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Experimental Human Pneumococcal Carriage
Published on: February 15, 2013
Safety and immunogenicity of a heptavalent pneumococcal conjugate vaccine in infants
Kenneth M Zangwill1, David P Greenberg, Chung-Yin Chiu
1UCLA Center for Vaccine Research, Harbor-UCLA Medical Center, Liu Research Building, 1124 W. Carson Street, Torrance, CA 90502, USA. kzangwill@rei.edu
Insights
This study found the heptavalent Streptococcus pneumoniae conjugate vaccine (PCV-OMPC) to be safe for infants. However, immune responses varied by serotype, and co-administration with certain Haemophilus influenzae type b (Hib) vaccines may affect immunogenicity.
Area of Science:
- Immunology
- Vaccinology
- Pediatrics
Background:
- Pneumococcal conjugate vaccines (PCV) are crucial for preventing invasive pneumococcal disease in infants.
- Evaluating the safety and immunogenicity of different vaccine lots and combinations is essential for optimizing vaccination strategies.
Purpose of the Study:
- To assess the safety and immunogenicity of two lots of a heptavalent Streptococcus pneumoniae conjugate vaccine (PCV-OMPC) in infants.
- To compare the immune responses elicited by PCV-OMPC when co-administered with different Haemophilus influenzae type b (Hib) conjugate vaccines.
Main Methods:
- A randomized trial involving 240 infants assigned to receive PCV-OMPC concurrently with either a CRM(197)-based Hib vaccine or an OMPC-based Hib-hepatitis b vaccine.
- Infants received vaccinations at 2, 4, 6, and 12 months of age.
- Serotype-specific antibody concentrations and seroconversion rates were measured.
Main Results:
- Both PCV-OMPC lots were well-tolerated with no vaccine-related serious adverse events.
- Antibody geometric mean concentrations (GMC) varied by serotype, with lower responses for serotypes 6B and 23F after the primary series.
- Co-administration with the OMPC-based Hib vaccine (Group 2) resulted in significantly lower antibody responses for certain serotypes compared to the CRM(197)-based Hib vaccine (Group 1).
Conclusions:
- The heptavalent Streptococcus pneumoniae conjugate vaccine (PCV-OMPC) is safe for infant immunization.
- Immune responses to PCV-OMPC are serotype-dependent.
- Concomitant administration of PCV-OMPC with a Hib vaccine using a homologous carrier (OMPC) may potentially reduce its immunogenicity.
Objective:
To evaluate the safety and immunogenicity of two lots of a heptavalent Streptococcus pneumoniae conjugate vaccine (PCV) containing seven capsular polysaccharide serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) conjugated to the outer membrane complex of Neisseria meningitidis serogroup B (OMPC) and administered to infants at 2, 4, 6, and 12 months of age.
Methods:
One hundred twenty infants were randomly assigned to concurrently receive PCV-OMPC and one of two Haemophilus influenzae type b (Hib) conjugate-DTwP combination vaccines: (1) Hib with a heterologous protein carrier (CRM(197), TETRAMUNE, Group 1) or (2) an experimental Hib-hepatitis b combination vaccine with the homologous carrier (OMPC, Group 2). All infants in Groups 1 and 2 received PCV-OMPC (lot 1) at 12 months of age. Another separate group of 120 infants (Group 3) received a different lot of PCV-OMPC concurrently with Hib-CRM(197) (TETRAMUNE) at 2, 4, and 6 months of age and then were randomized to receive either PCV-OMPC or a 23-valent polysaccharide (PS) pneumococcal vaccine at 12 months of age.
Results:
Each PCV-OMPC lot was generally well tolerated and no vaccine-related serious adverse events were reported. Following the primary series, serotype-specific anti-pneumococcal geometric mean concentrations (GMC) were highest for serotypes 14, 19F, and 4 and lowest for serotypes 6B and 23F. GMC and seroconversion rates in Group 3 (lot 2) were lower than in Group 1 (lot 1) for serotypes 6B, 14, 18C, and 23F. Antibody responses to serotypes 6B, 14, and 18C were significantly lower in Group 2 compared to Group 1. Following a booster dose of PCV-OMPC at 12 months of age, each lot was immunogenic with at least a 5-10-fold increase in antibody levels, and responses were significantly higher among those who received the PS vaccine.
Conclusions:
PCV-OMPC is generally safe in infants, displays variable immune response by serotype, and concomitant receipt of Hib vaccine with homologous carrier may impact on its immunogenicity.
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