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unspecified allergy vaccine (Staloral)

✓ Approved

Stallergenes · therapeutic agent

What is unspecified allergy vaccine?

unspecified allergy vaccine is a therapeutic agent developed by Stallergenes. It is approved for therapeutic indications via injectable (others) or oral (po) or subcutaneous injection or sublingual (sl)/oral transmucosal.

Drug Profile

Brand NamesStaloral
CompanyStallergenes
RouteInjectable (Others), Oral (PO), Subcutaneous Injection, Sublingual (SL)/Oral Transmucosal
StatusApproved
Sources: ClinicalTrials.gov, Stallergenes

Therapeutic Indications

unspecified allergy vaccine is developed for 2 unique indications across 1 therapeutic area.

Therapeutic AreaConditionPhase
Respiratory, thoracic and mediastinal disordersAsthma✓ Approved
Respiratory, thoracic and mediastinal disordersRhinitis allergic✓ Approved

Related Research Articles

PubMedAllergologia et immunopathologia2026-09-19

Complementary feeding routines and parental allergy follow-up behavior in early childhood.

Boyacıoğlu Özge Kangallı ÖK, Atay Özge Ö, Al Serdar S, Atakul Gizem G et al.

Early complementary feeding practices and timely allergen introduction are important components of current infant feeding recommendations. However, evidence remains limited regarding how complementary feeding routines and socioeconomic factors influence parental allergy-related healthcare-seeking behavior during early childhood.Objective: To examine the association between complementary feeding routines, early allergen introduction, socioeconomic characteristics, and parental allergy-related healthcare-seeking behavior in young children. In this cross-sectional study, parents of young children completed a structured questionnaire assessing complementary feeding routines, the timing and type of allergen introduction, allergy-related symptoms, and socioeconomic characteristics. All data were based on parental self-report and were not independently verified through clinical assessment or medical records. The primary outcome, allergy-related healthcare-seeking behavior, was operationally defined as any parent-reported healthcare contact, including at least one visit to a pediatrician or pediatric allergy clinic, due to suspected allergy-related symptoms or parental concern. Multivariable logistic regression analysis was performed to identify factors associated with allergy-related healthcare-seeking behavior. Early introduction of specific allergens, particularly egg white, was significantly associated with increased parental allergy-related healthcare-seeking behavior. The presence of allergy-related symptoms was also a strong determinant of healthcare utilization. In addition, socioeconomic factors, including household income and parental employment status, were associated with differences in healthcare-seeking patterns, likely reflecting variation in access to healthcare services and health awareness. The multivariable model demonstrated moderate sensitivity, indicating that while key factors associated with allergy-related healthcare-seeking behavior were identified, some cases could not be fully captured. Complementary feeding practices, early introduction of allergenic foods, and socioeconomic factors were associated with parental allergy-related healthcare-seeking behavior in early childhood. These findings highlight the need for targeted parental education, optimization of infant feeding recommendations with consideration of allergy risk, and improved clinical guidance for families reporting allergy-related symptoms. Prospective studies are warranted to confirm these associations and to support the development of effective preventive strategies.

PMID 42760874
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PubMedAllergologia et immunopathologia2026-09-19

Natural history and clinical factors associated with persistence in pediatric lentil allergy: a retrospective cohort study.

Miliordos Konstantinos K, Triga Maria M

Lentil is a widely consumed staple in Mediterranean countries and a significant cause of IgE-mediated legume allergy in children. Data on its natural history and the clinical factors associated with persistence remain limited. We retrospectively analyzed 62 children with confirmed lentil allergy who were followed at a tertiary pediatric allergy unit in Greece. Clinical manifestations, atopic comorbidities, food sensitization, lentil-specific IgE (sIgE), and Prick-to-Prick Test (PPT) wheal diameters were recorded. Tolerance was defined as a negative hospital-based oral food challenge. Primary prognostic analyses were restricted to children with OFC-confirmed outcomes. The median age at diagnosis was 4 years, and 46/62 children (74.2%) were male. Cutaneous reactions were the most common presentation (40/62, 64.5%), while 22/62 children (35.5%) experienced anaphylaxis. During follow-up, 49/62 children underwent OFC; 17/49 (34.7%) were tolerant, whereas 32/49 (65.3%) had persistent allergy. Among OFC-confirmed patients, tolerant children had lower lentil sIgE levels than children with persistent allergy (median 1.40 vs. 17.95 kU/L, p < 0.001) and smaller PPT wheal diameters (median 5 vs. 7 mm, p < 0.001). Lentil sIgE showed high discriminative ability for persistence (AUC 0.906, 95% CI 0.825-0.988), with a Youden-derived threshold of 9.95 kU/L. PPT showed good discriminative performance (AUC 0.794, 95% CI 0.660-0.929), with a threshold of 5.5 mm. Anaphylaxis and polysensitization were associated with higher odds of persistence but did not reach statistical significance. Lentil allergy was frequently persistent in this cohort. Among OFC-confirmed children, higher lentil sIgE levels and larger PPT wheal diameters were the most robust markers associated with persistence and may support prognostic counseling, as well as the timing of re-evaluation and supervised reintroduction challenges.

PMID 42760877
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PubMedAAPS PharmSciTech2026-09-19

Comprehensive Stability Assessment of Squalene in a Nanoemulsion Adjuvant and the SpiN-Tec Vaccine: HPLC Quantification, Stress Testing, and Stability Studies.

Gomes Isabela Pereira IP, Rivelli Graziella Gomes GG, Bagno Flávia Fonseca FF, Hojo-Souza Natália Satchiko NS et al.

Squalene-based nanoemulsions are widely used as adjuvants in vaccine formulations, but their stability can be affected by environmental factors such as pH, oxidative stress, temperature, and light. We have produced a squalene nanoemulsion (CTVad1) to support the clinical development of new vaccines. This study aimed to develop and validate an HPLC method for squalene quantification in SpiN-Tec, a recombinant protein vaccine against COVID-19. We also aimed to evaluate the stability of the CTVad1 adjuvant and SpiN-Tec under controlled storage conditions. A reversed-phase HPLC method was developed and validated, and comprehensive forced degradation studies were performed on the raw material and SpiN-Tec under acidic, basic, oxidative, thermal, and photolytic conditions to demonstrate the stability-indicating capability of the method. Physicochemical, morphological, and biological characteristics were assessed, and stability studies of both the vaccine and the CTVad1 adjuvant were performed under accelerated and long-term conditions. The HPLC method was selective, precise, accurate, linear, and robust. Squalene raw material degraded under all tested conditions, whereas formulation in nano-sized globules improved its stability, with degradation observed only under hydrogen peroxide and light exposure. CTVad1 remained stable over time, exhibiting only minor, non-critical changes within the specification limits in both accelerated and long-term stability studies, regardless of the glass packaging used (clear or amber). In addition, the SpiN-Tec vaccine maintained its physicochemical and biological integrity under all tested conditions, with all evaluated parameters remaining within the established specification ranges. Our findings demonstrate that proper formulation, packaging, and storage conditions can preserve squalene stability in nanoemulsion-based vaccines, ensuring the quality, safety, and efficacy of the SpiN-Tec vaccine and its adjuvant throughout shelf life.

PMID 42760453
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PubMedOcular immunology and inflammation2026-09-19

Bilateral Maculopathy in an Infant Following Measles, Mumps, Rubella, and Varicella-Zoster (MMRV) Vaccination.

Ben-Avi Ravid R, Amer Radgonde R

To report on the long-term clinical outcome of a healthy infant who presented with posterior uveitis following the administration of the combined measles, mumps, rubella, and varicella (MMRV) vaccine. Descriptive case report. A 13-month-old infant presented with bilateral visual loss two weeks after receiving the MMRV vaccine. Ophthalmic examination revealed bilateral retinitis and retinal vasculitis with exudative retinal detachment. Extensive infectious work-up was conducted including serologic exams and PCR testing of blood, aqueous humor, cerebrospinal fluid and urine. Serological tests for measles yielded positive IgM and IgG titers. PCR testing for measles in the aqueous humor and urine was negative. Neurologic assessment and neuroimaging were unremarkable, excluding central nervous system involvement. Empiric systemic antiviral and corticosteroid therapy was initiated. Gradual resolution of posterior uveitis ensued, culminating in bilateral macular scars. Over a six-year follow-up period, the patient demonstrated stable ocular findings with no evidence of recurrent inflammation or systemic autoimmune disease. Final visual acuity was 6/9 in each eye. This case represents a rare occurrence of non-necrotizing retinitis following MMRV vaccination. To our knowledge, this is the first report describing the sequential OCT characteristics of presumed measles vaccine-associated retinitis. The prolonged follow-up period supports the absence of an alternative etiology and provides valuable insight into the long-term course and visual prognosis of vaccine-associated retinopathy.

PMID 42760840
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PubMedAllergologia et immunopathologia2026-09-19

Products of compound probiotics combined with zinc and vitamin B ameliorate the risk of food allergy.

Lu Hanming H, Zhang Liwen L, Ren Mingxing M, Xue Guochang G et al.

Probiotics have emerged as a promising avenue for modulating immune responses implicated in food allergies, with zinc and vitamin B also exhibiting antiallergic properties. However, the clinical efficacy of compound probiotics combined with these nutrients in mitigating food allergy risk remains to be elucidated. In this randomized controlled trial, 796 children aged 0-6 years with food allergies were assigned to either an experimental group receiving compound probiotics, zinc, and vitamin B products alongside hydrolyzed protein formula milk, or a control group receiving only hydrolyzed protein formula milk. Serum IgE levels, specific food allergies, and key immunological factors were assessed at baseline, posttreatment, and post-follow-up time points. The experimental group demonstrated significantly reduced skin-prick test wheal diameters and serum total IgE levels compared with the control group after the 6-month intervention, with sustained efficacy at the 6-month follow-up. Furthermore, the prevalence of specific food allergies, including egg, milk, crab, shrimp, cashew, beef, mango, and shellfish, was significantly lower in the experimental group posttreatment and post-follow-up, highlighting the therapeutic potential of the intervention. Immunological analysis revealed a favorable modulation of Th1/Th2 balance, with increased IFN-γ levels and decreased IL-4 levels in the experimental group. Additionally, serum zinc and vitamin B2 levels were significantly elevated in the experimental group posttreatment and post-follow-up, indicating improved nutritional status. Compound probiotics combined with zinc and vitamin B represent a promising intervention for reducing the risk of food allergies in children, offering a multifaceted approach to immune modulation and nutritional support in this vulnerable population.

PMID 42760882
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PubMedAllergologia et immunopathologia2026-09-19

Systematic allergological evaluation enables NSAID allergy delabeling and identification of safe alternatives in adults.

Guzmán Avilán Rosa I RI, Avilés Vargas Silvia Rosario SR, González Díaz Sandra N SN, Ortega Natalhie Acuña NA et al.

Hypersensitivity reactions to nonsteroidal anti-inflammatory drugs (NSAIDs) are a frequent reason for allergy referral and a major diagnostic challenge. In everyday practice, overdiagnosis contributes to unnecessary drug avoidance, restricting therapeutic access to first-line analgesic and anti-inflammatory treatments and impacting clinical care. To determine the true prevalence of confirmed NSAID hypersensitivity in adults with suspected reactions through systematic allergological evaluation and assess its clinical impact on therapeutic access through safe delabeling and identification of alternative agents. We conducted a prospective, cross-sectional study including adults ≥18 years with suspected NSAID hypersensitivity evaluated at a tertiary referral center in Mexico between March and November 2025. All patients underwent standardized assessment including detailed clinical history, skin testing (prick and intradermal), and controlled drug provocation tests (DPTs) with acetylsalicylic acid, the implicated NSAID, and celecoxib. Clinical phenotypes were classified according to EAACI/ENDA guidelines. Associations between clinical variables and confirmed hypersensitivity were analyzed. Thirty-three patients were included; 72.7% were women, and 42.4% were aged 18-30 years. Atopy was present in 63.6%. Urticaria/angioedema predominated (69.7%). Ibuprofen and diclofenac were most frequently implicated (45.5%). Skin testing showed low diagnostic yield (6.1% prick; 21.2% intradermal). DPT was positive in 24.2%, mainly inducing urticaria. Celecoxib was tolerated in all patients with multiple hypersensitivity. Overall, 48.5% had no confirmed hypersensitivity and were successfully delabeled, restoring access to NSAID therapy. Multiple hypersensitivity occurred in 39.4% and selective reactions in 12.1%, with NIUAA as the predominant phenotype (33.4%). Atopy (p = 0.002) and recurrent episodes (p < 0.001) were associated with multiple hypersensitivity. Nearly half of adults labeled as NSAID-allergic were not truly hypersensitive. These prospective Mexican data demonstrate the clinical impact of systematic evaluation in reducing overdiagnosis and improving therapeutic access.

PMID 42760878
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