Delving into the Latest Updates on Influenza virus vaccine liposomal (Crucell) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine, Liposomal Drug

Synonyms

InfectoVac Flu, Inflexal V, Invivac

+ [1]

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication-

Inactive Indication

Influenza, Human

Originator Organization

Crucell NV

Active Organization-

Inactive Organization

Crucell Holland B.V.

Crucell NV

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

Regulation-

Login to view timeline

BACKGROUNDInfluenza remains a significant problem in elderly despite widespread vaccination coverage. This randomized, phase-I study in elderly compared different strategies of improving vaccine immunogenicity.METHODSA total of 370 healthy participants (⩾65years) were randomized equally 1:1:1:1:1:1 to six influenza vaccine treatments (approximately 60-63 participants per treatment arm) at day 1 that consisted of three investigational virosomal vaccine formulations at doses of 7.5, 15, and 45μg HA antigen/strain administered intradermally (ID) by MicronJet600™ microneedle device (NanoPass Technologies) or intramuscularly (IM), and three comparator registered seasonal vaccines; Inflexal V™ (Janssen) and MF59 adjuvanted Fluad™ (Novartis) administered IM and Intanza™ (Sanofi Pasteur) administered ID via Soluvia™ prefilled microinjection system (BD). Serological evaluations were performed at days 22 and 90 and safety followed-up for 6months.RESULTSIntradermal delivery of virosomal vaccine using MicronJet600™ resulted in significantly higher immunogenicity than the equivalent dose of virosomal Inflexal V™ administered intramuscularly across most of the parameters and strains, as well as in some of the readouts and strains as compared with the 45μg dose of virosomal vaccine formulation. Of 370 participants, 300 (81.1%) reported ⩾1 adverse event (AE); more participants reported solicited local AEs (72.2%) than solicited systemic AEs (12.2%).CONCLUSIONSIntradermal delivery significantly improved influenza vaccine immunogenicity compared with intramuscular delivery. Triple dose (45μg) virosomal vaccine did not demonstrate any benefit on vaccine's immunogenicity over 15μg commercial presentation. All treatments were generally safe and well-tolerated.

18 Mar 2013·Human Vaccines & ImmunotherapeuticsQ3 · MEDICINE

Head-to-head comparison of an intradermal and a virosome influenza vaccine in patients over the age of 60

Q3 · MEDICINE

Article

Author: Filippo Ansaldi ; Andrea Orsi ; Emanuela Rappazzo ; Daniela de Florentiis ; Giancarlo Icardi ; Valentina Parodi ; Martina Coppelli ; Paolo Durando

In the present study we first compare immunogenicity against vaccine and heterologous circulating A(H1N1)pdm09 strains, tolerability and safety of intradermal Intanza 15 μg and of virosomal adjuvanted, intramuscularly delivered influenza vaccine, Inflexal V, in healthy elderly volunteers. Five-hundred participants were enrolled in the study and randomly assigned to the two vaccine groups to receive either one dose of Intanza 15 μg or Inflexal V vaccine. All subjects reported solicited local and systemic reactions occurred within 7 d after vaccination and unsolicited adverse events up to 21 d post-immunization and any serious adverse event appeared during the study. A subset of 55 participants was randomly selected for immunogenicity and cross-protection evaluations. Serum samples were collected before and 1 and 3 mo after immunization. Antibody responses were measured using hemagglutination inhibition (HI) against all viruses used in the study and neutralization (NT) assays against A(H1N1)pdm09 strains. At least one of the CHMP criteria for influenza vaccine approval in the elderly was met by virosomal vaccine against all the tested viruses; intradermal vaccine met all criteria against all strains. Several parameters of immune response against strains with a different antigenic pattern from that of vaccine A/California/04/09(H1N1)pdm09 were significantly higher in the intradermal vaccine group compared with the virosomal group. Safety and systemic tolerability of both vaccines were excellent, but injection site reactions occurred significantly more frequently in the intradermal vaccination group. Immunogenicity of Intanza 15 μg intradermal vaccine tended to be higher than that of Inflexal V against heterologous strains in healthy elderly.

01 Jan 2013·Human Vaccines & ImmunotherapeuticsQ3 · MEDICINE

A matched case-control study

Q3 · MEDICINE

Article

Author: Donatella Panatto ; Stefania Rossi ; Daniela Amicizia ; Roberto Gasparini ; Piero Luigi Lai

Annual vaccination is the main mean of preventing influenza in the elderly. In order to evaluate the effectiveness of the adjuvanted seasonal influenza vaccines available in Italy in preventing hospitalization for influenza and pneumonia, a matched case-control study was performed in elderly subjects during the 2010-2011 season in Genoa (Italy). Cases and controls were matched in a 1:1 ratio according to gender, age, socio-economic status and type of influenza vaccine. Vaccine effectiveness was calculated as IVE = [(1-OR)x100] and crude odds ratios were estimated through conditional logistic regression models. Adjusted odds ratios were estimated through multivariable logistic models. In the study area, influenza activity was moderate in the 2010-2011 season, with optimal matching between circulating viruses and vaccine strains. We recruited 187 case-control pairs; 46.5% of cases and 79.1% of controls had been vaccinated. The adjuvanted influenza vaccines (Fluad (®) considered together with Inflexal V (®) ) were associated with a significant reduction in the risk of hospitalization, their effectiveness being 94.8% (CI 77.1-98.8). Adjusted vaccine effectiveness was 95.2% (CI 62.8-99.4) and 87.8 (CI 0.0-98.9) for Inflexal V (®) and Fluad (®) , respectively. Both adjuvanted vaccines proved effective, although the results displayed statistical significance only for Inflexal V (®) (p = 0.004), while for Fluad (®) statistical significance was not reached (p = 0.09). Our study is the first to provide information on the effectiveness of Inflexal V (®) in terms of reducing hospitalizations for influenza or pneumonia in the elderly, and demonstrates that this vaccine yields a high degree of protection and that its use would generate considerable saving for the National Health Service.

100 Deals associated with Influenza virus vaccine liposomal (Crucell)

Login to view more data

R&D Status

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Influenza, Human	Phase 3	China	Crucell Holland B.V.	01 Oct 2009
Influenza, Human	Phase 3	China	Crucell Holland B.V.	01 Oct 2009

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01631110 (CTgov)	Phase 3	Influenza, Human	110	Inflexal V (Elderly Subjects Aged Over 60 Years)	zyxlbsfhmo(hemisygvkx) = mkqomxaxdc plyzkopsec (cqeukbrsop, bywmugmifp - pdbcdiqfyw) View more	-	20 Dec 2013
				Inflexal V (Adults From 18 to 60 Years Old Inclusive)	zyxlbsfhmo(hemisygvkx) = lvxwgthnds plyzkopsec (cqeukbrsop, jbmdfscali - leyefaonbo) View more
NCT01306305 (CTgov)	Phase 4	Influenza, Human	110	Inflexal V (Adults)	fygboswkxs(lberceuzkh) = zpvybrosyw azoxmuaors (swxkwxtdhe, reoqrhgsmc - osqwazqufv) View more	-	29 Mar 2012
				Inflexal V (Elderly)	fygboswkxs(lberceuzkh) = hdmrotxyiq azoxmuaors (swxkwxtdhe, saykaofpqr - dbsorwzqay) View more
NCT01306253 (CTgov)	Phase 4	Influenza, Human	114	Inflexal V (Adults)	zwehowukmu(nxxmflkyzv) = vkotytwtel zzykgyuzxx (lmikgldrmc, ggyutgvvsp - mwjadlkrjl) View more	-	20 Jan 2012
				Inflexal V (Elderly)	zwehowukmu(nxxmflkyzv) = uwhbsgixtd zzykgyuzxx (lmikgldrmc, cqcamxkwhf - bnyommpqfa) View more
NCT01303510 (CTgov)	Phase 4	Influenza, Human	111	Inflexal V (Group A)	kppzavzioc(zbcjfsollt) = vnvgxxrjkt zpafbhptxp (phvyfifgiv, ztigrugexo - nbrqtgtrdq) View more	-	19 Dec 2011
				Inflexal V (Group B)	kppzavzioc(zbcjfsollt) = hmvfbutmao zpafbhptxp (phvyfifgiv, czzrlnwmcw - bxvjyuuara) View more