Open-Label Trial of Immunogenicity and Safety of a 13-Valent Pneumococcal Conjugate Vaccine in Adults ≥50 Years of Age in Mexico

Abstract

g This open-label multicenter clinical trial conducted in Mexico assessed the immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine (PCV13) in adults >50 years of age not previously vaccinated with the 23-valent pneumococcal polysaccharide vaccine (PPSV23). The PCV13 elicited a robust immune response in this study population, as reflected by the magnitude of fold rises in functional antibody levels measured by serotype-specific opsonophagocytic activity (OPA) assays before and 1 month after vaccination. Although the prevaccination OPA geometric mean titers (GMTs) for the majority of the serotypes were significantly lower in the 50-to 64-year age group than those in the >65-year age group, the postvaccination immune responses were generally similar. The overall immune responses were higher for the majority of the serotypes in the Mexican study population than those in similar adult study populations who received the PCV13 in Europe and the United States. PCV13 was well tolerated, and there were no vaccine-related serious adverse events. In conclusion, PCV13 is safe and immunogenic when administered to adults >50 years of age in Mexico and has the potential to protect against vaccine-type pneumococcal disease. (This study has been registered at ClinicalTrials.gov under registration no. NCT01432262.) D iseases caused by Streptococcus pneumoniae are a major worldwide public health problem affecting all age groups, with the highest mortality rates in adults Ͼ65 years of age and in individuals with underlying disease (1, 2). In adults Ն50 years of age in Latin American countries, including Mexico, communityacquired pneumonia (CAP) caused mainly by S. pneumoniae is associated with high rates of morbidity and mortality, with the incidence increasing substantially with age (3, 4). Worldwide, 20 serotypes account for Ͼ70% of invasive pneumococcal disease (IPD) in children Ͻ5 years of age, although the prevalence of each varies by region (5). In Latin American and Caribbean countries, the 21 most common serotypes causing IPD in young children, in order of decreasing frequency, are serotypes 14, 6B, 5, 1, 23F, 6A, 18C, 19F, 19A, 9V, 7F, 3, and 4, which are included in the 13-valent pneumococcal conjugate vaccine (PCV13), as well as nonvaccine serotypes 8, 15B, 12F, 2, 12A, 9A, 45, and 46 (5). Castañeda et al. (6) reported similar findings from the Sistema de Redes de Vigilancia de los Agentes Responsables de Neumonias y Meningitis Bacterianas (SIREVA) surveillance data from Latin America and the Caribbean from 2007 to 2009 in children Ͻ5 years of age; since the introduction of PCV7, serotype replacement with nonvaccine serotypes, especially 19A, has been observed. The Mexico-specific SIREVA II data from 2011 in children Ͻ6 years of age and adults Ն50 years of age reported that the PCV13 serotypes were the most frequently isolated, in particular, serotype 19A (7).Vaccination is considered an important preventive strategy for adults and children, in part because of the increased prevalence of S. pneumoniae ...

13-Valent Pneumococcal Conjugate Vaccine: A Review of Its Use in Adults

“…In addition to the phase III studies, an open-label study in PPSV23-naive adults C50 years of age (n = 324) in Mexico showed robust immune responses in terms of OPA GMTs for vaccine serotypes at 1 month following PCV13 administration [30]. For most serotypes, overall immune responses were higher than those previously reported in similar adult populations in the USA or Europe.…”

“…The modelling analysis of changes in outcomes attributable to PCV13 showed statistically significant (p \ 0.05) reductions of 37 % for IPD (95 % CI 20-51), 32 % (95 % CI 17-44) for noninvasive pneumococcal or lobar pneumonia and 12 % (95 % CI 6-17) for all-cause pneumonia among adults aged 18-39 years. There were also significant reductions in hospital admissions for noninvasive pneumococcal or lobar pneumonia in adults aged 40-64 years (by 25 %; 95 % CI [16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33] and in older adults aged C65 years (by 34 %; 95 % CI 27-41), and for IPD in those aged C65 years (by 29 %; 95 % CI . These findings suggest a strong and rapid development of herd protection.…”

Late onset of injection site reactions after vaccination with the 13-valent pneumococcal conjugate vaccine in adult study populations

“…AlPO 4 = aluminum phosphate; PCV13 = 13-valent pneumococcal conjugate vaccine; PPSV23 = 23-valent pneumococcal polysaccharide vaccine; TIV = trivalent inactivated influenza vaccine. A = South Africa 7 ; B = Japan 8 ; C = Japan 9 ; D = Mexico 10 ; E = Europe 11 ; F = United States and Sweden 13 ; G = United States and Europe 12 ; H = United States. 4-6 …”

Summary of NACI Statement: Interim Recommendations on the Use of Pneumococcal Vaccines in Immunocompetent Adults 65 Years of Age and Older

“…No studies on the effectiveness of PNEU-C-13 vaccine were identified through the literature search. Efficacy data of PNEU-C-13 to prevent IPD and CAP in adults who were immunocompetent at enrollment were reported in one trial (5) and three trials provided data on vaccine immunogenicity in immunocompetent and immunocompromised adults (6)(7)(8).…”