Delving into the Latest Updates on VAC-18193 with Synapse

Overview

Basic Info

Drug Type

Recombinant vector vaccine, Prophylactic vaccine

Synonyms

Ad26.RSV.preF/RSV preF Protein(Janssen Vaccines & Prevention)

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication-

Inactive Indication

Influenza, HumanLower Respiratory Tract InfectionsRespiratory Syncytial Virus Infections+ [1]

Originator Organization

Janssen Vaccines & Prevention BV

Active Organization-

Inactive Organization

Janssen Vaccines & Prevention BV

Johnson & Johnson (China) Investment Ltd.

IDT Biologika GmbH

+ [3]

License Organization-

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

Regulation-

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The purpose of the study is to evaluate safety and immunogenicity of various respiratory syncytial virus (RSV) pre-Fusion (preF)-based vaccine components followed by expanded safety evaluation and durability/revaccination evaluation of the selected RSV preF-based vaccine formulation in participants aged greater than or equal to (>=) 60 years in stable health.

Start Date13 Apr 2022

Sponsor / Collaborator

Janssen Vaccines & Prevention BV

100 Clinical Results associated with VAC-18193

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100 Translational Medicine associated with VAC-18193

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100 Patents (Medical) associated with VAC-18193

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21

Literatures (Medical) associated with VAC-18193

31 Dec 2024·Human Vaccines & Immunotherapeutics

Immunogenicity and safety of Ad26.RSV.preF/RSV preF protein vaccine at predicted intermediate- and end-of-shelf-life as an evaluation of potency throughout shelf life

Article

Author: van Montfort, Bart ; Bastian, Arangassery Rosemary ; Ligtenberg, Nynke ; Comeaux, Christy ; Hu, Weihong ; van Heesbeen, Roy ; Callendret, Benoît ; Hosman, Tessa ; Heijnen, Esther

This study assessed three Ad26.RSV.preF/RSV preF protein combinations, combining different Ad26.RSV.preF doses and naturally aged preF protein, representing the expected critical vaccine quality attributes close to release, around intermediate shelf-life (ISL) and near-presumed end-of-shelf-life (EoSL), as a way to evaluate the vaccine immunogenicity and safety throughout its shelf-life. A single dose of Ad26.RSV.preF/RSV preF protein vaccine was administered to adults 60-75 years of age. Solicited adverse events (AEs), unsolicited AEs, and serious AEs (SAEs) were assessed for 7-day, 28-day, and 6-month periods after vaccination, respectively. RSV preF-binding antibody concentrations and RSV neutralizing titers were measured 14 days post-vaccination as primary and secondary endpoints, respectively; binding antibodies were also measured 6 months post-vaccination. The RSV preF-binding antibody responses induced by Ad26.RSV.preF/RSV preF protein vaccine lots representing the critical quality attributes around ISL and near presumed EoSL were noninferior to the responses induced by the vaccine lot representing the critical quality attributes near release. The RSV preF-binding and RSV neutralizing antibody levels measured 14 days post-vaccination were similar across the 3 groups. RSV preF-binding antibody concentrations were also similar 6 months post-vaccination. Solicited AEs were mostly mild to moderate in intensity, and a decreased reactogenicity was observed from the Release group to the ISL and EoSL group. None of the reported SAEs were considered related to study vaccination. The study provided evidence of sustained immunogenicity and safety over the intended shelf-life of the Ad26.RSV.pref/RSV preF protein vaccine. The three vaccine lots had acceptable safety profiles.

31 Dec 2024·Human Vaccines & Immunotherapeutics

Immunogenicity, safety and reactogenicity of Ad26.RSV.preF/RSV preF protein vaccine in adults aged 60 to 75 years: A comparison of phase 2b and phase 3 clinical trial material

Article

Author: Ligtenberg, Nynke ; Heijnen, Esther ; Jastorff, Archana ; Klyashtornyy, Vladislav ; Callendret, Benoît ; Bastian, Arangassery Rosemary

The Ad26.RSV.preF/RSV preF protein vaccine has previously demonstrated efficacyin protecting older adults against respiratory syncytial virus (RSV)-related lower respiratory tract disease in a phase 2b study. This study compared the immunogenicity of vaccine clinical trial material (CTM) representative of phase 2b clinical studies with CTM used in phase 3 clinical studies. A total of 248 adults aged 60-75 years, randomized in a 1:1 ratio, received one dose of either phase 3 CTM or phase 2b CTM. Solicited adverse events (AEs), unsolicited AEs, and serious AEs (SAEs) were assessed for 7-d, 28-d, and 6-month periods post-vaccination, respectively. RSV preF-ELISA antibody titers and RSV neutralizing titers were measured before and 14 d after vaccination. The phase 3 CTM-induced preF-ELISA response at Day 15, in terms of geometric mean titer, was shown to be non-inferior to that induced by phase 2b CTM. The RSV neutralizing antibody titers were also similar in the two groups at Day 15. The safety profile in terms of solicited AEs, unsolicited AEs, or SAEs was in general similar between the phase 3 CTM and phase 2b CTM groups, and solicited AEs were mostly mild to moderate in intensity. No related SAEs were reported, and no safety concerns were identified.

01 Dec 2024·Vaccine

Immunogenicity and safety of different dose levels of Ad26.RSV.preF/RSV preF protein vaccine in adults aged 60 years and older: A randomized, double-blind, placebo-controlled, phase 2a study

Article

Author: Comeaux, Christy A ; Heijnen, Esther ; Bastian, Arangassery Rosemary ; Comeaux, Christy A. ; van Heesbeen, Roy ; Omoruyi, Edmund ; Rosen, Jeffrey ; Callendret, Benoit

BACKGROUNDRespiratory syncytial virus (RSV) can cause severe illness in older adults. A combination vaccine containing Ad26.RSV.preF and purified recombinant RSV preF protein has previously demonstrated efficacy and tolerability in older adults. We report results of a dose-ranging study to determine immunogenicity and safety of different doses of the Ad26.RSV.preF component in the combined Ad26.RSV.preF/RSV preF protein vaccine to support Ad26.RSV.preF drug product release and stability specifications.METHODSIn this randomized, double-blind, placebo-controlled, phase 2a study, adults aged ≥60 years in good or stable health were randomly assigned within 1 of 3 cohorts to receive either placebo or Ad26.RSV.preF/RSV preF protein, composed of different doses of Ad26.RSV.preF with a fixed dose of RSV preF protein (150 μg). Ad26.RSV.preF doses in Cohort 1 (4 dose-down groups) ranged from 3.7 × 10⁹ to 1.0 × 10¹¹ viral particles (vp). Doses in Cohorts 2 and 3 (2 dose-up groups, each) ranged from 1.0 to 1.6 × 10¹¹ vp. Primary endpoints were immunogenicity (RSV preF protein antibody titers) for Cohort 1 and safety (solicited local and systemic adverse events [AEs] and unsolicited AEs) for Cohorts 2 and 3. Immunogenicity analyses (RSV preF protein antibody titers, RSV A2 neutralizing antibodies, and RSV-F-specific interferon-γ enzyme-linked immunosorbent spot) were performed on the day of vaccination and 14 days, 3 months, and 6 months postvaccination. Safety was monitored from vaccination until study end.RESULTSOverall, 454 participants were enrolled and received 1 dose of study vaccine or placebo (Cohort 1, n = 226; Cohort 2, n = 124; Cohort 3, n = 104). No substantial differences in measured immune responses were observed between lower or higher Ad26.RSV.preF doses compared with Ad26.RSV.preF 1.0 × 10¹¹ vp across all postvaccination time points. All Ad26.RSV.preF doses between 3.7 × 10⁹ vp and 1.6 × 10¹¹ vp were well tolerated, with no safety issues identified.CONCLUSIONSResults of this dose-ranging study may be used to inform the refinement of Ad26.RSV.preF drug product release and stability specifications.CLINICAL TRIAL REGISTRATIONClinicalTrials.gov Identifier: NCT04453202.

100 Deals associated with VAC-18193

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Lower Respiratory Tract Infections	Phase 3	Finland	Janssen Vaccines & Prevention BV	21 Jul 2021
Lower Respiratory Tract Infections	Phase 3	Poland	Janssen Vaccines & Prevention BV	21 Jul 2021
Lower Respiratory Tract Infections	Phase 3	Australia	Janssen Vaccines & Prevention BV	21 Jul 2021
Lower Respiratory Tract Infections	Phase 3	New Zealand	Janssen Vaccines & Prevention BV	21 Jul 2021
Lower Respiratory Tract Infections	Phase 3	China	Janssen Vaccines & Prevention BV	21 Jul 2021
Lower Respiratory Tract Infections	Phase 3	South Africa	Janssen Vaccines & Prevention BV	21 Jul 2021
Lower Respiratory Tract Infections	Phase 3	United States	Janssen Vaccines & Prevention BV	21 Jul 2021
Lower Respiratory Tract Infections	Phase 3	Brazil	Janssen Vaccines & Prevention BV	21 Jul 2021
Lower Respiratory Tract Infections	Phase 3	United Kingdom	Janssen Vaccines & Prevention BV	21 Jul 2021
Lower Respiratory Tract Infections	Phase 3	Estonia	Janssen Vaccines & Prevention BV	21 Jul 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04908683 (EVERGREEN, CTgov)	Phase 3	Lower Respiratory Tract Infections \| Respiratory Syncytial Virus Infections	25,236	Placebo	uuqyomlwho(ojzfjpjjfq) = jzhnftvyui eecvebcpdq (lxkozxlxgm, tdnxeftuji - dfknsvsuwz) View more	-	08 Feb 2024
NCT05070546 (CTgov)	Phase 3	Respiratory Syncytial Virus Infections	1,124	RSV preF+Ad26.RSV.preF (Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein)	fvcbudycjr(rsqmbncwvo) = qlnypmaolt xtxrofsuzf (oihatnpgtz, xacpnkdtna - atgqelwbqq) View more	-	04 Oct 2023
				placebo (Group 2 (Cohort 1): Placebo)	fvcbudycjr(rsqmbncwvo) = yzettfecdf xtxrofsuzf (oihatnpgtz, rbhwzbwifc - lsdodwouqt) View more
NCT05083585 (CTgov)	Phase 3	Respiratory Syncytial Virus Infections	250	RSV preF Protein+Ad26.RSV.preF (Group 1 (Phase 3 CTM): Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg)	vbofvczvqv(vchfwntkbh) = ijrwwojfub coznjmfqdz (teedrzuoea, fegyhlvcdj - vquhfpydih) View more	-	11 Sep 2023
				RSV preF Protein+Ad26.RSV.preF (Group 2 (Phase 2b CTM): Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg)	vbofvczvqv(vchfwntkbh) = fxzpkounmg coznjmfqdz (teedrzuoea, npzuejogjk - sipbfwujih) View more
NCT05101486 (CTgov)	Phase 3	Respiratory Syncytial Virus Infections	755	RSV preF Protein+Ad26.RSV.preF (Group 1: Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg)	gxgwmoncne(fqqhlhucxo) = xuxyhcswub mlpjgmfihs (wafixewkxd, srhvnbhnzg - mrgpbivihg) View more	-	06 Sep 2023
				RSV preF Protein+Ad26.RSV.preF (Group 2: Ad26.RSV.preF 2.5*10^10 vp + RSV preF Protein 150 mcg)	gxgwmoncne(fqqhlhucxo) = gmdvfpnsxd mlpjgmfihs (wafixewkxd, wxgdphncsu - jnsrkbzuyk) View more
NCT03303625 (CTgov)	Phase 1/2	Respiratory Syncytial Virus Infections \| Respiratory Tract Infections	48	adenovirus serotype 26 respiratory syncytial virus e pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) (Cohort 0 (Adults): Ad26.RSV.preF)	tievhmedlb(dfqtngrvgf) = vbimdfdsph xnsotrcget (kabmhuqnav, qsemrpgokn - bgymyflufm) View more	-	23 Jun 2023
				placebo+Ad26.RSV.preF (Cohort 0 (Adults): Placebo)	tievhmedlb(dfqtngrvgf) = oshepcjqww xnsotrcget (kabmhuqnav, juymthuaii - cellliojww) View more
NCT03606512 (CTgov)	Phase 1/2	Respiratory Syncytial Virus Infections	38	Nimenrix (Placebo/Nimenrix)	cvghkcyaqx(afvoronqxj) = znaxbktyvj fnqaaactof (jtyiwiuttz, bvkxnusvar - qgyauehiba) View more	-	30 Nov 2022
				Ad26.RSV.preF (Ad26.RSV.preF)	cvghkcyaqx(afvoronqxj) = ujiglolkes fnqaaactof (jtyiwiuttz, cvibzowyof - ivcheuxwlp) View more
NCT03339713 (CTgov)	Phase 2	Influenza, Human	180	Fluarix+Placebo+Ad26.RSV.preF (Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo)	ijftoooytz(jrwcgknscm) = itytmirebl krgmefhjfz (oeyfadohny, cjlysapqtx - sivddivwgv) View more	-	18 Aug 2021
				Fluarix+Placebo+Ad26.RSV.preF (Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp))	ijftoooytz(jrwcgknscm) = vhbfvrdgey krgmefhjfz (oeyfadohny, wbptrvuojs - mexryeechb) View more
NCT03334695 (CTgov)	Phase 2	Respiratory Syncytial Virus Infections	64	Ad26.RSV.preF (Ad26.RSV.preF (1*10^11 vp))	qwyjgfmknm(qdscwkvpxb) = jzlgzruzbc akptylqrhi (ecutjnjdau, whegyggtkf - tyfcfdundb) View more	-	23 Jul 2021
				placebo (Placebo)	qwyjgfmknm(qdscwkvpxb) = diinbfxrvi akptylqrhi (ecutjnjdau, tlkhcqzusb - rmzxukilpi) View more
NCT03339713 (Pubmed \| Am J Trop Med Hyg \| J Infect Dis) Manual	Phase 2	Influenza, Human	180	Fluarix+Placebo+Ad26.RSV.preF (control)	(vbkrdbltxn) = uicwznzrif qzcvpocjhk (rplipzowwy )	Positive	24 Feb 2021
				Fluarix+Placebo+Ad26.RSV.preF (coadministration)	(vbkrdbltxn) = hfkpngyixc qzcvpocjhk (rplipzowwy )
NCT02926430 (Pubmed) Manual	Phase 1	Respiratory Syncytial Virus Infections	72	Ad26.RSV.preF (LD)	(usqdcnjsio) = No serious adverse events were related to vaccination. qsdfjoiejj (stppcxcqim )	Positive	17 Aug 2020
				Ad26.RSV.preF (HD)