Daily Respiratory Research Analysis
A phase 2/3 double-blind trial showed a locally manufactured Newcastle disease virus–based COVID-19 booster (AVX/COVID-12) was safe and immunogenic, supporting scalable vaccination in low- and middle-income countries. A multicountry diagnostic accuracy study validated centrifuge-free stool processing methods for Xpert Ultra in children, informing WHO-endorsed approaches to expand pediatric TB diagnosis. An ERS clinical guideline provides conditional recommendations for telemedicine in home mecha
Summary
A phase 2/3 double-blind trial showed a locally manufactured Newcastle disease virus–based COVID-19 booster (AVX/COVID-12) was safe and immunogenic, supporting scalable vaccination in low- and middle-income countries. A multicountry diagnostic accuracy study validated centrifuge-free stool processing methods for Xpert Ultra in children, informing WHO-endorsed approaches to expand pediatric TB diagnosis. An ERS clinical guideline provides conditional recommendations for telemedicine in home mechanical ventilation, guiding initiation and follow-up care.
Research Themes
- Scalable and affordable vaccine platforms for respiratory viruses
- Point-of-care pediatric TB diagnostics without laboratory infrastructure
- Telemedicine for initiation and follow-up of home mechanical ventilation
Selected Articles
1. Phase 2/3 study evaluating safety, immunogenicity, and noninferiority of single booster dose of AVX/COVID-12 vaccine.
In a double-blind, active-controlled phase 2/3 noninferiority trial (n=4,056), the NDV-LaSota HexaPro-S booster (AVX/COVID-12) was safe, well tolerated, and elicited neutralizing antibodies to ancestral SARS-CoV-2 and Omicron BA.2/BA.5, with CD8 IFN-γ responses. The locally manufactured platform addresses cost and access barriers in LMICs.
Impact: This is a large, well-designed phase 2/3 RCT demonstrating immunogenicity and safety of an LMIC-appropriate NDV-based COVID-19 booster, enabling scalable local manufacturing and variant coverage.
Clinical Implications: Provides an affordable, locally manufacturable booster option with neutralization of Omicron subvariants, supporting broader coverage where mRNA cold-chain is challenging. Policymakers can consider NDV-based boosters for national programs.
Key Findings
- Double-blind, active-controlled phase 2/3 trial (n=4,056) demonstrated safety and good tolerability.
- Neutralizing antibodies induced against ancestral SARS-CoV-2 and Omicron BA.2/BA.5.
- Elicited interferon-γ–producing CD8+ T-cell responses.
- NDV-LaSota HexaPro-S platform enables local, cost-effective manufacturing for LMICs.
Methodological Strengths
- Parallel-group, double-blind, active-controlled noninferiority design.
- Large sample size with variant-specific immunogenicity readouts.
Limitations
- Efficacy against clinical endpoints (infection, hospitalization) not reported in the abstract.
- Durability of immunity and breadth against newer variants beyond BA.5 not detailed.
Future Directions: Assess real-world effectiveness against clinical outcomes, durability of protection, and cross-reactivity to emergent variants; evaluate programmatic deployment in LMIC immunization schedules.
2. Centrifuge-free stool processing methods for Xpert MTB/RIF Ultra tuberculosis diagnosis in children in Uganda and Zambia: an observational, prospective, diagnostic accuracy study.
In 215 children (median age 1.8 years) from Uganda and Zambia, centrifuge-free stool processing methods for Xpert Ultra (SOS, SPK, OSF) showed similar sensitivities (~70–74%) and high specificities (>96%) versus a microbiological reference standard; SOS was rated easiest to use. Findings supported WHO endorsement of SOS and OSF methods, addressing major implementation barriers in LMICs.
Impact: By validating simple, centrifuge-free workflows with high specificity, this study enables broader pediatric TB diagnosis where laboratory infrastructure is limited, with direct influence on WHO guidance.
Clinical Implications: Primary and district-level facilities can implement SOS/OSF to expand access to TB microbiological confirmation in children without centrifuges, improving case detection and timely treatment.
Key Findings
- Sensitivity versus MRS: SOS 69.7%, SPK 69.7%, OSF 73.5%; specificity >96% for all.
- Study included 215 children (median age 1.8 years), with 31.6% HIV-positive.
- SOS method rated easiest by 6/7 operators due to minimal manipulation and no added reagents.
- Results contributed to WHO endorsement of SOS and OSF centrifuge-free methods.
Methodological Strengths
- Prospective multicountry diagnostic accuracy design with head-to-head method comparison.
- Use of a microbiological reference standard and operator usability assessment.
Limitations
- Relatively small number of MRS-positive cases (n=38) limits precision of sensitivity estimates.
- Study conducted at limited number of hospitals; generalizability to all settings requires further evaluation.
Future Directions: Implementation research on workflow integration, training, and cost-effectiveness at primary care level; evaluate performance across diverse epidemiologic contexts and malnutrition/HIV burden.
3. European Respiratory Society clinical practice guideline on telemedicine in home mechanical ventilation.
ERS provides GRADE-based conditional recommendations supporting telemedicine for HMV initiation in neuromuscular/restrictive thoracic diseases and COPD, and for follow-up care, while acknowledging low certainty and lack of consensus on monitoring parameters. The guideline outlines evidence gaps and highlights AI/data processing as future enablers.
Impact: This guideline standardizes telemedicine use in HMV across key patient groups, guiding service design and policy while defining research priorities in monitoring and outcomes.
Clinical Implications: Clinicians and programs can adopt telemedicine-supported initiation and follow-up for HMV in neuromuscular/restrictive disease and COPD, with shared decision-making and local workflow adaptation; monitoring parameters should be defined in implementation studies.
Key Findings
- Conditional recommendation to use telemedicine for HMV initiation in neuromuscular/restrictive thoracic disease and COPD.
- Conditional recommendation for telemedicine during HMV follow-up; no specific monitoring parameters endorsed.
- GRADE approach and Evidence-to-Decision framework used; overall certainty of evidence low.
Methodological Strengths
- Systematic evidence synthesis with GRADE and PICO-driven questions.
- Multidisciplinary task force including patient/caregiver representation.
Limitations
- Low certainty of evidence limits strength of recommendations.
- No consensus on telemonitoring parameters or standardized outcome sets.
Future Directions: Randomized/controlled implementation studies defining monitoring parameters, data standards, and AI-enabled decision support; cost-effectiveness and equity evaluations across health systems.