Monday, April 15, 2024

Herpes Vaccine Clinical Trials 2021

Herpa Greens Herpes Vaccine Formula

Moderna Starts Clinical Trials for HIV Vaccine

The key to the HerpaGreens formula, according to the researchers, is an organic blend of 57 cleansing herbs, grade A nutrients, prebiotics, probiotics, and specific vitamins. These include a superfood, antioxidant, and mushroom blend, a nutrient-dense herb and plant extracts blend, prebiotic fiber and digestive enzyme complex, and a probiotic blend.

The superfood, antioxidant, and mushroom blend contains quercetin sources such as asparagus, broccoli, green bell pepper, kale, and orange resveratrol sources, such as blackberries, blueberries, cranberries, raspberries, and concord grapes antioxidant sources, such as apricot, beet-root, cabbage, camu camu, cauliflower, cherry, cucumber, coconut juice, organic banana, parsley, pineapple, spirulina, spinach, tomato, and wheatgrass and also a blend of maitake, reishi, and shiitake Mushrooms.

The nutrient-dense herb and plant extracts blend contain sources of curcumin such as turmeric root, nutrient-dense acacia gum, and other herbs and extracts like acerola cherry extract, ashwagandha root, cinnamon bark, eleuthero root, ginseng root, ginger root, green tea leaf, mangosteen extract, and stevia leaf extract.

Researchers Refine Experimental Gene Therapy For Herpes

Two years after scientists showed that an experimental gene therapy for herpes can knock out most latent infection in mice, new tests reveal that it also suppresses the amount of transmissible virus shed by the treated animals.

It is encouraging news from researchers at Fred Hutchinson Cancer Center, where laboratory studies aimed at curing herpes simplex virus infections have continued despite disruptions caused by the COVID-19 pandemic.

Drs. Keith Jerome and , the Hutch virologists leading the research effort, report the treatment dramatically reduced or even eliminated viral shedding in treated mice compared to controls, an important milestone that the scientists also hope to achieve if the experimental therapy is eventually proven safe enough to test in humans.

âIf you ask people living with herpes what they care about, what they care most about is whether they have to worry about giving this virus to someone else, and shedding is how that happens,â Jerome said.

During multiple experiments, the researchers found substantial reductions in oral and genital viral shedding in the treated mice, with many of those treated showing no detectable virus shed.

The latest results were posted today on bioRxiv, a preprint server for scientists to report findings quickly, but without a critique from other researchers in the field â the âpeer reviewâ that accompanies publication in academic journals. As such, these findings are considered preliminary.

Trivalent Mrna Vaccine To Prevent Genital Herpes

In vivo transcribed mRNA was evaluated in the 1990s in preclinical models as a possible delivery mechanism for curing medical illnesses.53,54 However, problems emerged because of mRNA instability, undesirable inflammatory immune responses, and inefficient delivery. Years of innovative work by Kariko and Weissman yielded the technology to overcome these setbacks. These investigators and their colleagues substituted uridine residues with 1-methyl-pseudouridine to reduce triggering innate immune sensors they optimized 5 cap, 5 and 3 UTRs, and polyA tail-length to improve mRNA stability they removed double-stranded mRNA by purification to avoid triggering innate toll-like receptor sensors and they used lipid LNP to deliver the mRNA to antigen presenting cells.42,55, 56, 57, 58, 59 Based on these modifications, the mRNA induced potent CD4+ T-follicular helper cell and germinal center B cell responses.48,59,60 T-follicular helper cells are critical for germinal center formation, somatic hypermutation, development of high-affinity antibodies, and effective long-term B cell memory.61, 62, 63, 64 In preclinical studies, modified mRNA vaccines provide extraordinary protection in animal models for Zika, influenza, HSV-1, and HSV-2.47,49,58,64

You May Like: Can You Get Herpes If You Wear Protection

What Should I Do If I Catch Herpes

If you catch herpes, you should speak to a doctor or visit your local sexual health clinic. You can get tested for herpes or do a test at home. You can get treatment like antiviral medications to relieve symptoms and make your herpes outbreak shorter. To prevent herpes from being passed on to other people, you should use a condom.

Hsv Pathogenesis And Replication

Search

Replication is a multi-step process. Post-infection, HSV glycoproteins interact with and attach to the cell. The viral envelope then fuses with the cell membrane, releasing its contents into the cell. DNA is uncoated and transported into the nucleus when nucleocapsid fuses with the viral envelope . Here, immediate-early genes are transcribed . Primary herpes infection involves replication within epithelial cells, with an incubation period of 46 days. Mature virions are then transported to the cell membrane, where they are released, causing cell lysis and local inflammation. Replication continues until host immune responses contain the initial infection .

Herpesvirus ascends peripheral sensory nerves to spread to the trigeminal ganglion, where latent infection develops. Latent virus can be induced to reactivate. Reactivation has been associated with various stimuli including stress, infections, and UV light exposure. However, from a molecular standpoint, reactivation is a phenomenon that continues to be studied and is not clearly understood. Clinical manifestations of reactivation vary widely in terms of presentation and severity .

You May Like: What Vitamins Are Good For Herpes

A Rationally Designed Therapeutic Vaccine For Herpes

Founder and CEO, Agustin Fernand of Rational Vaccines that is developing a vaccine for herpes.

There is a pandemic raging across the world and it has nothing to do with a coronavirus. Approximately 500 million people worldwide suffer from genital herpes. Several billion more have an oral herpes infection. Herpes is a life-altering disease that can lead to chronic pain, blindness, and death, particularly in neonatal and pediatric populations and a major regulator is finally paying attention and developing a vaccine for herpes.

On July 22,Rational Vaccines, an investigational-stage company working to revolutionize the treatment of herpes announced that it had been awarded an Innovation Passport under the United Kingdoms new Innovative Licensing and Access Pathway . The designation was awarded for RVx201, a live-attenuated therapeutic vaccine the company is developing for genital herpes resulting from the herpes simplex type 2 virus.

Further Considerations For The Future Of Herpes Simplex Virus Vaccine Development

Our understanding of the complexities of herpes simplex virus pathogenesis and immune evasion is consistently evolving, along with our understanding of viral latency. Designing an effective therapeutic or prophylactic vaccine requires further understanding these processes.

Trials that had been successful in the pre-clinical realm with murine model and guinea pig models have been effective, but have not translated well in the clinical realm. Other trials like the GSK gD subunit vaccine and the GEN-003 vaccine have been suspended due to dwindling financial support . To us, the HSV-529 and G103 appear to be promising from early studies in the pre-clinical stage. Additionally, they are likely to have less issues with safety as they are not live-attenuated vaccines.

The rapid development of an mRNA vaccine for COVID-19 has re-vitalized interest in mRNA vaccines as viable options to produce viral immunity. The classical problems involving the creation of mRNA vaccines include mRNA stability and delivery systems. It remains to be seen whether mRNA vaccines might have a utility for HSV however, initial studies with the trivalent vaccine have been promising, showing increased efficacy compared to a subunit formulation .

The advantages of an mRNA vaccine were previously discussed: It does not integrate within the host genome, translates in both proliferating and non-proliferating cells, with immediate protein production for a controllable amount of time .

Don’t Miss: Is Amoxicillin Used For Herpes

Lessons Learned From Past Hsv Vaccine Clinical Trials

The vaccine clinical trials produced valuable lessons that should help improve future herpes subunit vaccines. Specifically, these trials emphasize four major gaps in our current knowledge: The need to incorporate protective herpes protein Ags, other than gB and gD, in the development of a future herpes therapeutic vaccine The need to design a vaccine strategy that induces anti-viral CD4+ and CD8+ T cell-mediated immunity for a better protection against recurrent herpes . This includes exploring new adjuvants and antigen delivery systems, and The need to develop a mucosal vaccine strategy that would induce strong tissue resident CD4+ and CD8+ TRM cells that would reduce virus reactivation from latently infected dorsal root ganglia and subsequent virus shedding in the genital tract and recurrent herpetic disease. This is because of the failure of past parenteral subunit vaccines that elicit systemic immune responses against HSV-2. Although most of these vaccine research trials have not been promising, we have gained a better understanding of the correlates of protective immunity for a therapeutic HSV vaccine, forming the platform for novel combinatorial vaccine strategies against HSV.

What Results Have You Seen That Support The Clinical Development Of Gd

A Vaccine Pathway for Herpes Virus with Gregory Smith, PhD

Extensive molecular and pre-clinical work has been completed for gD-2, which induces immunity against both HSV-1 and HSV-2 challenge in multiple pre-clinical models. Not only did the candidate prevent disease, but gD-2 also prevented the virus from reactivation. Latency refers to the ability of the herpes virus to remain dormant particularly in nerve tissue, often establishing lifelong infection with frequent subclinical or clinical reactivation.

In multiple preclinical models we demonstrated that vaccination with gD-2 completely protects from herpes disease and reactivation protection is strongly correlated with the formation of ADCC antibodies mediating the killing of infected cells and thereby blocking viral spread.

Read Also: Can Herpes Turn Into Hiv On Its Own

Herpes Vaccines And Hiv

People with HSV-2 infection are at least three times more likely to become infected with HIV if exposed. Thus, interventions targeting HSV-2, such as new HSV vaccines, have the potential for additional benefit against HIV, which could be particularly powerful in regions with a high incidence of co-infection.

Content sources: The WHO, US CDC, WHO, NIH, research papers, ClinicalTrials.gov, and the Precision Vaccinations news network. Content is fact-checked by healthcare providers, such as Dr. Robert Carlson.

Why Did Previous Attempts To Develop A Herpes Vaccine Focus On Neutralizing Antibodies

Decades of research in herpes vaccine development have focused primarily on subunit vaccines designed to elicit neutralizing antibodies against one or two viral proteins.6 When incubated with viral particles in vitro, neutralizing antibodies can prevent viral entry into cells. This strategy was effective as a vaccine for agents such as hepatitis B, however it had limited success with other pathogens such as herpes simplex viruses. The rationale for a subunit neutralizing antibody approach to HSV vaccine development emanated from observations that neutralizing antibodies that target viral glycoprotein D are elicited in response to natural human infection. While these antibodies do not prevent establishment of latency or prevent viral reactivation in pre-clinical models, they have been thought to limit the frequency and/or severity of clinical recurrences. Subunit vaccines comprised of recombinant gD alone or in combination with other viral proteins and with various adjuvants elicited high titer neutralizing antibodies and provided variable protection in pre-clinical models but the clinical trial outcomes have been uniformly disappointing.

You May Like: Can You Test For Herpes Simplex 1

Inactivated Killed Hsv Vaccines

HSV is a highly successful neurotropic virus that resides in the nervous system and therefore presents the risk of developing neuro-pathogenesis and life-threatening Herpes Simplex Encephalitis . Thus, back in the 70s and 80s, the first whole inactivated HSV vaccine approach used kill the whole virus after exposure to heat, UV-light or chemicals . These whole inactivated HSV vaccines induced antibodies, but not T cells, and as such have not been successful in the protection against recurrent HSV-1 or HSV-2 infections and diseases . Therefore, the live-attenuated HSV vaccines and replication-defective HSV vaccines were introduced .

New Approach Uses Mrna

Frontiers

Early efforts to produce a protein-based vaccine for herpes failed. But a new mRNA approach has outperformed the efficacy of the past vaccines in preclinical trials and is expected to be introduced in clinical trials in the second half of 2022, investigators say. This new approach for a prophylactic genital herpes vaccine showed great promise in early studies.1

Research into the mRNA herpes vaccine began long before the COVID-19 mRNA vaccines were developed, says Harvey M. Friedman, MD, professor of medicine/infectious diseases at the University of Pennsylvania Perelman School of Medicine.

Were pretty far along in the research, he says. We are using the mRNA technology in a vaccine effort for preventing genital herpes. Its not, at this point, intended for a treatment.

The vaccine, which was studied in mice and guinea pigs, showed exceptionally good prevention. Were hopeful it will make it into humans this year, Friedman says. Sometime in the summer of 2022 is our target.

This vaccine is good news for everyone at risk of STIs. More than one out of 10 Americans, age 49 years and younger, are infected with genital herpes, says Sita Awasthi, PhD, associate research professor in the infectious disease division at Perelman School of Medicine.

The vaccine also might help reduce HIV infection, since herpes greatly increases a persons risk of contracting HIV, Awasthi says.

You May Like: What Can Trigger Genital Herpes Outbreaks

A Study On The Reactogenicity Safety And Immune Response Of A Vaccine Against Herpes Simplex Virus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Recruitment Status : Terminated First Posted : February 21, 2021Last Update Posted : June 28, 2021
Condition or disease

Phase
Herpes Simplex Biological: Lower dose formulation of HSV vaccine Biological: Low dose formulation of HSV vaccine Biological: Medium dose formulation of HSV vaccine Biological: High dose formulation of HSV vaccine Drug: Placebo Phase 1
Layout table for study information

Study Type :
Treatment
Official Title: A Phase I, Single-blind, Randomised, Placebo-controlled, Dose Escalation Study to Evaluate the Reactogenicity, Safety and Immune Response of an HSV Vaccine in Healthy Participants Aged 18-40 Years
Actual Study Start Date :
  • Percentage of participants reporting solicited administration site events within 7 days after the first vaccine dose administered at Day 1 The solicited administration site events are pain, redness and swelling.
  • Immune Checkpoint Blockade Combined With Therapeutic Herpes Vaccine

    Pembrolizumab and nivolumab are the first of the anti-PD-1 pathway family of checkpoint inhibitors to obtain FDA approval for the treatment of melanoma. The FDA has also granted approval of nivolumab for squamous cell lung cancer and Hodgkin lymphoma , and MPDL-3280A, for bladder cancer and nonsmall cell lung cancer . From 2014-2017, the FDA approved several different anti-PD-1 mAbs opening the field of next vogues of so-called immune checkpoint therapy mAbs . Blocking the PD-1/PD-L1 pathway in animal models demonstrated an improvement in CD8+ T cell effector function against persistent viral infections . Recent reports show that the natural constitutive PD-L1 expression on corneal cells impacts the HSV-1 infection of corneas. Genetic deficiency in PD-L1 using B7-H12/2 mice and the use of antiPD-L1 blocking Ab significantly enhanced HSV-1 clearance from corneas of C57BL/6 mice mediated mainly by monocytes/macrophages . Based on our preliminary data of PD-L1 and GAL-9 blockade, we hypothesized that blocking PD-1, LAG-3, TIGIT and/or TIM-3 immune checkpoint pathways will help in restoring the function of HSV-specific CD8+ T cells in latently infected DRG and increasing efficacy and longevity of a therapeutic herpes vaccine.

    Recommended Reading: How Much Does Herpes Medicine Cost

    Primary And Secondary Immune Responses To Hsv

    Innate Immune Response

    The innate immune system consists of a variety of components including neutrophils, natural killer cells, monocytes, dendritic cells, macrophages, and the complement cascade . It is the first line of defense against pathogens. A strong innate immune response to foreign antigens is essential to the development of the adaptive humoral and cellular responses of long-lasting immunity . Adjuvants are added to subunit vaccines to elicit an innate response for this purpose. Pattern recognition receptors on host cells allow for the detection and response to viral infections. On binding to pattern recognition receptors , signal transduction leads to the production of various proteins including interferons . Interferons are glycoprotein signaling molecules produced by infected cell lines. They act locally, priming viral defense mechanisms within local cells .

    HSV-1 is known to have multiple ligands that bind TLRs, leading to activation of the NF-kB pathway . However, herpes simplex virus is also known to evade the innate immune responses, specifically TLR signaling and interferon production to further viral proliferation . Additionally, a critical aspect of the innate immune system that contributes to the adaptive response is antigen presentation. HSV infection can stimulate autophagy, leading to a more efficient presentation of antigens. However, HSV-1 ICP34.5 gene product antagonizes the response by binding Beclin 1 , essential to autophagy .

    What Does The Ceo Say About The Vaccine For Herpes

    Moderna set to begin clinical trials for an HIV vaccine

    For Rational Vaccines founder and Chief Executive Officer, Agustin Fernandez III, the primary importance is what the Innovation Passport signifies.

    I think the real value for the world, for patients who are suffering every day, the mother who has lost a child to herpes, the patient who is going blind from ocular herpes, the up to 34% of HIV cases that are directly attributable to HSV-2, is the human element, the fact that a very respected regulator for the first time ever said look, herpes is a serious disease, he told BioSpace.

    The current therapeutic regimen available to herpes patients consists of antiviral medications, which can prevent or shorten outbreaks. There is no cure and no approved vaccine for herpes or immunomodulating therapies for the disease. For Fernandez, who has HSV-1, herpes is personal.

    RVx201was created for patients like me to help us control the virus better. I would take the antivirals, and they would just not work. It started from a very personal point, and then I realized that there are so many people out there suffering the same way. So it began from a patient aspect, and it has grown into a patient’s aspect, he said.

    Our vaccine, as opposed to other past live attenuated vaccines, has been rationally engineered, hence the name. Weve found which protein specifically works to downregulate this immune response and we’ve mutated that protein. So, our mutant doesn’t have the ability to evade the immune system, Fernandez said.

    You May Like: What To Use For Herpes Outbreak

    Popular Articles
    Related news