Amanda J. Leach, Australia

Menzies School of Health Research Child Health Division

Presenter of 2 Presentations

INTERCHANGEABILITY OF PHID-CV10 AND PCV13 IN PRIMARY COURSE SCHEDULES (ID 204)

Abstract

Background

In remote communities of northern Australia, we previously demonstrated that the onset of otitis media (OM) in Aboriginal infants was preceded by acquisition of bacterial pathogens that colonise the nasopharynx (NP) soon after birth. We aimed to determine safety and effectiveness of mixed vaccine schedules against early infection due to non-typeable Haemophilus influenzae and Streptococcus pneumoniae.

Methods

In an open-label controlled trial, we randomised (1:1:1) Aboriginal infants at 28 to 38 days of age, to either Prevenar13™ (P, PCV13) at 2-4-6 months of age (_PPP), Synflorix™ (S, PHiD-CV10) at 2-4-6 months (_SSS), or Synflorix at 1-2-4 months plus Prevenar13 at 6 months (SSSP). Primary outcomes (assessor-blinded) were immunogenicity at 7 months of age against pneumococcal serotypes 3, 6A, and 19A, and protein D (GMCs and proportions of infants with IgG > 0·35 µg/mL or > 100 EL.U/mL, respectively). Secondary immunogenicity outcomes at 2 and 4 months are also reported.

Results

A 4-dose early 1-2-4-6 month combination schedule of Synflorix plus Prevenar13 (SSSP) provided superior overall immune protection against serotypes 3, 6A, 19A, and protein D, compared to standard 3-dose 2-4-6 month schedules (_SSS or _PPP).

Conclusions

These vaccines can be combined safely and effectively within this primary schedule, with no evidence of immune suppression.

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HEAD TO HEAD COMPARISONS AT 2, 4, AND 7 MONTHS, FOLLOWING STANDARD AND COMBINED PHID-CV10 AND PCV13 SCHEDULES. (ID 429)

Abstract

Background

Australian Aboriginal children are at high risk of early infection withStreptococcus pneumoniae and non-typeable Haemophilus influenzae (NTHi). We evaluated immunogenicity against 10 shared serotypes of a 4-dose combination schedule of PHiD-CV10 at 1-2-4 months plus PCV13 at 6 months, compared with standard 2-4-6 month schedules.

Methods

Infants were allocated (1:1:1) at 28 to 38 days of age, to 3-dose schedules of PCV13 (P) or PHiD-CV10 (S) at 2-4-6 months (_PPP or _SSS), or a combination schedule at 1-2-4-6 months (SSSP). Immunogenicity was measured at 2, 4, and 7 months.

Results

At 2 months the SSSP combination was superior to pre-vaccination (VTs other than 6B, 19F, or 23F). At 4 months SSSP was superior to _PPP (9 VTs) and _SSS (7 VTs), and _SSS was superior to _PPP (8 VTs). At 7 months, SSSP was superior to _PPP (1, 6B, 9V, 19F and 23F) and _SSS (8 VTs), and _PPP was superior to _SSS (8 VTs). OPA supports the SSSP schedule, particularly against 1, 6B, and 23F.

Conclusions

The 1-2-4-6 month schedule (SSSP) was superior at 2, 4, and 7 months of age compared to _SSS or _PPP, particularly for 1, 6B, and 23F at 7 months. At 4 months, _SSS was superior to _PPP.

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Author Of 4 Presentations

TWENTY YEARS OF PAEDIATRIC NASOPHARYNGEAL PNEUMOCOCCAL CARRIAGE IN REMOTE NORTHERN AUSTRALIA; SEROTYPES AND ANTIMICROBIAL RESISTANCE IN CHANGING PCV ERAS (ID 933)

Abstract

Background

Invasive pneumococcal disease and otitis media due to pneumococci disproportionately affect remote dwelling First Nations Australian children, driven by nasopharyngeal colonisation by respiratory pathogens in the first weeks of life. Microbiological samples have been collected from surveillance studies and clinical trials since 1996. We aimed to explore trends in nasopharyngeal (NP) pneumococcal carriage over time, and factors associated with serotype distribution and resistance.

Methods

This study collated NP microbiological data from the non-interventional arms of trials and cross-sectional studies. Carriage and serotype-specific rates by age category in the differing conjugate vaccine eras will be described. Hierarchical logistic regression will be used to account for confounders (age, clustering within individuals and communities).

Results

Interim findings from over 9,000 NP swabs from children with a median age of 19 months (range 0-18 years) suggest expected reductions in vaccine type pneumococci, with no significant change in overall carriage rates, replacement by non-vaccine serotypes with persistent low-level carriage of vaccine types. 16F was the most commonly isolated serotype, with 50% non-susceptible to penicillin.

Conclusions

Understanding the impact of PCVs on serotype dynamics and antibiotic non-susceptibility of S.pneumoniae in this remote-dwelling population will strengthen evidence for vaccine policy and ongoing antimicrobial stewardship in the region.

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INTERCHANGEABILITY OF PHID-CV10 AND PCV13 IN PRIMARY COURSE SCHEDULES (ID 204)

Abstract

Background

In remote communities of northern Australia, we previously demonstrated that the onset of otitis media (OM) in Aboriginal infants was preceded by acquisition of bacterial pathogens that colonise the nasopharynx (NP) soon after birth. We aimed to determine safety and effectiveness of mixed vaccine schedules against early infection due to non-typeable Haemophilus influenzae and Streptococcus pneumoniae.

Methods

In an open-label controlled trial, we randomised (1:1:1) Aboriginal infants at 28 to 38 days of age, to either Prevenar13™ (P, PCV13) at 2-4-6 months of age (_PPP), Synflorix™ (S, PHiD-CV10) at 2-4-6 months (_SSS), or Synflorix at 1-2-4 months plus Prevenar13 at 6 months (SSSP). Primary outcomes (assessor-blinded) were immunogenicity at 7 months of age against pneumococcal serotypes 3, 6A, and 19A, and protein D (GMCs and proportions of infants with IgG > 0·35 µg/mL or > 100 EL.U/mL, respectively). Secondary immunogenicity outcomes at 2 and 4 months are also reported.

Results

A 4-dose early 1-2-4-6 month combination schedule of Synflorix plus Prevenar13 (SSSP) provided superior overall immune protection against serotypes 3, 6A, 19A, and protein D, compared to standard 3-dose 2-4-6 month schedules (_SSS or _PPP).

Conclusions

These vaccines can be combined safely and effectively within this primary schedule, with no evidence of immune suppression.

Hide

HEAD TO HEAD COMPARISONS AT 2, 4, AND 7 MONTHS, FOLLOWING STANDARD AND COMBINED PHID-CV10 AND PCV13 SCHEDULES. (ID 429)

Abstract

Background

Australian Aboriginal children are at high risk of early infection withStreptococcus pneumoniae and non-typeable Haemophilus influenzae (NTHi). We evaluated immunogenicity against 10 shared serotypes of a 4-dose combination schedule of PHiD-CV10 at 1-2-4 months plus PCV13 at 6 months, compared with standard 2-4-6 month schedules.

Methods

Infants were allocated (1:1:1) at 28 to 38 days of age, to 3-dose schedules of PCV13 (P) or PHiD-CV10 (S) at 2-4-6 months (_PPP or _SSS), or a combination schedule at 1-2-4-6 months (SSSP). Immunogenicity was measured at 2, 4, and 7 months.

Results

At 2 months the SSSP combination was superior to pre-vaccination (VTs other than 6B, 19F, or 23F). At 4 months SSSP was superior to _PPP (9 VTs) and _SSS (7 VTs), and _SSS was superior to _PPP (8 VTs). At 7 months, SSSP was superior to _PPP (1, 6B, 9V, 19F and 23F) and _SSS (8 VTs), and _PPP was superior to _SSS (8 VTs). OPA supports the SSSP schedule, particularly against 1, 6B, and 23F.

Conclusions

The 1-2-4-6 month schedule (SSSP) was superior at 2, 4, and 7 months of age compared to _SSS or _PPP, particularly for 1, 6B, and 23F at 7 months. At 4 months, _SSS was superior to _PPP.

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