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Herpes Zoster vaccination is recommended for many people in May 2025
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Recent research suggests that a herpes zoster (HZ) vaccine, commonly referred to as the shingles vaccine, may reduce the risk of receiving a dementia diagnosis following vaccination.

According to a study published in JAMA on April 23, 2025, there is evidence of a beneficial effect of herpes zoster vaccination in preventing or delaying dementia, which is more likely to be causal than the associations reported in existing correlational evidence.

In this quasi-experimental study using electronic health record data from Australia, being eligible for herpes zoster vaccination based solely on date of birth significantly decreased the probability of receiving a new dementia diagnosis during 7.4 years by 1.8 percentage points.

A similar study conducted in Wales also showed that HZ vaccination appears to prevent or delay the onset of dementia by about 20%.

These researchers wrote, 'this study and the analysis in Wales provide evidence that is more robust to confounding concerns (eg, healthy vaccinee bias) than is the existing associational evidence.'

In the United States, shingles vaccination services are offered at most pharmacies in April 2025.

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Herpes vaccine candidates are conducting research in April 2025
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Shingles vaccines are available worldwide in 2025
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Most older adults and immunocompromised individuals are familiar with herpes zoster (HZ), which causes painful rashes upon activating the varicella-zoster virus (VZV).

Although the U.S. FDA has approved a vaccine (Shingrix®) for preventing shingles, its administration is commonly associated with high reactogenicity.

On March 14, 2025, results from a new study published by the journal Nature focused on ten different vaccine candidate designs using two different codon optimizations targeting the VZV glycoprotein E (gE).

For this evaluation, researchers developed several VZV modRNA vaccine candidates targeting the glycoprotein gE, one of the most abundant proteins on the surface of the virion.

A subset of mRNA constructs was formulated into lipid nanoparticles and assessed for their ability to induce specific cellular and humoral immune responses in mice following vaccination.

Notably, the selected mRNA vaccine candidates induced high antibody levels and robust CD4+ and CD8+ immune responses.

Moreover, this study showed that alternate lyophilized vaccines provide comparable immunogenicity to liquid frozen formulations and are stable under long-term storage conditions.

Some of these investigational VZV modRNA candidates, including a lyophilized presentation, are currently being tested in a Phase I/II clinical study sponsored by Pfizer Inc.

This study's primary completion estimate is in late 2025.

While somewhat similar, no herpes simplex virus (HSV) vaccines are approved for use in 2025. However, this is an HSV mRNA vaccine candidate conducting research as of March 2025.

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The World Health Organization (WHO) recently published a technical brief on encephalitis, a serious, life-threatening neurological condition characterized by brain inflammation.

On February 17, 2025, the WHO stated that different pathogens, such as herpes simplex virus (HSV), can cause encephalitis. 

Some pathogens, like the Japanese encephalitis virus (JEV), are spread by mosquitoes and ticks, but vaccination can prevent transmission.

As of 2025, JEV outbreaks are the leading cause of viral encephalitis in twenty-four countries in the WHO South-East Asia and Western Pacific Regions, exposing more than 3 billion people to infection risks.

For example, the WHO reported various JEV cases across Australia, including Queensland, New South Wales, South Australia, Victoria, the Australian Capital Territory, Tasmania, Western Australia, and the Northern Territory.

Encephalitis affects people across all age groups, has high mortality, and often leads to significant long-term complications (sequelae), including hearing loss, seizures, limb weakness, and difficulties with vision, speech, language, memory, and communication.

Globally, in 2021, encephalitis was the fourth leading cause of neurological health loss in children aged under 5 years and the 13th across all age groups.

"Encephalitis is a growing public health challenge, and by prioritizing it within global and national health agendas and strengthening collaboration, we can reduce its impact and save lives," said Dr Tarun Dua, Head of the Brain Health Unit, WHO, in a press statement.

The WHO technical brief, which forms part of the implementation of the broader Intersectoral global action plan on epilepsy and other neurological disorders, draws attention to the lack of access to essential care, especially in low-and middle-income countries. 

While no HSV vaccines are authorized, the U.S. FDA-approved JEV vaccine, IXIARO®, is available at clinics and pharmacies nationwide. According to the U.S. CDC, vaccination is recommended before visiting JEV outbreaks.

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Despite decades of clinical research, Herpes Simplex Virus (HSV) remains among the most prevalent infectious pathogens, impacting millions annually. While herpes vaccine candidates continue to progress in clinical trials, none have been approved.

However, an innovative HSV therapy may soon become available.

Theralase® Technologies Inc. announced today that the previous University of Manitoba research has been validated, proving that Ruvidar® is safe and effective in the inactivation of Herpes Simplex Virus, Type 1 (HSV-1), in an animal model.

In the latest Theralase® research, announced on February 10, 2025, Balb/C mice were infected with the human HSV-1 virus. On day 6 post-infection, 20 uL of a 1% Ruvidar® solution was applied topically over the area of well-developed lesions once daily for four days.

Four days of Ruvidar treatment resulted in complete healing of the HSV-1 cutaneous lesions.

In a press release, the Company stated that these 'results support the safety and efficacy of topically applied non-light activated Ruvidar® against cutaneous HSV-1 lesions in a mouse model.'

Kevin Coombs, B.A., M.A., Ph.D., professor of medical microbiology and infectious diseases at the Max Rady College of Medicine, University of Manitoba (retired), stated, "I am delighted that Theralase® researchers were able to successfully translate my team's cellular inactivation of HSV into a safe and effective therapy in an animal model."

"Their research may prove to be instrumental in developing a clinical program that will have real-world impacts on the lives of billions of people infected with this prolific disease."

Effective U.S. FDA-approved anti-herpetic drugs available in 2025 include acyclovir and later-generation derivatives (penciclovir, valacyclovir, famciclovir, and ganciclovir), which inhibit viral DNA synthesis. 

Independent research by the University of Manitoba verifies that Ruvidar is more effective than acyclovir in inactivating HSV after infection.

According to the Company's press release, Ruvidar inhibited HSV-1 replication at significantly lower concentrations.

The effects of Ruvidar versus acyclovir on HSV-1 yields when added 24 hours post-infection (hpi). Vero cells were infected with HSV-1 at a Multiplicity of infection ~ 1.5, incubated for 24 hours, and then treated at 24 hpi with indicated drug concentrations for an additional 44 hours.

Virus yields were then determined, and reductions in virus yields were compared to non-treated controls.

Roger DuMoulin-White, B.Sc., P.Eng, Pro.Dir., President and Chief Executive Officer, Theralase, stated, "Based on the success of Theralase®'s latest research, Theralase® plans to develop a vaccine and therapeutic for the prevention and treatment of HSV, with clinical development to commence thereafter."

This announcement was based on an animal model study, indicating the product is not commercially available.

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Curevo Vaccine today announced positive updated immunogenicity and safety data from its Phase 2 trial of amezosvatein (CRV-101) head-to-head versus Shingrix® in participants 50 years of age and older.

“The Day 421 Phase 2 data continue to support our view that amezosvatein has a comparable effect on the human immune system as Shingrix,” said Dr. Guy De La Rosa, Curevo’s Chief Medical Officer, in a press release on January 12, 2025.

CRV-101 is a non-mRNA adjuvanted subunit vaccine. Similar to Shingrix, amezosvatein uses a subunit protein antigen called glycoprotein ‘E’ (gE). Targeting the gE antigen is proven to elicit a long-term, protective immune response to prevent shingles.

Also, like Shingrix, amezosvatein uses an adjuvant targeting the TLR4 pathway to boost the immune response to the gE antigen.

The SLA-SE adjuvant formulation was developed at the Access to Advanced Health Institute. Amezosvatein was licensed from the Mogam Institute for Biomedical Research, a research institute funded by South Korea’s GC Biopharma.

“Amezosvatein’s non-inferior immunogenicity data and comparable herpes zoster case data, combined with amezosvatein’s improved tolerability versus Shingrix in this Phase 2 trial we reported this time last year, provide us with great confidence and excitement to continue development of this vaccine.”

“This is in a market expected to be worth over $5 billion in 2025,” noted George Simeon, Curevo’s Chief Executive Officer.

Currently, the U.S. CDC recommends two doses of the recombinant zoster vaccine (RZV, Shingrix) to prevent shingles and related complications in adults over> 50. And the CDC recommends two doses of RZV for adults who are or will be immunodeficient or immunosuppressed.

In 2025, Shingrix is offered at various pharmacies.

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MDX2201 Epstein-Barr Virus Vaccine

MDX2201 Epstein-Barr Virus Vaccine Clinical Trials, Indication, News

ModeX Therapeutics's MDX2201, an Epstein-Barr virus (EBV) vaccine candidate, is based on ModeX's ferritin nanoparticle vaccine platform, which can express as many as 24 copies of a recombinant antigen on its surface to enhance the presentation of key components of the virus and stimulate durable protective immunity. MDX2201 presents antigens from four viral proteins involved in viral entry into host cells. These include a recombinant antigen designed from the proteins gH, gL, and gp42 and an antigen derived from gp350. By using ModeX's multi-targeted approach, this combination inhibits infection in two cell types, B and epithelial cells, which contrasts with efforts previously focused on gp350 alone.

This EBV vaccine technology was the subject of preclinical data published in May 2022 in Science Translational Medicine.

ModeX, an OPKO Health company, is based in Weston, Massachusetts. For more information, please visit www.modextx.com. OPKO (NASDAQ: OPK) is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, please visit  www.opko.com.

MDX2201 Epstein-Barr Virus Vaccine Indication

According to the U.S. CDC, EBV is a member of the herpes virus family and is one of the most common human viruses. Most people are infected with EBV at some point during their lives. Since over 90% of adults have been infected with EBV, most adults will show antibodies to EBV. The presence of antibodies to both VCA and EBNA suggests past infection. EBV can cause infectious mononucleosis, also called mono, and is associated with other illnesses, including some specific types of cancer and multiple sclerosis. A sample of the patient's blood is required to perform a monospot test. There are currently no U.S. FDA-approved vaccines or treatments for EBV or herpes infections.

MDX2201 Epstein-Barr Virus Vaccine News

January 7, 2025 - "We are grateful to the participants and physicians who are actively engaged with Merck in our joint efforts to explore the potential of MDX2201 as a novel vaccine against EBV," said Elias Zerhouni, M.D., President and Vice Chairman of OPKO.

March 8, 2023 - OPKO Health, Inc. announced that ModeX Therapeutics, Inc., an OPKO Health company, entered into an exclusive worldwide license and collaboration agreement with Merck for the development of MDX-2201, ModeX's preclinical nanoparticle vaccine candidate targeting EBV.

MDX2201 Epstein-Barr Virus Vaccine Clinical Trials

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Trial to Evaluate the Safety, Tolerability, and Immunogenicity of V350A and V350B in Healthy Participants.

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ModeX Therapeutics Inc. today announced the dosing of the first participant in the Phase I clinical trial of an Epstein-Barr virus (EBV) vaccine candidate, MDX2201.

The U.S. CDC says EBV, a member of the herpes virus family (human herpesvirus 4), is one of the most common human viruses. Most people (90%) are infected with EBV at some point during their lives. EBV infection can affect a person's brain, spinal cord, and nerves.

As of January 8, 2025, there are no U.S. FDA-approved vaccines or treatments for EBV or herpes infections.

This EBV vaccine is based on ModeX’s ferritin nanoparticle platform. Its surface can express as many as 24 copies of a recombinant antigen, enhancing the presentation of key virus components and stimulating durable protective immunity.

MDX2201 presents antigens from four viral proteins involved in viral entry into host cells. These include a recombinant antigen designed from the proteins gH, gL, and gp42 and an antigen derived from gp350.

This combination, using ModeX’s multi-targeted approach, inhibits infection in two cell types: B and epithelial cells. This contrasts with efforts previously focused on gp350 alone.

“EBV infection can cause serious illness and pose long-term risks of cancer and autoimmunity..... Our nanoparticle vaccine aims to stimulate protective immunity in patients and prevent these diseases,” said Gary Nabel, M.D., Ph.D., President and Chief Executive Officer of ModeX and Chief Innovation Officer of OPKO, in a press release on January 7, 2025.

This study's (V350-001) estimated completion date is November 18, 2026.

MDX2201 is being developed in collaboration with Merck.

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