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Experimental Human Pneumococcal Carriage
Published on: February 15, 2013
Pneumococcal conjugated vaccine: PHiD-CV
Ener Cagri Dinleyici1, Zeynel Abidin Yargic
1Associate Professor in Pediatrics, Eskisehir Osmangazi University, Department of Pediatrics, TR-26480 Eskisehir, Turkey. timboothtr@yahoo.com
Insights
A new 10-valent pneumococcal vaccine (PHiD-CV) shows promise for preventing invasive pneumococcal disease (IPD) and otitis media in children. It is immunogenic and safe, with further post-marketing studies needed to confirm efficacy and herd immunity benefits.
Area of Science:
- Pediatric infectious diseases
- Vaccinology
- Immunology
Background:
- Pneumococcal infections pose a significant public health challenge globally.
- Conjugated pneumococcal vaccines have demonstrated success in reducing disease burden.
- A new 10-valent pneumococcal vaccine (PHiD-CV) has been developed for infants and children.
Purpose of the Study:
- To evaluate the immunogenicity, safety, and tolerability of the 10-valent pneumococcal vaccine (PHiD-CV).
- To compare the immunogenicity of PHiD-CV with the 7-valent pneumococcal conjugate vaccine (PCV-7).
- To assess the potential of PHiD-CV for active immunization against invasive pneumococcal disease (IPD) and acute otitis media.
Main Methods:
- Clinical trials assessing immunogenicity and safety in infants and children aged 6 weeks to 2 years.
- Comparison of antibody concentrations and opsonophagocytic activity responses against pneumococcal serotypes between PHiD-CV and PCV-7.
- Evaluation of coadministration with routine pediatric vaccines.
Main Results:
- PHiD-CV demonstrated noninferior immunogenicity compared to PCV-7 for shared serotypes, with exceptions for serotypes 6B and 23F.
- PHiD-CV showed immunogenicity for additional serotypes (1, 5, and 7F) not included in PCV-7.
- The vaccine was found to be immunogenic, safe, and well-tolerated in the pediatric population and can be coadministered with other vaccines.
Conclusions:
- PHiD-CV is an immunogenic and safe vaccine for preventing IPD and acute otitis media in children.
- Post-marketing surveillance is crucial to monitor vaccine efficacy for all targeted serotypes and assess herd immunity.
- Further research is needed to explore the advantages of Protein D as a carrier and the vaccine's efficacy against non-typeable Haemophilus influenzae, especially in low-income countries.
Abstract:
At the beginning of a new century, we have gained significant achievements against pneumococcal infections by using conjugated pneumococcal vaccines. In January 2009, the EMEA issued a positive opinion about, and recommended the approval of, GlaxoSmithKline's pediatric pneumococcal candidate vaccine, which is indicated for active immunization against invasive pneumococcal disease (IPD) and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks up to 2 years of age. The approved 10-valent pneumococcal vaccine (PHiD-CV) contains all serotypes in 7-valent pneumococcal conjugate vaccine (PCV-7) plus serotypes 1, 5 and 7F. Protein D from nontypeable Haemophilus influenzae is the carrier protein for eight serotypes, while tetanus and diphtheria toxins are in the carrier proteins for the remaining two serotypes. It has also been proved that PHiD-CV is immunogenic, safe and well-tolerated in children. This vaccine can be coadministered with routinely used pediatric vaccines. Noninferiority criteria of PHiD-CV compared with PCV-7 were established in shared serotypes, except for serotypes 6B and 23F, and PHiD-CV is immunogenic for additional serotypes as assessed by the percentage of subjects with antibody concentrations. PHiD-CV is also immunogenic for ten serotypes as assessed by post-primary and post-booster dose opsonophagocytic activity responses. Vaccine efficacy against IPD and other conditions should be monitored for shared serotypes and also additional serotypes during the postmarketing period. Optimal scheduling, safety and immunogenicity data in children with different risk factors for IPD, or whether it will provide herd immunity, are the questions waiting for answers in the postmarketing period. Further studies are needed to assess the potential advantages of protein D as a carrier and the potential efficacy of this new vaccine against H. influenzae. The potential public health efficacy of PHiD-CV in low-income countries, where IPD and pneumonia are a major public health problem, is a major concern.
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