A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of HIV-1 Vaccines Based on Chimpanzee Serotypes of Adenovirus Expressing Clade C gp140 and a CH505TF gp120 Protein Boost in Healthy, HIV- Uninfected Adult Participants

The purpose of this study is to evaluate the safety and immunogenicity of HIV-1 vaccines based on chimpanzee serotypes of adenovirus expressing clade C gp140 and a CH505TF gp120 protein boost in healthy, HIV- uninfected adult participants.

Start Date25 Nov 2021

Sponsor / Collaborator

HIV Vaccine Trials Network

[+3]

NCT04607408 / Active, not recruitingPhase 1

A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of the HIV-1 CH505 Transmitted/Founder gp120 Adjuvanted With GLA-SE in Healthy, HIV-exposed Uninfected Infants

This study will evaluate the safety and immune response in healthy HIV-exposed and uninfected infants to the protein vaccine, CH505TF gp120, adjuvanted with GLA-SE.

Start Date10 Nov 2020

Sponsor / Collaborator

HIV Vaccine Trials Network

[+1]

100 Clinical Results associated with Glucopyranosyl lipid A

100 Translational Medicine associated with Glucopyranosyl lipid A

100 Patents (Medical) associated with Glucopyranosyl lipid A

1,279

Literatures (Medical) associated with Glucopyranosyl lipid A

01 Feb 2024·The Journal of thoracic and cardiovascular surgery

Surgical ablation for atrial fibrillation is efficacious in patients with giant left atria

Article

Author: Melby, Spencer J ; Kelly, Meghan O ; Zemlin, Christian W ; Yates, Tari-Ann E ; Sinn, Laurie A ; Bakir, Nadia H ; McGilvray, Martha M O ; Damiano, Ralph J

OBJECTIVE:

The Cox-Maze IV procedure (CMP-IV) is the most effective treatment for atrial fibrillation. Increased left atrial (LA) size has been identified as a risk factor for failure to restore sinus rhythm. This has biased many surgeons against ablation in patients with giant left atrium (GLA), defined as LA diameter >6.5 cm. In this study we aimed to define the efficacy of the CMP-IV in patients with GLA.

METHODS:

From April 2004 through March 2020, 786 patients with a documented LA diameter underwent elective CMP-IV, 72 of whom had GLA. Median follow-up duration was 4 years (interquartile range, 1-7 years). Recurrence was defined as any documented atrial tachyarrhythmia (ATA) lasting 30 seconds. ATA recurrence and survival were analyzed across GLA versus non-GLA groups.

RESULTS:

Median age at surgery was 65 (interquartile range, 56-73) years. Median LA diameter within the GLA group was 7.0 (range, 6.6-10.0) cm. There were no differences in rates of postoperative complications for the 2 groups, including rate of postoperative stroke and pacemaker placement (GLA 14%; non-GLA 12%; P = .682). A trend toward increased 30-day mortality in the GLA group did not reach statistical significance (GLA 6%; non-GLA 2%; P = .051). Freedom from ATAs at 5 years postoperatively was comparable for the 2 groups (GLA 82%; non-GLA 84%).

CONCLUSIONS:

The CMP-IV had good efficacy in patients with GLA. Our results suggest that LA diameter >6.5 cm should not preclude a patient from undergoing surgical ablation for atrial fibrillation.

18 Jan 2024·The Canadian journal of infectious diseases & medical microbiology = Journal canadien des maladies infectieuses et de la microbiologie medicale

What Makes the Gut-Lung Axis Working? From the Perspective of Microbiota and Traditional Chinese Medicine

Review

Author: Wang, Ying ; Wang, Hui

Background. An increasing number of studies have proved that gut microbiota is involved in the occurrence and development of various lung diseases and can interact with the diseased lung. The concept of the gut-lung axis (GLA) provides a new idea for the subsequent clinical treatment of lung diseases through human microbiota. This review aims to summarize the microbiota in the lung and gut and the interaction between them from the perspectives of traditional Chinese medicine and modern medicine. Method. We conducted a literature search by using the search terms “GLA,” “gut microbiota,” “spleen,” and “Chinese medicine” in the databases PubMed, Web of Science, and CNKI. We then explored the mechanism of action of the gut-lung axis from traditional Chinese medicine and modern medicine. Results. The lung and gut microbiota enable the GLA to function through immune regulation, while metabolites of the gut microbiota also play an important role. The spleen can improve the gut microbiota to achieve the regulation of the GLA. Conclusion. Improving the gut microbiota through qi supplementation and spleen fortification provides a new approach to the clinical treatment of lung diseases by regulating the GLA. Currently, our understanding of the GLA is limited, and more research is needed to explain its working principle.

01 Jan 2024·Journal of colloid and interface science

Molecularly modulating solvation structure and electrode interface enables dendrite-free zinc-ion batteries

Article

Author: Wang, Pengfei ; Liu, Hai ; Xiao, Dan ; Gao, Taotao ; Jin, Zhaoyu ; Xiang, Jian ; Guo, Yongqiang ; Li, Xiaoqin ; Chen, Chao

The performance of aqueous Zn ion batteries (AZIBs) is hindered by the uncontrollable growth of Zn dendrites and side reactions at the Zn anode/electrolyte interface. Here, we introduce low-cost glucosamine hydrochloride (GLA) into the ZnSO₄ electrolyte system to modulate the Zn anode/electrolyte interface and the solvation structure of Zn²⁺, which leads to improved reversibility of Zn plating/striping. Through experimental and theoretical analyses, we demonstrate that GLA molecules could adsorp on the Zn metal surface to form a new interface with reduced active water, effectively suppressing water-induced side reactions. Moreover, after adding GLA, the flux of Zn²⁺ ions is regulated, the desolvation of the primary [Zn(H₂O)₆]²⁺ ions is promoted, and the Zn dendrite growth is significantly inhibited. Consequently, superior cyclic stability with a lower voltage hysteresis is simultaneously achieved in a Zn//Zn symmetric cell. When coupled with the Mn₃O₄ cathode, the fabricated Zn-Mn batteries with the modified ZnSO₄ + GLA electrolyte system deliver boosted capacity, improved long-term cycling stability, and better self-discharge performance. This work provides insight into the development of high-efficient and low-cost electrolytes for high-performance Zn-based energy storage devices.

News (Medical) associated with Glucopyranosyl lipid A

24 Mar 2023

·www.pharmaceutical-technology.com

Pharma Fix: The quest for the next tuberculosis vaccine

Credit: Shutterstock/ Helena Nechaeva Since the first human administration of the Bacillus Calmette-Guérin vaccine in 1921, no one has been able to successfully follow the vaccine’s path to become the next approved vaccine to tackle tuberculosis (TB). However, as the TB-related death toll remains high, the global need for another vaccine is steadily rising. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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British (+1284) Virgin Islands - US (+1340) Wallis & Futuna (+681) Yemen (North)(+969) Yemen (South)(+967) Zambia (+260) Zimbabwe (+263) Country UK USA Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos Islands Colombia Comoros Congo Democratic Republic of the Congo Cook Islands Costa Rica Côte d"Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati North Korea South Korea Kuwait Kyrgyzstan Lao Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, The Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestinian Territory Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Réunion Romania Russian Federation Rwanda Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Saint Vincent and The Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and The South Sandwich Islands Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates US Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela Vietnam British Virgin Islands US Virgin Islands Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Kosovo Submit By clicking the Download Free Report button, you accept the terms and conditions and acknowledge that your data will be used as described in the GlobalData privacy policy By downloading this Report, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services. Visit our privacy policy for more information about our services, how we may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report. TB is caused by the bacillus Mycobacterium tuberculosis and is transmitted when infected individuals expel bacteria into the air (e.g., by coughing). According to the World Health Organization (WHO), despite a reduction in TB cases during the Covid-19 pandemic, the incidence has risen again with 6.4 million new cases reported worldwide. Researchers expect TB to soon return to its pre-2020 position as the deadliest infectious disease globally. In light of World TB day on March 24, the field hopes to overcome some major barriers to the drug development landscape. Unfortunately, lack of funding and resources remain an obstacle within the TB field for developing new vaccines. The BCG vaccine is a live-attenuated virus vaccine. This vaccine is also being used in cancer therapies, studied as a Covid-19 prophylactic and is also being considered as a vaccine for Alzheimer’s . However, the vaccine is less effective in those who already have viral antibodies present in their blood, leaving out a large proportion of people. The vaccine also only has an efficacy of 22%.“When children reach adolescence and adult age group, [the BCG vaccine] really does not have an impact on TB disease. Thus, new vaccine approaches are needed,” says Christopher Fox, PhD, an associate professor of Global Health at the University of Washington, Seattle. This is important as TB is mostly spread by adults. Despite the dearth of options, researchers are cautiously optimistic about the having new vaccines in the pipeline. Helen McShane, PhD, a professor of vaccinology at the University of Oxford, says, “Twenty-three years ago, there were no new TB vaccines being tested in clinical trials. We now have 12 vaccines being tested in clinical trials at different stages of development.” New Developments for TB In a recent Phase I clinical trial (NCT03722472), researchers have been able to test the first thermostable TB vaccine in patients. In this trial, patients were given a thermostable version of the vaccine or a non-thermostable vaccine in two treatment regimens. The results showed that participants’ antibody responses remained elevated through six months after the last vaccination in both regimens. The ID93 vaccine is being developed by the Infectious Disease Research Institute (IDRI). The trial, led by IDRI in collaboration with the National Institutes of Health (NIH), investigated a thermostable formulation of the previously tested ID93 + GLA-SEDr adjuvant subunit vaccine. The results showed that participants’ antibody responses remained elevated through six months after the last vaccination for the thermostable version of the vaccine and a non-thermostable vaccine formulation. Fox, the principal scientist behind the trial, says this is an important development in TB vaccine research as the current BCG vaccine must be refrigerated. He explains that this new vaccine could be stored at 37 degree s Celsius for up to three months and may allow easier vaccine storage in more rural locations with a high prevalence of TB. Fox says adjuvant protein subunit vaccines can be a safer approach compared to live attenuated virus vaccines as there is a minimized risk of developing side effects. Using an adjuvant with an antigen can give specific tailored and potent immune responses, he adds. “There are a handful of vaccine candidates now that are using this approach and marching towards that efficacy testing stage in Phase II trials,” says Fox. The National Institutes of Health (NIH) is sponsoring a Phase II trial (trial ID?) of the ID93 + GLA-SEDr adjuvant subunit vaccine in South Africa. Copenhagen-based Statens Serum institut is also developing an adjuvant subunit vaccine called SSIH-56IC31 for the prevention of TB. McShane predicts the new pipeline vaccines could also address the issue of drug-resistance in TB. “We expect that all the [investigational] vaccines will work as well against drug resistant strains as they will against drug sensitive strains”. The Bill and Melinda Gates Medical Research Institute is also sponsoring an extensive, 26,000 participant-Phase III trial studying M72 (AS01E) , a protein adjuvant vaccine. Initially, GSK was studying the M72 TB vaccine but stopped funding the development after a successful Phase IIb study. News on this Phase III trial could be released in the next few months, says Dr. Alex Schmidt, Head of Vaccine Development at the Bill and Melinda Gates Medical Research Institute (MRI). The Phase IIb (NCT01755598) study found the vaccine to be 54% effective, making it a landmark in the field. However, McShane urges for the field not to become complacent. “We should not forget that we would not have accepted the Covid-19 vaccine that was only 50% effective. The Covid vaccines that we have are more than 90% effective, so it’s fantastic news… but we should not stop there,” she says. According to GlobalData, there are six TB vaccines in Phase III clinical trials right now. The Gamaleya Federal Research Center of Epidemiology and Microbiology is developing a protein subunit vaccine called GamTBvac for respiratory TB. GC Biopharma is also running a Phase III trial for its live-attenuated vaccine GC-3107A to replace BCG. Furthermore, the Serum Institute of India is also developing its own live-attenuated vaccine to replace BCG for infants, that can also be used by adults. GlobalData is the parent company of Pharmaceutical Technology. Stagnation in TB research Until approximately two decades ago, the field of TB vaccine development was stagnated due to the complexity of the virus and a lack of interest and funding. “As opposed to most viruses which often have 10 or 15 genes, MTB has 3,500 or so and we don’t understand the virulence factors. We also don’t understand why when 20 people are infected with MTB, only one gets ill and that’s a huge problem,” says Schmidt. Dr. Keertan Dheda, a professor of Mycobacteriology and Global Health at the University of Cape Town says, “We don’t know what biomarker identifies with successful immunity in TB…That has been a real challenge for TB vaccine development for decades now and we still don’t have a good idea”. The complexity of the virus and these unknown factors can also pose some challenges for clinical trials as larger patient cohorts are needed. McShane explains that TB vaccine efficacy trials involve 1,000s to 10,000s of subjects, cost tens of millions of dollars and can take more than five years to complete. With minimal funding, researchers have to carefully select which drug candidates are worth the “massive undertaking” needed for these studies, she adds. Dheda says “The one factor that has retarded development is money.” Schmidt adds, “There is no market and there’s no big disease burden in high income countries… Typically, policy people make money available for diseases that they feel close to.”. A lack of funding also slowed the development of the M72 vaccine. We need a Phase III study, but it’s been five years and the Phase III study for M72 hasn’t started yet,” says Dheda. Results from the Phase II trial were released for the vaccine in September 2018. Accounting for the time needed to complete the trial, publish results and manufacture the vaccine, if successful, market access to TB vaccines may be 10 years away. Clinical trials for TB are mostly funded through philanthropic means, but McShane says funding has seen fair improvement over the years, which has allowed for the recent progress in the field. Poverty and overcrowding, key factors leading to TB spreads, are challenging to tackle on a global level. “If we really want to impact TB our only hope is to have a good vaccine that can control TB, because better diagnostics and drugs , which we do have, aren’t doing the trick,” says Dheda. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. By GlobalData Submit Country Code UK (+44) USA (+1) Algeria (+213) Andorra (+376) Angola (+244) Anguilla (+1264) Antigua & Barbuda (+1268) Argentina (+54) Armenia (+374) Aruba (+297) Australia (+61) Austria (+43) Azerbaijan (+994) Bahamas (+1242) Bahrain (+973) Bangladesh (+880) Barbados (+1246) Belarus (+375) Belgium (+32) Belize (+501) Benin (+229) Bermuda (+1441) Bhutan (+975) Bolivia (+591) Bosnia Herzegovina (+387) Botswana (+267) Brazil (+55) Brunei (+673) Bulgaria (+359) Burkina Faso (+226) Burundi (+257) Cambodia (+855) Cameroon (+237) Canada (+1) Cape Verde Islands (+238) Cayman Islands (+1345) Central African Republic (+236) Chile (+56) China (+86) Colombia (+57) Comoros (+269) Congo (+242) Cook Islands (+682) Costa Rica (+506) Croatia (+385) Cuba (+53) Cyprus North (+90392) Cyprus South (+357) Czech Republic (+42) Denmark (+45) Djibouti (+253) Dominica (+1809) Dominican Republic (+1809) Ecuador (+593) Egypt (+20) El Salvador (+503) Equatorial Guinea (+240) Eritrea (+291) Estonia (+372) Ethiopia (+251) Falkland Islands (+500) Faroe Islands (+298) Fiji (+679) Finland (+358) France (+33) French Guiana (+594) French Polynesia (+689) Gabon (+241) Gambia (+220) Georgia (+7880) Germany (+49) Ghana (+233) Gibraltar (+350) Greece (+30) Greenland (+299) Grenada (+1473) Guadeloupe (+590) Guam (+671) Guatemala (+502) Guinea (+224) Guinea - Bissau (+245) Guyana (+592) Haiti (+509) Honduras (+504) Hong Kong (+852) Hungary (+36) Iceland (+354) India (+91) Indonesia (+62) Iran (+98) Iraq (+964) Ireland (+353) Israel (+972) Italy (+39) Jamaica (+1876) Japan (+81) Jordan (+962) Kazakhstan (+7) Kenya (+254) Kiribati (+686) Korea North (+850) Korea South (+82) Kuwait (+965) Kyrgyzstan (+996) Laos (+856) Latvia (+371) Lebanon (+961) Lesotho (+266) Liberia (+231) Libya (+218) Liechtenstein (+417) Lithuania (+370) Luxembourg (+352) Macao (+853) Macedonia (+389) Madagascar (+261) Malawi (+265) Malaysia (+60) Maldives (+960) Mali (+223) Malta (+356) Marshall Islands (+692) Martinique (+596) Mauritania (+222) Mayotte (+269) Mexico (+52) Micronesia (+691) Moldova (+373) Monaco (+377) Mongolia (+976) Montserrat (+1664) Morocco (+212) Mozambique (+258) Myanmar (+95) Namibia (+264) Nauru (+674) Nepal (+977) Netherlands (+31) New Caledonia (+687) New Zealand (+64) Nicaragua (+505) Niger (+227) Nigeria (+234) Niue (+683) Norfolk Islands (+672) Northern Marianas (+670) Norway (+47) Oman (+968) Palau (+680) Panama (+507) Papua New Guinea (+675) Paraguay (+595) Peru (+51) Philippines (+63) Poland (+48) Portugal (+351) Puerto Rico (+1787) Qatar (+974) Reunion (+262) Romania (+40) Russia (+7) Rwanda (+250) San Marino (+378) Sao Tome & Principe (+239) Saudi Arabia (+966) Senegal (+221) Serbia (+381) Seychelles (+248) Sierra Leone (+232) Singapore (+65) Slovak Republic (+421) Slovenia (+386) Solomon Islands (+677) Somalia (+252) South Africa (+27) Spain (+34) Sri Lanka (+94) St. Helena (+290) St. Kitts (+1869) St. Lucia (+1758) Sudan (+249) Suriname (+597) Swaziland (+268) Sweden (+46) Switzerland (+41) Syria (+963) Taiwan (+886) Tajikstan (+7) Thailand (+66) Togo (+228) Tonga (+676) Trinidad & Tobago (+1868) Tunisia (+216) Turkey (+90) Turkmenistan (+7) Turkmenistan (+993) Turks & Caicos Islands (+1649) Tuvalu (+688) Uganda (+256) Ukraine (+380) United Arab Emirates (+971) Uruguay (+598) Uzbekistan (+7) Vanuatu (+678) Vatican City (+379) Venezuela (+58) Vietnam (+84) Virgin Islands - British (+1284) Virgin Islands - US (+1340) Wallis & Futuna (+681) Yemen (North)(+969) Yemen (South)(+967) Zambia (+260) Zimbabwe (+263) Country UK USA Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos Islands Colombia Comoros Congo Democratic Republic of the Congo Cook Islands Costa Rica Côte d"Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati North Korea South Korea Kuwait Kyrgyzstan Lao Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, The Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestinian Territory Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Réunion Romania Russian Federation Rwanda Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Saint Vincent and The Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and The South Sandwich Islands Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates US Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela Vietnam British Virgin Islands US Virgin Islands Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Kosovo Submit By clicking the Download Free Report button, you accept the terms and conditions and acknowledge that your data will be used as described in the GlobalData privacy policy By downloading this Report, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services. Visit our privacy policy for more information about our services, how we may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report.

Phase 2VaccinePhase 3Phase 1Clinical Result

06 Mar 2023

·www.biospace.com

The Access to Advanced Health Institute Reports Encouraging Results of First-In-Human Trial of Its Temperature-Stable Tuberculosis Vaccine Candidate

SEATTLE--(BUSINESS WIRE)-- The Access to Advanced Health Institute (AAHI) published results of a Phase 1 clinical trial demonstrating the safety and immune responses in a new vaccine against tuberculosis (TB), the world’s second deadliest infectious disease (NCT03722472). AAHI’s TB vaccine combines several proteins from Mycobacterium tuberculosis (Mtb), the bacterium that causes TB, into a fusion protein (“ID93”) with a proprietary immune-stimulating adjuvant (“GLA-SE”) in a freeze-dried formulation that can be stored at elevated temperatures (nearly 100 degrees Fahrenheit) for several months. The novel single-vial presentation of this freeze-dried TB vaccine candidate elicited a stronger immune response than administration of the same vaccine using separate vials of antigen and liquid adjuvant formulation. AAHI’s single-vial TB vaccine candidate represents significant progress in global efforts to combat TB. This press release features multimedia. View the full release here: Raodoh Mohamath, Principal Research Associate and Author, in AAHI's Laboratories (Photo: Business Wire) The trial evaluated the safety, tolerability, and immunogenicity of AAHI’s thermostable, freeze-dried single-vial ID93 + GLA-SE vaccine candidate compared to the previous iteration of the vaccine—a two-vial presentation that had demonstrated promising safety and immunogenicity in Phase 2 clinical testing. Importantly, the thermostable single-vial presentation induced higher levels of antibodies than the two-vial presentation, while retaining the vaccine candidate’s ability to activate “helper T cells” that recruit additional immune cells for a stronger immune response. The trial enrolled 48 participants who were to receive two vaccine doses administered intramuscularly 56 days apart, after which the researchers observed the cellular immune response pro to be favorable for protection against Mtb. “Adjuvanted subunit vaccines have re-energized the field of TB vaccine development. This study represents the first temperature-stable adjuvant-containing subunit TB vaccine candidate to be evaluated in the clinic,” says Christopher Fox, PhD, Senior Vice President of Formulations and Principal Investigator of the contract awarded by the National Institutes of Health (NIH) that funded the trial. “An effective thermostable TB vaccine would not only be better suited to reach areas of the world most burdened by the disease, but it would also mitigate costs and reduce wastage associated with more stringent cold-chain storage requirements.” TB spreads when infected people expel the bacterium into the air; TB claimed 1.6 million lives and infected 10.6 million people in 2021. The World Health Organization estimates that nearly 2 billion people across the globe are infected with Mtb. The COVID-19 pandemic impeded global progress toward control of TB by diverting resources from TB prevention and treatment efforts. Available resources were dedicated to combatting the COVID-19 pandemic, which also led to a reduction in TB case reporting, resulting in a later detection and treatment of TB and creating the opportunity for additional community transmission of infection. If proved effective in larger clinical trials, AAHI’s vaccine candidate will be a unique asset in the arsenal of control tools to reverse the resurgence of TB. Additional studies will be needed to scaleup manufacturing and establish that the vaccine candidate will protect populations in low-resource communities most burdened by TB, such as in Southeast Asia and Sub-Saharan Africa, that struggle to maintain even simple refrigeration for vaccine transport and storage. By reducing the need for cold chain, AAHI’s TB vaccine candidate may significantly advance the global fight against TB. “Equitable access to vaccines has been significantly impeded by cold-chain requirements and, as observed with COVID-19, no one is safe until everyone is safe,” explains Corey Casper, MD, MPH, Chief Executive Officer at AAHI. “The development of a safe and immunogenic temperature-stable TB vaccine is a major achievement towards our mission of bringing vaccines to people who most need them, regardless of geography.” The research and development of the thermostable single-vial TB vaccine candidate received support from multiple partners: NIH/National Institute of Allergy and Infectious Diseases (NIAID), Saint Louis University, Lyophilization Technology Inc., Advanced Biosciences Laboratories, DF/Net Research, and the Center for Biocatalysis and Bioprocessing at the University of Iowa. The project described here is supported by NIAID contract HHSN272201400041C. The views and conclusions contained herein are those of the authors and should not be interpreted as necessarily representing the official policies or endorsements, either expressed or implied, of the U.S. Government. AAHI is a nonprofit biotech research institute located in Seattle, Washington, that combines the high-quality science of an academic research organization with the product-development capabilities of a biotech company to help combat some of the world’s deadliest diseases, including COVID-19, cancer, fungal and parasitic infections, and other non-communicable diseases. For nearly three decades, AAHI, previously known as the Infectious Disease Research Institute, has focused on creating immune-enhancing technologies that improve the body’s natural response to disease. Through collaborations, AAHI brings innovation from the lab to the clinic to the people, furthering AAHI’s mission to bring together the best experts, technologies, and platforms to create accessible, high-quality products and solutions. AAHI is working to build a world in which every person has access to tools that harness their immune system and allow them to live a healthy life free of illness and disease. For more information, go to AAHI.org or follow us on LinkedIn. View source version on businesswire.com: Contacts Casey Benadof Media@aahi.org (206) 960-1479 Source: The Access to Advanced Health Institute Smart Multimedia Gallery Photo Raodoh Mohamath, Principal Research Associate and Author, in AAHI's Laboratories (Photo: Business Wire) Logo View this news release and multimedia online at:

VaccineClinical ResultPhase 1

06 Mar 2023

·www.sciencedaily.com

Temperature-stable TB vaccine safe, prompts immune response

A clinical trial testing a freeze-dried, temperature-stable experimental tuberculosis (TB) vaccine in healthy adults found that it was safe and stimulated both antibodies and responses from the cellular arm of the immune system. A clinical trial testing a freeze-dried, temperature-stable experimental tuberculosis (TB) vaccine in healthy adults found that it was safe and stimulated both antibodies and responses from the cellular arm of the immune system. The Phase 1 trial was supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. A non-temperature stable form of the candidate previously had been tested in several clinical trials. However, this was the first clinical trial of any subunit TB vaccine candidate in a temperature-stable (thermostable) form. Results are published in Nature Communications. The experimental vaccine, ID93+GLA-SE, was developed by Christopher B. Fox, Ph.D., and scientists at the Access to Advanced Health Institute (formerly the Infectious Disease Research Institute) in Seattle. It is a recombinant subunit vaccine made from four proteins of Mycobacterium tuberculosis bacteria combined with GLA-SE, an immune-stimulating adjuvant. The freeze-dried formulation does not require refrigeration and is mixed with sterile water just prior to injection. Thermostable vaccines are desirable in settings where maintaining cold or frozen vaccines for long periods can be costly and difficult. The current trial investigated whether administering temperature-stable vaccine containing both ID93 and GLA-SE in a single vial would be as effective at inducing an immune response as a regimen in which non-thermostable ID93 and liquid GLA-SE are held in two vials and combined prior to injection. A single-vial presentation of a thermostable vaccine would have clear advantages in ease of storage, transport and administration, the investigators note. Daniel F. Hoft, M.D., Ph.D., director of the Saint Louis University Center for Vaccine Development, led the single-site trial at the university's School of Medicine. Twenty-three participants received the thermostable single-vial regimen, while 22 participants received the two-vial, non-thermostable regimen. Both vaccine presentations were safe and well-tolerated. Recipients of the single-vialled thermostable vaccine had robust T-cell responses and produced higher levels of antibodies in the blood than those receiving the non-thermostable two-vial presentation. The investigators note some limitations in this small trial. For example, no established correlates of protection define what immune responses are required for vaccine-induced protection from TB disease. Therefore, it is not possible to say whether the enhanced immune responses seen in the thermostable vaccine formulation would translate to improved protective vaccine efficacy. Nevertheless, they conclude, results of this trial demonstrate "a proof-of-concept that adjuvant-containing vaccines can be formulated in a freeze-dried single-vial presentation without detrimentally impacting clinical immunogenicity or safety characteristics."

Clinical ResultVaccinePhase 1Immunotherapy

100 Deals associated with Glucopyranosyl lipid A

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Indication	Highest Phase	Country/Location	Organization	Date
Influenza, Human	Phase 2	US	Protein Sciences Corp.	01 Jun 2010
Non-Hodgkin Lymphoma	Phase 2	-	Merck & Co., Inc.	-
Merkel Cell Carcinoma	Phase 1	-	Merck & Co., Inc.	-
Sarcoma	Phase 1	-	Merck & Co., Inc.	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02406781 (PEMBROSARC, Pubmed) Manual	Phase 2	Soft Tissue Sarcoma	17	Cyclophosphamide+Pembrolizumab+G 100	xhhcnxerfb(azdmykbenx) = tsuhcdhejo vuobrxvwah (ffngajyhti, 1.5 - 36.4)	Negative	27 Oct 2022
NCT02501473 (3475-174 \| IMDZ-G142 \| MK-3475-174, CTgov)	Phase 1/2	Follicular Lymphoma	52	G100 (Part 1: Local Radiation + G100 5μg/Tumor)	dtlnshevet(vastifpuie) = gtqkilseac znsztovivv (wcjpdylakh, isnxojwmdu - zycehwijnd) View more	-	09 Sep 2020
				G100 (Part 1: Local Radiation + G100 10μg/Tumor)	dtlnshevet(vastifpuie) = qktnpqqawh znsztovivv (wcjpdylakh, zghjcxwqse - whgpyastkg) View more
AACR2017	Not Applicable	Sarcoma	15	IT G100	yqduhtufbo(cthhgnqwbs) = vwldxcnjjm rffphmvhgz (moxuxtuweg ) View more	-	01 Jul 2017
				G100 (Radiation)	fttkcsrogy(jyiclqfhse) = hcdlonrwfi ihfzwlyclc (ivsxivebyx )
NCT02501473 (3475-174 \| IMDZ-G142 \| MK-3475-174, ASCO2017) Manual	Phase 1/2	Follicular Lymphoma	-	Glucopyranosyl lipid A	uyeqnrbcpl(ihwhjuzjee) = none dvclblrypd (tiaelyzwka ) View more	Positive	05 Jun 2017
NCT02035657 (ASCO2016) Manual	Phase 1	Merkel Cell Carcinoma	10	radiotherapy+G100 (loco-regional MCC)	iajnzeggal(eienoefoyo) = mostly grade 1/2 (injection site reactions) zukubonqzc (jlupgfeqij )	Positive	05 Jun 2016
				radiotherapy+G100 (metastatic MCC)

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