Jose Clemente, PhD, associate professor of Genetics and Genomics and Immunology at the Icahn School of Medicine at Mount Sinai

Early Microbiome Shifts May Define a Critical Window for Allergy Risk, With Jose Clemente, PhD

New ACTIVATE data found that vaginal seeding in cesarean-delivered infants was associated with altered early gut microbiome patterns and differences in 

Jose Clemente, PhD, associate professor of genetics and genomics and immunology at the Icahn School of Medicine at Mount Sinai, presented these late-breaking findings at the 2026 American Academy of Allergy, Asthma, & Immunology (AAAAI) in Philadelphia from February 27 to March 2. ACTIVATE, a double-blind, randomized trial, evaluated whether exposure to maternal vaginal microbiota at birth can influence food allergen sensitization in cesarean-delivered infants at high risk for allergic disease.

The study enrolled 39 vaginally delivered infants, 37 cesarean-delivered infants who received placebo seeding, and 37 cesarean-delivered infants who underwent vaginal seeding, along with their mothers. Vaginal seeding in the study involved placing sterile gauze in the maternal vagina approximately 1 hour before cesarean delivery, and then immediately after birth, using the gauze to swab the infant’s mouth, face, and body.

, abundant in maternal vaginal samples, was enriched in the stool of infants who received vaginal microbial transfer compared with placebo immediately after birth (

 =.002). At 3 months, infants who underwent vaginal seeding had stool microbiomes more similar to vaginally delivered infants than placebo-treated infants (similarity 0.876 ± 0.07 vs 0.9 ± 0.06;

 =.169); this effect was partial and waned over time. The analysis also showed that maternal vaginal microbiome composition itself was not associated with food sensitization at 12 months (

 =.86), but specific infant gut microbes identified at 12 months were associated with allergen sensitization (

during AAAAI, Clemente emphasized that even temporary microbial shifts may influence long-term immune trajectories.

“We see differences for the first few months, but then after a while, those differences, at least looking at the microbes…disappear,” Clemente said. “It doesn't matter if you've been exposed to the microbes or not when the babies are 1 year of age. We don't see differences anymore, but we think it's really those first few months when it’s critical to intervene if we want to lower [allergy] risk. I think a harder problem that comes out of it is, well, what happens if you have a child that already has an allergy? That's a much harder problem to tackle because we know that it's during these first few months when we can modulate the microbiome and modulate the immune development based on those interventions.”

Clemente J, Bu K, Cantor A, et al. Microbiome Associations with Food Sensitization in the ACTIVATE Trial: Exposure to Vaginal Microbiome in C-section Infants at High-risk for Allergies. 

Journal of Allergy and Clinical Immunology

doi:https://doi.org/10.1016/j.jaci.2025.12.935

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Early gut microbiome changes in c-section infants linked to food sensitization at 12 months, highlighting a potential critical intervention window.

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Food Allergy

Vaginal Seeding Partially Modifies Infant Microbiome in ACTIVATE, With Jose Clemente, PhD

Vaginal seeding in cesarean-delivered infants was associated with altered early gut microbiome patterns and differences in 

 at 12 months, according to late-breaking ACTIVATE trial data presented at the 2026 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Philadelphia.

The Journal of Allergy and Clinical Immunology had published a report on the link between delivery mode and allergy risk had been reported > 2 decades ago. However, as cesarean delivery rates continue to rise in the United States and globally, rising from 7% in 1990 to 21% in 2025, interest has intensified around how birth mode influences early immune development and allergy risk.

 spoke with Jose Clemente, PhD, associate professor of Genetics and Genomics and Immunology at the Icahn School of Medicine at Mount Sinai, who discussed the biologic rationale behind the trial and what the findings may mean for clinicians.

“A few years ago, we thought, okay… c-section is associated with different type of colonization with microbes. Maybe if we restore microbes in this c-section babies, we can hopefully modulate the risk for allergies,” Clemente said. “That's the whole idea behind…this particular trial.”

ACTIVATE is a double-blind, placebo-controlled, randomized clinical trial evaluating whether exposure to maternal vaginal microbiota at birth can influence food allergen sensitization in cesarean-delivered infants at high risk for allergic disease.

The study enrolled 39 vaginally delivered infants, 37 cesarean-delivered infants who received placebo seeding, and 37 cesarean-delivered infants who underwent vaginal seeding, along with their mothers.

Vaginal seeding in ACTIVATE involved placing sterile gauze in the maternal vagina approximately 1 hour prior to cesarean delivery. Immediately after birth, the gauze was used to swab the infant’s mouth, face, and body in an effort to approximate microbial exposure during vaginal birth.

Shotgun metagenomic sequencing confirmed microbial transfer. Lactobacillus, abundant in maternal vaginal samples, was enriched in the stool of infants who received vaginal microbial transfer compared with placebo immediately after birth (

At 3 months, the stool microbiome of infants who underwent vaginal seeding more closely resembled that of vaginally delivered infants than infants who underwent placebo seeding (similarity indices 0.876 ± 0.07 vs 0.9 ± 0.06;

 =.169), though the effect was partial and diminished over time. By 12 months, global microbiome composition differences between groups were no longer apparent.

Clemente emphasized that this partial modification is biologically meaningful. Vaginal seeding does not replicate the full microbial exposure of vaginal delivery, but even limited early colonization may act as a developmental primer, influencing downstream microbial succession and immune programming.

“When you're born, you're essentially born with no microbes,” Clemente said. “We think that this first exposure is important because it sets the baby on the correct developmental pathway. It sets the baby to acquire microbes then are going to lead to a transition to other microbes that might also be eventually beneficial, in terms of risk against risk of allergies.”

Maternal vaginal microbiome composition itself was not associated with food sensitization at 12 months (P =.86). Instead, specific infant gut microbes identified at 12 months were associated with allergen sensitization, including 

 = 0.013, 0.032, and 0.006, respectively). Infants with vagina seeding exhibited lower levels of R. gnavus, a microbe previously implicated in inflammatory pathways.

The investigators demonstrated that among infants who underwent vaginal seeding and in whom microbial transfer was effective, rates of sensitization were lower compared with placebo-seeded counterparts, although Clemente characterized the trial as exploratory and not yet practice-changing.

“It's important to remember that the activate trial is a pilot trial,” Clemente said. “One of the ideas behind the trial is to determine whether the procedure is safe, and that is the case, the procedure is not associated with increased adverse events. Two, whether we see a measurable benefit, and that's what we have shown that there is a measurable benefit, but it's not quite yet ready to be developing in clinic.”

McKeever TM, Lewis SA, Smith C, Hubbard R. Mode of delivery and risk of developing allergic disease. 

. 2002;109(5):800-802. doi:https://doi.org/10.1067/mai.2002.124046

Trial data show early microbiome shifts after vaginal microbial transfer in cesarean-delivered infants, with differences in food sensitization at 12 months.

Medical student at John Sealy School of Medicine, University of Texas in Galveston

Alleviating Pediatric Fracture Risk Concerns With Asthma ICS, With Lynchi Nguyen

 treated with inhaled corticosteroids (ICS) for asthma did not face a higher risk of fractures—in fact, those managed with short-acting beta agonists (SABA) alone had an 18% higher fracture risk compared with children receiving ICS therapy, according to new data analyzing more than 210,000 pediatric patients.

Asthma remains the most common chronic allergic and respiratory condition in children, and ICS is foundational to long-term asthma control. However, patient and family concerns about the potential skeletal effects of corticosteroids, particularly extrapolated from data on systemic steroids, continue to influence prescribing patterns and parental acceptance.

Lynchi Nguyen, a medical student at John Sealy School of Medicine, University of Texas Medical Branch in Galveston, addressed this concern at the 

American Academy of Allergy, Asthma & Immunology (AAAAI)

 2026 Annual Meeting held in Philadelphia, Pennsylvania, where she presented data from a large retrospective cohort study aiming to clarify ICS and fracture risk using the TriNetX U.S. Collaborative Network. The analysis included more than 210,000 children aged 6–18 years with asthma. Patients were categorized into 3 mutually exclusive groups: SABA-only therapy, ICS-only therapy, and ICS combined with a long-acting beta agonist (ICS + LABA). To ensure accurate comparisons, cohorts were propensity score matched for age, sex, and comorbidities, with exclusions for obesity, cystic fibrosis, autoimmune disease, and metabolic bone disorders.

The primary outcome was first-time pediatric-specific fracture occurring at least 1 year after medication initiation, including Salter-Harris fractures, torus fractures, greenstick fractures, and bent bone fractures, which are injuries particularly relevant to growing children.

Nguyen and colleagues found that compared with SABA-only controls, children in the ICS-only group demonstrated a lower fracture risk, with a relative risk (RR) of 1.18 (95% CI, 1.11–1.26) for the SABA-only cohort, indicating an 18% higher fracture risk among children treated with SABA alone. In contrast, there was no statistically significant difference in fracture risk between ICS + LABA therapy and SABA-only therapy (RR, 1.05; 95% CI, 0.95–1.15), nor between ICS + LABA and ICS-only regimens (RR, 0.97; 95% CI, 0.86–1.09).

Importantly, ICS use, whether alone or in combination, was not associated with increased fracture risk. In fact, the data suggest that children managed without ICS may face modestly higher fracture risk, potentially reflecting poorer asthma control or greater systemic steroid exposure from exacerbations.

These results reinforce international guideline recommendations that encourage early incorporation of ICS and move away from SABA monotherapy. Nguyen emphasized that inhaled corticosteroids are not equivalent to systemic steroids in their skeletal effects, and these findings should help clinicians confidently counsel families, address misconceptions, and support evidence-based asthma management in children.

“ICS use is not equivalent to systemic steroid use, [it doesn’t] confer the same risks, and that it's safe for our children to be on these medications…[It’s important for clinicians to incorporate] this into their counseling with parents so they don't feel as hesitant to adhere to these asthma regimens that include ICs,” Nguyen said.

Nguyen L, Lee A, Carmichael K, Acevado JA. Fracture Risk Among Pediatric Asthma Patients Treated With Inhaled Corticosteroids: A Retrospective Cohort Study. Presented at: AAAAI 2026 Annual Meeting, February 27-March 2, Philadelphia, Pennsylvania. Poster #L04

Nguyen emphasized the safety of inhaled corticosteroids vs SABA-only therapy in pediatric asthma.

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Matthew Krantz, MD, from Vanderbilt University Medical Center

HLA-A*32:01 Carrier Screening Feasibility Before Lamotrigine, With Matthew Krantz, MD

New data linked HLA-A*32:01 carriage to lamotrigine-induced drug reaction with 

eosinophilia and systemic symptoms (DRESS)

2026 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Philadelphi

a, Matthew Krantz, MD, from Vanderbilt University Medical Center, addressed how these data should guide management decisions and whether pre-prescription screening is feasible. He said a team led by Elizabeth Phillips, MD, from Vanderbilt, had developed a rapid single allele assay for 32:01 that uses allele-specific primers.

“You don’t get full HLA typing, but you get a binary result of whether an individual is a carrier for a 3201 or not,” Krantz said. “You also don't get information if an individual has 2 copies of a 3201; you would only get…that binary result. It's not a clinically available test, but in research settings where it's been optimized, these tests can be done with a several-hour turnaround. We do think that if these tests were to have evidence of meeting that threshold of a low number needed to test to prevent 1 case, that this is something that could be translated into the clinic.”

In the recently published multi-institutional cohort, HLA-A*32:01 was present in 40% of lamotrigine-induced DRESS cases compared with 5.5% of matched lamotrigine-tolerant controls, corresponding to an odds ratio of 12.1 (95% CI, 4.9–29.8; Bonferroni-corrected 

 < .001). Although this represents a substantial genetic association, DRESS remains rare. Among individuals exposed to high-risk medications for the requisite 2- to 8-week latency period, approximately 1 in 1000 may develop DRESS. At the population level, incidence is estimated at 1 to 3 per 100,000.

Given this low absolute risk, routine pre-prescription high-resolution HLA typing is not currently standard practice. Krantz noted that most patients will not have existing HLA class I data available to guide lamotrigine prescribing. An exception may include patients undergoing bone marrow or solid organ transplantation, where comprehensive HLA typing is already performed.

In situations where HLA-A*32:01 carriage is known, and lamotrigine is strongly indicated, Krantz suggested a risk-mitigation strategy rather than automatic exclusion. Lamotrigine is associated with a spectrum of cutaneous reactions, ranging from mild maculopapular eruptions to severe hypersensitivity. Standard prescribing protocols already emphasize low starting doses with gradual titration to reduce rash risk. In carriers, clinicians could consider even more cautious dose escalation, closer clinical follow-up, and vigilant monitoring for early systemic symptoms such as a rash.

The original cohort included 30 prospectively identified lamotrigine-induced DRESS cases (87% female; 93% self-identified White; median age 33 years [interquartile range, 25–56]) and 300 matched tolerant controls. Krantz acknowledged that the predominantly White, European ancestry composition limits the ability to detect ancestry-specific risk alleles.

“This really requires collaborative networks of academic medical centers identifying and precision phenotyping these individuals, obtaining… genetic data for sequencing, especially for HLA, to be able to generalize these results,” Krantz said. “We're really the first multi-institutional group to kind of show this. The next step would be for replication at other sites.”

Relevant disclosures for Krantz include Silk Road Medical, Inc., Boston Scientific Corporation, and Tactile Systems Technology Inc.

Krantz M, Gangula R, Yu A, et al. HLA-A*32:01 carriage is associated with lamotrigine-induced drug reaction with eosinophilia and systemic symptoms in a US cohort. 

doi:https://doi.org/10.1016/j.jaci.2025.12.953

Krantz M. HLA-A*32:01 Linked to Lamotrigine DRESS Risk, With Matthew Krantz, MD. HCPLive. Published on February 28, 2026. Accessed on February 28, 2026. 

https://www.hcplive.com/view/hla-a-32-01-linked-lamotrigine-dress-risk-matthew-krantz-md

HLA-A*32:01 carrier screening may identify patients at elevated risk for lamotrigine-induced eosinophilia and systemic symptoms, Krantz says at AAAAI 2026.

Victoria Johnson joined the MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and now HCPLive. You can reach her at vjohnson@mjhlifesciences.com

An exploratory pooled analysis of the Phase 3 METREX, METREO, and MATINEE trials has demonstrated that mepolizumab (Nucala; GSK) consistently reduced the annualized rate of moderate or severe exacerbations in people with 

 (COPD) compared with placebo, regardless of blood eosinophil count (BEC) variability pattern.

Mepolizumab was approved by the United States (US) Food and Drug Administration (FDA) in May 2025 as an add-on maintenance treatment for patients with COPD with an eosinophilic phenotype.

 BECs are an established biomarker of type 2 inflammation in COPD and are associated with increased exacerbation risk. Yet BEC levels are dynamic, influenced by infections, corticosteroid exposure, circadian variation, and other factors. Real-world data suggest that only 5–18% of patients demonstrate persistently high BEC ≥300 cells/µL, while nearly 30% exhibit intermittent elevations. This variability complicates clinical decision-making and raises important questions about how to identify patients most likely to benefit from biologic therapy.

The analysis, presented by Gerald Criner, MD, Chair and Professor of Thoracic Medicine and Surgery at Lewis Katz School of Medicine at Temple University, at the 

 2026 Annual Meeting held in Philadelphia, Pennsylvania, valuated mepolizumab 100 mg subcutaneously versus placebo in patients ≥40 years of age with COPD receiving inhaled triple therapy. Patients were stratified by longitudinal pre-randomization BEC patterns to assess whether variability in eosinophil levels influences response.

Criner and colleaguges found that across patients with evidence of type 2 inflammation, mepolizumab consistently reduced the annualized rate of moderate or severe exacerbations compared with placebo, regardless of BEC variability pattern.

In Subgroup 1 (BEC ≥300 cells/µL at screening and baseline), exacerbation rates were reduced from 1.31 events/year with placebo to 0.95 with mepolizumab (rate ratio [RR], 0.73; 95% CI 0.61–0.88), corresponding to a 27% relative risk reduction.

Subgroup 2 (persistently ≥300 cells/µL across all pre-randomization timepoints) showed a numerical reduction from 1.11 to 0.97 events/year (RR, 0.88; 95% CI 0.70–1.11), equating to a 12% relative risk reduction.

Subgroup 3, (high type 2 inflammation at screening [≥300 cells/µL] but short-term variability [<300 cells/µL at baseline]), experienced a decrease from 1.27 to 0.99 events/year (RR, 0.78; 95% CI 0.60–1.01), representing a 22% relative risk reduction.

Notably, Subgroup 4 (≥300 cells/µL at any pre-randomization timepoint with at least one measurement <150 cells/µL) demonstrated one of the largest treatment effects. Exacerbation rates declined from 1.43 to 0.91 events/year (RR, 0.64; 95% CI 0.45–0.89), corresponding to a 36% relative risk reduction. This subgroup also had among the highest placebo exacerbation rates, suggesting that patients with marked BEC variability may represent a particularly high-risk and responsive phenotype.

Patients meeting the US-approved eosinophilic phenotype definition (Subgroup 5: ≥150 cells/µL at screening and/or ≥300 cells/µL in the prior year) experienced a reduction from 1.36 to 1.10 events/year (RR, 0.81; 95% CI 0.72–0.91), a 19% relative risk reduction. Similar significant reductions were observed in Subgroup 6 (RR, 0.83; 17% risk reduction) and Subgroup 7 (RR, 0.79; 21% risk reduction).

In contrast, Subgroup 8 of non-type 2 COPD (persistently <150 cells/µL) showed no meaningful benefit; rates increased from 1.17 to 1.47 events/year (RR, 1.26; 95% CI 0.98–1.61), indicating no protective effect in the absence of type 2 inflammation.

For exacerbations requiring emergency department (ED) visit and/or hospitalization, results generally mirrored the moderate/severe findings, with efficacy across BEC levels except in Subgroup 8 in those without type 2 COPD Again, no meaningful benefit was observed (RR, 1.11; 95% CI 0.63–1.97).

Subgroup 3 demonstrated the largest relative reduction in severe outcomes, with rates decreasing from 0.27 to 0.12 events/year (RR, 0.44; 95% CI 0.25–0.80), representing a 56% relative risk reduction.

Subgroup 5 showed a reduction from 0.26 to 0.20 events/year (RR, 0.77; 95% CI 0.60–0.99), corresponding to a 23% relative risk reduction. Subgroups 6 and 7 demonstrated consistent directional improvements (RR, 0.77 and 0.76, reflecting 23% and 24% relative risk reductions, respectively).

Overall, this analysis supports the use of mepolizumab in patients with inadequately controlled COPD and documented type 2 inflammatory activity, consistent with its US-approved indication, and suggests that requiring persistent eosinophilia may unnecessarily exclude patients who could achieve meaningful risk reduction.

“Mepolizumab consistently reduces exacerbation rates in a wide spectrum of patients with COPD and type 2 inflammation versus placebo, both in those who have high and low variability in their BECsover time, as well as those with historically elevated BEC, prior to therapy initiation. These results support the use of mepolizumab in patients who have shown signsof type 2 inflammation, without necessarily being persistently eosinophilic,” Criner and colleagues wrote in their poster.

1. Criner GJ, Watz H, Han MK, et al. MepolizumabImproves Exacerbation Outcomes in Patients with COPD with Type 2 Inflammation and Variable Eosinophil Patterns. Presented at: AAAAI 2026 Annual Meeting, February 27-March 2, Philadelphia, Pennsylvania. Poster #L01.

2. Johnson V. FDA Approves Mepolizumab for Eosinophilic COPD. Article. HCPLive. May 22, 2025. 

https://www.hcplive.com/view/fda-approves-mepolizumab-for-eosinophilic-copd

Articles

Exploratory pooling of phase 3 METREX, METREO, and MATINEE evaluated mepolizumab 100 mg SC added to inhaled triple therapy in COPD patients ≥40 with type 2 inflammation. Despite substantial longitudinal blood eosinophil count (BEC) variability, mepolizumab reduced annualized moderate/severe exacerbations versus placebo across multiple BEC-pattern strata, including intermittent and highly variable eosinophilia. Largest effect occurred in those with any BEC ≥300 and at least one <150. No benefit was observed in persistently low BEC (<150) non–type 2 COPD. Severe ED/hospitalization events similarly declined in most type 2 strata.

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She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

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Latest News

Early Microbiome Shifts May Define a Critical Window for Allergy Risk, With Jose Clemente, PhD

Vaginal Seeding Partially Modifies Infant Microbiome in ACTIVATE, With Jose Clemente, PhD

Alleviating Pediatric Fracture Risk Concerns With Asthma ICS, With Lynchi Nguyen

HLA-A*32:01 Carrier Screening Feasibility Before Lamotrigine, With Matthew Krantz, MD

Mepolizumab Reduces Type 2 COPD Exacerbations Across Variable BEC Levels