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The Safety and Immunogenicity of a 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/TT) in Infants: A
Zhiqiang Xie1, Jiangjiao Li2, Xue Wang3
1Henan Province Center for Disease Control and Prevention, Zhengzhou 450003, China.
Insights
The 13-valent pneumococcal polysaccharide conjugate vaccine (PCV13i) showed comparable safety and non-inferior immunogenicity to the standard PCV13 in infants. Both vaccines effectively induced robust antibody responses against pneumococcal serotypes.
Area of Science:
- Immunology
- Vaccinology
- Pediatrics
Background:
- Pneumococcal conjugate vaccines are crucial for preventing invasive pneumococcal disease in infants.
- Evaluating novel vaccine formulations is essential for improving public health outcomes.
- The 13-valent pneumococcal polysaccharide conjugate vaccine (CRM197/TT) (PCV13i) is a new candidate for infant immunization.
Purpose of the Study:
- To assess the immunogenicity and safety of the experimental PCV13i compared to the licensed PCV13 in infants.
- To determine antibody responses and opsonophagocytic killing assay (OPA) titers following primary and booster vaccinations.
- To evaluate the incidence of adverse reactions associated with PCV13i administration.
Main Methods:
- A randomized controlled trial involving 1200 infants comparing PCV13i and PCV13.
- A three-dose primary vaccination series at 2, 4, and 6 months, followed by a booster at 12-15 months.
- Measurement of IgG antibody concentrations and OPA geometric mean titers (GMTs) pre- and post-vaccination, and assessment of adverse events.
Main Results:
- PCV13i demonstrated a safety profile comparable to PCV13.
- While IgG GMCs varied by serotype, overall antibody responses were robust for both vaccines.
- OPA GMTs showed mixed results by serotype post-primary vaccination, but PCV13i maintained higher GMTs for specific serotypes post-booster.
Conclusions:
- The experimental PCV13i is non-inferior to the control PCV13 in terms of immunogenicity.
- PCV13i is a safe and immunogenic vaccine candidate for infant immunization against pneumococcal disease.
Objectives:
This study aimed to evaluate the immunogenicity and safety of a 13-valent pneumococcal polysaccharide conjugate vaccine (CRM197/TT) (PCV13i) in infants.
Methods:
A total of 1200 infants were randomly assigned to either the experimental PCV13i group or the control PCV13 group in a 1:1 ratio. Each group received a three-dose series of the vaccine at 2, 4, and 6 months of age, followed by a booster dose at 12-15 months. Blood samples were collected before and 30 days after both primary and booster vaccinations. The primary immunogenicity endpoints were the seropositive rate and the geometric mean concentration (GMC) of IgG antibodies against the 13 pneumococcal serotypes. The primary safety endpoint was the incidence of adverse reactions within 0-7 days and 0-30 days after vaccination.
Results:
Results showed that the experimental PCV13i was well tolerated, with a safety profile comparable to that of the control vaccine. Following primary vaccination, the GMCs of IgG responses against serotypes 1, 5, 6A, 6B, 14, and 18C in the experimental group were lower than those in the control group, while responses against serotypes 3, 4, 7F, 9V, 19A, 19F, and 23F were higher. The experimental group exhibited higher opsonophagocytic killing assay (OPA) geometric mean titers (GMTs) for serotypes 3, 7F, 19A, and 19F compared to the control group, while GMTs for serotypes 1, 5, 6A, and 18C were lower. Following booster vaccination, OPA GMTs of the experimental group remained higher than those of the control group for serotypes 3, 7F, and 19F, while GMTs for serotype 5 were lower. Both vaccines induced robust immune responses, with high seropositive rates and significant increases in antibody levels following vaccination.
Conclusions:
The experimental PCV13i demonstrated non-inferiority to the control PCV13 in terms of immunogenicity.
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