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Published on: December 19, 2020
Insights
The new 13-valent pneumococcal conjugate vaccine offers broader protection against invasive pneumococcal infections in children. While generally immunogenic, specific serotypes require further study, but adverse effects remain comparable to the 7-valent vaccine.
Area of Science:
- Pediatric Infectious Diseases
- Vaccinology
- Immunology
Background:
- The 7-valent pneumococcal conjugate vaccine (PCV7) is standard for preventing invasive pneumococcal disease (IPD) in young children.
- A new 13-valent pneumococcal conjugate vaccine (PCV13) is authorized in the EU to replace PCV7, targeting at least 80% of European IPD cases.
Purpose of the Study:
- To evaluate the immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine (PCV13).
- To compare PCV13's immunogenicity against shared serotypes with the 7-valent pneumococcal conjugate vaccine (PCV7).
- To assess PCV13's non-inferiority to PCV7, considering the impact of polysorbate 80 and various vaccination schedules.
Main Methods:
- Clinical evaluation based on two immunogenicity studies.
- A non-inferiority study involving 500 children to assess the marketed PCV13 containing polysorbate 80.
- Analysis of 10 studies on the simultaneous administration of PCV13 with other routine childhood vaccines.
Main Results:
- PCV13 showed similar immunogenicity to PCV7 for shared serotypes, but lower for serotypes 3, 6B, and 9V.
- Target antibody titers were achieved after booster for most serotypes, except for serotype 3.
- Non-inferiority was established post-booster for all 13 valences, but not post-primary vaccination for serotypes 6B and 23F.
- Simultaneous administration of PCV13 did not affect the immunogenicity of other routine vaccines.
- PCV13 exhibited no significant increase in local or systemic adverse effects compared to PCV7.
Conclusions:
- PCV13 offers potential for further reduction in IPD incidence, pending epidemiological confirmation.
- While generally effective, specific serotypes (3, 6B, 9V) warrant further investigation regarding immunogenicity.
- PCV13 demonstrates a favorable safety profile and compatibility with other childhood vaccines, supporting its use as a PCV7 replacement.
Abstract:
The 7-valent pneumococcal conjugate vaccine (4, 6B, 9V, 14, 18C, 19F, 23F) is the standard vaccine for the prevention of invasive pneumococcal infections in infants and children under 5 years of age. A 13-valent pneumococcal conjugate vaccine (with the addition of valences 1, 3, 5, 6A, 7F and 19A) has now been authorised to replace the 7-valent vaccine within the European Union. This new vaccine, adapted to recent epidemiological data on invasive pneumococcal infections, is supposed to cover at least 80% of pneumococcal infections in Europe. The protective potency of the 13-valent vaccine has not yet been tested in clinical trials. Clinical evaluation is based on two immunogenicity studies, in which the immunogenic potency of the 13-valent vaccine was similar to that of the 7-valent vaccine for their shared serotypes, but lower for serotypes 3, 6B and 9V. For these last two serotypes and for the new serotypes, the usual target antibody titre was reached after a booster injection. This was not the case for valence 3. * The vaccine used in immunogenicity studies did not contain polysorbate 80 (an excipient), and a non-inferiority study of the marketed vaccine containing polysorbate 80 was therefore conducted in 500 children. Non-inferiority was established for all 13 valences after the booster injection, but not for valences 6B and 23F after primary vaccination. According to the results of 10 studies, simultaneous administration of the 13-valent pneumococcal conjugate vaccine does not affect the immunogenicity of other vaccines generally administered before the age of 5 years. Other immunogenicity studies support the use of a variety of vaccine schedules for infants and children under 5 years of age who have not yet been vaccinated or who have started vaccination with the 7-valent vaccine. Increasing the number of valences in the vaccine from 7 to 13 led to no marked increase in local adverse effects (hypersensitivity, indurations, erythema) or systemic reactions (mainly fever, decreased sleep and irritability). In practice, replacing the 7-valent pneumococcal conjugate vaccine with the 13 valence vaccine could lead to a further reduction in the incidence of invasive pneumococcal infections. However, this remains to be confirmed by well-conducted epidemiological follow-up studies.
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