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Biologicals. 2013 Nov;41(6):458-68. doi: 10.1016/j.biologicals.2013.08.006. Epub 2013 Sep 23.

Predictive markers of safety and immunogenicity of adjuvanted vaccines.

Author information

1
WHO Center for Vaccinology and Neonatal Immunology, University of Geneva, CMU, 1 rue Michel-Servet, 1211 Geneva 4, Switzerland. Electronic address: beatris.mastelic@unige.ch.

Abstract

Vaccination represents one of the greatest public health triumphs; in part due to the effect of adjuvants that have been included in vaccine preparations to boost the immune responses through different mechanisms. Although a variety of novel adjuvants have been under development, only a limited number have been approved by regulatory authorities for human vaccines. This report reflects the conclusions of a group of scientists from academia, regulatory agencies and industry who attended a conference on the current state of the art in the adjuvant field. Held at the U.S. Pharmacopeial Convention (USP) in Rockville, Maryland, USA, from 18 to 19 April 2013 and organized by the International Association for Biologicals (IABS), the conference focused particularly on the future development of effective adjuvants and adjuvanted vaccines and on overcoming major hurdles, such as safety and immunogenicity assessment, as well as regulatory scrutiny. More information on the conference output can be found on the IABS website, http://www.iabs.org/.

KEYWORDS:

3-O-desacyl-4′-monophosphoryl lipid A; AEs; APCs; AS; Adjuvant; BM; BNP; BVD; C-reactive protein; CRP; DDCs; Env; FDA; Food and Drug Administration; GFPDL; HA; HAI; HBV; HBsAg; HIV-1; Hepatitis B surface antigen; Hepatitis B virus; ID; IFN; IM; ISCOM; LAIV; LC; LPS; Langerhans cells; Live Attenuated Influenza Vaccine; MIV; MM6; MPL; MVA; Mo; MoA; Mono Mac 6; NA; NHP; PBMC; PGE2; PLA; SC; SPADE; SPR; T follicular helper cells; T(FH); TC; TIV; TLR; Vaccine; Vaccine safety; WHO; World Health Organization; adjuvant systems; adverse events; antigen presenting cells; bone marrow; bovine virus diarrhea; dermal dendritic cells; envelope glycoprotein; genome-fragment phage display libraries; hemagglutination-inhibition; hemagglutinin; human immunodeficiency virus type 1; human primary monocytes; immune stimulating complexes; induced bovine neonatal pancytopenia; interferon; intradermal; intramuscular; lipopolysaccharide; mPGES1; microsomal PGE synthase-1; mode of action; modified vaccinia ankara; monovalent inactivated vaccine; nAbs; neuraminidase; neutralizing antibody; non-human primates; peripheral blood mononuclear cells; poly-lactic; prostaglandin E2; rAd5; replication-defective adenovirus 5; spanning-tree progression analysis of density normalized events; subcutaneous; surface plasmon resonance; toll-like receptors; transcutaneous; trivalent inactivated vaccine

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