Gene/Protein Disease Symptom Drug Enzyme Compound
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Considerably higher vaccine efficacy estimate for clinical acute otitis media (AOM) has been obtained for the 11-valent pneumococcal conjugate vaccine with protein D of Haemophilus influenzae as a carrier (PncPD11) in the POET study than for the 7-valent pneumococcal conjugate vaccine (PncCRM7) in the Finnish Otitis Media (FinOM) Vaccine Trial. We recalculated PncCRM7 efficacy from the FinOM data using a case definition for AOM very close to the POET definition and a definition giving an incidence for AOM in the control group comparable to that obtained in the POET study. The different case definitions had only a slight impact on the vaccine efficacy estimates compared to the original case definitions. We were not able to show that the differences between the study results would be due to the case definitions used.
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PMID:Impact of different case definitions for acute otitis media on the efficacy estimates of a pneumococcal conjugate vaccine. 1842 Mar 15

Nontypeable Haemophilus influenzae is a significant pathogen in children, causing otitis media, sinusitis, conjunctivitis, pneumonia, and occasionally invasive infections. H. influenzae type b conjugate vaccines have no effect on infections caused by nontypeable strains because nontypeable strains are nonencapsulated. Approximately, one-third of episodes of otitis media are caused by nontypeable H. influenzae and the bacterium is the most common cause of recurrent otitis media. Recent progress in elucidating molecular mechanisms of pathogenesis, understanding the role of biofilms in otitis media and an increasing understanding of immune responses have potential for development of novel strategies to improve prevention and treatment of otitis media caused by nontypeable H. influenzae. Feasibility of vaccination for prevention of otitis media due to nontypeable H. influenzae was recently demonstrated in a clinical trial with a vaccine that included the surface virulence factor, protein D.
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PMID:Nontypeable Haemophilus influenzae as a pathogen in children. 1905 58

Nontypeable Haemophilus influenzae is an important human respiratory tract pathogen that causes about 30% of otitis media in infants and children. This proportion is increasing as a result of pneumococcal conjugate vaccines. Because of the morbidity associated with otitis media, a strong rationale exists to develop strategies to prevent these infections. A challenge to developing a vaccine for nontypeable H. influenzae is the antigenic heterogeneity of several major surface antigens and the genetic heterogeneity among strains. Several research groups have identified conserved surface proteins and tested them as putative vaccines. A recent clinical trial with protein D, a conserved surface antigen, demonstrated partial efficacy in preventing H. influenzae otitis media. This important result provides a proof of principle for developing a vaccine to prevent otitis media caused by nontypeable H. influenzae. Several vaccine antigens for nontypeable H. influenzae are in development.
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PMID:Current and Future Prospects for a Vaccine for Nontypeable Haemophilus influenzae. 1936 59

Although the currently available 7-valent pneumococcal conjugate vaccine (PCV7-CRM(197)) has been primarily designed for the prevention of invasive pneumococcal disease, it has also demonstrated the potential to prevent acute otitis media (AOM) and its associated complications. A candidate 11-valent pneumococcal conjugate vaccine (PCV11-HiD), which utilizes Haemophilus influenzae (Hi)-derived protein D as a carrier has demonstrated the ability to prevent AOM caused by not only vaccine serotypes of Streptococcus pneumoniae (Sp), but also those caused by Hi. The methodological, clinical, and epidemiological factors influencing results of vaccine trials for AOM prevention were reviewed and a model-based approach was developed, in order to assess the relative efficacy of different vaccine formulations. Six randomized trials having AOM as a measured outcome were identified. Vaccine efficacy (VE) ranged from -1% to 34% for all-cause AOM and between 56% and 64% for AOM caused by vaccine-type Sp. Using otopathogen-specific VE rates from the FinOM and POET trials and otopathogen distributions observed in three relatively unbiased studies, VE against all-cause AOM episodes under different scenarios was modeled. The most important factor explaining variation in VE estimates was bacterial replacement, which was present in the PCV7-CRM(197) FinOM study but not in the PCV11-HiD POET study. Another contributing factor was increased protection conferred against Hi AOM by protein D. Geographical variation in the distribution of otopathogens was a third factor explaining differences between trials. More studies on the current aetiology of AOM need to be performed to accurately predict the marginal benefit of a switch from PCV7-CRM(197) to the newly licensed PCV10-HiD-DiT or to the future PCV13-CRM(197).
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PMID:How to compare the efficacy of conjugate vaccines to prevent acute otitis media? 1936 79

Acute otitis media (AOM), one of the most common childhood diseases, is associated with a substantial medical, social and economic burden. Non-typeable Haemophilus influenzae (NTHi) and Streptococcus pneumoniae are the two main causes of bacterial OM. The 7-valent pneumococcal CRM(197)-conjugate vaccine (7vCRM, Prevnar/Prevenar, Wyeth) demonstrated efficacy against AOM caused by vaccine pneumococcal serotypes. Protection against overall AOM was also observed with an 11-valent pneumococcal protein D-conjugate vaccine (11Pn-PD) in the Pneumococcal Otitis Efficacy Trial (POET). Following POET, an optimized 10-valent pneumococcal non-typeable H. influenzae protein D-conjugate vaccine (PHiD-CV; Synflorix, GlaxoSmithKline Biologicals) was developed. This vaccine includes serotypes 1, 5, and 7F, in addition to those already included in 7vCRM, and was recently licensed in Europe for active immunization against invasive disease and AOM caused by S. pneumoniae in infants and children from 6 weeks up to 2 years of age. The use of protein D as carrier protein permits avoidance of possible interferences known to occur with some conjugate vaccines, and has the added potential benefit of providing protection against NTHi. This review seeks to highlight the recent advances in the field of OM vaccination, with a focus on data regarding the recently licensed PHiD-CV.
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PMID:Prevention of otitis media: now a reality? 1966 54

The 27th Annual Meeting of the European Society for Pediatric Infectious Disease (ESPID) was held in Brussels, Belgium, on 8-13 June 2009. Europe's largest pediatric infectious disease congress brought international pediatricians and experts on pediatric infectious disease and vaccine together. Owing to the numerous pediatric infectious topics and issues that were discussed, in this report we summarize the current knowledge about pneumococcal disease and pneumococcal conjugate vaccines (PCVs). The main topics covered are current pneumococcal seroepidemiology after the introduction of the 7-valent conjugated pneumococcal vaccine (PCV7), the efficacy and immunogenicity of a reduced-dose schedule of PCV7, and the effectiveness of PCV7 against invasive pneumococcal disease, otitis media and related conditions, pneumonia, and nasopharyngeal carriage. New studies, including that on the cost-effectiveness of the currently licensed 10-valent pneumococcal vaccine, which uses protein D from the nontypeable Haemophilus influenzae protein (PHiD-CV) and investigational PCVs (investigational 13-valent PCV [PCV13] and 11-valent PCV [PCV11]), were also presented. Next year, the 28th ESPID meeting will be held in Nice, France, on 4-8 June 2010. We will have a chance to see and evaluate, after the PCV7 and PHiD-CV era, current efficacy studies about new vaccines and investigational vaccines. With the 2015 key millennium development goalonly 5 years away, we need to accelerate the introduction of current vaccines and also evaluate newcomer vaccines in order to reduce the mortality rate among children younger than 5 years of age by two-thirds.
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PMID:27th Annual Meeting of the European Society for Pediatric Infectious Disease. 1972 87

The pneumococcal polysaccharide protein D-conjugate vaccine (PHiD-CV; Synflorix) contains ten capsular polysaccharide serotypes from the bacterium Streptococcus pneumoniae, eight of which are conjugated to a nonlipidated cell-surface liporotein (protein D) of non-typeable Haemophilus influenzae (NTHi) and two of which are conjugated to either tetanus or diphtheria toxoid. In a three-dose primary vaccination schedule in infants aged <6 months, PHiD-CV elicited high immune responses against all pneumococcal serotypes contained in the vaccine and was noninferior to an approved 7-valent pneumococcal conjugate vaccine (7vCRM) for eight of the ten serotypes (five of the seven common to both vaccines). Moreover, functional antibodies were elicited against all vaccine serotypes in an opsonophagocytic activity (OPA) assay. A fourth booster dose of PHiD-CV during the second year of life elicited an anamnestic response against all ten pneumococcal serotypes, as determined by both antibody concentrations and OPA titers. There were no clinically relevant changes in the immunogenicity of PHiD-CV when coadministered with meningococcal serogroup C conjugate or pentavalent whole cell pertussis combination vaccines, and polio vaccines using two different primary vaccination schedules. 11Pn-PD, an 11-valent prototype of PHiD-CV, demonstrated protection against episodes of acute otitis media (AOM) caused by S. pneumoniae and NTHi in infants aged <27 months. The first occurrence of an episode of AOM caused by pneumococcal vaccine serotypes was reduced by 52.6% in 11Pn-PD vaccinees compared with recipients of a control vaccine (primary endpoint). The tolerability profile of PHiD-CV was generally similar to that of 7vCRM.
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PMID:Pneumococcal polysaccharide protein D-conjugate vaccine (Synflorix; PHiD-CV). 1972

Following primary and booster vaccination with an 11-valent pneumococcall protein D conjugate vaccine there was a 42.8% (95% CI: -16.7 to 71.9, ns) reduction in the carriage of Streptococcus pneumoniae vaccine serotypes and a 42.6% (95% CI: 1.3-66.6) reduction in the carriage of Haemophilus influenzae identified by standard microbiological techniques. When PCR and immunoblot assays were used to further improve specificity of non-typeable H. influenzae strain identification, carriage of H. influenzae was still reduced with 38.6% (95% CI: -6.3 to 64.6, ns). Reduction of acute otitis media (AOM) episodes preceded the impact on carriage. These data provide further support of the functional role of the protein D immunity.
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PMID:Effect of vaccination with pneumococcal capsular polysaccharides conjugated to Haemophilus influenzae-derived protein D on nasopharyngeal carriage of Streptococcus pneumoniae and H. influenzae in children under 2 years of age. 1981 22

The global burden of disease due to Streptococcus pneumoniae remains high. The licensed 7-valent pneumococcal conjugate vaccine (7vCRM, Prevenar/Prevnar) has successfully reduced invasive disease in the USA, but serotype coverage is incomplete and some evidence suggests that serotype replacement has occurred. Recently, a new 10-valent pneumococcal nontypeable Haemophilus influenzae (NTHi) protein D (PD) conjugate vaccine (PHiD-CV, Synflorix) has been licensed in more than 40 countries, including Europe, for the prevention of invasive disease and acute otitis media (AOM) due to pneumococcus in infants and children. PHiD-CV is immunogenic in infants when administered as a three-dose primary vaccination in a range of schedules and has a safety profile comparable to that of 7vCRM. Additional serotypes in PHiD-CV (1, 5 and 7F) increase overall serotype coverage and improve coverage in specific age groups and against specific disease syndromes. The use of the PD carrier, which provided protection against AOM caused by NTHi in a large efficacy trial testing a prototype of the final vaccine formulation, suggests that PHiD-CV will also provide some protection against AOM due to NTHi.
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PMID:10-valent pneumococcal nontypeable Haemophilus influenzae PD conjugate vaccine: Synflorix. 1986 40

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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PMID:Pneumococcal conjugated vaccine: PHiD-CV. 1988 26


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