adjuvant CpG 1018 / Dynavax - LARVOL DELTA

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

Preclinical evaluation of a universal inactivated influenza B vaccine based on the mosaic hemagglutinin-approach. (PubMed, NPJ Vaccines) - "mHA split vaccines adjuvanted with a Toll-like receptor-9 agonist (CpG 1018) increased Th1 immunity and in vivo cross-protection, whereas adjuvanting with an MF59-like oil-in-water nano-emulsion (AddaVax) enhanced and broadened humoral immune responses and antibody-mediated cross-protection. 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."

Journal • Preclinical • Infectious Disease • Influenza • Respiratory Diseases

FACTORS ASSOCIATED WITH HIGH TITER RESPONSE TO HBV VACCINE IN PRIOR VACCINE NON-RESPONDERS WITH HIV: THE BEEHIVE TRIAL (AASLD 2024) - "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®, Dynavax Technologies Corporation) using a 2- or 3-dose regimen to a 3-dose HepB-Alum vaccine (Engerix-B®, SKF) in PWH who failed to mount a response to prior non-CpG adjuvanted vaccines... In a study of PWH with prior HBV vaccine non-response, a 3-dose regimen of HepB-CpG yielded high seroprotection titers independent of most known factors associated with lower vaccine response. Black and Asian races and younger age were predictive of high titers thought to predict HBV vaccine durability, which will be evaluated after trial completion."

Hepatitis B • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • CD4

Cancelled: Preventing Disease Progression in an Ovarian Cancer Mouse Model (AABB 2024) - "Riboflavin and UV inactivated cells with CpG1018, across all dose levels (groups 2, 3, and 4), consistently outperformed the Placebo control (group 1) with adjuvant alone, demonstrating lower mean BLI values throughout the study. 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)."

Preclinical • Oncology • Ovarian Cancer • Solid Tumor

HIV BG505 SOSIP.664 trimer with 3M-052-AF/alum induces broad and potent ADCC-mediating antibodies (HIVR4P 2024) - "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."

Late-breaking abstract • Human Immunodeficiency Virus • Infectious Disease • TLR4

BG505 SOSIP.664 adjuvanted with 3M-052 tunes IgG Fc glycosylation towards a more functional state (HIVR4P 2024) - "This study aimed to measure the impact of vaccine adjuvants on glycosylation and FcmEF to understand potentially programmable antibody features for future vaccine designs. HVTN 137 enrolled US adults without HIV (n=70) for a Phase 1 study evaluating an HIV-1 vaccine candidate featuring BG505 SOSIP.664gp140. Each group received a distinct adjuvant: CpG1018-Alum, 3M-052-AF-Alum, GLA-LSQ, or Alum... 3M-052-AF-Alum elicited the most functional antibody response evidenced by increased ADCP and ADCD post-vaccination three. 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."

Clinical • Late-breaking abstract • Human Immunodeficiency Virus • Infectious Disease

Hematologic Profile on SARS-CoV-2 Protein Subunit Recombinant Vaccine with Alum+CpG 1018 (IndoVac®) (V-Congress 2024) - No abstract available

Hematological Disorders • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

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

Journal • Preclinical • Infectious Disease • Influenza • Respiratory Diseases

Phase 1 trial of an investigational Tdap booster vaccine with CpG 1018 adjuvant compared with Boostrix in healthy adults and adolescents. (PubMed, Vaccine) - "Tdap-1018 3000 μg induced similar or higher immune responses than Boostrix. ACTRN12620001177943 (Australian New Zealand Clinical Trials Registry; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=ACTRN12620001177943p)."

Journal • P1 data • Infectious Disease • Pain • Pertussis • Respiratory Diseases • Tetanus

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 | Active, not recruiting | Sponsor: Uvax Bio LLC

New P1 trial • Human Immunodeficiency Virus • Infectious Disease

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. (ANZCTR) - P1 | N=34 | Active, not recruiting | Sponsor: Uvax Bio Australia, Pty, Ltd, a wholly owned subsidiary of Uvax Bio, LLC | Not yet recruiting ➔ Active, not recruiting | Initiation date: Jan 2024

Enrollment closed • Trial initiation date • Human Immunodeficiency Virus • Infectious Disease

Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine With CpG 1018® Adjuvant Compared With rF1V Vaccine in Adults 18 to 55 Years of Age (clinicaltrials.gov) - P2 | N=200 | Completed | Sponsor: Dynavax Technologies Corporation | Active, not recruiting ➔ Completed

Trial completion

Immunogenicity and safety of SARS-CoV-2 recombinant protein subunit vaccine (IndoVac) adjuvanted with alum and CpG 1018 in Indonesian adults: A phase 3, randomized, active-controlled, multicenter trial. (PubMed, Vaccine) - P3 | "IndoVac in adults showed favourable safety profile and elicited non-inferior immune response to Covovax. (ClinicalTrials.gov: NCT05433285, Indonesian Clinical Research Registry: INA-R5752S9)."

Journal • P3 data • Fatigue • Infectious Disease • Musculoskeletal Pain • Novel Coronavirus Disease • Pain • Respiratory Diseases

Immunogenicity and efficacy of VLA2001 vaccine against SARS-CoV-2 infection in male cynomolgus macaques. (PubMed, Commun Med (Lond)) - "We demonstrate that the VLA2001 adjuvanted vaccine is immunogenic both in mouse and NHP models and prevent cynomolgus macaques from the viruses responsible of COVID-19."

Journal • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases • CD4

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

New P1 trial • Infectious Disease