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Implications of Non-Specific Effects for Testing, Approving, and Regulating Vaccines

The current framework for testing and regulating vaccines was established before the realization that vaccines, in addition to their effect against the vaccine-specific disease, may also have "non-specific effects" affecting the risk of unrelated diseases. Accumulating evidence from epidemiological studies shows that vaccines in some situations can affect all-cause mortality and morbidity in ways that are not explained by the prevention of the vaccine-targeted disease.

A Phase III, multicenter, randomized, double-blind, active comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of V114 compared with PCV13 in healthy infants (PNEU-PED-EU-1)

V114 (15-valent pneumococcal conjugate vaccine [PCV]) contains all serotypes in 13-valent PCV (PCV13) and additional serotypes 22F and 33F. This study evaluated safety and immunogenicity of V114 compared with PCV13 in healthy infants, and concomitant administration with DTPa-HBV-IPV/Hib and rotavirus RV1 vaccines.

Modalities of group A streptococcal prevention and treatment and their economic justification

Infection by group A Streptococcus (Strep A) results in a diverse range of clinical conditions, including pharyngitis, impetigo, cellulitis, necrotising fasciitis, and rheumatic heart disease. In this article, we outline the recommended strategies for Strep A treatment and prevention and review the literature for economic evaluations of competing treatment and prevention strategies.

Correlates of immunity to Group A Streptococcus: a pathway to vaccine development

Understanding immunity in humans to Group A Streptococcus (Strep A) is critical for the development of successful vaccines to prevent the morbidity and mortality attributed to Strep A infections. Despite decades of effort, no licensed vaccine against Strep A exists and immune correlates of protection are lacking; a major impediment to vaccine development.

One vaccine for life: Lessons from immune ontogeny

There remains a general misconception that the immune status of the fetus and neonate is immature or insufficient. However, emerging research in immune ontogeny prompts reconsideration of this orthodoxy, reframing this period instead as one of unique opportunity. Vaccine responses (qualitative and quantitative) vary between individuals, and across demographic cohorts. Elements of baseline immune status and function predict vaccine response - some of these factors are well described, others remain a subject of ongoing research, especially with the rapidly expanding field of 'omics' research, enabled by development of highly granular immune profiling techniques and increasing computational capacity.

Barriers to influenza vaccination of children hospitalised for acute respiratory illness: A cross-sectional survey

To identify barriers to influenza vaccination of children hospitalised for acute respiratory illness in Australia. A total of 595 parents of children hospitalised with acute respiratory illness across five tertiary hospitals in 2019 participated in an online survey. Multivariate logistic regression identified factors most strongly associated with influenza vaccination barriers. 

Meningococcal serotype W septic arthritis: Case series in children

The epidemiology of invasive meningococcal disease has changed over the last decade and there has been an increase in cases caused by serogroup W135, particularly in Indigenous children. Extra‐meningeal and atypical presentations are associated with serogroup W and may delay diagnosis and therefore appropriate treatment. Public and clinician awareness are essential in facilitating effective new vaccine schedule implementation.

Risk of adverse maternal and foetal outcomes associated with inactivated influenza vaccination in first trimester of pregnancy

In many countries, influenza vaccination is routinely recommended during any stage of pregnancy, yet uptake remains low, particularly in the first trimester. This is thought to be due to maternal concerns regarding vaccine safety. We evaluated the safety of influenza vaccination in the first trimester of pregnancy.

Safety and immunogenicity of S-Trimer (SCB-2019), a protein subunit vaccine candidate for COVID-19 in healthy adults: a phase 1, randomised, double-blind, placebo-controlled trial

As part of the accelerated development of vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), we report a dose-finding and adjuvant justification study of SCB-2019, a protein subunit vaccine candidate containing a stabilised trimeric form of the spike (S)-protein (S-Trimer) combined with two different adjuvants.