ArticleThe Journal of infectious diseases2020
Safety and Immunogenicity of the Respiratory Syncytial Virus Vaccine RSV/ΔNS2/Δ1313/I1314L in RSV-Seronegative Children.
Article in The Journal of infectious diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01893554 (A Phase I Study of the Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine RSV ΔNS2 Δ1313 I1314L, Lot RSV#006A, Delivered as Nose Drops to RSV-Seropositive Children 12 to 59 Months of Age, RSV-Seronegative Infants and Children 6 to 24 Months of Age, and Infants 4 to 6 Months of Age), which is not on this map. Cited by 54 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase I Study of the Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine RSV ΔNS2 Δ1313 I1314L, Lot RSV#006A, Delivered as Nose Drops to RSV-Seropositive Children 12 to 59 Months of Age, RSV-Seronegative Infants and Children 6 to 24 Months of Age, and Infants 4 to 6 Months of Age
Who cites it
54 citing papers in PubMed, 3 syntheses or guidelines pooled it, 63 citations in OpenAlex.
- Efficacy and safety of respiratory syncytial virus vaccines.The Cochrane database of systematic reviews · 2025Pooled it
- Vaccines for the common cold.The Cochrane database of systematic reviews · 2022Pooled it
- The immunogenicity and safety of respiratory syncytial virus vaccines in development: A systematic review.Influenza and other respiratory viruses · 2021Pooled it
- Evaluation of the Live-Attenuated Intranasal Respiratory Syncytial Virus (RSV) Vaccine RSV/6120/ΔNS2/1030s in RSV-Seronegative Young Children.The Journal of infectious diseases · 2024Trial
- Evaluation of Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV/ΔNS2/Δ1313/I1314L and RSV/276 in RSV-Seronegative Children.The Journal of infectious diseases · 2022Trial
- Live human metapneumovirus vaccine candidates attenuated by temperature sensitivity mutations from human respiratory syncytial virus.Journal of virology · 2026Article
- A comprehensive look at Respiratory Syncytial Virus (RSV): from pathogenesis to prevention.Tropical diseases, travel medicine and vaccines · 2026Review
- Live-attenuated vaccines of human respiratory syncytial virus for infants and young children: Progress and prospects of an old yet promising platform.Biosafety and health · 2026Review
- Advances in Detection Methods for Human Respiratory Syncytial Virus Neutralizing Antibodies.Vaccines · 2026Review
- Codon-Pair Deoptimized (CPD) Intranasal RSV Vaccines: A Novel Strategy for Infant Protection.International journal of molecular sciences · 2026Review
- Structural Advances in Respiratory Syncytial Virus: Implications for Vaccine and Antiviral Development.Microorganisms · 2026Review
- Article
- Insights Into monoclonal antibodies and vaccines targeting respiratory viruses.Frontiers in pediatrics · 2026Review
- Evaluation of a strain Long human respiratory syncytial virus withFrontiers in immunology · 2026Article
- Rational design 2.0: transitioning from static structural biology to computational prioritization and iterative vaccine optimization for RSV.Frontiers in immunology · 2026Review
- Advances and prospects of respiratory mucosal vaccines: mechanisms, technologies, and clinical applications.NPJ vaccines · 2025Review
- Serum immunoglobulin A as a biomarker for respiratory syncytial virus infection in children aged <2 years.ERJ open research · 2025Article
- Challenges and Limitations of Current RSV Prevention Strategies in Infants and Young Children: A Narrative Review.Vaccines · 2025Review
- Vaccine Development for Human Pneumoviruses.Vaccines · 2025Review
- Article
Corrections and comments
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Authors and funding
6 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundRespiratory syncytial virus (RSV) is the leading global cause of severe pediatric acute respiratory tract illness, and a vaccine is needed. RSV/ΔNS2/Δ1313/I1314L contains 2 attenuating elements: (1) deletion of the interferon antagonist NS2 gene and (2) deletion of codon 1313 of the RSV polymerase gene and the stabilizing missense mutation I1314L. This live vaccine candidate was temperature-sensitive, genetically stable, replication restricted, and immunogenic in nonhuman primates.
methodsA single intranasal dose of RSV/ΔNS2/Δ1313/I1314L was evaluated in a double-blind, placebo-controlled trial (vaccine-placebo ratio, 2:1) at 106 plaque-forming units (PFU) in 15 RSV-seropositive children and at 105 and 106 PFU in 21 and 30 RSV-seronegative children, respectively.
resultsIn RSV-seronegative children, the 105 PFU dose was overattenuated, but the 106 PFU dose was well tolerated, infectious (RSV/ΔNS2/Δ1313/I1314L replication detected in 90% of vaccinees), and immunogenic (geometric mean serum RSV plaque-reduction neutralizing antibody titer, 1:64). After the RSV season, 9 of 20 vaccinees had increases in the RSV titer that were significantly greater than those in 8 of 10 placebo recipients (1:955 vs 1:69, respectively), indicating that the vaccine primed for anamnestic responses after natural RSV exposure.
conclusionRational design yielded a genetically stable candidate RSV vaccine that is attenuated yet immunogenic in RSV-seronegative children, warranting further evaluation. CLINICAL TRIALS REGISTRATION: NCT01893554.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.