**Author details**

*The Burden of Respiratory Syncytial Virus Infection in the Young*

the Phase II trial met its goals.

months of life in the neonate.

**Acknowledgements**

**Conflict of interest**

**5. Conclusions**

This vaccine consists of nearly the full-length F glycoprotein. This nanoparticle vaccine prompted transplacental antibody transfer within a guinea pig model [71]. Furthermore, in a Phase II study in healthy women of child-bearing age, the vaccine was well tolerated. The peak of Anti-F IgG antibody was day 14 and persisted for 3 months, optimal for administration during the third trimester [72]. Recently, the immunogenicity, with an aluminum adjuvant, was evaluated in a Phase II trial (Clinicaltrials.gov identifier #NCT02247726) in healthy third-trimester pregnant women. In this study in pregnant women, the primary outcome measures were safety and immunogenicity of the vaccine, as well as its impact on the number of infants with medically-attended RSV LRTI and age of onset of the infection. No results have been posted for this study. However, a Phase III study investigation in the same study population is set to be completed in 2019, thereby suggesting that

RSV is one of the most common causes of lower respiratory disease in infants,

We thank Dr. Frank Esper (Department of Infectious Disease, Cleveland Clinic Children's) for his insightful comments regarding an earlier version of this chapter.

This work was supported by a NIH K08 AI112781 (F.R.) grant.

The authors report no conflicts of interest.

young children, and the elderly. Treatment is currently limited to supportive care, such as supplemental oxygen, bronchodilators, or corticosteroids. Palivizumab prophylaxis is currently restricted to high-risk infants. There is currently no vaccine to prevent RSV infection. There are many challenges associated with developing an RSV vaccine candidate. When developing a live attenuated vaccine, an equilibrium must be struck between adequate immunogenicity and attenuation of the virus. Non-replicating vaccines, like in some vector-delivery systems and protein-based vaccines, can enhance RSV infection in RSV-naïve infants. Therefore, it may be necessary to develop separate vaccines for each at-risk population: neonates and young children, pregnant women, and the elderly. One highly promising strategy appears to be maternal immunization with a nonreplicating vaccine, as this may provide protection during the first few

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Debra T. Linfield1 and Fariba Rezaee2,3\*

1 Cleveland Clinic Lerner College of Medicine of Case Western Reserve University Cleveland, OH, USA

2 Center for Pediatric Pulmonary Medicine, Cleveland Clinic Children's, Cleveland, OH, USA

3 Department of Inflammation and Immunity, Lerner Research Institute Cleveland Clinic Foundation, Cleveland, OH, USA

\*Address all correspondence to: rezaeef@ccf.org

© 2019 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/ by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
