Researchers, led by Dr. Harvey Friedman, from the Perelman School of Medicine at the University of Pennsylvania are close to clinical trials testing a vaccine protecting against genital herpes. Phase I trials for this HSV vaccine candidate, that will test prevention of genital herpes in humans, are expected to begin in September 2022.
In 2019, UPenn first published news that a novel mRNA-based genital herpes vaccine had been developed that protected almost all animal subjects exposed to the virus in preclinical studies in Dr. Harvey Friedman’s lab.
This work is in partnership with BioNtech and Dr. Drew Weissman, creators of Pfizers Covid vaccine. Latest studies in mice by Dr Friedman have shown his vaccine candidate is effective at preventing genital infection caused by HSV-1. Additional studies from July 2020 and in October 2021 have also shown the same efficacy for HSV-2.
Dr. Friedman’s lab has indicated they are also doing preclinical testing on a therapeutic. Depending on results from the prophylactic vaccine, work on a therapeutic treatment to HSV-1 or HSV-2 may not be far behind. See recent video updates from Dr. Friedman provided from February 2021, and November 2021. Learn more on Dr. Friedman’s lab website here.
Want to help? Donate today to help advance Dr. Friedman’s work for the study of a therapeutic HSV treatment! Fundraising is underway, led by a Reddit group dedicated to dialogue on Herpes Cure Research.
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Herpes Cure Advocacy win! Our team worked with editors at Biocentury magazine on this article. Enjoy!
“After a decades long lull in innovation, a wave of candidates is advancing through the HSV pipeline that could combat drug resistance, suppress viral deactivation, or even clear the virus completely.”
In the global race for a Herpes cure, China is taking the lead. For the first time, transient gene-editing of the herpes simplex virus type 1 (HSV-1) using mRNA-based CRISPR was shown to cure herpes keratitis in mice. Chinese researchers reported in a paper published January 11, 2021 of NatureBiotechnology.
In a paper published May 2021, the team from Shanghai showed therapeutic efficacy in three different Herpes Simplex Keratitis (HSK) mouse models and human-derived corneas. The approach, an HSV-1-erasing lentiviral particle (referred to as HELP), was shown in these pre-clinical studies to significantly block HSV-1 replication and HSK occurrence in three different infection models, and eliminated the viral reservoir in the ganglia.
Patients worldwide are highly anticipating “first time in humans” clinical study results. Early results show that study subjects are effectively cured of the virus within 4-10 months and company representatives are expecting final results to show HELP is the worlds first proven treatment to cure for Herpes Keratitis. HELP is giving much hope to HSV carriers worldwide.
Dr. Cai Yujia, the corresponding author of the study, said: “Realizing the instantaneous delivery of gene editing enzymes in the body is the dream of our gene therapy scientists. With such a vector, we can maximize the safety of gene editing therapy, which also means The in vivo treatment of gene editing is infinitely close to clinical application.”
In August 2021, Shanghai BD Gene signed R&D cooperation agreements to explore the application of BDGene core delivery technology PVP-mrna in other major diseases such as nervous system diseases. They have also added HSV-2 to their pipeline although company reps indicate the approach is different than HSK. HSK is easier to administer treatment via intrastromal injection to the eye. For HSV-2, administering the treatment is more challenging, but something Shanghai BD Gene is considering. Alternatively this team is considering a viral-like approach for HSV-2 using mRNA.
Patient Advocates are hopeful that China, without the lengthy red tape and regulatory processes of the FDA that can take decades, bringing this treatment to market can happen quickly. Estimates indicate once results are published and peer reviewed in May 2022 that this treatment could be in the clinic, and available on the market for patients treatment, within 5 years.
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Have a news tip? Are you working on clinical research for HSV treatments and want to share updates with the public? Let us know!
Why do we need advocacy at the FDA? Because any Herpes Simplex Virus prevention strategy in the US is incomplete without an accurate diagnostic test. There is currently NO FDA-approved accurate diagnostic serology test (what we need to diagnose asymptomatic infection) on the market. With a virus that is primarily spread asymptomatically, 85% of new infections are spread by people who are asymptomatic and unaware of their status, the lack of accurate testing is a large and dangerous loophole.
People can currently be tested for HSV one of two ways:
Swab Test: A test of skin lesions (oral or genital) with either PCR or culture from an active outbreak.
Serology (blood) Test: A test of patient blood sample for the presence of HSV antibodies. The presence of antibodies can be measured to indicate the infection in the body. This type of test is used for routine STI screenings and/or for asymptomatic patients to diagnose infection.
The FDA approved serology tests (Herpeselect for example) have been proven to have low performance (see studies here, here and here). For this reason, the 2021 CDC STI treatment guidelines recommend confirmatory testing with the Western Blot, which is not FDA approved or covered by insurance.
There are a number of ways Herpes Advocates can ask the FDA to improve the landscape for HSV diagnostics. (Want to join the advocate army? Sign up for emails here.)
How can we advocate the FDA for better Herpes testing?
1. Contact the FDAdirectly: Email the following individuals to say that we need accurate FDA approved serology tests for HSV. Include the studies linked above.
Name of the company for which you are submitting an allegation: Focus Diagnostics
Telephone number: 800.838.4548
Address: DIASORIN MOLECULAR LLC 11331 Valley View Street Cypress, California, 90630-4717 USA
Name and model (if applicable) of the Medical Device(s) / Electronic Products in question: Herpeselect® 1 and 2 Immunoblot IgG
Lot numbers / serial numbers / part numbers: IB0900G
Under detailed description, please include:
This Herpeselect test has been proven to be inaccurate in a screening population in numerous studies. Additionally, the Product Insert is misleading, as the sensitivity/specificity study is in a pre-screened population that has already tested positive for HSV with a PCR/culture test. The studies enclosed show that when the same test is used to SCREEN people whose status is not known, the results are very different and accuracy is suboptimal.
In summary, the Product Information is misleading as the intended use for general HSV screening and the study design are not consistent which should be more clearly indicated.
See studies proving inaccuracy of this test in population that was not pre-screened here, here and here. Herpeselect, when used in combination with the confirmatory test Western Blot, does not confirm 50% of the time.
Hello Herpes Advocates, We’re happy you’re here. We believe part of the reason there have been no advances in treatment or prevention in 40 years is due to stigma and lack of activism. There has never been a centralized advocacy effort for HSV until now.
Getting started with Herpes Advocacy
Step 1: Know the facts so you can speak to them in your advocacy.
CDC: Department for Prevention of Sexually Transmitted Diseases
Why advocacy at CDC? The Center for Disease Control and prevention is responsible for prevention, surveillance, and establishes guidelines for testing and treatment for HSV in the United States. They currently recommend against screening for HSV. New STI treatment guidelines for HSV were published in 2021. Learn more about the CDC and their work here.
Increase prevention efforts, outline a clear strategy to reduce transmission for HSV in the United States
Increase training for new STI Treatment guidelines so that more people get tested (mild symptoms qualify someone for testing!)
There is a critical public health need for a functional, accurate, diagnostic test to diagnose asymptomatic infection
Dr. Jono Mermin Director of the National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP)
Why advocacy at FDA? The FDA reviews and approves new foods and medical products and provides regulatory oversight for businesses with products on market. The currently FDA-approved serologic antibody tests for diagnosing asymptomatic infection are wrong 50% of the time. Tell the FDA that we need higher standards for diagnostic tests! More background on the need for advocacy at the FDA is here.
Why advocacy at NIH? National Institutes of Health is responsible for research and development to bring new medical innovations to market in the United States. They fund both intra-curricular and extracurricular research through a robust grant program.
Dr. Emily Erbelding Director of the NIAID Division of Microbiology and Infectious Diseases (DMID)
AiCuris AG, a German biotech company, is currently recruiting for their clinical trial on Pritelivir. Pritelivir is a highly anticipated new treatment for resistant Herpes Simplex Virus infections that cannot be managed with the available anti-virals. It is currently being tested for immune compromised patients only and, if proven safe and effective, could become a new treatment option for this population.
Link here with more details on criteria and how to apply.
Patients they are recruiting for:
Group C: For patients that are immune compromised and Acyclovir resistant
Group D: For patients that are immune compromised and present (or develop through the course of trials) foscarnet resistance/intolerance
Group E: For patients that are immune compromised but are responsive to Acyclovir
There are additional inclusion and exclusion criteria so please check the trial page on ClinicalTrials.gov on the link above.
Not all centers are already open and recruiting so if the one in your area is not recruiting yet you may want to contact them to be added to a waitlist.
Los Angeles, California
New Haven, Connecticut
For Pierce, Florida
Baton Rouge, Louisiana
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It is widely recognized among providers of STI screening that serology tests for Herpes Simplex Virus types 1 & 2 are highly inaccurate and often lead to false positives. So much so, that HSV is often not included in standard STI screening, despite it being the largest STI in America with no effective treatment or cure.
Advocates are asking, “If these tests don’t work, why are they on the market?” And are calling for providers and patients to report faulty test results to the FDA immediately. “Testing is the first step on the path to prevention. Americans need to be protected from this virus, and we need tests that work to do that,” says Jason Goldstein, a patient advocate with Herpes Cure Advocacy.
New CDC STI treatment guidelines, released July 2021, recognize the faulty nature of serology tests for HSV and recommend two-step confirmatory testing. Guidelines recommend confirmatory testing using the Western Blot, a test that is only available via mail order from one laboratory at the Univ. of Washington, is not automated, covered by insurance or FDA-approved.
The most commonly used test, HerpeSelect HSV-2 enzyme immunoassay (EIA), often is falsely positive at low index values (1.1–3.0) (457–457). One study reported an overall specificity of 57.4%, with a specificity of 39.8% for index values of 1.1–2.9 (458). Because of the poor specificity of commercially available type-specific EIAs, particularly with low index values (<3.0), a confirmatory test (Biokit or Western blot) with a second method should be performed before test interpretation.
2021 CDC STI Treatment Guidelines for Genital Herpes Infections
Many provider advocates have already committed to reporting every test they find with inaccuracies – up to 10 a week in some practices. “It is time we start holding the FDA and manufacturers accountable. We are desperate for better tests and it’s not fair to patients to make them go through multiple, expensive tests to get an accurate answer,” says Terri Warren, RN, ANP, of Westover Research Group.
Advocates are asking providers and patients start reporting faulty tests to the FDA immediately so that manufacturers can be held accountable to either improve the test performance or develop a different test that works according to guidelines.
PROVIDERS: To report a faulty test, see the link for submission here. Each test report takes about 3-4 minutes.
PATIENTS: To report inaccurate test results submit a report here. Each test report takes about 3-4 minutes.
About Herpes Cure Advocacy: Herpes Cure Advocacy is a grassroots, membership-based international advocacy organization of 7,000+ members with a goal of cure and prevention for Herpes Simplex Virus types 1 and 2. Adequate treatment and prevention are needed for the 6 billion globally living with HSV urgently, because Herpes is not benign and because patients are waiting.