Delving into the Latest Updates on RSVdeltaNS2/delta1313/I1314L with Synapse

Overview

Basic Info

Drug Type

Live attenuated vaccine, Prophylactic vaccine

Synonyms-

Target-

Mechanism-

Therapeutic Areas

Infectious Diseases

Active Indication

Respiratory Syncytial Virus Infections

Inactive Indication-

Originator Organization

National Institute of Allergy & Infectious Diseases

Active Organization

National Institute of Allergy & Infectious Diseases

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Randomized Phase I Study of the Infectivity, Safety, and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Infants and Children 6 to 24 Months of Age

The purpose of this study is to evaluate the infectivity, safety, and immunogenicity of the recombinant live-attenuated respiratory syncytial virus (RSV) vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 or placebo when delivered as nose drops to RSV-seronegative infants and children 6 to 24 months of age.
This study is a companion study to IMPAACT 2018.

Start Date-

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

NCT03916185 / CompletedPhase 1/2IIT

Randomized Phase I/II Study of the Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Children 6 to 24 Months of Age

The purpose of this study is to evaluate the safety and immunogenicity of a single dose of the recombinant live-attenuated respiratory syncytial virus (RSV) vaccines, RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, and RSV 276, in RSV-seronegative children 6 to 24 months of age.

Start Date16 May 2019

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

NCT01893554 / Active, not recruitingPhase 1IIT

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

Human respiratory syncytial virus (RSV) is a common cause of respiratory illness in infants and children around the world. This study will evaluate the safety and immune response to a RSV vaccine in three groups of participants: healthy children who have already had an RSV infection (RSV seropositive), healthy infants and children who have not already had an RSV infection (RSV seronegative), and healthy younger infants who have not been screened for prior RSV infection.

Start Date01 Jun 2013

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

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100 Clinical Results associated with RSVdeltaNS2/delta1313/I1314L

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100 Translational Medicine associated with RSVdeltaNS2/delta1313/I1314L

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100 Patents (Medical) associated with RSVdeltaNS2/delta1313/I1314L

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2

Literatures (Medical) associated with RSVdeltaNS2/delta1313/I1314L

13 Dec 2022·The Journal of Infectious Diseases

Evaluation of Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV/ΔNS2/Δ1313/I1314L and RSV/276 in RSV-Seronegative Children

Article

Author: Chadwick, Ellen G ; Aziz, Mariam ; Paul, Mary ; Moye, Jack ; Libous, Jennifer ; Oliva, Jennifer ; Barr, Emily ; Rexroad, Vivian ; Collins, Peter L ; Johnston, Benjamin ; Perlowski, Charlotte ; Cunningham, Coleen K ; Schappell, Elizabeth ; Karron, Ruth A ; Cielo, Mikhaela ; Deville, Jaime G ; Jean-Philippe, Patrick ; Luongo, Cindy ; Yang, Lijuan ; Kelly, Matthew S ; McFarland, Elizabeth J ; Muresan, Petronella ; Buchholz, Ursula J

AbstractBackgroundThis United States-based study compared 2 candidate vaccines: RSV/ΔNS2/Δ1313/I1314L, attenuated by NS2 gene-deletion and temperature-sensitivity mutation in the polymerase gene; and RSV/276, attenuated by M2-2 deletion.MethodsRSV-seronegative children aged 6–24 months received RSV/ΔNS2/Δ1313/I1314L (106 plaque-forming units [PFU]), RSV/276 (105 PFU), or placebo intranasally. Participants were monitored for vaccine shedding, reactogenicity, and RSV serum antibodies, and followed over the subsequent RSV season.ResultsEnrollment occurred September 2017 to October 2019. During 28 days postinoculation, upper respiratory illness and/or fever occurred in 64% of RSV/ΔNS2/Δ1313/I1314L, 84% of RSV/276, and 58% of placebo recipients. Symptoms were generally mild. Cough was more common in RSV/276 recipients than RSV/ΔNS2/Δ1313/I1314L (48% vs 12%; P = .012) or placebo recipients (17%; P = .084). There were no lower respiratory illness or serious adverse events. Eighty-eight and 96% of RSV/ΔNS2/Δ1313/I1314L and RSV/276 recipients were infected with vaccine (shed vaccine and/or had ≥4-fold rises in RSV antibodies). Serum RSV-neutralizing titers and anti-RSV F IgG titers increased ≥4-fold in 60% and 92% of RSV/ΔNS2/Δ1313/I1314L and RSV/276 vaccinees, respectively. Exposure to community RSV during the subsequent winter was associated with strong anamnestic RSV-antibody responses.ConclusionsBoth vaccines had excellent infectivity and were well tolerated. RSV/276 induced an excess of mild cough. Both vaccines were immunogenic and primed for strong anamnestic responses.Clinical Trials RegistrationNCT03227029 and NCT03422237.

16 Jun 2020·The Journal of Infectious Diseases

Safety and Immunogenicity of the Respiratory Syncytial Virus Vaccine RSV/ΔNS2/Δ1313/I1314L in RSV-Seronegative Children

Article

Author: Buchholz, Ursula J ; Karron, Ruth A ; Mateo, Jocelyn San ; Collins, Peter L ; Wanionek, Kimberli ; Luongo, Cindy

AbstractBackgroundRespiratory 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 RegistrationNCT01893554.

100 Deals associated with RSVdeltaNS2/delta1313/I1314L

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Respiratory Syncytial Virus Infections	Phase 2	-	National Institute of Allergy & Infectious Diseases	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Pubmed	Not Applicable	-	-	RSV/ΔNS2/Δ1313/I1314L	ihsjfjrspr(dqxhuibyxu) = RSV/276 induced an excess of mild cough oayiartvie (bpreipctsc )	-	23 Jun 2022
				RSV/ΔNS2/Δ1313/I1314L (RSV/276)
NCT03227029 (CTgov)	Phase 1	Respiratory Syncytial Virus Infections	65	RSV ΔNS2/Δ1313/I1314L (RSV ΔNS2/Δ1313/I1314L Vaccine)	ybtnhizcwn(gvcvmissjw) = drtyvyxbna pldvchvlap (lymwvejwkr, jyyidulmgd - sexzakiyec) View more	-	08 Jan 2021
				RSV 276 (RSV 276 Vaccine)	ybtnhizcwn(gvcvmissjw) = jfzkcwslnp pldvchvlap (lymwvejwkr, vivaxmbvdn - ekkowdpcah) View more