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An H5N1 clade 2.3.4.4b virus vaccine that elicits cross-protective antibodies against conserved domains of H5 and N1 glycoproteins.

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A human cytomegalovirus prefusion-like glycoprotein B subunit vaccine elicits humoral immunity similar to that of postfusion gB in mice.

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A recombinant N2 neuraminidase-based CpG 1018® adjuvanted vaccine provides protection against challenge with heterologous influenza viruses in mice and hamsters.

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Structure-based design of a soluble human cytomegalovirus glycoprotein B antigen stabilized in a prefusion-like conformation.

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Development of the CpG Adjuvant 1018: A Case Study.

John D Campbell1

  • 1Dynavax Technologies Corporation, 2929 Seventh Street, Suite 100, Berkeley, CA, 94710, USA. DCampbell@Dynavax.com.

Methods in Molecular Biology (Clifton, N.J.)
|October 9, 2016
PubMed
Summary
This summary is machine-generated.

CpG oligonucleotides like 1018 offer a potent alternative to alum adjuvants for vaccines. Clinical trials show CpG adjuvant 1018 rapidly induces protective antibodies against hepatitis B virus (HBV).

Keywords:
1018AdjuvantCpGHBsAgHEPLISAV-B™TLR-9Vaccine

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Area of Science:

  • Immunology
  • Vaccinology
  • Molecular Biology

Background:

  • Aluminum salts (alum) are traditional vaccine adjuvants with poorly understood mechanisms.
  • There is a need for alternative adjuvants, especially when alum is suboptimal.
  • CpG oligonucleotides stimulate the innate immune system via Toll-like receptor-9 activation.

Purpose of the Study:

  • To outline the preclinical and clinical development of a CpG oligonucleotide (1018) as a vaccine adjuvant.
  • To evaluate the efficacy and safety of 1018 as an adjuvant for hepatitis B virus (HBV) immunization.

Main Methods:

  • Development and testing of a 22-mer CpG oligonucleotide sequence (1018).
  • Preclinical studies comparing HBsAg + 1018 to HBsAg + alum in rodents and primates.
  • Clinical trials evaluating HBsAg + 1018 in various human populations.

Main Results:

  • Preclinical studies showed 1018 induced higher antibody titers and had a favorable safety profile compared to alum.
  • Clinical studies demonstrated more rapid induction of protective antibody titers with 1018 versus alum.
  • 1018 proved effective in diverse populations, including the elderly and immunocompromised.

Conclusions:

  • CpG-motif-containing oligonucleotide 1018 serves as an improved adjuvant for enhancing HBsAg immunogenicity.
  • 1018 demonstrates potential as a superior adjuvant for HBV vaccination.
  • HBsAg + 1018 (HEPLISAV-B™) is in late-stage clinical development for HBV prophylaxis.