Safety evaluation of a vaccine: Effect in maternal reproductive outcome and fetal anomaly frequency in rats using a leishmanial vaccine as a model.
While the immunogenic potential of the vaccination against infectious diseases was extensively shown, data on the safety assessment of recombinant proteins in vaccine formulations administered during pregnancy are still scarce. In the current study, the antigenicity of a vaccine against leishmaniasi...
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| Format: | Article |
| Language: | English |
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Public Library of Science (PLoS)
2017-01-01
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| Series: | PLoS ONE |
| Online Access: | http://europepmc.org/articles/PMC5332059?pdf=render |
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| author | Rafaianne Q Moraes-Souza Ana Paula Reinaque Thaigra S Soares Ana Luiza T Silva Rodolfo C Giunchetti Maria A S Takano Milena A Akamatsu Flávia S Kubrusly Fernanda Lúcio-Macarini Isaias Raw Dmitri Iourtov Paulo Lee Ho Lilian L Bueno Ricardo T Fujiwara Gustavo T Volpato |
| author_facet | Rafaianne Q Moraes-Souza Ana Paula Reinaque Thaigra S Soares Ana Luiza T Silva Rodolfo C Giunchetti Maria A S Takano Milena A Akamatsu Flávia S Kubrusly Fernanda Lúcio-Macarini Isaias Raw Dmitri Iourtov Paulo Lee Ho Lilian L Bueno Ricardo T Fujiwara Gustavo T Volpato |
| author_sort | Rafaianne Q Moraes-Souza |
| collection | DOAJ |
| description | While the immunogenic potential of the vaccination against infectious diseases was extensively shown, data on the safety assessment of recombinant proteins in vaccine formulations administered during pregnancy are still scarce. In the current study, the antigenicity of a vaccine against leishmaniasis (based on Leishmania braziliensis recombinant protein peroxidoxin) during pregnancy and possible maternal reproductive outcomes and fetal anomalies after immunization with a leishmanial vaccine or adjuvant alone (Bordetella pertussis derived MPLA adjuvant) were assessed. Rats were mated and allocated in three groups: Control-rats received saline; Adjuvant-rats received the adjuvant MPLA, and Vaccine-rats received the combination of MPLA and peroxidoxin. The administration was subcutaneously at the dorsal region, three times (days 0, 7, 14 of pregnancy). On day 21 of pregnancy, all rats were bled for biochemical and immunological measurements. The gravid uterus was weighed with its contents, and the fetuses were analyzed. The immunization with peroxidoxin induced a significant production of circulating IgG levels compared to other groups but caused a significant in post-implantation loss (14.7%) when compared to Control (5.0%) and Adjuvant (4.4%) groups. Furthermore, a significantly high rate of fetal visceral anomalies, such as hydronephrosis and convoluted ureter, was also observed in animals that received vaccine when compared to Control or Adjuvant groups. These data indicate the importance of safety evaluation of vaccines during pregnancy and the limited use of peroxidoxin administration during pregnancy. More importantly, the safety monitoring of immunization with MPLA derived from Bordetella pertussis demonstrated no reproductive outcomes associated with adjuvant administration, suggesting its safe use during pregnancy. |
| first_indexed | 2024-12-12T08:38:39Z |
| format | Article |
| id | doaj.art-5df6fec1c87c47fa9749ddad2347ed7e |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-12-12T08:38:39Z |
| publishDate | 2017-01-01 |
| publisher | Public Library of Science (PLoS) |
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| spelling | doaj.art-5df6fec1c87c47fa9749ddad2347ed7e2022-12-22T00:30:51ZengPublic Library of Science (PLoS)PLoS ONE1932-62032017-01-01123e017252510.1371/journal.pone.0172525Safety evaluation of a vaccine: Effect in maternal reproductive outcome and fetal anomaly frequency in rats using a leishmanial vaccine as a model.Rafaianne Q Moraes-SouzaAna Paula ReinaqueThaigra S SoaresAna Luiza T SilvaRodolfo C GiunchettiMaria A S TakanoMilena A AkamatsuFlávia S KubruslyFernanda Lúcio-MacariniIsaias RawDmitri IourtovPaulo Lee HoLilian L BuenoRicardo T FujiwaraGustavo T VolpatoWhile the immunogenic potential of the vaccination against infectious diseases was extensively shown, data on the safety assessment of recombinant proteins in vaccine formulations administered during pregnancy are still scarce. In the current study, the antigenicity of a vaccine against leishmaniasis (based on Leishmania braziliensis recombinant protein peroxidoxin) during pregnancy and possible maternal reproductive outcomes and fetal anomalies after immunization with a leishmanial vaccine or adjuvant alone (Bordetella pertussis derived MPLA adjuvant) were assessed. Rats were mated and allocated in three groups: Control-rats received saline; Adjuvant-rats received the adjuvant MPLA, and Vaccine-rats received the combination of MPLA and peroxidoxin. The administration was subcutaneously at the dorsal region, three times (days 0, 7, 14 of pregnancy). On day 21 of pregnancy, all rats were bled for biochemical and immunological measurements. The gravid uterus was weighed with its contents, and the fetuses were analyzed. The immunization with peroxidoxin induced a significant production of circulating IgG levels compared to other groups but caused a significant in post-implantation loss (14.7%) when compared to Control (5.0%) and Adjuvant (4.4%) groups. Furthermore, a significantly high rate of fetal visceral anomalies, such as hydronephrosis and convoluted ureter, was also observed in animals that received vaccine when compared to Control or Adjuvant groups. These data indicate the importance of safety evaluation of vaccines during pregnancy and the limited use of peroxidoxin administration during pregnancy. More importantly, the safety monitoring of immunization with MPLA derived from Bordetella pertussis demonstrated no reproductive outcomes associated with adjuvant administration, suggesting its safe use during pregnancy.http://europepmc.org/articles/PMC5332059?pdf=render |
| spellingShingle | Rafaianne Q Moraes-Souza Ana Paula Reinaque Thaigra S Soares Ana Luiza T Silva Rodolfo C Giunchetti Maria A S Takano Milena A Akamatsu Flávia S Kubrusly Fernanda Lúcio-Macarini Isaias Raw Dmitri Iourtov Paulo Lee Ho Lilian L Bueno Ricardo T Fujiwara Gustavo T Volpato Safety evaluation of a vaccine: Effect in maternal reproductive outcome and fetal anomaly frequency in rats using a leishmanial vaccine as a model. PLoS ONE |
| title | Safety evaluation of a vaccine: Effect in maternal reproductive outcome and fetal anomaly frequency in rats using a leishmanial vaccine as a model. |
| title_full | Safety evaluation of a vaccine: Effect in maternal reproductive outcome and fetal anomaly frequency in rats using a leishmanial vaccine as a model. |
| title_fullStr | Safety evaluation of a vaccine: Effect in maternal reproductive outcome and fetal anomaly frequency in rats using a leishmanial vaccine as a model. |
| title_full_unstemmed | Safety evaluation of a vaccine: Effect in maternal reproductive outcome and fetal anomaly frequency in rats using a leishmanial vaccine as a model. |
| title_short | Safety evaluation of a vaccine: Effect in maternal reproductive outcome and fetal anomaly frequency in rats using a leishmanial vaccine as a model. |
| title_sort | safety evaluation of a vaccine effect in maternal reproductive outcome and fetal anomaly frequency in rats using a leishmanial vaccine as a model |
| url | http://europepmc.org/articles/PMC5332059?pdf=render |
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