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Medical Outcomes in Women Who Became Pregnant after Vaccination with a Virus-Like Particle Experimental Vaccine against Influenza A (H1N1) 2009 Virus

tetano

Editor, Senior Moderator
Viruses. 2019 Sep 17;11(9). pii: E868. doi: 10.3390/v11090868.
[h=1]Medical Outcomes in Women Who Became Pregnant after Vaccination with a Virus-Like Particle Experimental Vaccine against Influenza A (H1N1) 2009 Virus Tested during 2009 Pandemic Outbreak.[/h] C?rbulo-V?zquez A[SUP]1[/SUP], Arriaga-Pizano L[SUP]2[/SUP], Cruz-Cure?o G[SUP]3[/SUP], Bosc?-G?rate I[SUP]4[/SUP], Ferat-Osorio E[SUP]5[/SUP], Pastelin-Palacios R[SUP]6[/SUP], Figueroa-Damian R[SUP]7[/SUP], Castro-Eguiluz D[SUP]8[/SUP], Mancilla-Ramirez J[SUP]9[/SUP], Isibasi A[SUP]10[/SUP], L?pez-Mac?as C[SUP]11,[/SUP][SUP]12,[/SUP][SUP]13[/SUP].
[h=3]Author information[/h] 1 Facultad de Medicina, Plan de Estudios Combinados en Medicina (MD, PhD Program), Universidad Nacional Aut?noma de M?xico, Mexico City CP 04510, Mexico. cerbulo@unam.mx. 2 Unidad de Investigaci?n M?dica en Inmunoqu?mica, Hospital de Especialidades del Centro M?dico Nacional Siglo XXI, Instituto Mexicano del Seguro Social (IMSS), Mexico City CP 06720, Mexico. landapi@hotmail.com. 3 Escuela Nacional de Ciencias Biol?gicas, Programa de Inmunolog?a, Instituto Polit?cnico Nacional, Mexico City CP 11340, Mexico. gabrielacruz30@gmail.com. 4 Unidad de Investigaci?n M?dica en Inmunoqu?mica, Hospital de Especialidades del Centro M?dico Nacional Siglo XXI, Instituto Mexicano del Seguro Social (IMSS), Mexico City CP 06720, Mexico. ibosco45@hotmail.com. 5 Servicio de Cirug?a Gastrointestinal, Unidad M?dica de Alta Especialidad, Hospital de Especialidades Dr Bernardo Sep?lveda Guti?rrez, Centro M?dico Nacional Siglo XXI, Instituto Mexicano del Seguro Social (IMSS), Mexico City CP 06720, Mexico. eduardoferat@prodigy.net.mx. 6 Departamento de Biolog?a, Facultad de Qu?mica, Universidad Nacional Aut?noma de M?xico, Mexico City CP 04510, Mexico. rodolfop@unam.mx. 7 Departamento de Infectolog?a, Instituto Nacional de Perinatolog?a, Mexico City CP 11000, Mexico. rfd6102@yahoo.com.mx. 8 Consejo Nacional de Ciencia y Tecnolog?a (CONACYT)- Departamento de Investigaci?n Cl?nica, Instituto Nacional de Cancerolog?a, Mexico City CP 14080, Mexico. angeldenisse@gmail.com. 9 Escuela Superior de Medicina, Instituto Polit?cnico Nacional; Hospital de la Mujer, Secretaria de Sauld, Mexico City CP 11340, Mexico. javiermancilla@hotmail.com. 10 Unidad de Investigaci?n M?dica en Inmunoqu?mica, Hospital de Especialidades del Centro M?dico Nacional Siglo XXI, Instituto Mexicano del Seguro Social (IMSS), Mexico City CP 06720, Mexico. isibasi@prodigy.net.mx. 11 Unidad de Investigaci?n M?dica en Inmunoqu?mica, Hospital de Especialidades del Centro M?dico Nacional Siglo XXI, Instituto Mexicano del Seguro Social (IMSS), Mexico City CP 06720, Mexico. constantino@sminmunologia.mx. 12 Visiting Professor of Immunology, Nuffield Department of Medicine, University of Oxford, Oxford OX3 7LF, UK. constantino@sminmunologia.mx. 13 Mexican Translational Immunology Research Group, Federation of Clinical Immunology Societies Centers of Excellence, National Autonomous University of Mexico, Mexico City 04510, Mexico. constantino@sminmunologia.mx.

[h=3]Abstract[/h] The clinical effects and immunological response to the influenza vaccine in women who later become pregnant remain to be thoroughly studied. Here, we report the medical outcomes of 40 women volunteers who became pregnant after vaccination with an experimental virus-like particle (VLP) vaccine against pandemic influenza A(H1N1)2009 (influenza A(H1N1)pdm09) and their infants. When included in the VLP vaccine trial, none of the women were pregnant and were randomly assigned to one of the following groups: (1) placebo, (2) 15 μg dose of VLP vaccine, or (3) 45 μg dose of VLP vaccine. These 40 women reported becoming pregnant during the follow-up phase after receiving the placebo or VLP vaccine. Women were monitored throughout pregnancy and their infants were monitored until one year after birth. Antibody titers against VLP were measured in the mothers and infants at delivery and at six months and one year after birth. The incidence of preeclampsia, fetal death, preterm delivery, and premature rupture of membranes was similar among groups. All vaccinated women and their infants elicited antibody titers (≥1:40). Women vaccinated prior to pregnancy had no adverse events that were different from the nonvaccinated population. Even though this study is limited by the sample size, the results suggest that the anti-influenza A(H1N1)pdm09 VLP experimental vaccine applied before pregnancy is safe for both mothers and their infants.


[h=4]KEYWORDS:[/h] antibody titers; influenza A(H1N1)pdm09; pregnant women; vaccination; virus-like particle

PMID: 31533277 DOI: 10.3390/v11090868
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