditions, and the production technology is being scaled. QUIMI-ViO is currently in clinical evaluation for license in pediatric use in 2015. During the last years, the Phase I clinical trials were conducted in healthy young, children 4-5 year-old and infants 7-months, demonstrating the safety and preliminary immunogenicity of vaccine. A phase II-III clinical trial in children is ongoing with the aim to demonstrate immunogenicity and efficacy. These studies pave the way toward the first Latin-American conjugate vaccine against S. pneumoniae.