Testing for Herpes: Step-by-Step Guide

How to get tested for Herpes

Testing for herpes is complicated and can be confusing in America.

Currently available, FDA-approved IgG antibody tests sometimes present with false positive results where the test says you are infected with HSV and you are not. Tests can also have false negative results. Most often, false positive results are found in the index value range of 1.1 to 5.0 but IgG false positives can be as high as 17.

As a result, CDC guidelines call for TWO STEP testing to confirm a herpes diagnosis. Meaning once the initial IgG antibody test is performed, a follow-up confirmatory test is recommended. This two-step process has been recommended per the CDC guidelines because currently available diagnostic IgG antibody tests are so often false negative/positive.

Availability of the confirmatory test (the second step test) is limited and many providers do not know how to take steps to order the confirmatory testing for patients.

To access confirmatory testing and confirm a herpes diagnosis – patients will need to order the Western Blot (WB) from the University of Washington. The WB test is not FDA-approved, needs to be ordered directly from UW, and a blood sample sent directly to their academic lab for processing.

The UW Western Blot is widely considered the gold standard for herpes antibody testing. While the initial IgG test looks for a single antibody protein to distinguish and identify HSV-1 and HSV-2, the WB looks for all of the proteins associated with herpes antibody. This makes the Western Blot test a much more comprehensive look for evidence of HSV infection. There is no such thing as a false positive WB.

Patients and professionals wanting to order Western Blot directly from Univ. Washington, can do so by taking the following steps:

Order Herpes Testing with University of Washington Western Blot

How do I confirm a herpes diagnosis? Read how here.

STEP 1: CALL TO ORDER: 1-800-713-5198 or 1- 206-685-6066.

The package contains blood draw and transport tubes, lab instructions, lab requisition form, labels for the outside of the packaging, address to ship back to the University of Washington. The kit comes in an anonymous brown cardboard box and says nothing about the sender (Univ. Washington) or it’s contents on the packaging.

STEP 2: BLOOD DRAW: Drawing of blood for testing.

The patient (and/or healthcare professional needs to identify a location to draw and process their blood sample. The location chosen must include a centrifuge to spin down the blood sample to separate the red cells from the clear serum.

NOTE: LabCorp and Quest WILL NOT draw blood to ship for testing to Univ. of Washington. They currently do not offer any confirmatory testing for Herpes.

Below is a list of labs to go to for a blood draw.

Any Lab Test Now: ARCpoint lab will draw and ship with a label.

ARCpoint laboratories:  They will also draw blood for a feeand you can enter your zip code in their website for a lab location near you.  

YOUR LOCAL HOSPITAL OUT PATIENT LAB: A hospital lab may be able to draw blood using the WB kit. Check with your local hospital lab or your own health care provider!

STEP 3: A physician or health care provider fills out a form for University of Washington.

Patients need to identify a health care provider to fill out a form and order this test. The required lab requisition form will be included in the UW kit. Patients who need a health care provider can work with your own physician.

To confirm your herpes diagnosis from an HSV expert, contact Westover Heights Clinic for support with this process from anywhere in the United States.

STEP 4: Ship blood sample, completed form and a check for payment to University of Washington.

Patients will need to purchase a pre-paid shipping label from UPS or FedEx to ship the sample to UW.

The laboratory that draws your blood can usually ship it the kit after they have processed your sample.

STEP 5: Your provider will contact you with your results!

Results usually take 1-2 weeks, and sometimes longer. The possible results are positive, negative or indeterminate. There are no numbers associated with these results.

Herpes Diagnosis: Learn more about University of Washington Western Blot

Additional guidance from University of Washington to order a Western Blot is available here.

UW Virology lab catalog available here.

Learn more about the Herpes testing and advocacy at the FDA!


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We lost our baby daughter to neonatal herpes

We lost our baby to neonatal herpes, and her life mattered. Our daughter would be turning a year old this coming September 2022. Instead of celebrating her birth, though, we will be gathering to memorialize her 27 days of life. Our daughter died a horrible death due to acquiring HSV-2 in the birth canal, also known as Neonatal Herpes.

As I write this, the guilt and anger that I must reckon with each day fills my chest with unbearable grief knowing that she died because of me. However, by telling our story it is my intention that some of my guilt and anger be used to create justice and change in the standards of care for women as well as infants. What happened to our baby is inexcusable because it was avoidable. If I had known my status, the proper steps would have been taken to ensure that our first and only child entered this world safely and in good health. 

I am 37 years old and had to go through IVF to create the embryo that would later develop into our beautiful daughter. I think back on all of the blood tests, invasive ultrasounds, vaginal examinations, and wonder how something like this could get past all of those screenings. I am fortunate in that I had access to the best doctors and medical care available and attended every appointment in addition to monthly ultrasounds due to my “geriatric” age. My pregnancy was wonderful. It was easy and I loved having 38 weeks to imagine what this creature would be like and who she would become. If you are a parent, you know that the imagining of who your baby is and what life will be like with them is a large part of the waiting and preparing for their arrival. When your baby is born, so are all your hopes and dreams for them.

Our daughter was delivered vaginally and without an epidural. I, like many mothers, had meticulously planned how I wanted delivery to go and I was determined to stick with it. My point in including these details is because I was doing everything I could to avoid a C-section. Statistically, if you are medicated and are in labor for longer than is convenient, doctors can push a cesarian. There’s less liability and it saves time. The ironic thing about my birth plan is that it was planned to avoid the very thing that might have saved our daughter – having a C-Section. 

Had HSV been included on the extensive list of other STI’s and STD’s that women are tested for during initial OB appointments, it is very likely that I would have known that I was a carrier. I say likely because there is a high false positive rate for HSV serology tests along with a high rate of positive asymptomatic carriers. As of today, contemporary medical practice depends upon its patients having physical and/or visual symptoms to determine whether to test for HSV or not. I have never had any symptoms or anything that would have prompted me to seek medical attention and/or ask to be tested. Instead, I found out that I was HSV-2 positive through the death of my daughter. I would never know otherwise.

Medical protocols aside, I had never even heard of Neonatal Herpes. I’m an educated woman, read every baby book, went to every medical appointment required in the many months of prenatal care. Not one single baby book or pamphlet out of all the baby books and other educational literature that I read to prepare for our daughter mentioned a risk of neonatal herpes. Not one. My doctors never mentioned neonatal herpes. It is detestable that not only did it take my daughter’s life to learn that I carried this deadly virus but that it was a risk to be aware of to begin with. WHY? Why aren’t we preventing this when we have tests to help? We should be doing more, It is unjustifiable that I, along with other mothers both knowing and not of their status, am having to ask this.

WHY? Why aren’t we preventing this when we have tests to help? We should be doing more, It is unjustifiable that I, along with other mothers both knowing and not of their status, am having to ask this.

After three torturous and grueling days in the Pediatric Intensive Care Unit where our daughter was kept alive through life support, the doctors gave us our daughters’ diagnosis. Neonatal Herpes. They told us that statistically a baby dying from herpes is comparable to being struck by lightning twice in one lifetime and yet it happened to us. It is remarkable how quickly a statistic becomes personal when you are a part of the data. Suddenly something that was once so far away from your life’s orbit falls into existence with the force of a meteorite hitting planet earth. It’s explosive. 

 Our daughter’s diagnosis was not made known to us until 30 hours after she was admitted to the PICU for seizures. She had exhibited symptoms prior to the seizures but none that deviated enough from the norm to raise alarm. Typical symptoms of Neonatal Herpes are lethargy, slow weight gain, rapid breathing or difficulty breathing, jaundice, blisters on skin, and irritability. If you have had a newborn, you can see just how easy it is to mistake one thing for another. In our case, our daughter exhibited slow weight gain and in retrospect, lethargy. However, we were taking her to the pediatrician every other day to be weighed and examined and therefore assumed everything was okay. The doctor wasn’t alarmed so neither were we. Slowly she began to gain weight and aside from being a challenge to wake up for feedings, she presented as a typical newborn. 

It was around day 25 that I began to suspect something was not right. Several times while holding her to calm her from fussing, she would tense her entire body and turn a scarlet red. Her cry changed to a lower vocal range. It was alarming but our baby nurse said it was gas and it truly did look like that. Now knowing that the virus attacks the brain first, I can only assume that she was experiencing a pain that no adult could endure. This is what haunts me most. 

The day after a second episode of the body tensing and unusual but temporary change in skin pigment, she developed raspy breathing. When we brought her to the pediatrician, she examined our daughters’ eyes and immediately told us to take her to the ER and not to stop for any reason. This would be the last time I held my daughter, free from tubes and monitors and tears. A day and a half later, my husband and I, along with my parents held her as she took her last breaths. 

Writing our story, our daughter’s story, for others to read is an act of courage and I am doing it for her. There is no justice that will right the loss of her life—of any life. Herpes virus is deadly and yet it has been allowed to spread and kill and ruin lives despite our knowledge of this. I do not understand how a virus that is so common has been allowed to continue to be consciously omitted from standardized STI/STD testing and, at the very least, from OB and pediatric education. I happen to be one of the “lucky” asymptomatic carriers but I will forever grieve the precious life of my child. 

TAKE ACTION TO HELP PREVENT NEONATAL HERPES

Herpes Cure Advocacy has launched a new Neonatal Herpes Task Force to provide support for families, engage with stakeholders, physicians, and scientists, and create change to protect Americans from neonatal herpes.

Click here to learn more!

Families, clinicians and professionals, public health policy, and any advocates for change are welcome.

Neonatal Herpes Task Force Kickoff Meeting

September 14th, 2022 @ 6pm EST

Register in advance for this meeting.

After registering, you will receive a confirmation email containing information about joining the meeting.


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Important Win for Herpes Advocacy: FY 2023 Congress Budget Update

Herpes Cure Advocacy celebrates and thanks the US House of Representatives for their prioritization of federal action for Herpes Simplex Virus cure, treatment and prevention in the FY 2023 House budget report.

In the house budget report for FY 2023, published on June 29, there is report language that directs NIH to assemble a multi-council working group of NIH staff to investigate the NIH clinical research HSV treatment, cure and prevention, and provide recommendations to address the infectious disease which impacts 1 out of 2 Americans.

This direction for NIH gives multiple institutes the opportunity to work together to address the gaps and opportunities in HSV cure, treatment, and prevention in a coordinated effort that leverages medical knowledge across institutes. Also, congress has directed NIH to issue a funding analysis that outlines NIH-funded clinical research for HSV. Report language is included on page 146 and also below.

Please note, that before this FY 2023 budget is passed into law, it still needs to have support on the senate side.


Herpes Cure Advocacy: CALL TO ACTION

It is more important than ever for advocates for herpes cure, treatment and prevention to write to their elected representatives in the US Senate and ask them to support the increased federal funding for HSV for FY 2023.

Find your elected representatives.


Report Language in FY 2023 House Budget Report

Herpes Simplex Virus, Types 1 and 2.—The Committee recognizes the serious nature of herpes simplex virus, a neuropathic infectious disease which impacts nearly one in two Americans, and the critical need for Federal investment in treatment and prevention.

The Committee is concerned with potential health, quality of life, and economic impacts for herpes simplex virus seropositive individuals, as well as the risk for severe, persistent disease in a significant portion of Americans. The Committee directs NIH to prioritize research and development of curative approaches to herpes simplex virus, with a specific focus on research projects with commercial viability and intention of bringing new HSV treatments to market.

The Committee understands that herpes simplex virus is a pathogen with considerations beyond a single NIH Institute or Center and directs NIH to assemble a multi-council working group to ensure a coordinated and focused effort across NIH. Institutes and Centers may include, but are not limited to: NIAID, NIMH, NCI, NIA, NIMHD and NINDS. This working group will assemble a review of NIH efforts in herpes simplex virus treatment and prevention with commercial viability, outline gaps and/or misconceptions in currently available research, and outline future priority areas for new clinical research, with a focus on addressing Americans holistic health and well-being. The multi-council working group will also provide a funding analysis to illustrate NIH priorities, gaps, and opportunities in clinical research of HSV treatment to date.



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Possible herpes keratitis cure takes another step: BDGene of China applies for Orphan Drug Designation at the FDA

Chinese company BDGene from Shanghai continues to lead in the global race for a herpes keratitis cure. The highly anticipated treatment, BD111 has reached a big milestone as it applied for Orphan Drug designation from the US FDA. Previously, BD111 has received international attention for its progress with a gene editing cure for herpes keratitis. We reported on its progress – which it has published in the top international academic journals Nature Biotechnology and Nature Biomedical Engineering.

BD Gene has (in collaboration with the Eye and ENT Hospital of Fudan University) carried out 3 cases of IIT human clinical trials, and has reported pre-clinical results where study subjects were cleared of the virus. The potential to change the landscape for Herpes treatment has patient advocates very excited.

Orphan drugs, also known as rare disease drugs, refer to drugs used for the prevention, treatment and diagnosis of rare diseases. The orphan drug designation granted by the FDA applies to drugs and biologics for rare diseases that affect less than 200,000 people in the United States each year, and provides policy support for related products. Therefore, obtaining orphan drug designation is of great advantage for manufacturers bringing new medicines to market.

Possible herpes cure takes another important step

According to the U.S. FDA Orphan Drug Act, new drugs that have obtained orphan drug qualification allows for a series of advantages for BDGene including quicker, easier processes to get to market in the US. Supports include tax credit for clinical research expenses, Exemption of NDA/BLA application fees, access to special R&D funds, special approval channels, exemption from the declaration of some clinical data, and a seven-year market exclusivity period after the drug is approved. Orphan Drug Designation can also bring investment as the company continues to lead the market.

About Herpes Keratitis: Herpes virus keratitis is caused by herpes simplex virus (HSV-1) infection and is the most common infectious blindness disease. Current first-line antiviral drugs can only inhibit viral replication by interfering with viral DNA synthesis. These drugs can inhibit HSV-1 DNA replication, but cannot clear the latent viral genome in the cornea and trigeminal ganglion, which leads to the disease. Repeated attacks can lead to blindness in severe cases.

About BD111: CRISPR-based gene editing technology can directly degrade the viral genome, providing the possibility of fundamentally curing the disease. BD111 gene editing drugs get rid of the drawbacks of traditional related drugs that need to be repeatedly administered, and only need to be injected once. The drug uses the original delivery technology of VLP to transduce the CRISPR gene editing tool to directly target and cut the HSV-1 genome, so as to achieve the purpose of removing the HSV-1 virus genome, thereby realizing the treatment of herpes virus keratitis. The characteristics of the BD111 drug are: (1) Cas9 mRNA is delivered, and the gene enzyme stays in the body for a short time, which can reduce the risk of immune response and gene editing off-target; (2) It cuts the viral genome and does not need to change anyone’s genes, not detected to off-target effects on the human genome.


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New Clinical Trial for Herpes Vaccine from Biontech + UPenn

The BioNTech team and UPenn have previously partnered on pre-clinical study of an mRNA-based vaccine candidate to prevent genital herpes. This work is led by lead investigator Dr. Harvey Friedman and team at the University of Pennsylvania.

A new clinical trial A Clinical Trial in Healthy Volunteers to Study the Safety, Tolerability, and Immune Responses After Vaccination With an Investigational Vaccine Designed to Prevent Genital Herpes Lesions is now testing the BioNTech/UPenn formulation, BNT163, and it is recruiting as of today.

The clinical trial, posted on ClinicalTrials.gov on June 27th, is enrolling HSV negative individuals to test the effectiveness of a vaccine candidate to prevent genital herpes. Trials are set to begin in September 2022 with a completion date of 2025. Locations for the study are to be determined and will be posted when finalized.

This clinical trial is for HSV negative, healthy participants to test safety and efficacy in a two-part study. Part A will be multiple doses of vaccine, The highest dose that is well tolerated will be studied in a larger number of subjects in part B.

Regarding a therapeutic to treat those living with genital herpes: Within the next 1-2 months, Dr. Friedman and his lab will be turning energies towards a therapeutic, plans for an experimental approach are underway.

HSV- patients interested in participation can contact: patients@biontech.de


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New Clinical Trial for Herpes Simplex Virus

GlaxoSmithKline Pipeline Update

GSK has officially updated its clinical research pipeline to include a vaccine for HSV-2! Their therapeutic vaccine for HSV-2 isn’t mRNA (or what they called SAM technology) but an adjuvanted therapeutic vaccine.

The trial (currently recruiting) is a Phase 1/2 combined trial that ends in 2024. GSK will test 9 different formulations as a prophylactic, the one that has the highest efficacy will then be tested in Part 2 as a therapeutic. Ultimately, advocates assume, that GSK will make one vaccine as both a prophylactic/therapeutic.

GSK Formulation: GSK3943104A: Therapeutic HSV (Immunomodulator): Active Immunization to suppress recurrence of genital herpes in adults aged 18 years and older.

GSK is the manufacturer of Shingrix (shingles vaccine released in 2017) and is perfectly positioned to leverage their knowledge from this very effective vaccine for another herpes virus for a new formulation to treat Herpes Simplex. Shingrix is also a recombinant protein adjuvanted vaccine with 90-97% efficacy over 7 years with one 2-dose regimen.

GSK has a proven platform for developing a highly effective recombinant protein – adjuvanted herpes vaccine. They are now simply tweaking it slightly for a new target in HSV-2. HSV and VZV (VZV = Varicella-zoster virus the virus that causes chickenpox and shingles) are both alpha herpes viruses. They are genetically very closely related, are latent viruses that live in the body for life, and when reactivated exhibit symptoms in the body similarly. Both herpes simplex and zoster are viruses that hide in the nerve ganglia and reactivate on the skin in the same manner with blisters, prodrome, etc.

Advocates are excited that GSK is taking this approach and hopeful that as one of the largest pharma companies globally, and entering clinical studies for herpes simplex for the second time, they’re confident about the safety and efficacy of this formulation. The new formulation is estimated to reduce viral shedding to the extent that the infection would be non-transmissible to partners or what is known as a functional cure.

For other projects in the Herpes Cure Pipeline, see here.

For more details on the new GSK clinical trial for Herpes and to apply to participate please visit here.


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Fundraising begins for a Herpes Cure

Herpes Cure Advocacy is excited to announce we are pursuing filing as a non-profit organization with 501c3 status.

Herpes Cure Advocacy is launching a small capital campaign to raise $25,000 – these funds will allow us to further our work to advance the treatment and prevention of Herpes Simplex Virus types 1 and 2 in the United States.

Resources will allow the expansion of HCA grassroots advocacy work to broaden, be more effective, and to leverage professional tools and strategies that can effectively create change in the complex public health landscape. Resources will be used to support the following efforts:

Funds can support:

  • Legal and accounting fees
  • Marketing, communications, operations to support organizational goals
  • Admin and operational support staff
  • Conference fees and travel

We’re fundraising to support Herpes cure advocacy, including stakeholder engagement and lobbying congress for clinical research for a herpes cure, vaccine and treatments.


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Testing and Diagnosis for Herpes: A Dialogue

Herpes Cure Advocacy is proud to offer a 2-part webinar series in partnership with NCSD.

STI Testing and Diagnosis for Herpes is Challenging

Testing for HSV, especially of asymptomatic infection, is complex and can be challenging for both patient and clinician alike. Join our two-part workshop for an open and safe dialogue to learn, ask questions, and discuss the nuances and best practices of testing for herpes simplex virus in clinical practice.

What about Herpes?
Part 1: Dialogue on Patient-Centered Care for HSV Diagnostic Testing and Diagnosis
May 26th, 2022, 2-3:00pm ET

Join us to learn more from an advocates’ and clinical perspective about the landscape of HSV diagnostic tools, what is currently available and where there is opportunity to develop new tools. We will hear patient experiences during herpes testing and diagnosis and discuss ways to improve outcomes during clinical care. There will also be opportunities to speak with advocates about what patient-centered care for HSV looks like and advocate-preferred language for clinical counseling during herpes screening and diagnosis.

Guests:
Terri Warren, RN, ANP

Westover Clinic

Part 2: Dialogue on Implementation of HSV Testing and Treatment Guidelines in Clinical Practice
June 2nd, 2022, 2-3:00pm ET

Join us for a safe and non-judgmental discussion on complications of testing for genital herpes in clinical practice. We will also learn about new updates to testing for herpes according to the CDC 2021 STI Treatment guidelines as well as how to implement them in practice, how to handle patients who are asymptomatic, when to order a confirmatory test, and best tips for counseling a newly-diagnosed patient. 

Guests:
Dr. Christine Johnston

University of Washington


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Help HCA ask for Federal Funding for Treatment and Prevention of HSV!

The landscape for Herpes treatment and prevention is, while the are glimmers of hope, very ugly. There are no public health interventions to stop transmission and no accurate test to diagnose asymptomatic infection. The treatment pipeline is slim, improving – yet slim. And NIH is investing less than 10 million a year in clinical research for HSV with commercial viability.

Help advocate for federal investment for treatment and prevention of Herpes

Herpes Cure Advocacy is asking the federal government for 225+ million in the FY 2023 budget. To increase our chances of getting this federal funding – we need to show the American people want this!

Contact your elected reps at the links below. Call. Email. Better yet, ask them for a meeting. Have a meeting scheduled? Let us know. We’d love to join!

Sample email is here!
Senate
House

Here’s what we’re asking for specifically:

DHHS: HSV Strategic Plan Implementation Funds

In 2022, OASH has a $250,000 budget for a National Strategy and Strategic Plan for the treatment and prevention of HSV types 1 and 2. This was HCA big win in 2021! In 2023, we want to make sure they have funding to implement this plan.

NIH: Clinical research for HSV treatment

The NIH has a 30+ billion budget. Yet they are spending less than 10 million a year on translational research for HSV, or clinical research with intention of bringing a product to market. They have indicated Herpes treatment and vaccine are a priority. The funding strategy tells another story. We urgently need these funds for clinical research at NIH, with a focus on clinical research projects with commercial viability.

NIH: Interagency working group

NIH has 21 agencies focusing on different disease areas. Herpes is primarily addressed by NIAID with the Division of Microbiology and Infectious Diseases. It’s also neuropathic, impacts primarily women and minorities, is a recognized driver of HIV/AIDS, has mental health implications, and is being studied for association with Alzheimer’s Disease. This working group will bring together various NIH agencies that Herpes may impact, to approach treatment from an interdisciplinary perspective, and ensure a coordinated effort.

NIH: Clinical research on neurological complications

Herpes has a suspected association with Alzheimer’s Disease, and proven links to neurological complications such as encephalitis, meningitis, and Bells Palsy. Medical knowledge on neurological complications is not complete – these funds will support clinical research specifically to assess risk of potential known or unknown neurological complications as a result of the infection.

CDC: Interagency testing development working group

There is no accurate diagnostic test (that is commercial available or FDA-approved) to diagnose asymptomatic infection. Without one, the prevention strategy for Herpes is fundamentally flawed. This working group, led by CDC, will outline next steps for the advancement of HSV diagnostic tests.


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Monoclonal Antibodies: What’s in the pipeline for Herpes treatments?

What new treatments are coming for Herpes?

In the Herpes Cure Pipeline, there are several monoclonal antibody treatments. What kind of advantages do monoclonal antibody (MAB) treatments have over anti-virals or therapeutic vaccines? What makes monoclonals work?

In simple terms, monoclonal antibodies are lab developed antibodies that are directly injected into the body. The antibodies support the immune system by responding to viral pathogens, like herpes, preventing them from entering cells and infecting them.

Herpes lives in the nervous system where it is able to avoid the defenses of immune system. Only when reactivated, and traveling from the ganglia nerves to the skin surface, is the virus vulnerable to attack from immune system. In theory, if you could generate antibodies from a MAB, the presence of antibodies may be able to catch the virus when it leaves the nerve cells, before it reaches the epithelial cells on in the mouth or genital region where it causes an outbreak. This would require the right antibodies being properly designed to attack and kill a virus.

One advantage of MAB is that it is possible to inject significantly more of them than the immune system is capable of making. The disadvantages of monoclonal antibodies are they don’t last forever so (while dosing is less frequent than the currently available daily AVTs) MABs would require regular, ongoing dosing. The lifespan for effectiveness is short, so patients will need regular monthly or quarterly injections to maintain efficacy. Also, cost may be a factor, as MABs are expensive to make and regularly dosing could be costly.

What is in the pipeline for Herpes treatment with monoclonal antibodies?

There are two companies with clinical research projects in the Herpes Cure Pipeline are testing MABS: United BioPharma has 3 studies underway (Phase 1 completed, Phase 2 are expected to start in 2022) and Heidelberg Immunotherapeutics who just finished a Phase 2 trial in January 2022. Patient advocates are currently waiting for the Phase 2 results from Heidelberg’s formula HDIT-101.

United BioPharma

There are three Phase 2 clinical trials expected to started in 2022 from United BioPharma, looking at three separate and unique data sets for their mAB formulation, UB-621. They will be measuring the rate of viral shedding, but first will be collecting the rate of occurrences, pre and post dosage, in earlier trial participants.

The studies are focused on genital HSV-2, although it is indicated that UB-621 could also be effective against HSV-1.

What does UB-621 do? It is a fully humanized viral entry inhibitor antibody that recognizes glycoprotein D (gD) of HSV type I and type II.

  • Neutralizes both HSV-1 and HSV-2
  • Long half-life up to 25 days
  • The leading antibody drug for treatment of HSV infection
  • High binding affinity to the gD protein : 3.6 x 10-11 M

Study 1: Safety & Efficacy Against recurrent genital infection (Estimated start of October 2021, Delayed)

Study 2: Repeat Dose for Tolerance and Effectiveness (Estimated start of December 2022)

Study 3: Efficacy to reduce viral shedding (Estimated start of June 2022)

Other parts of the immune system like cd4 and 8 cells have typically been thought to be much more important than antibodies for fighting HSV so these results are highly anticipated.

Heidelberg Immunotherapeutics

Heidelberg Immunotherapeutics just finished Phase 2 clinical trials in Europe for a monoclonal antibody in 2022. This research team is based in The National Center for Tumor Diseases (NCT) Heidelberg, a joint venture of the German Cancer Research Center and the Heidelberg University Hospital. Their formula HDIT101 is administered via an intravenous transfusion, read more about their preclinical work here.

Heidelberg focuses on the discovery, design, engineering and production of novel antibody-based therapeutics for immunotherapy of malignant tumors and viral diseases. 


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