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Published on: December 19, 2020
Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine
Kristina A Bryant1, Stan L Block, Sherryl A Baker
1Department of Pediatrics, University of Louisville, Louisville, KY 40292, USA. k0brya01@louisville.edu
Insights
The 13-valent pneumococcal conjugate vaccine (PCV13) demonstrated strong immunogenicity and safety in infants, comparable to the 7-valent pneumococcal conjugate vaccine (PCV7). PCV13 effectively targets additional Streptococcus pneumoniae serotypes, enhancing protection against invasive pneumococcal disease.
Area of Science:
- Pediatric Infectious Diseases
- Vaccinology
- Immunology
Background:
- Invasive pneumococcal disease (IPD) rates have decreased with the introduction of the 7-valent pneumococcal conjugate vaccine (PCV7).
- However, nonvaccine Streptococcus pneumoniae serotypes continue to cause significant illness and death.
- The 13-valent pneumococcal conjugate vaccine (PCV13) was developed to broaden protection against additional serotypes.
Purpose of the Study:
- To compare the safety and immunogenicity of PCV13 against PCV7 in infants.
- To evaluate antibody responses to both shared and unique serotypes covered by PCV13.
Main Methods:
- Infants were randomized to receive either PCV13 or PCV7 at 2, 4, and 6 months of age.
- Antibody concentrations (immunoglobulin G) and functional antibody levels (opsonophagocytic assay - OPA) were measured post-vaccination.
- Safety was assessed by monitoring local reactions and systemic events.
Main Results:
- PCV13 elicited robust immunogenic responses across all 13 serotypes, with high percentages of infants achieving protective antibody concentrations.
- Antibody levels for shared serotypes were comparable between PCV13 and PCV7 groups.
- OPA titers for PCV13-exclusive serotypes were significantly higher in the PCV13 group, and local/systemic reactions were similar between vaccines.
Conclusions:
- PCV13 is well-tolerated and immunogenic in infants.
- The vaccine induces significant antibody and OPA responses to all 13 targeted Streptococcus pneumoniae serotypes.
- PCV13 offers enhanced protection against a broader range of pneumococcal serotypes compared to PCV7.
Objective:
Invasive pneumococcal disease rates have declined since immunization with 7-valent pneumococcal conjugate vaccine (PCV7) (Prevenar/Prevnar [Wyeth Pharmaceuticals, Philadelphia, PA]) became routine. Certain nonvaccine Streptococcus pneumoniae serotypes (1, 3, 5, 6A, 7F, and 19A) still cause significant morbidity and mortality. The safety and immunogenicity of PCV7 were compared with those of 13-valent PCV (PCV13), which contains saccharides from serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F conjugated to CRM(197).
Patients And Methods:
Infants were randomly assigned to receive PCV13 or PCV7 at ages 2, 4, and 6 months with other vaccines. Post-third-dose antibodies to each pneumococcal polysaccharide were measured by immunoglobulin G enzyme-linked immunosorbent assay. Antibacterial functional antibodies were measured by opsonophagocytic assay (OPA).
Results:
Subjects received PCV13 (n = 122) or PCV7 (n = 127). All PCV13 serotypes were immunogenic, with 88% to 98% of infants achieving antibody concentrations of > or =0.35 microg/mL to shared PCV7 serotypes. For the 6 additional serotypes, 97% to 100% of PCV13-vaccinated infants achieved antibody concentrations of > or =0.35 microg/mL. Geometric mean antibody concentration for PCV13 recipients ranged from 1.32 microg/mL (serotype 23F) to 4.26 microg/mL (serotype 14). The ratio of OPA geometric mean titers for the 7 shared serotypes (PCV13:PCV7) ranged from 0.6 to 1.4, suggesting no clinically meaningful differences. For PCV13-only serotypes, OPA geometric mean titers were significantly higher in the PCV13 group than in the PCV7 group. Local reactions and systemic events were similar between groups.
Conclusions:
PCV13 was well tolerated and immunogenic, with most infants developing antipolysaccharide antibody concentrations of > or =0.35 microg/mL, as well as OPA responses, to each of the 13 serotypes.
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