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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Published inPloS one Vol. 12; no. 3; p. e0172525
Main Authors Moraes-Souza, Rafaianne Q, Reinaque, Ana Paula, Soares, Thaigra S, Silva, Ana Luiza T, Giunchetti, Rodolfo C, Takano, Maria A S, Akamatsu, Milena A, Kubrusly, Flávia S, Lúcio-Macarini, Fernanda, Raw, Isaias, Iourtov, Dmitri, Ho, Paulo Lee, Bueno, Lilian L, Fujiwara, Ricardo T, Volpato, Gustavo T
Format Journal Article
LanguageEnglish
Published United States Public Library of Science 01.03.2017
Public Library of Science (PLoS)
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Summary: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.
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Conceptualization: RQMS APR RTF GTV.Data curation: RQMS APR ALTS LLB RTF GTV.Formal analysis: RQMS APR LLB RTF GTV.Funding acquisition: RCG DI PLH RTF GTV.Investigation: RQMS APR TSS ALTS MAST MAA FSK FLM IR.Methodology: ALTS RCG MAST MAA FSK FLM IR DI PLH LLB RTF GTV.Project administration: RQMS APR RTF GTV.Resources: IR DI PLH LLB RTF GTV.Supervision: RTF GTV.Validation: RQMS APR TSS ALTS MAST MAA FSK FLM.Visualization: RQMS APR TSS ALTS RCG MAST MAA FSK FLM IR DI PLH LLB RTF GTV.Writing – original draft: RQMS APR TSS ALTS RCG DI PLH LLB RTF GTV.Writing – review & editing: RQMS APR TSS ALTS RCG MAST MAA FSK FLM IR DI PLH LLB RTF GTV.
Competing Interests: The authors have declared that no competing interests exist.
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0172525