A controlled clinical trial comparing the safety and immunogenicity of a new adjuvanted hepatitis B vaccine with a standard hepatitis B vaccine

Dupont, Juan; Altclas, Javier; Lepetic, Alejandro; Lombardo, Mónica E.; Vázquez, Vicente; Salgueira, Claudia; Seigelchifer, Mauricio; Arndtz, Nathaly; Antunez, Ernesto; Eschen, Kenneth Von; Janowicz, Zbigniew A.

doi:10.1016/j.vaccine.2006.06.053

Cited by 59 publications

(31 citation statements)

References 18 publications

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“…In contrast, an adjuvant effect of TLR activation has been demonstrated in an H. influenzae type B vaccine conjugated with a meningococcal protein (201), consistent with the activation of TLR2 by Neisseria outer membrane proteins (8,234,262). Furthermore, two hepatitis B virus vaccines using TLR4 agonists as adjuvants have been approved (79). One concern is whether a TLR4 agonist may mimic the effects of LPS and induce endotoxic shock (177).…”

Section: Therapeutic Implicationsmentioning

confidence: 96%

Pathogen Recognition and Inflammatory Signaling in Innate Immune Defenses

2009

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SUMMARY The innate immune system constitutes the first line of defense against invading microbial pathogens and relies on a large family of pattern recognition receptors (PRRs), which detect distinct evolutionarily conserved structures on pathogens, termed pathogen-associated molecular patterns (PAMPs). Among the PRRs, the Toll-like receptors have been studied most extensively. Upon PAMP engagement, PRRs trigger intracellular signaling cascades ultimately culminating in the expression of a variety of proinflammatory molecules, which together orchestrate the early host response to infection, and also is a prerequisite for the subsequent activation and shaping of adaptive immunity. In order to avoid immunopathology, this system is tightly regulated by a number of endogenous molecules that limit the magnitude and duration of the inflammatory response. Moreover, pathogenic microbes have developed sophisticated molecular strategies to subvert host defenses by interfering with molecules involved in inflammatory signaling. This review presents current knowledge on pathogen recognition through different families of PRRs and the increasingly complex signaling pathways responsible for activation of an inflammatory and antimicrobial response. Moreover, medical implications are discussed, including the role of PRRs in primary immunodeficiencies and in the pathogenesis of infectious and autoimmune diseases, as well as the possibilities for translation into clinical and therapeutic applications.

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Section: Therapeutic Implicationsmentioning

confidence: 96%

Pathogen Recognition and Inflammatory Signaling in Innate Immune Defenses

2009

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“…Anti-HBV titers were significantly higher at all time points for the Supervax® group. Based on these findings and an acceptable safety profile, the RC-529 conjugated HBV vaccine was approved for use in Argentina [117] .…”

Section: Tlr4mentioning

confidence: 99%

TLR-based immune adjuvants

Steinhagen

Kinjo

Bode

et al. 2011

Vaccine

423

372

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“…RC529 is a member of the aminoalkylglucosamine phosphate family, and possesses a monoglucosamine backbone with 3 fatty acyl side chains. RC529-SE had not been previously administered to humans, although a Hepatitis B vaccine containing RC529 (not formulated as an emulsion) is approved for use in humans in Argentina [25, 26]. Recombinant GM-CSF (Leukine) was obtained from Amgen (Thousand Oaks, CA).…”

Section: Methodsmentioning

confidence: 99%

Safety and immunogenicity of a CTL multiepitope peptide vaccine for HIV with or without GM-CSF in a phase I trial

Spearman¹,

Kalams²,

Elizaga³

et al. 2009

Vaccine

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There is an urgent need for a vaccine capable of preventing HIV infection or the development of HIV-related disease. A number of approaches designed to stimulate HIV-specific CD8+ cytotoxic T cell responses together with helper responses are presently under evaluation. In this phase 1, multicenter, placebo-controlled trial, we tested the ability of a novel multi-epitope peptide vaccine to elicit HIV-specific immunity. To enhance the immunogenicity of the peptide vaccine, half of the vaccine recipients received recombinant GM-CSF protein as a co-adjuvant. The vaccine was safe; tolerability was moderate, with a number of adverse events related to local injection site reactogenicity. Anti-GM-CSF antibody responses developed in the majority of GM-CSF recipients but were not associated with adverse hematologic events. The vaccine was only minimally immunogenic. Six of 80 volunteers who received vaccine developed HIV-specific responses as measured by interferongamma ELISPOT assay, and measurable responses were transient. This study failed to demonstrate that GM-CSF can substantially improve the overall weak immunogenicity of a multiepitope peptidebased HIV vaccine.

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A controlled clinical trial comparing the safety and immunogenicity of a new adjuvanted hepatitis B vaccine with a standard hepatitis B vaccine

Cited by 59 publications

References 18 publications

Pathogen Recognition and Inflammatory Signaling in Innate Immune Defenses

Pathogen Recognition and Inflammatory Signaling in Innate Immune Defenses

TLR-based immune adjuvants

Safety and immunogenicity of a CTL multiepitope peptide vaccine for HIV with or without GM-CSF in a phase I trial

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