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Background: Respiratory syncytial virus (RSV) and influenza are both typically seasonal diseases, with winter peaks in temperate climates. Coadministration of an RSV vaccine and influenza vaccine could be a benefit, requiring 1 rather than 2 visits to a healthcare provider for individuals receiving both vaccines., Methods: The primary immunogenicity objective of this phase 3, 1:1 randomized, double-blind, placebo-controlled study in healthy adults aged ≥65 years in Australia was to demonstrate noninferiority of immune responses with coadministration of the stabilized RSV prefusion F protein-based vaccine (RSVpreF) and seasonal inactivated influenza vaccine (SIIV) versus SIIV or RSVpreF administered alone, using a 1.5-fold noninferiority margin (lower bound 95% confidence interval >.667). Safety and tolerability were evaluated by collecting reactogenicity and adverse event data., Results: Of 1403 participants randomized, 1399 received vaccinations (median age, 70; range, 65‒91 years). Local reactions and systemic events were mostly mild or moderate when RSVpreF was coadministered with SIIV or administered alone. No vaccine-related serious adverse events were reported. Geometric mean ratios were 0.86 for RSV-A and 0.85 for RSV-B neutralizing titers at 1 month after RSVpreF administration and 0.77 to 0.90 for strain-specific hemagglutination inhibition assay titers at 1 month after SIIV. All comparisons achieved the prespecified 1.5-fold noninferiority margin., Conclusions: The primary study objectives were met, demonstrating noninferiority of RSVpreF and SIIV immune responses when RSVpreF was coadministered with SIIV and that RSVpreF had an acceptable safety and tolerability profile when coadministered with SIIV. The results of this study support coadministration of RSVpreF and SIIV in an older-adult population., Clinical Trials Registration: https://clinicaltrials.gov/study/NCT05301322., Competing Interests: Potential conflicts of interest. E. A. reports receiving consulting fees from Moderna for vaccine advisory meeting. R. J. S. reports being an investigator for Pfizer (consultant doctor/medical investigator for the University of the Sunshine Coast Clinical Trials team; received consulting fees to work as a medical investigator; and was involved with the conduct of the clinical trial for Pfizer RSVpreF vaccine at the clinical trial site in Queensland, Australia). A. G. reports patents planned, issued, or pending: WO2017/1096729. All authors (except E. A. and R. J. S.) are employees of Pfizer, Inc, and may hold stock or stock options. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

In 2017, influenza seasonal activity was high in the southern hemisphere. We present interim influenza vaccine effectiveness (VE) estimates from Australia. Adjusted VE was low overall at 33% (95% confidence interval (CI): 17 to 46), 50% (95% CI: 8 to 74) for A(H1)pdm09, 10% (95% CI: -16 to 31) for A(H3) and 57% (95% CI: 41 to 69) for influenza B. For A(H3), VE was poorer for those vaccinated in the current and prior seasons.

Several observational studies provide evidence that acellular pertussis vaccines (aP) are less protective against pertussis disease than highly effective whole-cell pertussis vaccines (wP), however, concerns have been raised that some of these findings may be confounded by age. By undertaking age-stratified and restricted analyses on a cohort of Australian children primed with either aP-only, wP-only or mixed pertussis vaccine schedules, we demonstrate that compared to aP the association of wP with increased protection from pertussis is not confounded by age, nor by aP booster-dose receipt., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Background: Inactivated quadrivalent influenza vaccine (IIV4) containing two influenza A strains and one strain from each B lineage (Yamagata and Victoria) may offer broader protection against seasonal influenza than inactivated trivalent influenza vaccine (IIV3), containing a single B strain. This study examined the safety, immunogenicity, and lot consistency of an IIV4 candidate., Methods: This phase III, randomized, controlled, multicenter trial in children/adolescents (9 through 17 years) and adults (18 through 60 years) was conducted in Australia and in the Philippines in 2012. The study was double-blind for IIV4 lots and open-label for IIV4 vs IIV3. Children/adolescents were randomized 2:2:2:1 and adults 10:10:10:1 to receive one of three lots of IIV4 or licensed IIV3. Safety data were collected for up to 6 months post-vaccination. Hemagglutination inhibition and seroneutralization antibody titers were assessed pre-vaccination and 21 days post-vaccination., Results: 1648 adults and 329 children/adolescents received IIV4, and 56 adults and 55 children/adolescents received IIV3. Solicited reactions, unsolicited adverse events, and serious adverse events were similar for IIV3 and IIV4 recipients in both age groups. Injection-site pain, headache, malaise, and myalgia were the most frequently reported solicited reactions, most of which were mild and resolved within 3 days. No vaccine-related serious adverse events or deaths were reported. Post-vaccination antibody responses, seroconversion rates, and seroprotection rates for the 3 strains common to both vaccines were comparable for IIV3 and IIV4 in both age groups. Antibody responses to IIV4 were equivalent among vaccine lots and comparable between age groups for each of the 4 strains. IIV4 met all European Medicines Agency immunogenicity criteria for adults for all 4 strains., Conclusions: In both age groups, IIV4 was well tolerated and caused no safety concerns, induced robust antibody responses to all 4 influenza strains, and met all EMA immunogenicity criteria for adults., Clinical Trial Registry Number: NCT01481454., (Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Ross River virus (RRV) is endemic in Australia and several South Pacific Islands. More than 90,000 cases of RRV disease, which is characterized by debilitating polyarthritis, were reported in Australia in the last 20 years. There is no vaccine available to prevent RRV disease. A phase 3 study was undertaken at 17 sites in Australia to investigate the safety and immunogenicity of an inactivated whole-virus Vero cell culture-derived RRV vaccine in 1,755 healthy younger adults aged 16 to 59 years and 209 healthy older adults aged ≥60 years. Participants received a 2.5-μg dose of Al(OH)(3)-adjuvanted RRV vaccine, with a second and third dose after 3 weeks and 6 months, respectively. Vaccine-induced RRV-specific neutralizing and total IgG antibody titers were measured after each immunization. Vaccine safety was monitored over the entire study period. The vaccine was safe and well-tolerated after each vaccination. No cases of arthritis resembling RRV disease were reported. The most frequently reported systemic reactions were headache, fatigue, and malaise; the most frequently reported injection site reactions were tenderness and pain. After the third immunization, 91.5% of the younger age group and 76.0% of the older age group achieved neutralizing antibody titers of ≥1:10; 89.1% of the younger age group and 70.9% of the older age group achieved enzyme-linked immunosorbent assay (ELISA) titers of ≥11 PanBio units. A whole-virus Vero cell culture-derived RRV vaccine is well tolerated in an adult population and induces antibody titers associated with protection from RRV disease in the majority of individuals. (This study is registered at www.clinicaltrials.gov under registration no. NCT01242670.)., (Copyright © 2015, American Society for Microbiology. All Rights Reserved.)

Case Report: A domestic pigeon developed a sterile granuloma following vaccination with an oil-adjuvant, inactivated La Sota strain of Newcastle disease. The aim of vaccination was to provide protection against pigeon paramyxovirus-1 (PPMV-1), a disease previously considered exotic to Australia. Granuloma formation is considered a rare complication of vaccination against PPMV-1 in pigeons. Clinical signs consistent with neuropathic pain became apparent during the extensive management of the granuloma, which included surgical removal of foreign material, control of the pain and inflammation and protection against antimicrobial contamination., Conclusion: PPMV-1 is now considered endemic in Australia and protecting pigeons with vaccination is important. Until a product is registered for use, vaccination remains off-label and the risk of adverse reaction, including sterile granuloma, must be considered., (© 2014 Australian Veterinary Association.)

A real-time reverse transcription polymerase chain reaction (qRT-PCR) test for the matrix gene of type A influenza viruses was used during the 2007 Australian equine influenza (EI) outbreak in order to confirm diagnosis and, later, eradication of the virus. During the EI outbreak, horses being exported required vaccination and individual proof of freedom from EI. At the end of the outbreak, positive results were obtained from four horses destined for export, because of contamination of the samples with the vaccine. This report highlights the need for EI testing and vaccination to occur on separate days and with the collection of swabs for testing to precede vaccination., (© 2011 The Authors. Australian Veterinary Journal © 2011 Australian Veterinary Association.)

Seasonal influenza causes annual epidemics in temperate climates and is associated with economic costs, morbidity and mortality. Vaccination is the primary method of prevention. Intanza(®) (Sanofi Pasteur, Lyon, France) is a newly licensed, trivalent, inactivated influenza vaccine that is delivered intradermally with a proprietary micoinjection system. Two dosage formulations have been approved for use in Europe and Australia. The dosage level of 9 µg of hemagglutinin per strain is approved for persons 18-59 years of age, and its immunogenicity is noninferior to the standard dosage (15 µg per strain) administered intramuscularly. In addition, the dosage level of 15 µg of hemagglutinin per strain administered intradermally is approved for persons 60 years of age and older and has superior immunogenicity compared with that induced by the same dosage administered intramuscularly. Intanza has more frequent injection-site reactions than intramuscularly delivered vaccine, but it is safe and well tolerated. Intanza provides a new option for the prevention of influenza.

Purpose of Review: Japanese encephalitis is the most common vaccine-preventable viral encephalitis in Asia. In view of the production cessation of the inactivated mouse brain-derived Japanese encephalitis vaccine, it is timely to provide an update on new Japanese encephalitis vaccines and revised vaccine recommendations., Recent Findings: A new inactivated, adjuvanted, Vero cell-culture-based Japanese encephalitis vaccine, IC51, was licensed in Europe and the United States in 2009. Administered in a two-dose regimen at 0 and 28 days, it was shown to be well tolerated and produce high seroconversion rates. In addition, Chimerivax Japanese encephalitis, a novel live-attenuated one-dose chimeric vaccine comprising the structural genes of SA 14-14-2 virus and nonstructural genes of yellow fever 17D virus, is in the process of getting licensed in Australia and in south east Asia., Summary: Previous recommendations for Japanese encephalitis vaccination of travelers were predicated on minimizing exposure to a mouse-brain-derived vaccine with a poorly understood and worrisome safety profile, whereas the risk of acquiring Japanese encephalitis itself during travel was assessed to be relatively low. With the availability of a new cell-culture-derived vaccine IC51 with an excellent safety profile, it is appropriate to reconsider benefit-risk considerations for the vaccination of travelers. These considerations are reflected in the March 2010 revised recommendations by the United States Advisory Committee on Immunization Practices.

An outbreak of H3N8 Equine Influenza virus (EIV) that occurred in vaccinated horses in Japan was caused by a genetically divergent EIV isolate of the Florida clade 1 sub-lineage. This virus subsequently entered Australia where it infected thousands of immunologically naïve horses. The objective of this study was to evaluate the ability of a non-updated whole inactivated equine influenza (EI) vaccine to protect if used in the face of an outbreak induced by a virus similar to the ones circulating in Japan and Australia in 2007. Seven naïve Welsh mountain ponies were immunised twice with the commercially available vaccine Duvaxyn IE-T Plus and experimentally infected with A/eq2/Sydney/2888-8/07. Five ponies remained unvaccinated as controls. The ponies were challenged in an ACDP (Advisory Committee on Dangerous Pathogens) Category III containment facility by exposure to a nebulised aerosol of A/eq2/Sydney/2888-8/07 two weeks after the second vaccination. Clinical signs and virus shedding were monitored for 14 days post-challenge infection. After challenge infection, all control ponies developed clinical signs of disease with coughing being particularly noteworthy when compared with vaccinated ponies. Only 3 out of 5 controls developed pyrexia for up to 3 days, and 1 out of 7 vaccinates was pyretic for 1 day. Nasal discharge was evident in both control and vaccinated ponies with no significant difference between groups. Three different methods were used to measure virus shedding in nasal secretions (i.e. titration in embryonated hens' eggs, EIV NP ELISA and EIV NP qRT-PCR). The intensity and duration of EIV shedding significantly decreased in the vaccinated group when compared with the control ponies. All control ponies seroconverted after experimental infection with A/eq2/Sydney/2888-8/07 whereas only 1 out of 7 vaccinated ponies had a significant increase in antibody. Duvaxyn IE-T Plus therefore reduced clinical signs and virus shedding when ponies were challenged with A/eq2/Sydney/2888-8/07 (H3N8), 2 weeks after a second dose of vaccine., (Copyright 2010 Elsevier B.V. All rights reserved.)

Japanese encephalitis (JE) is a mosquito-borne flavivirus infection responsible for significant morbidity and mortality across Asia. Indigenous populations and those who undertake short- and long-term travel to endemic regions are at risk of infection and development of neuroinvasive disease. Effective mouse brain-derived vaccines have been available in select countries, including the United States, for decades. Limited access in Asia and safety concerns with regard to mouse brain products prompted the Chinese to develop a live, attenuated virus vaccine (SA14-14-2; Chengdu Institute of Biological Products), which has proven to be safe and efficacious following administration of >300 million doses. Recently, the portfolio of JE vaccines increased again with licensure in the United States, Europe, and Australia of a purified, inactivated virus JE vaccine (IC51; Intercell AG) and filing for licensure in Thailand and Australia of a Yellow fever-JE chimeric vaccine (ChimeriVax-JE; Sanofi Pasteur). JE is a vaccine-preventable disease with numerous options now available for active immunization. Aggressive and responsible vaccination programs should greatly diminish the burden of disease.

An autologous killed trivalent vaccine (3x10(8) colony-forming units [CFU]), based on three Salmonella serovars (Typhimurium - serogroup B, Mbandaka - serogroup C, and Orion - serogroup E) prevalent in the flocks of Australian poultry companies, was developed using Salenvac techniques. At 20 weeks, hens vaccinated at 12 and 17 weeks as well as non-vaccinated hens were challenged (250 microl of 10(7) CFU) with autologous and heterologous serovars belonging to serogroup B (Typhimurium and Agona), serogroup C (Mbandaka and Infantis) and serogroup E (Orion and Zanzibar). Overall, vaccination resulted in a significant difference in carriage of Salmonella between non-vaccinated and vaccinated commercial Cobb hens (P <0.05) for serogroups B and C. However, due to low colonization rates in the non-vaccinated birds, no significant difference (P>0.05) could be determined for serogroup E. All vaccinated flocks produced a significant antibody response (P<0.001) to the S. Typhimurium vaccine strain, measured using a S. Typhimurium enzyme-linked immunosorbent assay (Guildhay), which peaked at 20 weeks of age, with 39% of the hens positive. Maternal antibodies were detected in 16% of the yolks from eggs produced by these flocks. There was a significant difference after challenge with Salmonella (P <0.05) among 1-day-old chicks from vaccinated versus non-vaccinated parents, when challenged using 10(4) CFU but not when challenged with 10(8) CFU. The success of this trial resulted in the incorporation of this vaccine into a Salmonella control system in commercial broiler breeder production.

The mosquito-borne Japanese encephalitis virus (JEV) is a major threat to human health in Asia. An estimated 50,000 cases occur in the region, accounting for at least 10,000 deaths and 15,000 cases of neuropsychiatric sequelae. A new purified, inactivated JEV vaccine (IC51, Ixiaro) has been developed. Since early 2009, the vaccine has been licensed in Australia, the USA and Europe. A series of successful Phase III studies has been published. Results indicate a very good safety and efficacy profile. The vaccine promises to become a modern approach to active immunization against Japanese encephalitis. With the availability of a new product, wider use of Japanese encephalitis vaccine will be prudent in the future, and guidelines and recommendations should be revised.

Objective: Few prospective studies of inactivated split virion influenza vaccine have been conducted in infants and children. Our objective was to evaluate the safety, reactogenicity and immunogenicity of a thimerosal-free inactivated influenza vaccine (Fluvax; CSL Limited, Parkville, Australia) in children aged 6 months to <9 years., Methods: A prospective, open-label, phase III clinical trial was conducted in 298 healthy children previously unvaccinated with influenza, commencing in the Southern Hemisphere 2005 autumn. Participants were divided into two groups (Group A: > or =6 months to <3 years; Group B: > or =3 years to <9 years), and received two doses of the 2005 vaccine, and one dose of the 2006 vaccine one year later (Group A: 0.25 ml per dose; Group B: 0.5 ml per dose). Vaccine safety and reactogenicity was evaluated for 30 days after each dose. Immunogenicity was assessed using hemagglutination inhibition and single radial hemolysis assays., Results: There were no withdrawals due to adverse events (AEs). The majority of solicited local and systemic AEs were of mild severity. A maximum intensity of severe was reported for injection site pain and fever by only 3.0% and 3.4% of participants, respectively. The vaccine was immunogenic for all antigens, with > or =95% of both younger and older children achieving seroprotection after dose 2., Conclusions: This thimerosal-free inactivated influenza vaccine had a favorable safety profile and was immunogenic in children aged > or =6 months and <9 years. Primary and booster vaccination produced consistently immunogenic responses including in children under 3 years of age receiving 0.25 ml doses of vaccine.

A field trial was undertaken from 1999 until 2004 to determine the efficacy of a killed M. a. paratuberculosis vaccine, Gudair, for the control of ovine Johne's disease (OJD) in merino sheep run under Australian pastoral conditions. On each of three farms experiencing significant OJD losses (5-15% per annum), 200 merino lambs (age 1-4 months) were vaccinated, and 200 lambs were left unvaccinated. Animal assessments and sample collections were conducted twice yearly until 4 or 5 years of age. The impact of vaccination on mortality rate, faecal shedding of M. a. paratuberculosis (by pooled and individual faecal culture), liveweight, wool productivity, vaccine injection site lesions and cellular (BOVIGAM) and humoral (PARACHEK) immunity was examined. Vaccination stimulated cell-mediated and humoral immune responses, reduced mortalities due to OJD by 90% and delayed faecal shedding for the first year post-vaccination. Thereafter, the prevalence of shedders among vaccinates was reduced by 90%. The numbers of M. a. paratuberculosis excreted by the vaccinated groups were also reduced by at least 90% at most sampling times. However, high levels of excretion by vaccinates occurred on some occasions, and although only 7 of 600 vaccinates died from OJD, all 7 had multibacillary lesions. Thus there remains a risk that some vaccinated sheep will transfer the disease. Small reductions in liveweight were found in vaccinated lambs in the first year, but there was little effect on wool production. Vaccine injection site lesions were detected in almost 50% of sheep after 2 months, and these persisted for at least 4 years in 20-25% of vaccinates. Data from this trial enabled the registration of Gudair in Australia in 2002 and underpins the pivotal role of vaccination in the current management of OJD.

Reasons for Performing Study: A silent cycle of equine herpesvirus 1 infection has been described following epidemiological studies in unvaccinated mares and foals. In 1997, an inactivated whole virus EHV-1 and EHV-4 vaccine was released commercially in Australia and used on many stud farms. However, it was not known what effect vaccination might have on the cycle of infection of EHV-1., Objective: To investigate whether EHV-1 and EHV-4 could be detected in young foals from vaccinated mares., Methods: Nasal and blood samples were tested by PCR and ELISA after collection from 237 unvaccinated, unweaned foals and vaccinated and nonvaccinated mares during the breeding season of 2000., Results: EHV-1 and EHV-4 DNA was detected in nasal swab samples from foals as young as age 11 days., Conclusions: These results confirm that EHV-1 and EHV-4 circulate in vaccinated populations of mares and their unweaned, unvaccinated foals., Potential Relevance: The evidence that the cycle of EHV-1 and EHV-4 infection is continuing and that very young foals are becoming infected should assist stud farms in their management of the threat posed by these viruses.

Japanese encephalitis (JE) is a severe disease that is widespread throughout Asia and is spreading beyond its traditional boundaries. Three vaccines are currently in use against JE but only one is available internationally, a mouse-brain-derived inactivated vaccine first used in the 1930s. Although this vaccine has been effective in reducing the incidence of JE, it is relatively expensive and has been linked to severe allergic and neurological reactions. Cell-culture-derived inactivated and attenuated vaccines have been developed but are only used in the People's Republic of China. Other vaccines currently in various stages of development are DNA vaccines, a chimeric yellow fever-JE viral vaccine, virus-like particle vaccines and poxvirus-based vaccines. Poxvirus-based vaccines and the chimeric yellow fever-JE vaccine have been tested in Phase I clinical trials. These new vaccines have the potential to significantly reduce the impact of JE in Asia, particularly if used in an oral vaccine delivery strategy.

A soft tissue sarcoma occurred in the interscapular area of a cat, 1 to 7 months after vaccination at that site. The vaccine contained inactivated feline panleucopaenia virus combined with modified live feline herpesvirus and calicivirus. The tumour showed histological features of both fibrosarcoma and malignant fibrous histiocytoma. The tumour was observed to evolve from the site of a presumed postvaccinal granuloma. Local recurrence 6 weeks post excision necessitated more radical resection. Euthanasia was performed 2 years later when pleural effusion developed. The cause of effusion was not determined. There was no palpable evidence of local tumour regrowth at the time of euthanasia. A causal relationship between vaccination and sarcoma formation is considered based on the temporal association between the two events, the anatomical location of the tumour and histopathology consistent with postvaccinal sarcomas reported overseas. Six other vaccine site fibrosarcomas, potentially vaccine associated using the above criteria, are summarised.

Isolation of 8 serotypes of bluetongue virus (BTV) in Australia has led to widespread debate on how to prepare for an outbreak of bluetongue disease and the type of vaccine best suited to control bluetongue in Australia. This article describes the vaccine options under consideration by research workers and animal health administrators. The most widely discussed options are live attenuated virus, killed virus and virus-like particles (VLP) generated by recombinant baculoviruses. Attenuated virus vaccines are cheap and easy to produce and are administered in a single dose. They replicate in sheep without causing significant clinical effects and provide protection against challenge with virulent virus of the same serotype. The possibility that insects could acquire vaccine virus by feeding on vaccinated animals and transmit it to sheep or cattle cannot be eliminated. This poses a risk because attenuated viruses are teratogenic if ewes are infected in the first half of pregnancy. In addition, vaccine virus replication in insects and ruminants may lead to a reversion to virulence. Killed virus vaccines have been shown to be efficacious in small laboratory trials and cannot be transmitted to other animals in the field, but are significantly more expensive to produce than attenuated viruses and require at least 2 doses with adjuvant to elicit an immune response. More work is needed to properly assess their effectiveness and determine their cost of production. Recombinant VLP contain the 4 major structural proteins of BTV but no nucleic acid. VLP are relatively easy to isolate, but it is unlikely that the purification methods currently used in laboratories will be adapted for use commercially. Despite the enthusiasm of recent years, little commercial progress appears to have been made. Although scientific research in Australia and overseas has provided a number of options for development of bluetongue vaccines, the decisions on which to use in an outbreak are complex and will require, not only consideration of factors discussed here, but also agreement from industry and government.