Developmental and reproductive toxicity (DART) study of a novel SARS-CoV-2 tetravalent recombinant protein vaccine (SCTV01E) in rats

IF 3.3 4区医学 Q2 REPRODUCTIVE BIOLOGY

Reproductive toxicology Pub Date : 2025-03-04 DOI:10.1016/j.reprotox.2025.108878

Xiao Zhang , Jilei Jia , Gaojian Chen , Dan Meng , Juan Ma , Huimin Wang , Shaozheng Zhou , Lin Ma , Qianqian Qian , Xuejie Liu , Xuefeng Li , Liangzhi Xie

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引用次数: 0

Abstract

SCTV01E, a novel SARS-CoV-2 tetravalent protein vaccine containing recombinant spike proteins of Alpha (B.1.1.7), Beta (B.1.351), Delta (B.1.617.2) and Omicron BA.1 (B.1.1.529.1) variants and SCTVA02B adjuvant, has received Emergency Use Authorization (EUA) in China and the United Arab Emirates (UAE) as a next-generation COVID-19 vaccine. A comprehensive reproductive and developmental toxicity evaluation was conducted in Sprague-Dawley (SD) rats under Good Laboratory Practice (GLP) conditions. Maternal animals were intramuscularly injected with 1 × or 3 × the highest human dose every other week prior to mating, followed by booster immunizations during gestation and lactation periods. The main findings showed that SCTV01E vaccination elicited robust binding IgG and neutralizing antibody responses against all four target variants. While no vaccine-related adverse reproductive effects were observed in parental male or female rats, transient injection site reactions and slight, reversible reductions in body weight gain and food consumption were noted. Key developmental parameters were not affected, and postnatal evaluation revealed no evidence of embryo-fetal malformations, developmental delays, or functional impairments in offspring. These results suggest a favorable safety profile for SCTV01E and its possible suitability for clinical trials in humans of reproductive potential. Furthermore, the efficient transplacental and lactational transfer of maternal antibodies observed in animal models suggests a potential protection: direct immunization of mothers may confer passive immunity to both fetuses in utero and neonates during breastfeeding.

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来源期刊

Reproductive toxicology 生物-毒理学

CiteScore

6.50

自引率

3.00%

发文量

131

审稿时长

45 days

期刊介绍： Drawing from a large number of disciplines, Reproductive Toxicology publishes timely, original research on the influence of chemical and physical agents on reproduction. Written by and for obstetricians, pediatricians, embryologists, teratologists, geneticists, toxicologists, andrologists, and others interested in detecting potential reproductive hazards, the journal is a forum for communication among researchers and practitioners. Articles focus on the application of in vitro, animal and clinical research to the practice of clinical medicine. All aspects of reproduction are within the scope of Reproductive Toxicology, including the formation and maturation of male and female gametes, sexual function, the events surrounding the fusion of gametes and the development of the fertilized ovum, nourishment and transport of the conceptus within the genital tract, implantation, embryogenesis, intrauterine growth, placentation and placental function, parturition, lactation and neonatal survival. Adverse reproductive effects in males will be considered as significant as adverse effects occurring in females. To provide a balanced presentation of approaches, equal emphasis will be given to clinical and animal or in vitro work. Typical end points that will be studied by contributors include infertility, sexual dysfunction, spontaneous abortion, malformations, abnormal histogenesis, stillbirth, intrauterine growth retardation, prematurity, behavioral abnormalities, and perinatal mortality.