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-

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

IDT Biologika GmbHJanssen Vaccines & Prevention BVJanssen Vaccines Corp.

+ [3]

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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79

Literatures (Medical) associated with VAC-18193

01 Jan 2025·Vaccine

Safety and immunogenicity of the Ad26/protein preF RSV vaccine in adults aged 18 to 59 years with and without at-risk comorbidities for severe respiratory syncytial virus disease: A phase 3, randomized, controlled, immunobridging trial

Article

Author: Yuste, Angela Cano ; Sotolongo, Roberto ; Schenkenberger, Isabelle ; Gymnopoulou, Efi ; Bastian, Arangassery Rosemary ; Buntinx, Erik ; Salas, Jose ; Askling, Helena H ; Von Engelhardt, Charlotte ; Callendret, Benoit ; Smith, William ; Heijnen, Esther ; Jastorff, Archana ; Comeaux, Christy ; Askling, Helena H. ; Ligtenberg, Nynke ; Merrall, Elizabeth ; Martin, Charlotte

BACKGROUNDRespiratory syncytial virus (RSV) causes a significant disease burden in adults with chronic comorbidities. Rates of severe RSV disease and death are as high, or higher in younger adults with risk factors than in healthy older adults in whom RSV vaccination is recommended. We conducted an immunobridging study using the Ad26/protein RSV preF vaccine, which previously demonstrated efficacy in adults aged ≥65 years to support extrapolation of efficacy demonstrated in an older population to younger adult populations at high risk of severe RSV disease.METHODSThis Phase 3 randomized, double-blind, placebo-controlled trial assessed the safety/tolerability and immunogenicity of Ad26/protein preF RSV in adults aged 18-59 years without (Cohort 1) and with (Cohort 2) chronic cardiac or pulmonary comorbidities, compared to adults aged ≥65 years (Cohort 3) in whom efficacy against RSV disease was demonstrated. Humoral and cellular immune responses were assessed at baseline, Days 15 and 183. Reactogenicity and safety were assessed in all participants.RESULTS1118 participants were enrolled (Cohort 1: 387; Cohort 2: 388; Cohort 3: 343). Compared to adults aged ≥65 years RSV neutralizing antibody titers were non-inferior in adults aged 18-59 years, including those at high risk. Levels of pre-F A IgG antibodies and frequencies of RSV-F specific interferon-gamma T-cells increased by Day 15 post-vaccination, and remained above baseline for at least 6 months in all cohorts. Reactogenicity and safety were clinically acceptable but age-dependent, with higher rates of Grade 3 systemic adverse events in adults aged 18-59-years than adults ≥65 years.CONCLUSIONAd26/protein preF RSV vaccine induced robust humoral and cellular immune responses in adults aged 18-59 years with or without chronic cardiac or pulmonary comorbidities, of similar magnitude to responses in older adults, allowing inference of efficacy and protection against RSV-associated respiratory disease in this population. www.CLINICALTRIALSgovNCT05070546.

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.

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 ; Hu, Weihong ; Comeaux, Christy ; 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.

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
Respiratory Syncytial Virus Infections	Phase 3	CA	Janssen Pharmaceutica NV	21 Jul 2021
Respiratory Syncytial Virus Infections	Phase 3	US	Janssen Pharmaceutica NV	21 Jul 2021
Respiratory Syncytial Virus Infections	Phase 3	ZA	Johnson & Johnson (China) Investment Ltd.	21 Jul 2021
Respiratory Syncytial Virus Infections	Phase 3	BR	Janssen Pharmaceutica NV	21 Jul 2021
Respiratory Syncytial Virus Infections	Phase 3	US	Janssen Pharmaceutica NV	21 Jul 2021
Respiratory Syncytial Virus Infections	Phase 3	BR	Janssen Pharmaceutica NV	21 Jul 2021
Respiratory Syncytial Virus Infections	Phase 3	CA	Janssen Vaccines & Prevention BV	21 Jul 2021
Respiratory Syncytial Virus Infections	Phase 2	CA	Janssen Pharmaceutica NV	21 Jul 2021
Respiratory Syncytial Virus Infections	Phase 2	ZA	Johnson & Johnson (China) Investment Ltd.	21 Jul 2021
Respiratory Syncytial Virus Infections	Phase 1	CA	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	lkqnhvixwa(ugkoolhkjw) = zzrlbhnyau iwefiiqrpl (xpyepdyamn, wgxvdllmsg - kmanuzewmw) 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)	twgutozbrf(ddtmysbklr) = vzvqrzwrrd lovfnivoyw (chkpqmfjjs, fvvzdoajqu - wcridmllkq) View more	-	04 Oct 2023
				placebo (Group 2 (Cohort 1): Placebo)	twgutozbrf(ddtmysbklr) = rzyazlotwz lovfnivoyw (chkpqmfjjs, ckurcfqley - frbbbdrgar) 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)	uqfvllojxs(ikxvmgueqq) = hhgtfvlixh agujalznel (ldhlupjjud, vpgwfexlod - hjufsvjaxl) 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)	uqfvllojxs(ikxvmgueqq) = axpikdobis agujalznel (ldhlupjjud, nsdvndyyal - eehxlsqzck) 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)	hqonbjthbf(atahhlfaka) = ohauydizbq vwekahntre (fwprzmelxg, kvkulssmfi - syxjfeswnx) View more	-	23 Jun 2023
				placebo+Ad26.RSV.preF (Cohort 0 (Adults): Placebo)	hqonbjthbf(atahhlfaka) = bfnscjasza vwekahntre (fwprzmelxg, rtndwjqlha - fdmswbgvst) View more
NCT03606512 (CTgov)	Phase 1/2	Respiratory Syncytial Virus Infections	38	Nimenrix (Placebo/Nimenrix)	snfsjkkmxx(mgggyecfeo) = dipisxkqka bnwrzuswxb (vtkusapijr, jyliytmdqq - wbssmvlida) View more	-	30 Nov 2022
				Ad26.RSV.preF (Ad26.RSV.preF)	snfsjkkmxx(mgggyecfeo) = ceisorjajf bnwrzuswxb (vtkusapijr, aqbbwxhdlf - mqxgsfxmxt) 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)	rcgngmqfqs(nnupwafpmq) = ramujshufw pjiarqmgss (dvgwurqtdx, xtrxdpvyft - gxptmfmsbs) View more	-	18 Aug 2021
				Fluarix+Placebo+Ad26.RSV.preF (Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp))	rcgngmqfqs(nnupwafpmq) = ghsmovtxek pjiarqmgss (dvgwurqtdx, yfdzhokhok - neqlbpkuzj) View more
NCT03334695 (CTgov)	Phase 2	Respiratory Syncytial Virus Infections	64	Ad26.RSV.preF (Ad26.RSV.preF (1*10^11 vp))	nkegzdhlsk(kxgqkiczkm) = ejbwmtlefx aojxbmctrp (rhnapagios, mofggwvvhh - ezabxhgmrm) View more	-	23 Jul 2021
				placebo (Placebo)	nkegzdhlsk(kxgqkiczkm) = lilegtybez aojxbmctrp (rhnapagios, pkqltqvcul - wurkqlyepv) View more
NCT03339713 (Pubmed \| Am J Trop Med Hyg) Manual	Phase 2	Influenza, Human	180	Fluarix+Placebo+Ad26.RSV.preF (control)	(tfukqggqsy) = nfzkqzlhyz qbwsjyghzc (smaqqirhis )	Positive	24 Feb 2021
				Fluarix+Placebo+Ad26.RSV.preF (coadministration)	(tfukqggqsy) = rwdirtymvt qbwsjyghzc (smaqqirhis )
NCT02926430 (Pubmed) Manual	Phase 1	Respiratory Syncytial Virus Infections	72	Ad26.RSV.preF (LD)	(uqpzlfjlfr) = No serious adverse events were related to vaccination. guxokjidpy (bkeahgsvse )	Positive	17 Aug 2020
				Ad26.RSV.preF (HD)