adjuvant CpG 1018 / Dynavax - LARVOL DELTA

Compatibility and Stability of a Shigella Polysaccharide-Protein Conjugate Antigen Formulated with Aluminum Salt and CpG 1018® Adjuvants. (PubMed, Vaccines (Basel)) - "In contrast, the glycoconjugate antigen and CpG adjuvant were both bound to the AH adjuvant and stable at 2-8 °C, pH 7.0. This AH-CpG formulation of the O-PS-IpaB conjugate antigens was identified as a promising candidate for future animal immunogenicity testing."

Journal • Infectious Disease

CIP2023-001: Safety and Immunogenicity of Innocell Autologous Cellular Immunotherapy for Recurrent Epithelial Ovarian Cancer (clinicaltrials.gov) - P1 | N=8 | Recruiting | Sponsor: PhotonPharma, Inc. | Not yet recruiting ➔ Recruiting | Trial primary completion date: Jun 2026 ➔ Dec 2026

Enrollment open • Trial primary completion date • Epithelial Ovarian Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • BRCA • HRD

Innate Immunity Stimulation Via TLR9 in Early AD (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: NYU Langone Health | Trial primary completion date: Nov 2025 ➔ Nov 2026 | Trial completion date: Nov 2025 ➔ Nov 2026

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Effect of Different Adjuvants on the Immunogenicity of a Recombinant Herpes Zoster Vaccine in Mice, Rats and Non-Human Primates. (PubMed, Vaccines (Basel)) - "The selected gE/SWE/CpG1018 combined with the adjuvant vaccine combination could effectively stimulate the humoral and cellular immune responses in SD rats and rhesus monkeys. The gE/SWE/CpG1018 combined with adjuvant vaccine may be a low-cost and highly effective vaccine candidate for the prevention of varicella zoster."

Journal • Preclinical • Herpes Zoster • Neuralgia • Pain • Varicella Zoster

Reconstruction of the lymphatic system by transplantation of a centrifuge-based bioengineered lymphatic tissue. (PubMed, Nat Commun) - "Lymph node-like structures composed of transplant- and host-derived cells, including immune cells, generate immune responses to an immunostimulant CpG1018. Here we show CeLyTs composed of lymphatic endothelial cells and MSCs reconstruct a lymph node and may represent a promising therapy for secondary lymphedema."

Journal • Oncology • Transplantation

Seroprotection of Hepb-Alum vs Hepb-Cpg Vaccines in People With HIV: A Meta-Analysis and Systematic Review (ACG 2025) - "HepB-CpG, which incorporates a Toll-like receptor 9 agonist (CpG 1018) as an adjuvant, has shown superior immunogenicity in the general population and is now being explored in PWH... Our meta-analysis included 459 participants (224 HepB-alum; 235 HepB-CpG). The pooled odds of achieving seroprotection ( defined as HBsAb ≥10 IU/L) were significantly higher with HepB-CpG compared to HepB-alum (OR 5.34; 95% CI: 1.71–16.65; p=0.004), with moderate heterogeneity (I² = 66%). In subgroup analysis, absence of diabetes was associated with higher seroconversion (84.1%), while rates were comparable in participants with chronic kidney disease, prior use of steroids or biologics."

Retrospective data • Review • Chronic Kidney Disease • Diabetes • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Metabolic Disorders • Nephrology • Renal Disease

A CpG 1018S/QS-21-Adjuvanted HBsAg Therapeutic Vaccine as a Novel Strategy Against HBV. (PubMed, Vaccines (Basel)) - "These responses collectively contributed to the reversal of T cell exhaustion and breakdown of immune tolerance, facilitating sustained viral suppression. Our findings demonstrate that the CpG 1018S/QS-21-adjuvanted vaccine induces potent humoral and cellular immunity against chronic HBV infection and represents a promising candidate for clinical chronic HBV (CHB) treatment."

IO biomarker • Journal • Hepatitis B • Infectious Disease • Inflammation • CD4 • CD8 • HAVCR2 • IL21 • TIGIT • TNFA

CD4-DEPENDENT MECHANISMS DRIVE HEPLISAV-B MEDIATED HBSAG CLEARANCE AND ANTI-HBV IMMUNITY IN CHRONIC HBV CARRIER MICE (AASLD 2025) - "HEPLISAV-B, an FDA-approved HBV vaccine combining HBsAg with the TLR9 agonist CpG-1018, has demonstrated superior immunogenicity clinically. HEPLISAV-B effectively breaks immune tolerance in chronic HBV infection, leading to stable HBsAg clearance, suppressed viral production, and robust, durable anti-HBV humoral and cellular immunity. Our findings unequivocally demonstrate that CD4 T cells are critically essential for mediating these therapeutic effects. These results highlight HEPLISAV-B's strong potential as a promising therapeutic vaccine candidate for achieving functional cure in patients with chronic HBV infection."

IO biomarker • Preclinical • Hepatitis B • Hepatology • Infectious Disease • CD4 • CD8 • IFNG • PTPRC • TNFA

Innate and T-cellular immune responses to sequential vaccination with chimeric hemagglutinin split influenza virus vaccines in mice. (PubMed, Vaccine) - "Here we provide an in-depth characterization of the innate immune response and antigen-specific T-cellular immune response in mice after sequential immunization with the group 2 cH15/3HK14N2HK14 and cH4/3HK14N2HK14 virus vaccine candidates with or without CpG 1018 adjuvant and during a heterologous virus challenge...Passive transfer of T-cells from immunized to naïve mice did not reduce weight loss and viral replication but affected the innate immune cell population dynamics and cytokine response in mouse lungs after the challenge. The depletion of CD4+ T-cells did not affect viral replication in mouse lungs but influenced cytokine production and innate immune cell population dynamics."

Journal • Preclinical • Infectious Disease • Influenza • Oncology • Respiratory Diseases • CD4 • IFNG • IL10 • IL13 • IL2 • IL4 • IL5 • TNFA

Immune responses to a heterologous booster with mRNA based COVID-19 vaccine after priming with an inactivated Newcastle disease virus recombinant vaccine expressing the SARS-CoV-2 spike protein (NDV-HXP-S). (PubMed, Vaccine) - "The immune responses stimulated by the heterologous boost with bivalent mRNA vaccine in the NDV-HXP-S primed groups were high especially among the hybrid immune subgroup. Thai Clinical Trial Registry: WHO REGISTRY PLATFORM- TCTR20230809003."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG

Multivalent COBRA Hemagglutinin and Neuraminidase Influenza Vaccines Adjuvanted with TLR9 Agonist CpG 1018. (PubMed, Vaccines (Basel)) - "Overall, CpG 1018 adjuvanted COBRA HA/NA elicited enhanced protective antibodies compared to the unadjuvanted vaccine against several drifted H1N1 and H3N2 influenza viruses in pre-immune mice that were either intramuscularly or intranasally vaccinated with a balanced Th1/Th2 immune response."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Immunogenicity and cellular response of a herpes zoster virus gEgI fusion protein adjuvanted with CpG-emulsion in mice. (PubMed, J Nanobiotechnology) - "Furthermore, we introduced a composite adjuvant, an emulsion-type adjuvant combined with CpG1018 (XUA09C), which was shown to enhance both humoral and cellular immune responses beyond the capabilities of XUA09 with CpG alone. Single-cell RNA sequencing highlighted that gEgI/XUA09C more effectively promotes early immune activation, B and T cell proliferation, and memory T cell augmentation compared to Shingrix. These findings position the XUA09C-adjuvanted gEgI as a promising candidate for further development in HZ vaccine strategies, potentially better serving the needs of the immunocompromised population."

Journal • Preclinical • Herpes Zoster • Infectious Disease • Varicella Zoster • CD4

Study to Evaluate the Safety and Immunogenicity of an HIV-1 Vaccine Regimen of Adjuvanted UVAX-1107 Followed by Adjuvanted UVAX-1107 or Adjuvanted UVAX-1197 in Healthy Subjects Aged 25-55 Years. (clinicaltrials.gov) - P1 | N=34 | Completed | Sponsor: Uvax Bio LLC | Active, not recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease

Hepatitis B vaccination with HepB-CpG in people living with HIV: a narrative review. (PubMed, Expert Rev Vaccines) - "This review explores recent research on the two-dose HepB-CpG (HEPLISAV-B) vaccine, which is a potential solution to the challenge of suboptimal immune responses to three-dose HBV vaccines (HepB-alum) in people living with HIV (PLWH)...HepB-CpG might be more immunogenic in vaccine-naive and vaccine-experienced PLWH. Both attributes make HepB-CpG a possible future standard of care for adult HBV vaccination in PLWH."

Journal • Review • Fibrosis • Hepatitis B • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation • Liver Cancer • Liver Cirrhosis • Oncology • Solid Tumor

A novel MF59 and CpG1018 adjuvant combination enhances the humoral and cellular immune responses against a truncated varicella-zoster viral glycoprotein E. (PubMed, Immunol Lett) - "Furthermore, the tgE/MF59+CpG1018 also elicited robust humoral and CMI responses in both SD rats and cynomolgus monkeys. These findings established the novel tgE/MF59+CpG1018 vaccine as a highly promising prophylactic candidate against HZ."

Journal • Herpes Zoster • Varicella Zoster

Highly Durable Seroprotection With HepB-CpG Vaccine in People With HIV (PWH): ACTG A5379 (BEeHIVe) (CROI 2025) - "Group A was randomized 1:1:1 to: 2-CpG intramuscularly (IM) (20 mcg recombinant HBsAg, 3000 mcg CpG 1018® adjuvant) at Wks 0 and 4; 3-CpG IM at Wks 0, 4, 24; or 3-alum IM (20 mcg recombinant HBsAg) at Wks 0, 4, 24...Conclusions In PWH, higher end of study seroprotection was achieved with HepB-CpG over HepB-alum, and 3 doses of HepB-CpG over 2 doses. HepB-CpG achieved durable seroprotection in both vaccine-naïve and prior vaccine non-response groups."

Cardiovascular • Diabetes • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders • CD4

VLA1601-102: Phase 1 Trial to Assess the Safety and Immunogenicity of an Inactivated, Adjuvanted Whole Zika Virus Vaccine Candidate (VLA1601) in Healthy Adults (clinicaltrials.gov) - P1 | N=150 | Active, not recruiting | Sponsor: Valneva Austria GmbH | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2026 ➔ Apr 2026 | Trial primary completion date: Jul 2025 ➔ May 2025

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease

Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged 40 Years and Older (clinicaltrials.gov) - P1/2 | N=960 | Recruiting | Sponsor: Ab&B Bio-tech Co., Ltd.JS

New P1/2 trial • Herpes Zoster • Varicella Zoster • CD40LG • IFNG • IL2 • TNFA

A Phase 1/2 Safety and Immunogenicity Trial of COVID-19 Vaccine COVIVAC (Phase 1) (clinicaltrials.gov) - P1 | N=120 | Completed | Sponsor: Institute of Vaccines and Medical Biologicals, Vietnam | Phase classification: P1/2 ➔ P1 | N=420 ➔ 120

Enrollment change • Phase classification • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

PfCSP-ferritin nanoparticle malaria vaccine antigen formulated with aluminum-salt and CpG 1018® adjuvants: Preformulation characterization, antigen-adjuvant interactions, and mouse immunogenicity studies. (PubMed, Hum Vaccin Immunother) - "The in vivo immunological impact of various adjuvanted formulations of the 155 antigen was investigated in mice. The results support the formulation of 155 with AlhydrogelTM + CpG 1018® adjuvants as a promising recombinant malaria vaccine candidate from both a pharmaceutical and immunological perspective."

Journal • Preclinical • Infectious Disease • Malaria

Safety and immunogenicity of a SARS-CoV-2 recombinant protein subunit vaccine adjuvanted with Alum + CpG 1018 in healthy Indonesian adults: A multicenter, randomized, comparative, observer-blind, placebo-controlled phase 2 study. (PubMed, Hum Vaccin Immunother) - "Thus, follow-up was only performed for the 25 µg dose vaccine, demonstrating antibody persistence at month six and had a favorable safety profile. These results position this SARS-CoV-2 recombinant protein subunit vaccine adjuvanted with Alum + CpG 1018 as a promising candidate to fight against COVID-19."

Clinical • Journal • P2 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

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) - P1 | N=127 | Completed | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Active, not recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease

Functional efficacy of nanoparticle conjugated P. vivax circumsporozoite protein subdomain vaccine (ASTMH 2024) - "Mice were immunized with different recombinant CSP subunits formulated with CpG-1018 as adjuvant and surface conjugated to PLGA nanoparticles and the immunogenicity was evaluated. 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 ."

Clinical • Hepatology • Infectious Disease • Malaria

Synergy Effects of HPV E6-E7 Encoding mRNA and Nucleic Acid Immunostimulators Improve Therapeutic Potential in TC-1 Graft Tumor. (PubMed, J Med Virol) - "In TC-1 tumor-bearing mice, the subcutaneous immunization of LNP-CPG 1018 capsulated HPV E6-E7 mRNA elicited robust tumor-specific T-cell immunity, reshaped the tumor microenvironment, and inhibited tumor growth. In conclusion, the LNP-CPG 1018 system is a promising delivery platform for facilitating the development of HPV E6-E7 mRNA cancer vaccines."

Journal • Cervical Cancer • Human Papillomavirus Infection • Infectious Disease • Oncology • Solid Tumor

VLA1601-102: Phase 1 Trial to Assess the Safety and Immunogenicity of an Inactivated, Adjuvanted Whole Zika Virus Vaccine Candidate (VLA1601) in Healthy Adults (clinicaltrials.gov) - P1 | N=150 | Recruiting | Sponsor: Valneva Austria GmbH | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2024 ➔ Jul 2025

Trial completion date • Trial primary completion date • Infectious Disease