Virology & Mycology
Open Access

Safety and immunogenicity of new cuban pneumococcal conjugate vaccine

Joint Event on 31^st Annual Congress on Vaccines, Clinical Trials & B2B & 11^th International Conference on Virology and Microbiology

July 27-28, 2018 | Vancouver, Canada

Maria E Toledo-Romani, Nivaldo Linares, Maria F. Casanova, RInaldo Puga-Gomez, Carlos P Dotres, Beatriz Paredes, Darielys Santana, Dagmar Garc�?­a- Rivera, Yury Vald�?©s-Balbin, V. Verez-Bencomo, Laura Rodriguez-Noda

Tropical Medicine Institute â�?�?Pedro Kour�?­â�?, Cuba
Finlay Vaccine Institute, Cuba
University Pediatric Hospital â�?�?Paquito Gonz�?¡lez Cuetoâ�?. Cuba
International Clinic â�?�?Cira Garc�?­a. Cuba
Pediatric Hospital â�?�?Ju�?¡n Manuel M�?¡rquezâ�?, Cuba

Posters & Accepted Abstracts: Virol Mycol

Abstract :

Background and Aims: A new pneumococcal conjugate vaccine is currently undergoing advanced clinical evaluation in Cuba. We present the safety and immunogenicity current results of clinical research of PCV7-TT. Methods: PCV7-TT contains 2�?¼g of capsular polysaccharide from serotypes 1, 5, 14, 18C, 19F and 23F and 4�?¼g of 6B conjugated to tetanus toxoid (TT). The results of three randomized control trials are synthetized to demonstrated the safety and immunogenicity including: 1) adults (n=40), 2) preschool children 4-5y/o (n=15) and infants 7-11 months (n=30) and 3) preschool children 1-5y/o (n=1135). The infants and preschool children were followed for 30 days after each doses to assess adverse events. Serum was obtained 30 days after the second and third dose for evaluating the immunogenicity. Serotype specific OPA and ELISA were performed at the WHO Reference Laboratory, UCL Institute of Child Health. Results: No serious adverse events were reported in none group of age. Following a single-dose in 4â�?�?5-year-old children and infants vaccinated at 7, 8 and 11 months induced statistically significant (pâ�?¤ 0.05) increase of IgG GMC and OPA for seven common serotypes with Synflorix�?® as control vaccine. New insights since a protective efficacy clinical trial including 1135 preschool children and using PREVNAR�?® as control vaccine, showing that more than 90% of children have IgG titers â�?¥0.35 for 6 of 7 vaccine serotypes, and more than 77% for serotype 5. Conclusions: The Cuban pneumococcal vaccine candidate is safe and immunogenic. This results are useful to support the decisionmaking to introduce the new vaccine in Cuba.