This single-center, double-blind, placebo-controlled study will recruit in total 39 participants with either Mild Cognitive Impairment due to Alzheimer's disease (MCI) or Mild Alzheimer's disease dementia (mild AD). There will be 3 Dose levels. An initial cohort of 13 subjects will be randomized to a Dose level 1 (0.1 mg/kg vs. placebo) lasting 8 weeks. An additional 13 subjects will be recruited and randomized into Dose level 2 (0.25 mg/kg vs. placebo) for 8 weeks and 13 subjects for the last Dose level 3 (0.5 mg/kg vs. placebo) for 8 weeks. The primary objective will be to assess safety and tolerability of CpG 1018.

Start Date13 Mar 2023

Sponsor / Collaborator

NYU Langone Health

[+1]

NCT04177355 / CompletedPhase 1IIT

A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of HIV-1 BG505 SOSIP.664 gp140 With TLR Agonist and/or Aalum Adjuvants and VRC HIV Env Trimer 4571 and 3M-052-AF With Alum in Healthy, HIV-uninfected Adults

The purpose of this study is to evaluate the safety and immunogenicity of HIV-1 BG505 SOSIP.664 gp140 with TLR agonist and/or alum adjuvants in healthy, HIV-uninfected adults.

Start Date13 Jan 2020

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

[+5]

100 Clinical Results associated with CpG1018

100 Translational Medicine associated with CpG1018

100 Patents (Medical) associated with CpG1018

Literatures (Medical) associated with CpG1018

31 Dec 2024·Human vaccines & immunotherapeutics

Development of a quantitative ELISA for SARS-CoV-2 vaccine candidate, NDV-HXP-S, with CpG 1018® adjuvant

Article

Author: Bzami, Anan ; Lal, Manjari ; White, Jessica A. ; Estrada, Marcus ; Zhu, Changcheng

NDV-HXP-S is a Newcastle disease virus (NDV) vectored vaccine candidate which expresses the S-antigen of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This vaccine candidate is under evaluation in human clinical studies with and without cytosine phosphate guanine (CpG) 1018® adjuvant. Existing potency methods for NDV-HXP-S do not allow for quantification of the S-antigen when the adjuvant is present. To support evaluation of NDV-HXP-S with CpG 1018® adjuvant, an inhibition enzyme-linked immunosorbent assay (ELISA) was developed to allow for quantification and stability assessments of the vaccine. A pilot 6-month stability study was conducted on NDV-HXP-S vaccine with and without CpG 1018® adjuvant under refrigerated conditions (2°C to 8°C) and accelerated stability testing conditions (40°C). The vaccine was mixed with and without CpG 1018® adjuvant in saline and maintained S-antigen content at 2°C to 8°C for the entire 6-month period. Additionally, a pilot controlled temperature chain (CTC) stability study was conducted at the completion of the 6-month study and demonstrated the possibility for this vaccine candidate to attain CTC stability labeling.

31 Dec 2024·Human Vaccines & Immunotherapeutics

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

Article

Author: Maddeppungeng, Martira ; Alimuddin, Suriani ; Pelupessy, Ninny Meutia ; Darussalam, Andi Husni Esa ; Wahyuni, Sitti ; Masadah, Rina ; Mahati, Endang ; Hapsari, Rebriarina ; Anggrainy, Fenty ; Maharani, Nani ; Nency, Yetty Movieta ; Djaharuddin, Irawaty ; Soedjatmiko, Soedjatmiko ; Darma, Sidrah ; Hidayah, Najdah ; Pramudo, Setyo Gundi ; Deza, Putri Awaliyah ; Sekartini, Rini ; Medise, Bernie Endyarni ; Nurdin, Asrawati ; Farhanah, Nur ; Tri Anantyo, Dimas ; Ramadhani, Nur ; Yani, Finny Fitry ; Fikri, Bahrul ; Massi, Muh. Nasrum ; Putri, Azka Zhafira ; Ramadany, Sri ; Santoso, Arif ; Setyaningsih, Lilis ; Chalid, Maisuri Tadjuddin

Globally, dozens of COVID-19 vaccines are licensed under emergency or conditional authorization, but especially in low and middle-income countries, their availability varies. Indonesia decided to become independent and produce its own vaccines locally. This study investigated the safety and immunogenicity of a SARS-CoV-2 recombinant protein subunit vaccine adjuvanted with Alum + CpG 1018. This study involved 360 adults aged 18 years and above. It compared two vaccine dosages, a-12.5 µg and a 25-µg dose of receptor binding domain protein, to a placebo (1:1:1). A total of 40.6% of participants in this study experienced at least one adverse event (AE), with most being mild. There was no statistically significant difference in AEs between the groups. The microneutralization test showed the highest neutralizing antibody titer (IU/mL) in the 25 µg dose vaccine group at day 28 after the second dose (3,300 95%CI 2,215-4,914), although it was not statistically different from the 12.5 µg dose group (3,157 95%CI 2,135-4,669). Similarly, IgG antibody concentrations in the 25 µg dose vaccine group at day 28 were the highest compared to the 12.5 µg dose and placebo. According to protocol, only the formulation with the better antibody profile and comparable reactogenicity was further evaluated at months three and six. 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.

01 Nov 2024·JOURNAL OF MEDICAL VIROLOGY

Synergy Effects of HPV E6‐E7 Encoding mRNA and Nucleic Acid Immunostimulators Improve Therapeutic Potential in TC‐1 Graft Tumor

Article

Author: Zhang, Lizhi ; Niu, Haiying ; He, Shuang ; Tao, Zhonge ; Qu, Quanxin

ABSTRACT:

Cervical cancer is the second most common cancer among women globally and the most prevalent cancer in developing countries, which was caused by human papillomavirus (HPV) infection. Messenger RNA (mRNA) vaccines have opened up new avenues for vaccine development and pandemic preparedness with potent scalability, which may possess the potential antitumor effects of an mRNA‐HPV therapeutic vaccine containing nononcogenic E6 and E7 proteins. Here, we reported a lipid nanoparticle (LNP) plus nucleic acid immunostimulators (CPG 1018 and Poly I:C) mRNA vaccine platform. The LNP‐CPG 1018 capsulated HPV E6‐E7 mRNA significantly promoted the maturation of bone marrow‐derived dendritic cells (BMDC) in vitro and were capable of efficiently migrating to lymph nodes (LN) in vivo. 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.

News (Medical) associated with CpG1018

03 Dec 2024

·www.globenewswire.com

ACTG Announces Publication of BEe-HIVe Trial in JAMA

Data demonstrate superiority of HepB-CpG vaccination over conventional hepatitis B vaccines among people living with HIVLOS ANGELES, Dec. 03, 2024 (GLOBE NEWSWIRE) -- ACTG, a global clinical trials network focused on HIV and other infectious diseases, today announced the publication of “HepB-CpG vs HepB Vaccine in People with HIV and Prior Vaccine Nonresponse: The BEe-HIVe Randomized Clinical Trial” in JAMA. The publication reports that two- and three-dose regimens of HepB-CpG vaccine provided superior protection compared to three doses of the conventional hepatitis B vaccine among people living with HIV who had previously not responded to the conventional vaccines. Hepatitis B is a leading cause of liver-related mortality worldwide resulting in more than 1 million deaths in 2022. It is a major cause of liver injury, cirrhosis, and liver cancer among people living with HIV, who often do not develop protective antibodies after receiving conventional hepatitis B vaccines. The HepB-CpG (HEPLISAV-B® [Hepatitis B Vaccine (Recombinant) Adjuvanted]) vaccine includes a TLR-9 agonist adjuvant (CpG 1018® adjuvant) and is known to achieve high protection against hepatitis B among people living with HIV, but until now there have been limited data about its protection among people living with HIV who had not responded to conventional hepatitis B vaccines. “These findings are tremendous news for people living with HIV who have struggled to achieve protection against hepatitis B,” said ACTG Chair Joseph J. Eron, M.D., University of North Carolina. “As a result of this data, the U.S. Department of Health and Human Services’ ‘Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents With HIV’ have been updated and clinical practice is already changing. Ultimately, we expect them to have an important impact on people living with HIV.” BEe-HIVe (B-Enhancement of HBV Vaccination in Persons Living With HIV, also known as A5379) was an international study evaluating the HepB-CpG vaccine among people living with HIV who were on antiretroviral therapy (ART) and had not responded to prior conventional hepatitis B vaccination and thus remained vulnerable to hepatitis B infection. This phase 3 randomized, open-label clinical trial included 561 people from 41 sites in 10 countries in Africa, Asia, North America, and South America. Study participants were equally randomized to one of three groups, receiving either: Two doses of HepB-CpG intramuscularly at week 0 and week 4Three doses of HepB-CpG intramuscularly at week 0, week 4, and week 24Three doses of HepB-alum (conventional hepatitis B vaccine) intramuscularly at week 0, week 4, and week 24 The primary analysis published in JAMA demonstrates that 99 percent of those receiving three doses of the HepB-CpG vaccine and 93 percent of those receiving two doses of the HepB-CpG vaccine achieved protection against hepatitis B compared to 81 percent receiving three doses of the conventional hepatitis B vaccine. The study demonstrates that the three-dose regimen of the HepB-CpG vaccine led to higher levels of protective antibodies, which may have long-term implications related to vaccine durability. Long-term protection results will be available in 2025. There were no unexpected safety concerns. “This study provides strong evidence that people living with HIV for whom prior hepatitis B vaccination was not successful should be re-vaccinated with the HepB-CpG vaccine to reduce their risk of future hepatitis B infection," said lead author and Protocol Co-Chair Kristen Marks, M.D., Weill Cornell Medicine. BEe-HIVe is led by Kenneth Sherman, M.D., Ph.D., University of Cincinnati and Massachusetts General Hospital (Protocol Chair) and Dr. Marks. ACTG is led by Dr. Eron and Rajesh T. Gandhi, M.D., Massachusetts General Hospital and Harvard Medical School (ACTG Vice-Chair). It is sponsored by the National Institute of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID, which also funds ACTG) under award numbers UM1 AI068636, UM1 AI107716, and UM1 AI068634. HEPLISAV-B® was provided by Dynavax Technologies Corporation. For more information about BEe-HIVe, please visit clinicaltrials.gov. About ACTG ACTG is the world’s largest and longest running clinical trials network focused on HIV and other infectious diseases and the people living with them. It is funded by NIAID and collaborating NIH Institutes. Founded in 1987, ACTG conducts research to improve the management of HIV and its comorbidities; develop a cure for HIV; and innovate treatments for tuberculosis, hepatitis B, and emerging infectious diseases. It comprises thousands of dedicated researchers, staff, and community members who are pursuing research into novel treatments and cures for infectious diseases at 65 locations across four continents, with the ultimate goal of advancing science that meaningfully impacts the lives of the people we serve. Disclaimer: This content is solely the responsibility of ACTG and does not necessarily represent the official views of the NIH. Media Contact:Jenna Conley, ACTGjenna@conleycommunications.net

Clinical ResultVaccinePhase 3

26 Nov 2024

·www.prnewswire.com

Dynavax to Present at the 7th Annual Evercore HealthCONx Conference

EMERYVILLE, Calif., Nov. 26, 2024 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today announced that the Company will present at the 7th Annual Evercore HealthCONx Conference on Tuesday, December 3 at 2:35 p.m. ET. The presentation will be webcast and may be accessed through the "Events & Presentations" page on the "Investors" section of the Company's website at . About Dynavax Dynavax is a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines to help protect the world against infectious diseases. The Company has two commercial products, HEPLISAV-B® vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted], which is approved in the U.S., the European Union and Great Britain for the prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older, and CpG 1018® adjuvant, currently used in HEPLISAV-B and multiple adjuvanted COVID-19 vaccines. For more information about our marketed products and development pipeline, visit . For Investors/Media: Paul Cox [email protected] 510-665-0499 Nicole Arndt [email protected] 510-665-7264 SOURCE Dynavax Technologies WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

VaccineDrug Approval

19 Nov 2024

·pipelinereview.com

Uvax Bio Announces Interim Results from a Phase 1 Clinical Trial Evaluating its HIV-1 Vaccine

The UVAX-1107 protein nanoparticle vaccine was safe and well-tolerated in healthy volunteers at the planned Interim Analysis #1 The planned Interim Analysis #1 was performed after two priming doses of UVAX-1107, out of the planned two priming vaccinations with UVAX-1107 followed by two booster vaccinations with UVAX-1107/UVAX-1197 A planned immunogenicity analysis showed robust vaccine-matched IgG antibody responses in 100% of subjects after receiving two priming doses of UVAX-1107 NEWARK, DE, USA I November 19, 2024 I Uvax Bio, LLC , (“Uvax” or “the Company”) a privately held, clinical-stage vaccine company utilizing rational design principles to deliver novel protein-based nanoparticle vaccines, today announced the results of the interim analysis from their first Phase 1 clinical trial evaluating the Company’s HIV-1 vaccine candidates, UVAX-1107 and UVAX-1197, in healthy volunteers in Australia. In the first stage of this trial, the subjects received either UVAX-1107 adjuvanted with CpG 1018 ® (Dynavax) and aluminum hydroxide or placebo. UVAX-1107 utilizes Uvax Bio’s 1c-SApNP ® vaccine development platform to generate virus-like particles (VLPs) which closely resemble the target virus in size, shape, and multivalent antigen display; in this case, 20 copies of the native-like, prefusion-stabilized trimeric HIV-1 antigen. Safe and Well Tolerated “We are pleased that our first Phase 1 trial is progressing smoothly, and we have preliminary confirmation that UVAX-1107 was well tolerated at all doses by the study participants, and no vaccine-related serious adverse events were reported,” said Pedro Garbes, M.D., Vice President and Global Clinical Lead of Uvax Bio. “As per the time of this 1 st interim analysis, no participant was withdrawn from the study due to local/systemic reactogenicity; local and systemic adverse events were mild to moderate, transient, and they resolved on average within two days. These preliminary safety results are aligned with expectations for an adjuvanted protein-based vaccine.” Early Immune Responses UVAX-1107 was immunogenic and generated robust IgG responses to the vaccine antigen derived from an HIV-1 strain known as BG505. 100% of subjects in the vaccine group demonstrated antibody responses after two priming vaccinations with UVAX-1107. Antibody response titers increased >200-fold 14 days after the 2 nd dose as compared to the same period following the first dose. About the Uvax Bio HIV-101 Phase 1 HIV-1 Vaccine Trial The first-in-human clinical trial UVAX-HIV-101 (ClinicalTrials.gov ID NCT06541093) is evaluating two different regimens of the UVAX-1107 and UVAX-1197 vaccines in 34 healthy adult volunteers who meet the study eligibility criteria. The primary endpoints of the study will measure safety and immunogenicity of UVAX-1107 and UVAX-1197 after the priming and boosting dose series being evaluated in parallel arms. The study will also investigate whether either vaccine or the combination of both produces the optimal immunological response. Uvax Bio expects to report topline data from a 2 nd interim analysis after the first booster vaccination (out of two boosters with UVAX-1107/UVAX-1197/Placebo) for the Phase 1 trial in the first quarter of 2025. The need for an HIV Vaccine There is a tremendous unmet need for a vaccine to help protect against HIV-1 infection. The Joint United Nations Programme on HIV/AIDS estimates that 39 million people worldwide are currently living with HIV. According to the World Health Organization (WHO), an estimated 1.3 million people worldwide become infected with HIV annually. Globally, 9.2 million people living with HIV are not receiving treatment. The majority of new infections come from undiagnosed or undertreated HIV patients (WHO/CDC). About UVAX-1107 and UVAX-1197 The UVAX-1197 HIV-1 vaccine was designed and produced based on Uvax Bio’s proprietary 1c-SApNP ® technology. These vaccines employ two innovative technologies. This first is the unique antigen design of the uncleaved prefusion-optimized (UFO) HIV-1 envelope (Env) trimers. The second is the self-assembled, multi-layered protein nanoparticle which displays 20 copies of the UFO trimer in a symmetrical manner. UVAX-1107 employs a third advanced technology called “glycan-trimming” to remove a portion of the glycan shield to allow better access to the conserved neutralizing epitopes on HIV-1 Env. This third technology was recognized by the International Union of Pure and Applied Chemistry (IUPAC) – who dubbed it “low-sugar vaccination” – as one of the Top Ten Emerging Technologies in Chemistry for 2023. The UFO trimer, 1c-SApNP platform, and glycan trimming strategy were developed by Dr. Jiang Zhu’s laboratory at Scripps Research in La Jolla, CA ( https://www.scripps.edu/faculty/zhu/ ). About Uvax Bio Uvax Bio, LLC , a spin-off vaccine company from Scripps Research, employs proprietary 1c-SA p NP ® platform technology invented by Scripps researchers to develop and commercialize vaccines for challenging infectious diseases. The 1c-SA p NP ® platform utilizes the latest advances in computational and structural biology to design and produce complex protein structures (VLPs) that closely resemble the target virus in its infectious form. These intricately designed VLPs activate and prolong interaction with the immune system, which is expected to generate more potent and durable immune responses compared to soluble protein vaccines. Uvax Bio holds exclusive worldwide rights to the 1c-SApNP ® platform and an expanding portfolio of 12 patented vaccine candidates in development at stages ranging from optimization to clinical development. In addition to the leading clinical candidates for HIV-1, Uvax Bio is working to advance its vaccine candidates for influenza, respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and hepatitis C virus (HCV). Uvax Bio vaccines are produced using a single-step, universal, cell-based manufacturing process. For more information, visit www.uvaxbio.com . UVAX HIV-101 Phase 1 Clinical Study Clinical Trials.gov https://clinicaltrials.gov/study/NCT06541093?term=NCT06541093&rank=1 SOURCE: Uvax Bio

VaccineClinical ResultPhase 1

100 Deals associated with CpG1018

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Indication	Highest Phase	Country/Location	Organization	Date
Alzheimer Disease	Phase 1	-	NYU Langone Health	01 Nov 2022
Mild cognitive disorder	Phase 1	-	NYU Langone Health	01 Nov 2022

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