adjuvant CpG 1018 / Dynavax 
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  • ||||||||||  adjuvant CpG 1018 / Dynavax
    Preclinical, Journal:  Preclinical evaluation of a universal inactivated influenza B vaccine based on the mosaic hemagglutinin-approach. (Pubmed Central) -  Nov 18, 2024   
    The mHA vaccines with or without adjuvant were subsequently evaluated in mice that were previously immunized to closely mimic human pre-existing immunity to influenza B viruses and the contribution of innate and cellular immunity was evaluated in this model. We believe these preclinical studies using the mHA strategy represent a major step toward the evaluation of a universal influenza B virus vaccine in clinical trials.
  • ||||||||||  adjuvant CpG 1018 / Dynavax, Heplisav-B (hepatitis B vaccine (recombinant), adjuvanted) / Dynavax, Engerix-B (hepatitis B vaccine recombinant) / GSK
    FACTORS ASSOCIATED WITH HIGH TITER RESPONSE TO HBV VACCINE IN PRIOR VACCINE NON-RESPONDERS WITH HIV: THE BEEHIVE TRIAL () -  Oct 15, 2024 - Abstract #AASLD2024AASLD_1083;    
    Prior data suggest that a CpG 1018 adjuvanted vaccine may improve response and achieve higher antibody titers which have historically been associated with greater vaccine durability... ACTG A5379 BEeHIVe (B-Enhancement of HBV Vaccination in PWH) trial included a 3-arm, open-label, 1:1:1 randomization comparing recombinant HepB-CpG (HEPLISAV-B
  • ||||||||||  Varivax (varicella virus vaccine live) / Merck (MSD), adjuvant CpG 1018 / Dynavax
    Functional efficacy of nanoparticle conjugated P. vivax circumsporozoite protein subdomain vaccine (Convention Center - Hall I-1 (1st Floor); In-Person-Only) -  Oct 11, 2024 - Abstract #ASTMH2024ASTMH_2168;    
    NP conjugated rCSP subunit formulations induced high titer antibodies to the respective rCSP antigens that could recognize the native antigen on the sporozoite. Preliminary studies revealed that the antibodies produced by NP conjugated rPvCSP sub-domains showed inhibition of transgenic P. berghei sporozoites expressing PvCSP liver stage development in vitro .
  • ||||||||||  adjuvant CpG 1018 / Dynavax
    Cancelled: Preventing Disease Progression in an Ovarian Cancer Mouse Model () -  Oct 8, 2024 - Abstract #AABB2024AABB_300;    
    Furthermore, there was no statistically significant difference in mean BLI values between the combination of Riboflavin and UV inactivated cells with adjuvant based on the number of inactivated cells in the formulation. Survival was assessed for all groups against the Placebo control group (group 1).
  • ||||||||||  adjuvant CpG 1018 / Dynavax
    Preclinical, Journal:  A recombinant N2 neuraminidase-based CpG 1018 (Pubmed Central) -  Sep 14, 2024   
    The combination of CpG 1018 adjuvant and alum induced a balanced and robust humoral and T-cellular immune response against the NA, which provided protection and reduced morbidity against homologous and heterologous viral challenges in mouse and hamster models. This study supports Syrian hamsters as a useful complementary animal model to mice for pre-clinical evaluation of influenza virus vaccines.
  • ||||||||||  adjuvant CpG 1018 / Dynavax, BG505 SOSIP 664 gp140 adjuvanted vaccine / GSK, IAVI
    BG505 SOSIP.664 adjuvanted with 3M-052 tunes IgG Fc glycosylation towards a more functional state (Poster Exhibition) -  Sep 10, 2024 - Abstract #HIVR4P2024HIVR4P_957;    
    Antibodies generated post-vaccination two lacking effector functions suggests qualitative tuning of the response. Our data suggest increased Fc galactosylation and fucosylation and decreased sialylation could contribute to increased phagocytic function and can be tuned by adjuvant selection.
  • ||||||||||  adjuvant CpG 1018 / Dynavax, BG505 SOSIP 664 gp140 adjuvanted vaccine / GSK, IAVI
    HIV BG505 SOSIP.664 trimer with 3M-052-AF/alum induces broad and potent ADCC-mediating antibodies (Limatambo 5/Channel 3) -  Sep 10, 2024 - Abstract #HIVR4P2024HIVR4P_942;    
    HVTN 137-Part B is a phase 1 clinical trial to evaluate the immunogenicity of the HIV-1 subtype A stabilized trimer, BG505 SOSIP.664 gp140, in combination with different adjuvants: the TLR9 agonist CpG 1018, the TLR7/8 agonist 3M-052-AF, both given with Alum, the TLR4 agonist GLA-LSQ, or Alum alone. 3M-052-AF+Alum represents a potent adjuvant that can elicit broad ADCC responses in addition to neutralizing responses and represents a strong candidate for use in future HIV vaccine trials.
  • ||||||||||  adjuvant CpG 1018 / Dynavax
    Enrollment change, Trial completion date, Trial primary completion date:  Innate Immunity Stimulation Via TLR9 in Early AD (clinicaltrials.gov) -  Mar 12, 2024   
    P1,  N=15, Recruiting, 
    Participants were randomized 1:1:1 to: 2 doses of HepB-CpG intramuscularly (IM) (20 mcg recombinant HBsAg, 3000 mcg CpG 1018 N=39 --> 15 | Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2024 --> Nov 2025
  • ||||||||||  IndoVac (SARS-CoV-2 protein subunit recombinant vaccine) / Bio Farma Indonesia
    Trial completion:  Immuno-bridging Study of COVID-19 Protein Subunit Recombinant Vaccine (clinicaltrials.gov) -  Nov 29, 2023   
    P3,  N=4050, Completed, 
    This raises concerns about the effectiveness of ACVs booster vaccinations against Omicron. Active, not recruiting --> Completed
  • ||||||||||  rF1V vaccine with CpG 1018 / Dynavax, US Department of Defense, adjuvant CpG 1018 / Dynavax
    Enrollment closed, Trial completion date, Trial primary completion date:  Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine With CpG 1018 (clinicaltrials.gov) -  Oct 3, 2023   
    P2,  N=200, Active, not recruiting, 
    In addition, in the pre- and post-exposure challenge assays, LNP Recruiting --> Active, not recruiting | Trial completion date: Jan 2024 --> Apr 2024 | Trial primary completion date: Feb 2023 --> Nov 2023
  • ||||||||||  BG505 SOSIP 664 gp140 adjuvanted vaccine / GSK, IAVI
    Trial completion date, Trial primary completion date:  Evaluating the Safety and Immunogenicity of HIV-1 BG505 SOSIP.664 gp140 With TLR Agonist and/or Alum Adjuvants in Healthy, HIV-uninfected Adults (clinicaltrials.gov) -  Jun 12, 2023   
    P1,  N=127, Active, not recruiting, 
    Compared with the micron-sized AH + CpG formulation, the two stabilized nanoAH + CpG formulations of RBD-J demonstrated no enhancement in SARS-CoV-2 pseudovirus neutralizing titers in mice, but the PA-containing nanoAH + CpG formulation showed improved RBD-J storage stability trends (at 4, 25, and 37 Trial completion date: Jul 2023 --> Nov 2024 | Trial primary completion date: Jul 2023 --> Nov 2024
  • ||||||||||  adjuvant CpG 1018 / Dynavax
    Enrollment open:  Innate Immunity Stimulation Via TLR9 in Early AD (clinicaltrials.gov) -  Apr 11, 2023   
    P1,  N=39, Recruiting, 
    Active, not recruiting --> Completed Not yet recruiting --> Recruiting
  • ||||||||||  adjuvant CpG 1018 / Dynavax, MVC-COV1901 / National Institutes of Health, Medigen Biotech, Dynavax, Vaxzevria (ChAdOx1-S recombinant) / Oxford Biomedica, Emergent Biosolutions, Jenner Institute, Vaccitech, AstraZeneca, University of Oxford
    Journal, Benefit-risk assessment:  A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for the Medigen COVID-19 protein vaccine. (Pubmed Central) -  Apr 4, 2023   
    This article uses the BRAVATO template to review the features of the MVC-COV1901 vaccine, a recombinant protein subunit vaccine based on the stabilized pre-fusion SARS-CoV-2 spike protein S-2P, adjuvanted with CpG 1018 and aluminum hydroxide, manufactured by Medigen Vaccine Biologics Corporation in Taiwan...The main clinical trials include placebo-controlled phase 2 studies in healthy adults (CT-COV-21), adolescents (CT-COV-22), and elderly population (CT-COV-23) as well as 3 immunobridging phase 3 trials (CT-COV-31, CT-COV-32, and CT-COV-34) in which MVC-COV1901 was compared to AZD1222...Antigen-specific T-cell responses, particularly a Th1-biased immune response characterized by high levels of interferon gamma and IL-2 cytokines, have also been observed. Coupled with this, MVC-COV1901 has favorable thermostability and better safety profiles when compared to other authorized vaccines from different platforms, which make it potentially a good candidate for vaccine supply chains in global markets.
  • ||||||||||  MVC-COV1901 / National Institutes of Health, Medigen Biotech, Dynavax
    P2 data, Journal:  Safety and immunogenicity of SARS-CoV-2 vaccine MVC-COV1901 in Taiwanese adolescents: a randomized phase 2 trial. (Pubmed Central) -  Dec 18, 2022   
    P2
    MVC-COV1901 is a subunit SARS-CoV-2 vaccine based on stabilized spike protein adjuvanted with CpG 1018 and aluminum hydroxide that has received emergency use approval (EUA) for adults in Taiwan...All immunogenicity endpoints in the adolescent group were non-inferior to the endpoints seen in the young adult and placebo groups. The results here advocate the use of MVC-COV1901 in adolescents in the ongoing efforts to control the pandemic.ClinicalTrials.gov registration: NCT04951388.
  • ||||||||||  adjuvant CpG 1018 / Dynavax
    Journal:  Nanoparticle vaccines can be designed to induce pDC support of mDCs for increased antigen display. (Pubmed Central) -  Dec 9, 2022   
    We examined vaccines based on the E2 protein nanoparticle platform that delivered encapsulated TLR9 agonist bacterial-like DNA (CpG1826 or CpG1018) or TLR7 agonist viral ssRNA to determine their efficacy over free agonists in activating both mDCs and pDCs for antigen presentation...Only when treated with nanoparticle-conjugated vaccine could pDCs secrete factors to induce antigen display on naïve mDCs. These results reveal that pDCs can aid mDCs, highlighting the importance of activating both pDCs and mDCs in designing effective cancer vaccines, and demonstrate the advantage of using nanoparticle-based vaccine delivery.
  • ||||||||||  adjuvant CpG 1018 / Dynavax
    Journal:  Overcoming Aging-Associated Poor Influenza Vaccine Responses with CpG 1018 Adjuvant. (Pubmed Central) -  Nov 15, 2022   
    The pdm09 vaccine in the presence of CpG 1018 elicited significant protection against lethal viral challenges, while the pdm09 vaccine alone failed to confer significant protection in young adult or aged mice. Our study provided strong evidence to support the high effectiveness of the CpG 1018 adjuvant to boost influenza vaccination in aged mouse models.
  • ||||||||||  Trial completion, Trial completion date, Trial primary completion date:  Assess the Safety and Immunogenicity of NDV-HXP-S Vaccine in Thailand (clinicaltrials.gov) -  Nov 15, 2022   
    P1/2,  N=455, Completed, 
    Our study provided strong evidence to support the high effectiveness of the CpG 1018 adjuvant to boost influenza vaccination in aged mouse models. Recruiting --> Completed | Trial completion date: Dec 2023 --> Sep 2022 | Trial primary completion date: Dec 2023 --> Sep 2022
  • ||||||||||  Trial completion date, Trial primary completion date:  Assess the Safety and Immunogenicity of NDV-HXP-S Vaccine in Thailand (clinicaltrials.gov) -  Nov 14, 2022   
    P1/2,  N=460, Recruiting, 
    Recruiting --> Completed | Trial completion date: Dec 2023 --> Sep 2022 | Trial primary completion date: Dec 2023 --> Sep 2022 Trial completion date: May 2023 --> Dec 2023 | Trial primary completion date: May 2023 --> Dec 2023
  • ||||||||||  CoviVac / Chumakov Centre
    Trial completion, Trial completion date:  A Phase 1/2 Safety and Immunogenicity Trial of COVID-19 Vaccine COVIVAC (clinicaltrials.gov) -  Nov 14, 2022   
    P1/2,  N=420, Completed, 
    Trial completion date: May 2023 --> Dec 2023 | Trial primary completion date: May 2023 --> Dec 2023 Recruiting --> Completed | Trial completion date: Sep 2022 --> Mar 2022