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Exploring the evidence behind the comparable impact of the pneumococcal conjugate vaccines PHiD-CV and PCV13 on overall pneumococcal disease.

ABSTRACT: The worldwide implementation of pneumococcal conjugate vaccines (PCVs) in children has reduced the overall pneumococcal disease burden. Two PCVs are widely available for infant vaccination: the pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) and the 13-valent PCV (PCV13). While these PCVs differ in serotype composition (PCV13 includes polysaccharides of serotypes 3, 6A and 19A; PHiD-CV does not), their impact on the overall pneumococcal disease burden in children is comparable. This commentary summarizes the evidence of comparability between PHiD-CV and PCV13 and explores why differences in serotype composition may not necessarily translate into a differential clinical impact. Both vaccines confer similarly high protection against disease caused by vaccine serotypes and lead to a partial replacement by non-vaccine serotypes. PHiD-CV does not protect against serotype 3 disease (not included in the vaccine) and PCV13's effect on this serotype has been inconsistent. PHiD-CV provides some cross-protection against disease caused by vaccine-related serotype 19A but neither vaccine has fully controlled 19A disease. While protection against 19A is higher for PCV13 than PHiD-CV, replacement by non-PCV13 serotypes in settings with a PCV13 program appears to compensate for this difference. This results in a similar residual overall disease burden with both vaccines.

SUBMITTER: Izurieta P

PROVIDER: S-EPMC8920200 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Exploring the evidence behind the comparable impact of the pneumococcal conjugate vaccines PHiD-CV and PCV13 on overall pneumococcal disease.

Izurieta Patricia P Nieto Guevara Javier J

Human vaccines & immunotherapeutics 20210219 1

The worldwide implementation of pneumococcal conjugate vaccines (PCVs) in children has reduced the overall pneumococcal disease burden. Two PCVs are widely available for infant vaccination: the pneumococcal non-typeable <i>Haemophilus influenzae</i> protein D conjugate vaccine (PHiD-CV) and the 13-valent PCV (PCV13). While these PCVs differ in serotype composition (PCV13 includes polysaccharides of serotypes 3, 6A and 19A; PHiD-CV does not), their impact on the overall pneumococcal disease burde ...[more]

PMID: 33605846

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Project description:BackgroundThe relationship between pneumococcal conjugate vaccine-induced antibody responses and protection against community-acquired pneumonia (CAP) and acute otitis media (AOM) is unclear. This study assessed the impact of the ten-valent pneumococcal nontypable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) on these end points. The primary objective was to demonstrate vaccine efficacy (VE) in a per-protocol analysis against likely bacterial CAP (B-CAP: radiologically confirmed CAP with alveolar consolidation/pleural effusion on chest X-ray, or non-alveolar infiltrates and C-reactive protein ≥ 40 µg/ml); other protocol-specified outcomes were also assessed.Methods and findingsThis phase III double-blind randomized controlled study was conducted between 28 June 2007 and 28 July 2011 in Argentine, Panamanian, and Colombian populations with good access to health care. Approximately 24,000 infants received PHiD-CV or hepatitis control vaccine (hepatitis B for primary vaccination, hepatitis A at booster) at 2, 4, 6, and 15-18 mo of age. Interim analysis of the primary end point was planned when 535 first B-CAP episodes, occurring ≥2 wk after dose 3, were identified in the per-protocol cohort. After a mean follow-up of 23 mo (PHiD-CV, n = 10,295; control, n = 10,201), per-protocol VE was 22.0% (95% CI: 7.7, 34.2; one-sided p = 0.002) against B-CAP (conclusive for primary objective) and 25.7% (95% CI: 8.4%, 39.6%) against World Health Organization-defined consolidated CAP. Intent-to-treat VE was 18.2% (95% CI: 5.5%, 29.1%) against B-CAP and 23.4% (95% CI: 8.8%, 35.7%) against consolidated CAP. End-of-study per-protocol analyses were performed after a mean follow-up of 28-30 mo for CAP and invasive pneumococcal disease (IPD) (PHiD-CV, n = 10,211; control, n = 10,140) and AOM (n = 3,010 and 2,979, respectively). Per-protocol VE was 16.1% (95% CI: -1.1%, 30.4%; one-sided p = 0.032) against clinically confirmed AOM, 67.1% (95% CI: 17.0%, 86.9%) against vaccine serotype clinically confirmed AOM, 100% (95% CI: 74.3%, 100%) against vaccine serotype IPD, and 65.0% (95% CI: 11.1%, 86.2%) against any IPD. Results were consistent between intent-to-treat and per-protocol analyses. Serious adverse events were reported for 21.5% (95% CI: 20.7%, 22.2%) and 22.6% (95% CI: 21.9%, 23.4%) of PHiD-CV and control recipients, respectively. There were 19 deaths (n = 11,798; 0.16%) in the PHiD-CV group and 26 deaths (n = 11,799; 0.22%) in the control group. A significant study limitation was the lower than expected number of captured AOM cases.ConclusionsEfficacy was demonstrated against a broad range of pneumococcal diseases commonly encountered in young children in clinical practice.Trial registrationwww.ClinicalTrials.gov NCT00466947.

Project description:The immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines were evaluated among infants from Singapore and Malaysia, where PHiD-CV has been licensed.In the primary vaccination phase, 298 infants from Singapore and 168 infants from Malaysia were randomised to receive the Phase III Clinical (Clin) or the Commercial (Com) lot of PHiD-CV at 2, 3, and 5 months of age. In the booster vaccination phase, 238 toddlers from Singapore received one dose of the PHiD-CV Commercial lot at 18-21 months of age. Immune responses to pneumococcal polysaccharides were measured using 22F-inhibition enzyme-linked immunosorbent assay (ELISA) and functional opsonophagocytic activity (OPA) assay and to protein D, using ELISA.Immune responses induced by primary vaccination with the PHiD-CV Commercial lot were non-inferior to the Phase III Clinical lot in terms of adjusted antibody geometric mean concentration (GMC) ratios for each vaccine pneumococcal serotype and protein D. For each vaccine pneumococcal serotype, ?93.6% and ?88.5% of infants from Malaysia and Singapore had post-primary vaccination antibody concentrations ?0.2 ?g/mL and OPA titres ?8, in the Clin and Com groups, respectively. For each vaccine pneumococcal serotype, ?60.8% and ?98.2% of toddlers from Singapore had pre- and post-booster antibody concentrations ?0.2 ?g/mL, in the Clin and Com groups, respectively. All children, except one, had measurable anti-protein D antibodies and the primary and booster doses of the co-administered vaccines were immunogenic. The incidence of each grade 3 solicited symptom was ?11.1% in both study phases. No serious adverse events considered causally related to vaccination were reported throughout the study.PHiD-CV given as three-dose primary vaccination to infants in Singapore and Malaysia and booster vaccination to toddlers in Singapore was shown to be immunogenic with a clinically acceptable-safety profile.This study has been registered at http://www.clinicaltrials.govNCT00808444 and NCT01119625.

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Exploring the evidence behind the comparable impact of the pneumococcal conjugate vaccines PHiD-CV and PCV13 on overall pneumococcal disease.

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Exploring the evidence behind the comparable impact of the pneumococcal conjugate vaccines PHiD-CV and PCV13 on overall pneumococcal disease.

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