Preprint Review Version 1 This version is not peer-reviewed

The Immunogenicity and Safety of Rsv Vaccines in Development: A Systematic Review

Version 1 : Received: 29 May 2020 / Approved: 31 May 2020 / Online: 31 May 2020 (16:07:57 CEST)

How to cite: Shan, J. The Immunogenicity and Safety of Rsv Vaccines in Development: A Systematic Review. Preprints 2020, 2020050477 (doi: 10.20944/preprints202005.0477.v1). Shan, J. The Immunogenicity and Safety of Rsv Vaccines in Development: A Systematic Review. Preprints 2020, 2020050477 (doi: 10.20944/preprints202005.0477.v1).

Abstract

Background: Respiratory syncytial virus (RSV) is a leading cause of acute lower respiratory infection globally. There are vaccines in pipeline to prevent it but a systematic review on immunogenicity and safety of vaccine is lacking. Methods: This systematic review of RSV vaccine clinical trials was undertaken using 4 databases. Searches were conducted using both controlled vocabulary terms such as ‘Respiratory Syncytial Virus, Human’, ‘Respiratory Syncytial Virus Infections’, ‘Respiratory Syncytial Virus Vaccines’, ‘Immunization’, ‘Immunization Programs’ and ‘Vaccines’ and corresponding text word terms. The searches for published papers were limited to clinical trials published from January 2000 to August 6th, 2018. RSV infection case was defined as RSV associated medically attended acute respiratory illness (MAARI) or RSV infection by serologically-confirmed test (Western Blot) during the RSV surveillance period. We calculated the relative risk of each vaccine trial with RSV infection case. Results: Of 4395 publications, 24 were included and data were extracted covering 4 major types of RSV vaccine candidates, these being live-attenuated/chimeric (n=9), recombinant-vector (n=10), subunit (n=1) and nanoparticle vaccines (n=4). For RSV infection cases, 7 trials were involved and none of them showed a vaccine-related increased MAARI during RSV surveillance season. Conclusion: LID ∆M2-2, MEDI M2-2, and RSVcps2 (live-attenuated) were considered the most promising vaccine candidates in infant and children. In the elderly, a nanoparticle F vaccine candidate was considered as a potential effective vaccine. Although no promising vaccine was identified from pregnant-women test, RSV F-024 subunit vaccine candidate and an RSV F nanoparticle vaccine showed encouraging results in healthy non-pregnant women.

Subject Areas

respiratory syncytial virus vaccine; clinical trial; safety and immunogenicity; RSV promising vaccine

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