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 was 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 Date20 Jun 2019

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

NCT03227029

/ CompletedPhase 1IIT

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 6 to 24 Months of Age

The purpose of this study was to evaluate the infectivity, safety, and immunogenicity of the recombinant live-attenuated respiratory syncytial virus (RSV) vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 when delivered as nose drops to RSV-seronegative infants 6 to 24 months of age.
This study was a companion study to Center for Immunization Research (CIR) 321.

Start Date22 Sep 2017

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

100 Clinical Results associated with RSV-276

100 Translational Medicine associated with RSV-276

100 Patents (Medical) associated with RSV-276

Literatures (Medical) associated with RSV-276

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 ; Karron, Ruth A ; Schappell, Elizabeth ; Perlowski, Charlotte ; Cunningham, Coleen K ; Cielo, Mikhaela ; Deville, Jaime G ; Jean-Philippe, Patrick ; Luongo, Cindy ; Yang, Lijuan ; Kelly, Matthew S ; Muresan, Petronella ; McFarland, Elizabeth J ; 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.

100 Deals associated with RSV-276

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Respiratory Syncytial Virus Infections	Phase 2	United States	National Institute of Allergy & Infectious Diseases	20 Jun 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03916185 (CTgov)	Phase 1/2	Respiratory Syncytial Virus Infections	67	RSV ΔNS2/Δ1313/I1314L Vaccine (RSV ΔNS2/Δ1313/I1314L Vaccine)	ozbsnuaetc(iypyftnkcn) = yjkqipiwib cjsciubfkw (ywsfvsmccu, xxyqiwjinr - xvssyrkofl) View more	-	21 Feb 2025
				RSV 6120/ΔNS2/1030s Vaccine (RSV 6120/ΔNS2/1030s Vaccine)	ozbsnuaetc(iypyftnkcn) = ebhnlisiee cjsciubfkw (ywsfvsmccu, mgloltvfse - zewyzpujvy) View more
NCT03227029 (CTgov)	Phase 1	Respiratory Syncytial Virus Infections	65	RSV ΔNS2/Δ1313/I1314L (RSV ΔNS2/Δ1313/I1314L Vaccine)	nvbvhgvukg(agybiwfrma) = wwtoyejvzw cwpsimaoez (kcijayglss, pwjfnyedrv - vaxgyfhnzb) View more	-	08 Jan 2021
				RSV 276 (RSV 276 Vaccine)	nvbvhgvukg(agybiwfrma) = tbfmclrtmc cwpsimaoez (kcijayglss, xnzrkbmvqy - tnoxixdbzp) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

RSV-276

Overview

Basic Info

Structure/Sequence

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation