Immunogenicity of an investigational hepatitis B vaccine (hepatitis B surface antigen co-administered with an immunostimulatory phosphorothioate oligodeoxyribonucleotide) in nonresponders to licensed hepatitis B vaccine

Halperin, Scott A.; Ward, Brian J.; Dionne, Marc; Langley, Joanne M.; McNeil, Shelly; Smith, Bruce R.; MacKinnon‐Cameron, Donna; Heyward, William L.; Martin, Jacob T.

doi:10.4161/hv.24256

Cited by 21 publications

(39 citation statements)

References 36 publications

(46 reference statements)

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“…T erefore, it is paradoxical that today, when we judiciously add very well characterized adjuvants to wellcharacterized vaccines, people and regulatory agencies are very conservative in reviewing and adopting them and view adjuvants as "new technology. " Because adjuvants already are and will be even more in the future an essential part of future vaccines, especially in the aging population with a declining immune system, here we will review the state of the art of adjuvant development and the potential of the f eld in the future (Table 1) (9)(10)(11)(12)(13)(14).…”

Section: Introductionmentioning

confidence: 99%

Developing vaccines for an aging population

2015

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The demographics of the world's population are changing, with many adults now surviving into their 80s. With this change comes the need to protect the aging and other underserved populations not only against infectious diseases but also against cancer and other chronic conditions. New technologies derived from recent advances in the fields of immunology, structural biology, synthetic biology, and genomics have brought a revolution in the vaccine field. Among them, vaccine adjuvants have the potential to harness the immune system to provide protection against new types of diseases, improve protection in young children, and expand this protection to adults and the elderly. However, in order to do so we need also to overcome the nontechnical challenges that could limit the implementation of innovative vaccines, including controversies regarding the safety of adjuvants, increasing regulatory complexity, the inadequate methods used to assess the value of novel vaccines, and the resulting industry alienation from future investment. This Perspective summarizes the outcome of a recent multidisciplinary symposium entitled "Enhancing Vaccine Immunity and Value," held in Siena, Italy, in July 2014, that addressed two related questions: how to improve vaccine efficacy by using breakthrough technologies and how to capture the full potential of novel vaccines.

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Section: Introductionmentioning

confidence: 99%

Developing vaccines for an aging population

2015

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“…A substudy examining the anti-HBs responses to additional doses of investigational vaccine or comparator, in non-responders to four to six Engerix-B vaccines, suggested that HEPLISAV-B™ may have improved immunogenicity in non-responders. Larger studies are required to consolidate this finding [53]. HEPLISAV-B™ is a promising new hepatitis B vaccine that shows increased immunogenicity in the different populations studied.…”

Section: Immunostimulatory Dna Sequencesmentioning

confidence: 96%

“…Older age and obesity are known to be associated with suboptimal response to HBsAg vaccines (Table 1), and two doses of HEPLISAV-B™ appear to induce anti-HBs titres faster, higher and more frequently seroprotective in older and more obese people than three doses of Engerix-B. A study was also conducted in known non-responders to three doses of Engerix-B to investigate whether the administration of an additional dose of HEPLISAV-B™ was superior to Engerix-B for inducing seroprotective anti-HBs concentrations [53]. No statistically significant differences in seroprotection rates or geometric mean antibody concentrations were found in the primary study.…”

Section: Immunostimulatory Dna Sequencesmentioning

confidence: 98%

Old and new adjuvants for hepatitis B vaccines

Leroux‐Roels

2014

Med Microbiol Immunol

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The safety and immunogenicity profiles of currently available recombinant hepatitis B vaccines are excellent. However, it remains a real challenge to induce protective immunity in the target groups that respond poorly or not at all to conventional vaccines. Ideally, a hepatitis B vaccine can be developed that conveys lifelong protection against infection rapidly after the injection of a single dose. Although this goal is far from being reached, important improvements have been made. Novel vaccine adjuvants have been developed that enhance the immunogenicity of recombinant hepatitis B vaccines while maintaining a good safety profile. The different adjuvants and adjuvant systems that are discussed herein have all been thoroughly evaluated in clinical trials and some have reached or are close to reach the market.

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“…The remaining 19 articles were evaluated through full-text review. After reviewing full text, 13 publication were excluded, among which nine articles did not contain an adequate methodology description in randomisation and blind methods, one article was without HBsAg-Eng as a control group [15], one article had an obscure vaccination schedule and difficulty in extracting relevant data [16], and two articles had data that could not be obtained from figures or tables [17,18]. For using raw data from same the RCTs, two articles were excluded [19,20].…”

Section: Study Screeningmentioning

confidence: 99%

Comparative analysis of the safety and efficacy of HBsAg-1018 versus HBsAg-Eng: a meta-analysis

Zhang¹,

Guo²,

Duan³

2019

cejoi

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Introduction: In addition to alum adjuvant, a wide diversity of adjuvants have been developed to enhance immune response of hepatitis B virus (HBV) vaccine in varying subjects, either in healthy vaccinators or subjects with hypo-immunity. In this context, a novel HBV vaccine HBsAg-1018, formulated with a toll-like receptor 9 agonist, was developed, and is currently in the phase of clinical trials. So, the first meta-analysis was performed to examine the safety and immune response of HBsAg-1018 among varying subjects. Material and methods: On the basis of inclusion criterion, eligible studies that reported safety and immunogenicity induced by HBsAg-1018 vaccination in randomised, controlled trials (RCTs) were involved from three databases: PubMed, EMBASE, and the Cochrane Library, and further confirmed by two reviewers. Meta-analysis was conducted using RevMan 5.3. The pooled relative risk (RR) for safety and immunogenicity was calculated using random-effects or fixed-effects models according to the heterogeneity of included studies. The methodology quality of eligible studies was assessed using the Cochrane Handbook for Systematic Reviews of Interventions version 5.1.0. Results: In total 5073 subjects administrated with HBV vaccine from four eligible publications were included in this meta-analysis. The data related to immunogenicity and safety post vaccination were pooled for meta-analysis. For safety, the combined RRs for adverse reactions were 0.98

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Immunogenicity of an investigational hepatitis B vaccine (hepatitis B surface antigen co-administered with an immunostimulatory phosphorothioate oligodeoxyribonucleotide) in nonresponders to licensed hepatitis B vaccine

Cited by 21 publications

References 36 publications

Developing vaccines for an aging population

Developing vaccines for an aging population

Old and new adjuvants for hepatitis B vaccines

Comparative analysis of the safety and efficacy of HBsAg-1018 versus HBsAg-Eng: a meta-analysis

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