Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants in the United States.
Pediatr Infect Dis J
; 40(10): 944-951, 2021 10 01.
Article
em En
| MEDLINE
| ID: mdl-34525007
ABSTRACT
BACKGROUND:
The development and widespread use of pneumococcal conjugate vaccines (PCVs) substantially reduced the global burden of pneumococcal disease. Expanding the serotypes covered by PCVs may further reduce disease burden. A 20-valent PCV (PCV20) has been developed to add coverage for 7 additional serotypes (8, 10A, 11A, 12F, 15B, 22F and 33F) to those in the existing 13-valent PCV (PCV13). This phase 2 study evaluated the safety, tolerability and immunogenicity of PCV20 in healthy US infants.METHODS:
In this randomized, active-controlled, double-blind study, 460 infants were randomized 11 to receive a 4-dose series of either PCV20 or PCV13 at 2, 4, 6 and 12 months of age. Solicited local reactions and systemic events, adverse events (AEs) and serious AEs were recorded. Immunogenicity was assessed by measuring serotype-specific IgG concentrations and opsonophagocytic activity titers at 1 month after Dose 3, before Dose 4 and 1 month after Dose 4.RESULTS:
Of 460 infants, 82.8% completed the 1-month visit after Dose 4. Local reactions and systemic events were mostly mild to moderate in severity and similar between the PCV20 and PCV13 groups. Treatment-related AEs were uncommon, with no related serious AEs or deaths reported. IgG and opsonophagocytic activity responses elicited by PCV20 were robust and demonstrated a booster response after Dose 4.CONCLUSIONS:
Administration of PCV20 in US infants was well tolerated, with a safety profile similar to PCV13, and induced robust serotype-specific immune responses. These findings support continued development of PCV20 in the pediatric population.
Texto completo:
1
Coleções:
01-internacional
Contexto em Saúde:
2_ODS3
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4_TD
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7_ODS3_muertes_prevenibles_nacidos_ninos
Base de dados:
MEDLINE
Assunto principal:
Vacinas Pneumocócicas
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Sorogrupo
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Imunogenicidade da Vacina
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Anticorpos Antibacterianos
Tipo de estudo:
Clinical_trials
Limite:
Female
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Humans
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Infant
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Male
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Pediatr Infect Dis J
Ano de publicação:
2021
Tipo de documento:
Article