Immunogenicity, reactogenicity and safety of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Mexican infants.

Guillermo M Ruiz-Palacios, M Lourdes Guerrero, Lorena Hernández-Delgado, Antonio Lavalle-Villalobos, Abigail Casas-Muñoz, Yolanda Cervantes-Apolinar, Marta Moreira, Lode Schuerman

Journal: Human vaccines 2012;7(11):1137-45

PMID: 22048109

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Abstract

The immunogenicity and safety of the 10-valent pneumococcal conjugate vaccine, PHiD-CV, have been documented in European and Asian studies. In this open study conducted in Mexico (NCT00489554), 230 healthy infants received three doses of PHiD-CV and DTPa-HBV-IPV/Hib vaccines at 2, 4 and 6 months of age and two doses of oral human rotavirus vaccine at 2 and 4 months. Serotype-specific pneumococcal responses and opsonophagocytic activity (OPA) were measured one month post-dose 3. PHiD-CV's primary vaccination course was highly immunogenic against each of the 10 pneumococcal vaccine serotypes and carrier protein D. Antibody responses against pneumococcal serotypes and protein D were generally higher in Mexican infants compared with European antibody responses, and functional OPA responses were also higher or in the same range. The most frequent solicited local symptom was pain, with high but similar incidences of grade 3 pain reported at both injection sites (up to 15% of all doses). PHiD-CV was well tolerated, with no serious adverse events considered as causally related to vaccination. Most solicited symptoms were mild and there was no increase in incidence of solicited symptoms with successive vaccine doses.

Address: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, México. [email protected]

DOI: 10.4161/hv.7.11.17984

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MeSH Terms: Antibodies, Bacterial, Bacterial Proteins, Carrier Proteins, Diphtheria-Tetanus-Pertussis Vaccine, Female, Haemophilus Infections, Haemophilus Vaccines, Haemophilus influenzae, Hepatitis B Vaccines, Humans, Immunization Schedule, Immunoglobulin D, Infant, Lipoproteins, Male, Mexico, Opsonin Proteins, Phagocytosis, Pneumococcal Infections, Pneumococcal Vaccines, Poliovirus Vaccine, Inactivated, Rotavirus Vaccines, Serotyping, Streptococcus pneumoniae, Treatment Outcome, Vaccines, Combined, Vaccines, Conjugate