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GSK plc today announced the U.S. Food and Drug Administration (FDA) had granted a Fast Track designation for its Neisseria gonorrhoeae investigational vaccine (NgG).
Fast Track designation is intended to facilitate the development and expedite the review of potentially important new drugs and vaccines to treat or prevent serious conditions with unmet medical needs.
As of June 27, 2023, the vaccine candidate is conducting a Phase II clinical trial and aims to demonstrate proof of concept by assessing the efficacy of the NgG vaccine in healthy adults.
Phil Dormitzer, Global Head of Vaccines R&D, GSK, commented in a related press release, "This designation recognizes the potential for a vaccine that could help protect millions of people across the world against the serious health consequences of infection with a bacterium that is considered a 'high priority' pathogen by the World Health Organisation."
Gonorrhoea is the second most prevalent bacterial sexually transmitted infection worldwide, with an estimated 82 million new cases yearly.
In the U.S., rates of reported gonorrhea have increased by 118% from 2009 to 2021.
Furthermore, antimicrobial resistance to gonorrhea has increased over the past 80 years, rendering many classes of antibiotics used to treat the disease ineffective.
Vaccines can play a critical role in the fight against AMR by helping prevent bacterial, viral, and other infections.
Currently, no gonorrhea-specific vaccines are approved anywhere in the world, says GSK.
However, in France, the meningococcal (MenB-4C) vaccine is recommended against gonorrhea.
And Intravacc's Avacc 11® is the prophylactic intranasal gonorrhea candidate vaccine.
As of June 28, 2023, gonorrhea vaccine and treatment news have been published by Precision Vaccinations.
The U.S. Centers for Disease Control and Prevention (CDC) today republished an expanded global polio outbreak Travel Health Notice.
On June 26, 2023, the CDC identified thirty destinations with circulating poliovirus.
And, before travel to any destination listed, adults who previously completed the full, routine polio vaccine series may receive a single, lifetime booster dose of a polio vaccine.
In the U.S., the IPV vaccine has been offered since 2000. Oral polio vaccines are provided in various countries in 2023.
For example, the new nOPV2 vaccine has been administered over 620 million times in recent years.
The CDC says polio is a crippling and potentially deadly disease that affects the nervous system.
Because the virus that causes polio lives in the feces of an infected person, people infected with the disease can spread it to others when they do not wash their hands well after defecating.
People can also be infected if they drink water or eat food contaminated with infected feces.
Most people with polio do not feel sick. Some people have only minor symptoms, such as fever, tiredness, nausea, headache, nasal congestion, sore throat, cough, stiffness in the neck and back, and pain in the arms and legs.
In rare cases, polio infection causes permanent loss of muscle function. Polio can be fatal if the muscles used for breathing are paralyzed or if there is an infection of the brain, says the CDC.
Xinhua recently reported Israel had detected a case of mpox for the first time in 2023.
In a statement on June 23, 2023, Israel's Health Ministry confirmed that a man who traveled from Portugal to Israel contracted mpox despite being vaccinated (JYNNEOS®, MVA-BN) against the virus.
An epidemiological investigation revealed that no other people had contact with the man and were exposed to the virus.
According to the ministry, vaccinated people may contract the mpox again if others around them have a high viral load.
Between May and October 31, 2022, Israel's ministry reported 262 mpox cases were diagnosed.
On June 24, 2023, the World Health Organization (WHO) published Situation Report #25 for the multi-country outbreak of mpox, which provides details on the latest epidemiology and recommendations for the care of pregnant women with mpox.
Between January 2022 and June 11, 2023, 58 mpox cases were reported by pregnant women.
Since June 19, 2023, 114 new confirmed or probable mpox cases and (1) recent death have been reported to WHO.
Furthermore, 19 of the 112 affected countries have reported new mpox cases within the last 21 days. Six of these countries are in the Region of the Americas, and five are in the European Region.
In the U.S., the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices presented various mpox outbreak data and published Notes from the Field on June 23, 2023.
As of June 27, 2023, mpox breakthrough cases were recently confirmed in Chicago, Denver, New Jersey, and New York City.
IAVI announced today that the initial participants had been vaccinated with a Sudan virus (SUDV) vaccine candidate in a first-in-human Phase I clinical trial in the U.S.
As of June 27, 2023, the IAVI C108 IAVI-sponsored trial is funded by the Biomedical Advanced Research and Development Authority (BARDA).
IAVI C108 will occur at two U.S.-based clinical trial sites, where the vaccine candidate will be administered intramuscularly at three dosage levels.
This is essential news since there are no SUDV vaccines available.
Furthermore, like the Zaire Ebolavirus (ZEBOV), SUDV is responsible for recurring viral hemorrhagic fever outbreaks across sub-Saharan Africa.
In past Ebola outbreaks, the estimated case fatality ratios of SUDV disease have varied from 41% to 100%.
This study evaluates the safety and immunogenicity of an investigational SUDV vaccine candidate previously donated to IAVI by Merck. This investigational SUDV vaccine candidate was produced for IAVI from an existing investigational bulk drug substance previously manufactured by Merck.
IAVI is responsible for all aspects of the candidate’s future development, including demonstrating equivalence between this SUDV vaccine candidate and IAVI’s other SUDV vaccine candidate, which utilizes the same viral vector but is manufactured using a new production platform.
The SUDV vaccine candidate being evaluated in IAVI C108 uses the same recombinant vesicular stomatitis virus (rVSV) viral vector platform as ERVEBO®, Merck’s single-dose ZEBOV vaccine, which is licensed in the U.S., U.K., European Union, Canada, Switzerland, and 10 African countries.
“IAVI C108 represents an important first step toward generating the data needed for eventual licensure of an rVSV-SUDV vaccine. The development and licensure of ERVEBO® have resulted in an important tool in Ebola Zaire outbreak responses. If proven effective, we’re hopeful that a vaccine candidate built on the same viral platform will be similarly important in future SUDV outbreaks,” said Swati Gupta, Ph.D., vice president and head of emerging infectious diseases and epidemiology at IAVI, in a related press release.
The rVSV platform has been used extensively in adults and children. The underlying vesicular stomatitis virus is a common animal virus that does not cause serious illness in humans and has been investigated extensively as a vaccine vector.
In the vaccine platform, it is engineered to encode a surface protein from a target pathogen, in this case, SUDV, to prompt the body to mount an immune response.
Much of the research and development on IAVI’s rVSV platform is performed at the IAVI Vaccine Design and Development Lab in Brooklyn, New York.
The U.K. The Foreign, Commonwealth, and Development Office (FCDO) recently advised against all but essential travel to various states in Mexico as some areas of Mexico have a high crime rate and civil unrest.
On June 22, 2023, the FCDO stated that when considering travel to any of these areas in Mexico, including Cancun, please see the Safety and Security section for more detailed information on the risks.
Additionally, if you plan to pass through another country to return to the U.K., check the travel advice for your transiting country says the FCDO.
From a health perspective, the U.S. CDC issued a Disease Outbreak News, confirming an outbreak of suspected fungal meningitis associated with surgical procedures performed under spinal anesthesia.
The CDC suggests speaking with a healthcare provider about travel vaccine options, such as dengue, one month before visiting Mexico.
Sanofi - Aventis Groupe today announced positive topline Phase 2b clinical data in atopic dermatitis support amlitelimab as a potential first and best-in-class novel investigational anti-OX40-ligand monoclonal antibody.
The primary endpoint was met in the Phase 2b study (STREAM-AD) of amlitelimab in adults with moderate-to-severe atopic dermatitis whose disease cannot be adequately controlled with topical medications or for whom topical medications are not a recommended treatment approach.
Amlitelimab is a fully human non-depleting monoclonal antibody that binds to OX40-Ligand, a key immune regulator.
It can be a first-in-class treatment for various immune-mediated diseases and inflammatory disorders, including moderate-to-severe atopic dermatitis and asthma.
By targeting OX40-Ligand, amlitelimab aims to restore immune homeostasis between pro-inflammatory and regulatory T cells.
Naimish Patel, M.D., Head of Global Development, Immunology and Inflammation, Sanofi, commented in a press release on June 27, 2023, "While we have made significant strides in the treatment of atopic dermatitis, there are patients who are still in need of new options."
"We believe that the results from this Phase 2b study with amlitelimab support our perspective that targeting OX40-Ligand has the potential to provide a first and best-in-class treatment option that addresses type 2 and non-type 2 inflammation to meet the individual needs of people living with atopic dermatitis and other chronic inflammatory diseases."
"We look forward to advancing into a larger Phase 3 clinical development program and continuing to drive momentum in our Immunology pipeline to deliver first or best-in-class treatments."
In this dose-ranging study, treatment with amlitelimab resulted in statistically significant improvements in average Eczema Area and Severity Index score from baseline at 16 weeks compared to placebo for all four subcutaneous doses that were studied.
There were also improvements in key secondary outcome measures, and continued improvements were observed through week 24 in primary and key secondary outcomes.
Biomarker results support an effect on both type 2 and non-type 2 pathways.
Amlitelimab was well-tolerated in the study across all dose arms, and no new safety concerns were identified.
Furthermore, Amlitelimab is under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.
The U.S. NIH says atopic dermatitis, often referred to as eczema, is a chronic (long-lasting) disease that causes inflammation, redness, and irritation of the skin. It is a common condition that usually begins in childhood.
However, anyone can get the disease at any age.
And atopic dermatitis is not contagious, so it cannot be spread from person to person.
AC Immune SA today announced that it had received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its anti-amyloid beta (Abeta) active immunotherapy (vaccine)-candidate, ACI-24.060, for the treatment of Alzheimer’s disease (AD).
Confirmed on June 27, 2023, this news follows FDA clearance of the Investigational New Drug (IND) application enabling expansion to the USA of the ongoing Phase 1b/2 ABATE study of ACI-24.060 in patients with AD and individuals with Down syndrome (DS).
Furthermore, the first individual with DS has been dosed in ABATE.
Dr. Michael Rafii, Medical Director of the Alzheimer’s Therapeutic Research Institute, Professor of Neurology at the Keck School of Medicine, and the Principal Investigator of the clinical trial, commented in a press release, “Despite representing the world’s largest population that is genetically at high risk for AD, individuals with DS are vastly underserved and underrepresented in clinical trials."
"I applaud AC Immune for seeking to address the urgent needs of this population and believe ACI-24.060 holds great promise as a novel therapy that can lower Abeta plaques to delay, or perhaps even prevent, the onset of clinical dementia symptoms in AD and DS-related AD."
"Moreover, I believe the potential safety, efficacy, and logistical advantages of a vaccine over monoclonal antibodies strongly support the development of therapeutics such as ACI-24.060 as the next generation of anti-Abeta therapies.”
Alzheimer's vaccine candidates are not FDA-approved as of June 27, 2023.
The journal Nature Communications recently published an article that concluded interim data from 2 parts of the phase 1/2 clinical trial support the continued development of mRNA-1010.
The mRNA-1010 vaccine candidate elicited either higher or comparable immune responses to a standard-dose, influenza quadrivalent inactivated vaccine.
Overall, these first-in-human safety and immunogenicity findings highlight, on June 19, 2023, the potential of the mRNA platform to improve the effectiveness of influenza vaccines.
Vaccines using mRNA technology are readily amenable to antigenic drift and shift in influenza strains, allowing for rapid deployment of vaccines. In addition, mRNA-based platforms allow for the expression of multiple antigens, raising the possibility for an increased breadth of protective responses against seasonal influenza or multiple respiratory diseases.
However, approved cell-based influenza vaccines, such as Flucelvax® Quadrivalent (QIVc), currently produce an exact antigenic match for circulating flu trains.
Further, based on findings with mRNA-1273, an mRNA-based vaccine against SARS-CoV-2, mRNA vaccines may also induce strong cellular immune responses and prolonged germinal center reactions that can improve protection in older adults, a population at particular risk for infection and severe outcomes.
While mRNA-1010 had an acceptable safety profile in this trial, transient solicited adverse reactions were more common after mRNA-1010 than with the active comparator.
Additional clinical trials are ongoing to assess further this vaccine candidate's safety, efficacy, and immunogenicity and a licensed influenza vaccine comparator (NCT05566639 and NCT05415462).
Moderna, Inc. was involved in the study design, data collection and analysis, and the writing of this manuscript. Moderna funded this study.
