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Antibody responses to routine pediatric vaccines administered with 13-valent pneumococcal conjugate vaccine
Kristina A Bryant1, Alejandra Gurtman, Douglas Girgenti
1University of Louisville University of Louisville, Louisville, KY 40202, USA. k0brya01@louisville.edu
Insights
The 13-valent pneumococcal conjugate vaccine (PCV13) does not interfere with infant immune responses to routine pediatric vaccines. Studies show PCV13 elicits noninferior immune responses compared to the 7-valent pneumococcal conjugate vaccine (PCV7).
Area of Science:
- Immunology
- Vaccinology
- Pediatrics
Background:
- The 13-valent pneumococcal conjugate vaccine (PCV13) is widely used to prevent pneumococcal disease.
- Concerns exist regarding potential interference of PCV13 with immune responses to other routine childhood vaccines.
Purpose of the Study:
- To assess whether PCV13 impacts immune responses when administered concurrently with standard pediatric vaccines.
- To compare the immunogenicity of PCV13 versus the 7-valent pneumococcal conjugate vaccine (PCV7) when given alongside other routine immunizations.
Main Methods:
- Two randomized studies involved infants receiving either PCV13 or PCV7 at 2, 4, and 6 months, along with diphtheria, tetanus, acellular pertussis, inactivated polio, hepatitis B, and Haemophilus influenzae type b vaccines.
- Antibody levels to vaccine antigens were measured one month after the infant series and again after a toddler dose (12-15 months), which included measles, mumps, rubella, varicella, and hepatitis A vaccines.
- Key metrics included the percentage of responders and immunoglobulin G antibody geometric mean concentrations/titers for each vaccine antigen.
Main Results:
- Noninferiority criteria were met for all tested antigens regarding the percentage of responders in both PCV13 and PCV7 groups.
- Immunoglobulin G antibody geometric mean concentration/titer ratios (PCV13/PCV7) ranged from 0.91-1.33 after the infant series and 0.83-1.03 after the toddler dose, meeting noninferiority standards.
Conclusions:
- Concomitant administration of PCV13 with routine pediatric vaccines results in immune responses that are noninferior to those elicited by PCV7.
- PCV13 can be safely co-administered with other essential childhood vaccines without compromising immunogenicity.
Background:
A 13-valent pneumococcal conjugate vaccine (PCV13) has been licensed in >100 countries to broaden coverage against pneumococcal disease. We assessed whether PCV13 interferes with immune responses to concomitantly administered routine pediatric vaccines.
Methods:
Healthy US infants were randomly assigned in 2 studies to receive PCV13 or 7-valent PCV (PCV7) at age 2, 4 and 6 months concomitantly with diphtheria, tetanus, acellular pertussis, inactivated polio virus, hepatitis B and Haemophilus influenzae type b, and at age 12-15 months with measles, mumps, rubella, varicella and hepatitus A. Antibodies to pertussis antigens, diphtheria, tetanus toxoid, poliovirus types 1-3, Haemophilus influenzae type b polyribosylribitol phosphate capsular polysaccharide and polyribosylribitol phosphate capsular polysaccharide were measured 1 month after the infant series; measles, mumps, rubella, varicella and polyribosylribitol phosphate capsular polysaccharide were determined 1 month after the toddler dose. Both the percentages of responders (subjects reaching a prespecified antibody concentration) and immunoglobulin G antibody geometric mean concentrations/titers were calculated for each concomitant vaccine antigen.
Results:
Not all assays were performed on all subjects. Data were available from 153 to 239 infants and 163-230 toddlers in the PCV13 group and 173-240 infants and 167-214 toddlers in the PCV7 group. One month after both infant series and the toddler dose, noninferiority criteria were met for all antigens with respect to percentage of responders in both PCV7 and PCV13 groups. Immunoglobulin G antibody geometric mean concentration/titer ratios (PCV13/PCV7) were 0.91-1.33 and 0.83-1.03 at 1 month after the infant series and toddler dose, respectively, and met predetermined noninferiority criteria.
Conclusions:
Immune responses to routine pediatric vaccines concomitantly administered with PCV13 were noninferior to responses achieved when administered with PCV7.
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