New insights in mucosal vaccine development

Pavot, Vincent; Rochereau, Nicolas; Genin, Christian; Verrier, Bernard; Paul, Stéphane

doi:10.1016/j.vaccine.2011.11.003

Cited by 175 publications

(143 citation statements)

References 118 publications

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“…Although the antibody response did not appear to affect efficacy or safety, it is likely that various mucosal surfaces differ in their innate ability to mount immune responses to foreign antigens. (18) For example, oral vaccines may require strong adjuvants to mount an effective immune response. As such, it is plausible that GI mucosa is less efficient than the nasopharyngeal mucosa at mounting an immune response to this potential antigen.…”

Section: Discussionmentioning

confidence: 99%

A phase 3 trial of the efficacy and safety of oral recombinant calcitonin: The oral calcitonin in postmenopausal osteoporosis (ORACAL) trial

Binkley

Bolognese²,

Sidorowicz-Bialynicka³

et al. 2012

Journal of Bone and Mineral Research

131

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The Oral Calcitonin in Postmenopausal Osteoporosis (ORACAL) study was a randomized, double-blind, double-dummy, active-and placebo-controlled, multiple-dose, phase 3 study to assess the efficacy and safety of oral recombinant calcitonin for treatment of postmenopausal osteoporosis. A total of 565 women age 46 to 86 (mean 66.5) years were randomized (4:3:2) to receive oral recombinant salmon calcitonin (rsCT) tablets (0.2 mg/d) plus placebo nasal spray, synthetic salmon calcitonin (ssCT) nasal spray (200 IU/d) plus placebo tablets, or placebo (placebo tablets plus placebo nasal spray), respectively for 48 weeks. All women received calcium (!1000 mg/d) and vitamin D (800 IU/d). Women randomized to oral rsCT had a mean AE SD percent increase from baseline in lumbar spine bone mineral density (BMD) (1.5% AE 3.2%) that was greater than those randomized to ssCT nasal spray (0.78% AE 2.9%) or placebo (0.5% AE 3.2%). Lumbar spine BMD change in those receiving nasal calcitonin did not differ from placebo. Oral rsCT treatment also resulted in greater improvements in trochanteric and total proximal femur BMD than ssCT nasal spray. Reductions in bone resorption markers with oral rsCT were greater than those observed in ssCT nasal spray or placebo recipients. Approximately 80% of subjects in each treatment group experienced an adverse event, the majority of which were mild or moderate in intensity. Gastrointestinal system adverse events were reported by nearly one-half of women in all treatment groups and were the principal reason for premature withdrawals. Less than 10% of women experienced a serious adverse event and no deaths occurred. Overall, oral rsCT was superior to nasal ssCT and placebo for increasing BMD and reducing bone turnover. Oral rsCT was safe and as well tolerated as ssCT nasal spray or placebo. Oral calcitonin may provide an additional treatment alternative for women with postmenopausal osteoporosis. ß

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Section: Discussionmentioning

confidence: 99%

A phase 3 trial of the efficacy and safety of oral recombinant calcitonin: The oral calcitonin in postmenopausal osteoporosis (ORACAL) trial

Binkley

Bolognese²,

Sidorowicz-Bialynicka³

et al. 2012

Journal of Bone and Mineral Research

131

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“…Subunit-based approaches involve covalent and noncovalent O-polysaccharide-protein conjugates targeting S. flexneri, S. sonnei, and S. dysenteriae, LPS-Ipa-protein complexes protecting against S. flexneri 2a and S. sonnei, and S. flexneri 2a-directed outer membrane vesicles. These candidates, together with major efforts to increase the immunogenicity of mucosal vaccines as well as the selection and design of potent adjuvants and antigen carriers, promise fast progress toward a long-awaited safe and powerful vaccine against Shigella (571,573). Unfortunately, various factors have hindered a rapid solution thus far (454).…”

Section: Clinical Considerationsmentioning

confidence: 99%

Recent Advances in Understanding Enteric Pathogenic Escherichia coli

et al. 2013

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SUMMARY Although Escherichia coli can be an innocuous resident of the gastrointestinal tract, it also has the pathogenic capacity to cause significant diarrheal and extraintestinal diseases. Pathogenic variants of E. coli (pathovars or pathotypes) cause much morbidity and mortality worldwide. Consequently, pathogenic E. coli is widely studied in humans, animals, food, and the environment. While there are many common features that these pathotypes employ to colonize the intestinal mucosa and cause disease, the course, onset, and complications vary significantly. Outbreaks are common in developed and developing countries, and they sometimes have fatal consequences. Many of these pathotypes are a major public health concern as they have low infectious doses and are transmitted through ubiquitous mediums, including food and water. The seriousness of pathogenic E. coli is exemplified by dedicated national and international surveillance programs that monitor and track outbreaks; unfortunately, this surveillance is often lacking in developing countries. While not all pathotypes carry the same public health profile, they all carry an enormous potential to cause disease and continue to present challenges to human health. This comprehensive review highlights recent advances in our understanding of the intestinal pathotypes of E. coli .

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“…13 The epithelial cells lining the mucous membranes express pattern recognition receptors and antimicrobial effector molecules, which enables them to respond to microorganisms. These mucosal epithelial cells initiate the first steps in the host-pathogen interaction and largely influence the type of immune response elicited by the host.…”

Section: Antigen Sampling and Presentation At Mucosal Surfacesmentioning

confidence: 99%

“…PLA (poly(lactic acid) or PLGA (poly(lactic-co-glycolic acid) nanoparticles are interesting protein carriers that offer antigen protection, increased penetration across mucosal surfaces and controlled release of encapsulated antigen. 13,146 In humans, the oral delivery of PLG-encapsulated CS6 antigen from E. coli induced mucosal IgA responses, but complementary studies are required to assess its potency compared with free. 147 In preclinical models, other modified lipidbased delivery systems such as liposomes, ISCOMS, virosomes, proteosomes have shown encouraging results in mucosal vaccination settings.…”

Section: Particulate Delivery Systemsmentioning

confidence: 99%

“…147 In preclinical models, other modified lipidbased delivery systems such as liposomes, ISCOMS, virosomes, proteosomes have shown encouraging results in mucosal vaccination settings. 13,148 In healthy volunteers, the intranasal administration of a proteosome-based influenza vaccine seemed to be efficacious and well tolerated. 149 Lastly, β-glucans composed of carbohydrate polymers found in the cell walls of fungi, yeast, plants, and bacteria, which bind to dectin-1 and CR2, have demonstrated intrinsic adjuvant activity for the enhancement of humoral and cellular.…”

Section: Particulate Delivery Systemsmentioning

confidence: 99%

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