title: Safety and preliminary immunogenicity of Cuban pneumococcal conjugate vaccine candidate in healthy children: a randomized phase I clinical trial.
abstract: A new heptavalent conjugate vaccine (PCV7-TT) is under development in Cuba. PCV7-TT contains 2 μg of serotypes 1, 5, 14, 18C, 19F, 23F and 4 μg of 6B, each one conjugated to tetanus toxoid (TT). This vaccine was designed with the serotypes that cause most invasive pneumococcal diseases (IPD) worldwide. In the present study, we investigated the safety and explored the immunogenicity of PCV7-TT during a controlled, randomized and double blind clinical trial phase I in 4-5-year-old children. PCV7-TT was well tolerated and as safe as Synflorix used as control vaccine. Following a single-dose vaccination, all individual serotypes included in PCV7-TT induced statistically significant increase of IgG GMC and OPA GMT. These are the first clinical results of PCV7-TT in children and they pave the way toward next clinical trials in children and infants. This clinical trial was published in the Cuban Public Register of Clinical Trials with code RPCEC00000173.
authors: Children University Hospital "Juan Manuel Marquez", Marianao, Havana 11400, Cuba.
authors: Carlos P
authors: CP
authors: Dotres
authors: Children University Hospital "Juan Manuel Marquez", Marianao, Havana 11400, Cuba.
authors: Rinaldo
authors: R
authors: Puga
authors: Children University Hospital "Juan Manuel Marquez", Marianao, Havana 11400, Cuba.
authors: Yariset
authors: Y
authors: Ricardo
authors: Children University Hospital "Juan Manuel Marquez", Marianao, Havana 11400, Cuba.
authors: Carmen R
authors: CR
authors: Broño
authors: Center for Biomolecular Chemistry, 200 and 21 Street, Playa, Havana 11600, Cuba.
authors: Beatriz
authors: B
authors: Paredes
authors: Center for Biomolecular Chemistry, 200 and 21 Street, Playa, Havana 11600, Cuba.
authors: Vladimir
authors: V
authors: Echemendía
authors: Center for Biomolecular Chemistry, 200 and 21 Street, Playa, Havana 11600, Cuba.
authors: Sandra
authors: S
authors: Rosell
authors: Center for Biomolecular Chemistry, 200 and 21 Street, Playa, Havana 11600, Cuba.
authors: Nadezhda
authors: N
authors: González
authors: Center for Biomolecular Chemistry, 200 and 21 Street, Playa, Havana 11600, Cuba. Electronic address: dagmar.garcia@cqb.cu.
authors: Dagmar
authors: D
authors: García-Rivera
authors: Center for Biomolecular Chemistry, 200 and 21 Street, Playa, Havana 11600, Cuba.
authors: Yury
authors: Y
authors: Valdés
authors: University College London, Institute of Child Health, London WC1N 1EH, United Kingdom.
authors: David
authors: D
authors: Goldblatt
authors: Center for Biomolecular Chemistry, 200 and 21 Street, Playa, Havana 11600, Cuba.
authors: Vicente
authors: V
authors: Vérez-Bencomo
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D000917:Antibody Formation; D002675:Child, Preschool; D003462:Cuba; D004311:Double-Blind Method; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D011008:Pneumococcal Infections / Q000517:prevention & control*; D022242:Pneumococcal Vaccines / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000907:Antibodies, Bacterial; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D007074:Immunoglobulin G; C547294:PHiD-CV vaccine; D022242:Pneumococcal Vaccines
keywords: Clinical trial; Immunogenicity; Pneumococcal conjugated vaccine; Safety