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Can Vaccines Curtail Alaska's Tuberculosis Outbreak

Alaska TB testing and BCG vaccinations under utilized

January 22, 2023

Fact checked by Robert Carlson, MD

Breast Cancer Remains Most Clinically Studied Disease

Breast cancer clinical trials require AI tools

January 19, 2023

Fact checked by Robert Carlson, MD

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The Janssen Pharmaceutical Companies of Johnson & Johnson and a consortium of global partners announced the results of an independent, scheduled data review of the Phase 3 Mosaico study of Janssen's investigational HIV vaccine regimen.

The study's independent Data and Safety Monitoring Board (DSMB) determined that the regimen was ineffective in preventing HIV infection compared to placebo.

In light of the DSMB's determination, the Mosaico clinical trial was discontinued.

Mosaico began in 2019 and completed vaccinations in October 2022.

The study included approximately 3,900 cisgender men and transgender people who have sex with cisgender men and/or transgender people, who represent groups and populations vulnerable to HIV, at over 50 trial sites in Argentina, Brazil, Italy, Mexico, Peru, Poland, Puerto Rico, Spain, and the U.S.

"We are disappointed with this outcome and stand in solidarity with the people and communities vulnerable to and affected by HIV," said Penny Heaton, M.D., Global Therapeutic Area Head, Vaccines, Janssen Research & Development, LLC., in a press release on January 18, 2023.

"We remain steadfast in our commitment to advancing innovation in HIV, and we hope the data from Mosaico will provide insights for future efforts to develop a safe and effective vaccine."

The Mosaico findings align with developments in the Phase 2b “Imbokodo” clinical trial, which tested a similar HIV vaccine regimen in women in sub-Saharan Africa.

That DSMB determined in August 2021 that the experimental vaccine regimen was also ineffective in protecting against HIV acquisition.

As of January 19, 2023, the U.S. Food and Drug Administration had not approved an HIV vaccine candidate.

Vaccine Treats:

HIV

Image:

Image Caption:

by Gerd Altmann

Live Blog Update Author:

Don Hackett

Location Tags:

Leiden

Vaccine:

HIV Vaccines 2023

Avacc 11 Gonorrhea Vaccine

Avacc 11® Gonorrhea Vaccine 2023

Intravacc's Avacc 11® (NGoXIM) is the prophylactic intranasal gonorrhea candidate vaccine being developed in partnership with Therapyx Inc. This vaccine candidate consists of outer membrane vesicles (OMVs) and microsphere (ms)-encapsulated interleukin-12 (IL-12 ms) induced Th1-driven immunity, with circulating and genital antibodies to Neisseria gonorrhoeae, after intravaginal (i.vag.) administration.

Since intranasal immunization has previously been shown to induce antibody responses in both male and female genital tracts, the companies evaluated this route of immunization with gonococcal OMVs plus IL-12 ms. The administration is not a practical means of delivery. It is inapplicable to males and may not be acceptable to women. The Company's proprietary OMV platform-based gonorrhea vaccine candidate, combined with encapsulated IL-12, showed protection against subsequent infection with Neisseria gonorrhea (NG). Results were published in the peer-reviewed journal MSphere of the American Society of Microbiology on December 20, 2022.

In October 2022, Intravacc was awarded a $14.6 Million NIH/NIAID contract to develop this intranasal candidate gonorrhea vaccine further. In December 2023, mSphere published: Microencapsulated IL-12 Drives Genital Tract Immune Responses to Intranasal Gonococcal Outer Membrane Vesicle Vaccine and Induces Resistance to Vaginal Infection with Diverse Strains of Neisseria Gonorrhea. And in January 2023, the Company announced preclinical data of Avacc 11® demonstrated protection against gonorrhea infection.

Intravacc, located at Utrecht Science Park Bilthoven in the Netherlands, is a leading global contract development and manufacturing organization for infectious diseases and therapeutic vaccines. Therapyx is a privately held pharmaceutical company headquartered in Buffalo, New York.

Avacc 11® Indication

Avacc 11 is being developed to prevent infection with NG (i.e., gonorrhea). Gonorrhea remains highly prevalent, with an estimated 87 million new infections yearly. In the United States, incidence increased by 66% from 2014 to 2018, exceeding 580,000 reported cases in 2018, although the actual incidence is believed to be even greater. N. gonorrhoeae is listed by the WHO as an "urgent threat" among human pathogens because of the emergence of resistance to currently available antibiotics, and cases of extreme resistance have been reported.

Avacc 11® Vaccine News 2023

January 16, 2023 - Dr. Jan Groen, Intravacc's CEO, says: "Together with our partner Therapyx, we are very pleased with the preclinical data of the intranasal candidate vaccine Avacc 11®. This intranasal gonococcal vaccine is more suitable to fight gonorrhea infections, which are becoming increasingly resistant to antibiotic treatments.

October 5, 2022 – Intravacc announced that it had been awarded a contract with base and options that may total US$14.6 million from the US National Institute of Allergy and Infectious Diseases to develop a prophylactic intranasal vaccine against NG. Intravacc will develop a prophylactic vaccine based on its proprietary OMV platform technology.

Avacc 11® Clinical Trials

This candidate is currently being studied in mice. These study results show that i.n. immuImmunizationh gonococcal OMVs plus IL-12 ms as an adjuvant is at least as effective as i.vag. immunImmunization of the same vaccine in mice.

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Manufacturer:

Intravacc

Reviewer:

Robert Carlson, MD

Vaccine:

Avacc 11 Gonorrhea Vaccine

VIS:

PDF

Availability:

N/A

Generic:

NGoXIM

Drug Class:

Intransal Vaccine

Condition:

Gonorrhea

Last Reviewed:

Wednesday, June 28, 2023 - 07:50

Brand:

Avacc 11

Status:

Candidate

Manufacturer Country ID:

Gonorrhea Vaccines

Gonorrhea Vaccines 2024

The WHO Global Health Sector Strategy on Sexually Transmitted Infections (STIs) set goals for reducing gonorrhea incidence by vaccination by 90% by 2030. As of September 2024, no gonorrhea vaccines have been approved by the U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) to prevent gonorrhea infection. However, the United Kingdom supports vaccinations to prevent gonorrhea. A systematic review of 12 studies published in 2024 evaluated the evidence of vaccine effectiveness (VE) of meningococcal B (MenB) outer membrane vesicle (OMV) vaccines against gonorrhea and a non-OMV-based vaccine (MenB-FHbp). This study concluded that 4CMenB and MenB-OMV vaccines show moderate effectiveness against gonorrhea infection.

Repurposed Vaccines Against Gonorrhea

On November 10, 2023, the U.K.'s Joint Committee on Vaccination and Immunisation (JCVI) advised the government of a routine targeted vaccination program to prevent gonorrhea. The JCVI agreed that a targeted program should be initiated using the 4CMenB (Bexsero®) vaccine for the prevention of gonorrhea in those who are at most significant risk of infection. In addition, a modeling study indicated that vaccinating at-risk people could prevent 110,000 gonorrhea cases in England. Meningococcal (MenB-4C, Bexsero) vaccination is recommended in France against Gonorrhea.

A Research Letter published by the JAMA Network Infectious Diseases on August 31, 2023, concluded that the Outer Membrane Vesicles-based meningococcal group B vaccine was 47% (95% CI, 13%-68%) effective in preventing gonorrhea among recipients aged 18 to 29. These results are consistent with other study findings that OMV-based vaccines may offer protection against gonorrhea. Other STI vaccine news (herpes, HPV, mpox) is posted at this link.

On February 19, 2023, Mark Mascolini reported a meningococcal vaccine (4CMenB) continued to cut the risk of STIs in MSM using preexposure prophylaxis (PrEP) in the DOXYVAC trial. A study published in Clinical Infectious Diseases on June 1, 2022, suggests that a meningococcal serogroup B vaccine may offer cross-protection against gonorrhea infection. Clinical studies (April 22) published in the Lancet Infectious Diseases reported that two doses of the 4CMenB vaccine were around 33% to 40% effective against gonorrhea in adolescents and young adults.

On July 17, 2017, a GSK-funded study concluded that exposure to MeNZB was associated with reduced rates of gonorrhea diagnosis. This is the first time a vaccine has shown any protection against gonorrhea. The results of this study provide proof of principle that can inform prospective vaccine development not only for gonorrhea but also for meningococcal vaccines.

Gonorrhea Vaccine Candidates

GSK announced on June 27, 2023, that the U.S. FDA had granted a Fast Track designation for its Neisseria gonorrhea (NgG) investigational vaccine. GSK is conducting a Phase I/II first-time in-human clinical study evaluating the vaccine candidate's safety and efficacy in individuals aged 18-50. Phase I of the study was a completed dose-escalation safety lead-in conducted in healthy adults; the Phase II segment of the study is ongoing and aims to demonstrate Proof of Concept by assessing the NgG vaccine's efficacy in healthy adults at risk of gonorrhea.

Intravacc's Avacc 11® is an experimental gonococcal vaccine consisting of outer membrane vesicles (OMVs) and microsphere (ms)-encapsulated interleukin-12 (IL-12 ms) that induces Th1-driven immunity. The prophylactic intranasal gonorrhea candidate vaccine is being developed in partnership with Therapyx Inc. Clinical study results were published in the journal MSphere of the American Society of Microbiology in December 2022. In October 2022, Intravacc was awarded a $14.6 Million NIH/NIAID contract to develop this intranasal candidate gonorrhea vaccine further. On January 16, 2024, the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator awarded $633k to Intravacc to develop a Neisseria gonorrhoeae preventive vaccine.

LimmaTech Biologics AG is advancing the development of its novel vaccine candidate targeted to prevent Neisseria gonorrhoeae infections.

UMass Chan Medical School received a U.S. National Institutes of Health (NIH) grant for the preclinical development of gonorrhea vaccine candidates identified by Evaxion. A report was published in the journal mBio in 2019.

Evaxion Biotech A/S EVX-B2 was initially designed as a protein-based prophylactic vaccine candidate. The novel preclinical data for the mRNA-version of the vaccine substantiates that AI-Immunology™ identified vaccine antigens are delivery modality agnostic and can be applied across different vaccine modalities.

Gonorrhea Vaccine News

September 9, 2024 - Evaxion Biotech A/S announced new preclinical data demonstrating the ability of its novel EVX-B2 mRNA gonorrhea vaccine candidate to eliminate gonorrhea bacteria by triggering a targeted immune response.

March 28, 2024 - The U.S. CDC Morbidity and Mortality Weekly Reports confirmed the China Gonococcal Resistance Surveillance Program revealed that the prevalence of ceftriaxone-resistant Neisseria gonorrhoeae was 8.1% in 2022, nearly three times the 2.9% prevalence reported in 2017.

February 27, 2024 - "Resistant strains of Neisseria gonorrhoeae have evaded all but one existing antibiotic (ceftriaxone)," said Erin Duffy, PhD, R&D Chief of CARB-X. "Vaccines are powerful tools in the prevention of bacterial infections. LimmaTech's vaccine project, if successful, could prevent the disease and significantly curb the spread of resistant bacteria across the globe."

January 16, 2024 - "Drug-resistant strains of Neisseria gonorrhoeae have evaded all but one existing antibiotic (ceftriaxone)," said Erin Duffy, PhD, R&D Chief of CARB-X. "Vaccines are powerful tools in the prevention of bacterial infections. With an appropriate vaccination strategy, Intravacc's vaccine project, if successful, could prevent the disease and significantly curb the spread of resistant bacteria across the globe."

November 10, 2023—The U.K.'s Joint Committee on Vaccination and Immunisation published an Independent Report agreeing that a targeted program should be initiated using the 4CMenB vaccine to prevent gonorrhea in those at the highest risk of infection.

August 31, 2023 - Researchers with the Oregon Public Health Division suggest that the meningococcal group B vaccine may offer protection against gonorrhea infection.

June 27, 2023 - GSK plc announced today the US FDA has granted a Fast Track designation for its Neisseria gonorrhoeae investigational vaccine.

April 29, 2023 - Gonorrhea Risk Reduced with Oral Antibiotic.

April 11, 2023 - The U.S. CDC published - U.S. STI Epidemic Showed No Signs of Slowing in 2021 – Cases Continued to Escalate.

March 1, 2023 - Developing advanced vaccines for STI pathogens gains U.S. NIAID support.

February 17, 2023 - Promising gonorrhea vaccine may prevent 40% of cases.

January 16, 2023 - Intravacc announced favorable preclinical data for Avacc 11®, the prophylactic intranasal gonorrhea candidate vaccine developed with Therapyx Inc. Dr. Jan Groen, Intravacc's CEO, commented, "This intranasal gonococcal vaccine is more suitable to fight gonorrhea infections, which are becoming increasingly resistant to antibiotic treatments."

December 20, 2022 - mSphere published: Microencapsulated IL-12 Drives Genital Tract Immune Responses to Intranasal Gonococcal Outer Membrane Vesicle Vaccine and Induces Resistance to Vaginal Infection with Diverse Strains of Neisseria gonorrhoeae.

September 29, 2022 - The UMass Chan Medical School received a U.S. NIH grant for the preclinical development of gonorrhea vaccine candidates identified by Evaxion, a clinical-stage biotech company in Denmark.

July 27, 2022 - Aidsmap published: Taking antibiotic after sex cuts STIs by two-thirds, 'DoxyPEP' study finds.

April 12, 2022—The Lancet published effectiveness of a serogroup B outer membrane vesicle meningococcal vaccine against gonorrhea: a retrospective observational study. MenB-4C vaccination was associated with a reduced prevalence of gonorrhea and could offer cross-protection against Neisseria gonorrhoeae.

April 11, 2022 - The journal Frontiers published: Recent Progress Towards a Gonococcal Vaccine.

January 4, 2022 - The NEJM published Eliminating gonorrhea with a Vaccine?

Gonorrhea Test

On November 15, 2023, the U.S. FDA granted marketing authorization to LetsGetChecked for the Simple 2 Test for use in adult patients ages 18. LetsGetChecked is the first OTC diagnostic test for gonorrhea with at-home sample collection to be granted marketing authorization. Before today's authorization, the only cleared tests for either condition were used with samples collected at the point of care, such as a doctor's office.

7 min read

Reviewer:

Robert Carlson, MD

Last Reviewed:

Monday, September 9, 2024 - 11:25

Description:

Vaccination offers protection from bacteria that causes gonorrhea.

Condition:

Gonorrhea

Vaccine:

Bexsero Meningitis B Vaccine

TB Vaccine Accelerator Council Announced

BCG vaccination reduces TB risks

January 17, 2023

Fact checked by Robert Carlson, MD

0 min read

During today's World Economic Forum Annual Meeting in Switzerland, Dr. Tedros Adhanom Ghebreyesus and others discuss what mechanisms can accelerate the development and deploy safe and effective tuberculosis (TB) vaccines.

The 'Ending Tuberculosis: How Do We Get There' live discussion is at this link.

While no new TB vaccine has been licensed in 100 years, the prospects for novel effective TB vaccines have improved recently, with at least 16 vaccine candidates under development.

According to the World Health Organization (WHO) 2022 Global TB report, more than 10 million people fell ill from TB, and 1.6 million died.

The WHO confirmed effective vaccines would undoubtedly be the best solution to prevent and potentially eradicate TB.

A recent WHO-commissioned study, An investment case for new TB vaccines, estimates that, over 25 years, a vaccine that is 50% effective in preventing disease among adolescents and adults could avert up to 76 million new TB cases and US$ 6.5 billion in costs.

The current century-old bacille Calmette-Guérin (BCG) vaccine continues offering disease protection.

According to a recent study funded by the U.S. NIH, BCG vaccination at birth effectively prevents TB in young children.

And on August 15, 2022, research published by Cell Reports Medicine suggested BCG protection against infectious diseases and vaccine efficacy takes 1-2 years to manifest, but the protection may last decades.

In the U.S., the BCG vaccine is a limited distributed product. BCG is only considered for people who meet specific criteria and are in consultation with a TB expert., says the U.S. CDC.

Vaccine Treats:

Tuberculosis

Image:

Image Caption:

by Anil Sharma

Live Blog Update Author:

Staff Review

Location Tags:

Davos

Vaccine:

Bacille Calmette-Guerin (BCG) Vaccine

0 min read

The Coalition for Epidemic Preparedness Innovations (CEPI) and Vaxxas today announced an agreement to advance the development of needle-free vaccine-patch delivery technology in a project that could end the need for frozen storage of mRNA vaccines.

CEPI confirmed on January 17, 2023, it would provide up to $4.3 million (AUD6.4 million) for preclinical testing of Vaxxas' platform, a needle-free, high-density microarray patch (HD-MAP) to assess its stability, safety, and immunogenicity.

And to evaluate its potential as a rapid-response technology for heat-stable, dried-formulation mRNA vaccines.

In addition to a Phase I clinical study of a COVID-19 vaccine candidate patch, Vaxxas is performing demonstration work in preparation for clinical evaluation under contract with the U.S. government on pandemic vaccination solutions.

HD-MAPs comprise thousands of microscopic points attached to a small patch.

Each of these micro-projections contains a tiny dose of vaccine in a dried formulation. When applied to the skin, the patch delivers the vaccine to the abundant immune cells immediately below the skin surface.

HD-MAP vaccine delivery offers many advantages over more traditional vaccine administration methods.

For example, the dried form of the vaccine is more stable at higher temperatures than vaccines in liquid formulations.

Vaxxas' HD-MAPs have proven safe and tolerable in hundreds of trial participants and have been shown to induce equal or greater immune responses to injected vaccines at lower doses.

Compared with needle and syringe systems, they are also much easier to administer and are likely to have greater acceptability.

Ultimately, HD-MAP patches could enable a future in which vaccine patches could be mailed directly to peoples' homes, workplaces, and schools, avoiding the delay and inconvenience of traditional needle-and-syringe vaccine scheduling and administration.

David Hoey, Vaxxas's CEO, commented in a related press release, "Earning this significant funding from one of the world leaders in vaccine development is a great honor and validates the benefits offered by Vaxxas' HD-MAP vaccine platform in the fight against global epidemic and pandemic threats."

"In addition to providing an opportunity to get life-saving vaccines for infectious diseases that have a disproportionate impact on the most vulnerable populations around the world, the advanced development of HD-MAP delivery of mRNA vaccines could also prove very beneficial for the development of Vaxxas' internal pipeline across several diseases, including Covid-19."

Vaxxas' core technology was initially developed at The University of Queensland in Australia. The private company was established as a start-up in 2011.

On December 5, 2022, Vaxxas announced it completed a financing round that raised US$23 million in new funds.

CEPI is an innovative partnership between public, private, philanthropic, and civil organizations, launched in 2017, to develop vaccines against future epidemics. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all needy people.

Vaccine Treats:

COVID-19

Image: