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Background/Objectives: The dengue virus remains endemic in over 100 countries, transmitted by mosquito bites. Current management relies on supportive care, as no highly effective vaccine or approved antiviral exists. The CYD-TDV (Dengvaxia®) vaccine, licensed since 2015 with around 60% efficacy, raises the risk of severe dengue in seronegative children. The newer “Qdenga” vaccine offers up to 80% efficacy after a year but provides suboptimal protection against DENV-3 in seronegative individuals. Over the past two decades, virus-like particles (VLPs) have gained attention as safe, replication-incompetent vaccine platforms. This study evaluates the toxicity profile of dengue VLP-based antigens in BALB/c mice. Methods: A total of 80 BALB/C mice were randomly divided into two experimental groups: acute and chronic. Each group consisted of a treatment subgroup (10 males and 10 females) and a control subgroup (10 males and 10 females). In the acute group, the VLP was administered intramuscularly on day 1, while in the chronic group, a second VLP dose was given on day 14. The study was conducted over a 28-day period. Throughout the experiment, body temperature, body weight, mortality, and clinical signs were monitored regularly to assess the functional condition of various organs. Results: The results showed no notable alterations in mortality rates, body temperature, body weight, clinical signs, or histopathological observations of the examined organs across all groups, including in the hematological and blood biochemical parameters. Conclusions: The administration of tetravalent dengue VLP vaccine in BALB/c mice did not result in adverse effects in acute or chronic toxicity evaluations. Therefore, the VLP supports progression toward clinical evaluation, with dendritic cell activation providing additional rationale.

The development of nonhuman primate models that replicate human systemic lupus erythematosus (SLE) remains limited. This study aimed to develop a pristane-induced SLE model in Macaca fascicularis and evaluate its capacity to mimic human-like clinical and laboratory immunological alterations. An experimental, single-arm investigation was performed using six female M. fascicularis (2-3 years old, 3-4 kg), which received a single intraperitoneal pristane injection (5 mL/kg body weight) to induce SLE and were monitored biweekly. Throughout the 24-week study period, all macaques developed hallmark SLE-like changes without requiring a booster, including a pronounced increase in antinuclear antibody titers (p = 0.002), with anti-dsDNA positivity detected at the study endpoint. Significant decline was observed in hemoglobin, leukocyte, and lymphocyte count (p < 0.05), reflecting hematologic perturbations consistent with human SLE. Physiologic deterioration, manifested as hyperthermia and weight loss, also emerged early (p = 0.001). Biochemical assessment demonstrated mild hepatic and renal dysfunction marked by elevated serum glutamic pyruvic transaminase (SGPT) and urea concentrations (p < 0.05). Uniform proteinuria further indicated renal involvement, although the absence of hematuria suggests a spectrum of renal injury that may be less severe than that observed in advanced human SLE and may require longer observation. Overall, the reproducibility of autoantibody elevation and multisystem involvement demonstrates the model's translational potential. This nonhuman primate model offers a significant framework for investigating SLE pathogenesis and assessing novel therapy approaches.