A Multi-Center, Phase IV, Randomized, Controlled, Observer Blind Study to Evaluate the Immunogenicity, Safety, and Tolerability of a Trivalent Subunit Inactivated Influenza Vaccine in Healthy Subjects Aged 50 Years and Above

Start Date10 Sep 2013

Sponsor / Collaborator

Novartis Vaccines & Diagnostics Srl

EUCTR2012-000657-30-ES / Not yet recruitingPhase 3

A Phase IIIB, Open Label, Multi-Center Extension Study of V72_28 to assess antibody persistence, and the safety and tolerability of a booster dose after the completion of the vaccination course in study V72_28. - Not available

Start Date31 May 2013

Sponsor / Collaborator

Novartis Vaccines & Diagnostics Srl

EUCTR2011-003694-29-IT / Not yet recruitingNot Applicable

A Phase 3b, Multi-Center, Open-label Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2-Month Schedule in Healthy at-risk Adults

Start Date26 Mar 2013

Sponsor / Collaborator

Novartis Vaccines & Diagnostics Srl

100 Clinical Results associated with Novartis Vaccines & Diagnostics Srl

0 Patents (Medical) associated with Novartis Vaccines & Diagnostics Srl

Literatures (Medical) associated with Novartis Vaccines & Diagnostics Srl

01 Apr 2020·VaccineQ3 · MEDICINE

Adsorption onto aluminum hydroxide adjuvant protects antigens from degradation

Q3 · MEDICINE

Article

Author: Ferlicca, Francesca ; Senesi, Silvia ; Pallaoro, Michele ; O'Hagan, Derek T ; Colaprico, Annalisa ; Ugozzoli, Mildred ; Brunelli, Brunella

Aluminum based adjuvants are widely used in commercial vaccines, since they are known to be safe and effective with a variety of antigens. The effect of antigen adsorption onto Aluminum Hydroxide is a complex area, since several mechanisms are involved simultaneously, whose impact is both antigen and formulation conditions dependent. Moreover, the mode of action of Aluminum Hydroxide is itself complex, with many mechanisms operating simultaneously. Within the literature there are contrasting theories regarding the effect of adsorption on antigen integrity and stability, with reports of antigen being stabilized by adsorption onto Aluminum Hydroxide, but also with contrary reports of antigen being destabilized. With the aim to understand the impact of adsorption on three recombinant proteins which, following in vivo immunization, are able to induce functional bactericidal antibodies against Neisseria meningitidis type B, we used a range of physico-chemical tools, such as DSC and UPLC, along with in vitro binding of antibodies that recognize structural elements of the proteins, and supported the in vitro data with in vivo evaluation in mice studies. We showed that, following exposure to accelerated degradation conditions involving heat, the recombinant proteins, although robust, were stabilized by adsorption onto Aluminum Hydroxide and retain their structural integrity unlike the not adsorbed proteins. The measure of the Melting Temperature was a useful tool to compare the behavior of proteins adsorbed and not adsorbed on Aluminum Hydroxide and to predict protein stability.

01 Jul 2016·VaccineQ3 · MEDICINE

Anticipating policy considerations for a future HIV vaccine: a preliminary study

Q3 · MEDICINE

Article

Author: Bertholet, Sylvie ; Zazzi, Maurizio ; Lewis, David J M ; Williams, Emmanuel Ato

BACKGROUNDNew human immunodeficiency virus (HIV) infections continue to occur worldwide. Despite previous failures, there is renewed optimism about developing an efficacious HIV prophylactic vaccine following the 31.2% vaccine efficacy (modified intention to treat analysis) achieved in the RV-144 trial. Intense efforts at characterising the immune responses in the trial participants who appeared to gain some protection from the candidate vaccine are ongoing to delineate correlates of protection. However, the characteristics of a vaccine suitable for programmatic introduction in high prevalence areas remain undefined.AIMSWe set out to ascertain the vaccination policies and strategies that policy makers involved in vaccine introductions would advise were a candidate HIV vaccine to become available.METHODSStructured questionnaires in both English and French were self-administered to consenting policy makers such as members of National Immunisation Technical Advisory Groups. Members from three out of the six WHO regional groups were purposively reached for their responses.RESULTSThirty-seven key opinion leaders were approached through self-administered questionnaires delivered by e-mail or in person. Nine responses were received, representing a 24.3% response rate. The responses received were from three [Africa (6), Americas (1) and Europe (2)] out of the six WHO regions. All respondents would prioritise the vaccination of commercial sex workers over other risk groups if there was an efficacious HIV vaccine. Vaccine efficacy was considered to be the most important factor, ahead of vaccine safety and cost, in determining the acceptability of a new prophylactic HIV vaccine.CONCLUSIONSIt is expected that the first generation HIV vaccines may be modestly efficacious. However, even a modestly efficacious vaccine might curtail the spread of HIV if universal or near-universal coverage is achieved. It is important to anticipate policy discussions which would influence how rapidly an HIV vaccine would be rolled-out programmatically to achieve maximum impact.

01 Feb 2016·VaccineQ3 · MEDICINE

Multiplex immunoassay for in vitro characterization of acellular pertussis antigens in combination vaccines

Q3 · MEDICINE

Article

Author: O'Hagan, Derek T ; Ugozzoli, Mildred ; Mori, Elena ; Galletti, Bruno ; Pergola, Carlo ; Agnolon, Valentina ; Baudner, Barbara C ; Bruno, Cristina

Vaccines characterization is required to ensure physical, chemical, and biological integrity of antigens and adjuvants. Current analytical methods mostly require complete antigen desorption from aluminum-based adjuvants and are not always suitable to distinguish individual antigens in multivalent formulations. Here, Luminex technology is proposed to improve the analytics of vaccine characterization. As proof of concept, TdaP (tetanus, diphtheria and acellular pertussis) combination, adjuvanted with aluminum hydroxide, was chosen as model formulation to quantify and determine the level of adsorption of acellular pertussis (aP) antigens onto adjuvant surface at the same time. The assay used specific antibodies bound to magnetic microspheres presenting unique digital signatures for each pertussis antigen, allowing the simultaneous recognition of respective antigens in the whole vaccine, avoiding laborious procedures for adjuvant separation. Accurate and reproducible quantification of aP antigens in TdaP vaccine has been achieved in the range 0.78-50 ng/mL, providing simultaneously information on antigen identity, quantity, and degree of adsorption to aluminum hydroxide. The current study could further be considered as a model to set up in vitro potency assays thus supporting the replacement of animal tests accordingly to the 3Rs concept.

100 Deals associated with Novartis Vaccines & Diagnostics Srl

100 Translational Medicine associated with Novartis Vaccines & Diagnostics Srl

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