Impact of Palivizumab on RSV Hospitalizations for Children with Hemodynamically Significant Congenital Heart Disease

Chang, Ruey‐Kang R.; Chen, Alex Y.

doi:10.1007/s00246-009-9577-0

Cited by 33 publications

(36 citation statements)

References 18 publications

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“…Interestingly, using the Advax-1 adjuvant alone induced minor pathology in the lung, but was more severe when combined with the RSV vaccine. In contrast, this pathology was not induced using Synagis, 3,31,[74][75][76] an antibody directed against F protein, but does occur with F protein immunization with alum or live RSV priming. It is possible that treatment with anti-F antibody, then RSV exposure, may prime the host for exacerbated RSV lung disease should a second infection occur.…”

Section: Discussionmentioning

confidence: 88%

Delta inulin-derived adjuvants that elicit Th1 phenotype following vaccination reduces respiratory syncytial virus lung titers without a reduction in lung immunopathology

Wong

Petrovsky

Bissel

et al. 2016

Human Vaccines & Immunotherapeutics

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Respiratory syncytial virus (RSV) is a significant cause of lower respiratory tract infections resulting in bronchiolitis and even mortality in the elderly and young children/infants. Despite the impact of this virus on human health, no licensed vaccine exists. Unlike many other viral infections, RSV infection or vaccination does not induce durable protective antibodies in humans. In order to elicit high titer, neutralizing antibodies against RSV, we investigated the use of the adjuvant Advax TM , a novel polysaccharide adjuvant based on delta inulin microparticles, to enhance antibody titers following vaccination. BALB/c mice were vaccinated intramuscularly with live RSV as a vaccine antigen in combination with one of two formulations of Advax TM . Advax-1 was comprised of the standard delta inulin adjuvant and Advax-2 was formulated delta inulin plus CpG oligodendronucleotides (ODNs). An additional group of mice were either mock vaccinated, immunized with vaccine only, or administered vaccine plus Imject Alum. Following 3 vaccinations, mice had neutralizing antibody titers that correlated with reduction in viral titers in the lungs. Advax-1 significantly enhanced serum RSV-specific IgG1 levels at week 6 indicative of a Th2 response, similar to titers in mice administered vaccine plus Imject Alum. In contrast, mice vaccinated with vaccine plus Advax-2 had predominately IgG2a titers indicative of a Th1 response that was maintained during the entire study. Interestingly, regardless of which Advax TM adjuvant was used, the neutralizing titers were similar between groups, but the viral lung titers were significantly lower (»10EC3pfu/g) in mice administered vaccine with either Advax TM adjuvant compared to mice administered adjuvants only. The lung pathology in vaccinated mice with Advax TM was similar to Imject Alum. Overall, RSV vaccine formulated with Advax TM had high neutralizing antibody titers with low lung viral titers, but exacerbated lung pathology compared to unvaccinated mice.

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Section: Discussionmentioning

confidence: 88%

Delta inulin-derived adjuvants that elicit Th1 phenotype following vaccination reduces respiratory syncytial virus lung titers without a reduction in lung immunopathology

Wong

Petrovsky

Bissel

et al. 2016

Human Vaccines & Immunotherapeutics

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“…Significant controversy remains regarding the cost effectiveness of palivizumab prophylaxis in high-risk patients, including those with CHD25,26). Eventually this may be considered as the limitation of passive immunization.…”

Section: Global Trends Of Respiratory Syncytial Virus Infection With mentioning

confidence: 99%

Respiratory syncytial virus infection in children with congenital heart disease: global data and interim results of Korean RSV-CHD survey

Jung

2011

Korean J Pediatr

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Respiratory syncytial virus (RSV) is a main cause of hospitalization for bronchiolitis and pneumonia in infants worldwide. Children with hemodynamically significant congenital heart disease (HS-CHD), as well as premature infants are at high risk for severe RSV diseases. Mortality rates for CHD patients hospitalized with RSV have been reported as about 24 times higher compared with those without RSV infection. Recently with advances in intensive care, mortality rates in CHD patients combined with RSV have decreased below 2%. The requirements of intensive care and mechanical ventilation for CHD patients with RSV infection were still higher than those without RSV infection or with non-CHD children. RSV infection has frequently threatened CHD infants with congestive heart failure, cyanosis, or with pulmonary hypertension. As a progressive RSV pneumonitis in those infants develops, the impairment of oxygen uptake, the breathing workload gradually increases and eventually causes to significant pulmonary hypertension, even after the operation. Preventing RSV infection as much as possible is very important, especially in infants with HS-CHD. A humanized monoclonal antibody, palivizumab, has effective in preventing severe RSV disease in high-risk infants, and progressive advances in supportive care including pulmonary vasodilator have dramatically decreased the mortality (<1%). Depending on the global trend, Korean Health Insurance guidelines have approved the use of palivizumab in children <1 year of age with HS-CHD since 2009. Korean data are collected for RSV prophylaxis in infants with CHD.

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“…The authors concluded that in the state of California, 7 fewer RSV hospitalizations per year occurred among children younger than 2 years with hemodynamically significant CHD following recommendations for palivizumab prophylaxis in this group. 41 Other investigators describe rates of RSV hospitalizations among patients with hemodynamically significant CHD (2%-3%) who do not receive prophylaxis as lower than the 9.7% rate reported in the placebo arm of the cardiac study. [42][43][44][45][46] As the rate of RSV hospitalization decreases among children who do not receive prophylaxis, the cost to prevent 1 hospitalization with prophylaxis increases.…”

Section: Infants With Hemodynamically Significant Chdmentioning

confidence: 99%

Updated Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection

Brady¹,

Byington²,

Davies³

et al. 2014

Pediatrics

312

170

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Guidance from the American Academy of Pediatrics (AAP) for the use of palivizumab prophylaxis against respiratory syncytial virus (RSV) was first published in a policy statement in 1998. Guidance initially was based on the result from a single randomized, placebo-controlled clinical trial conducted in 1996–1997 describing an overall reduction in RSV hospitalization rate from 10.6% among placebo recipients to 4.8% among children who received prophylaxis. The results of a second randomized, placebo-controlled trial of children with hemodynamically significant heart disease were published in 2003 and revealed a reduction in RSV hospitalization rate from 9.7% in control subjects to 5.3% among prophylaxis recipients. Because no additional controlled trials regarding efficacy were published, AAP guidance has been updated periodically to reflect the most recent literature regarding children at greatest risk of severe disease. Since the last update in 2012, new data have become available regarding the seasonality of RSV circulation, palivizumab pharmacokinetics, the changing incidence of bronchiolitis hospitalizations, the effects of gestational age and other risk factors on RSV hospitalization rates, the mortality of children hospitalized with RSV infection, and the effect of prophylaxis on wheezing and palivizumab-resistant RSV isolates. These data enable further refinement of AAP guidance to most clearly focus on those children at greatest risk.

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Impact of Palivizumab on RSV Hospitalizations for Children with Hemodynamically Significant Congenital Heart Disease

Cited by 33 publications

References 18 publications

Delta inulin-derived adjuvants that elicit Th1 phenotype following vaccination reduces respiratory syncytial virus lung titers without a reduction in lung immunopathology

Delta inulin-derived adjuvants that elicit Th1 phenotype following vaccination reduces respiratory syncytial virus lung titers without a reduction in lung immunopathology

Respiratory syncytial virus infection in children with congenital heart disease: global data and interim results of Korean RSV-CHD survey

Updated Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection

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