BNT163 Herpes Vaccine Clinical Trials, Dosage, Indication, Side Effects

BioNTech SE BNT163 herpes simplex virus (HSV) vaccine candidate is under development to prevent genital lesions caused by Herpes Simplex Virus-2 (HSV-2) and potentially Herpes Simplex Virus-1 (HSV-1). Based on the Company's Messenger RNA (mRNA) platform, BNT163 encodes three HSV-2 glycoproteins to help prevent HSV cellular entry and spread, as well as counteract the immunosuppressive properties of HSVs. BNT163 is an anti-viral ribonucleic acid (RNA) vaccine candidate from BioNTech's infectious disease mRNA vaccine collaboration with the Perelman School of Medicine at the University of Pennsylvania (Penn) in Philadelphia to enter the clinic. The program is Part of BioNTech's strategy to address diseases with a high unmet medical need.

Announced on December 21, 2022, BioNTech's placebo-controlled, observer-blinded, dose-escalation Phase 1 clinical trial is expected to enroll around 108 healthy volunteers aged 18 to 55 without current or history of symptomatic genital herpes infections in the U.S. The first subject was dosed on December 21, 2022. The study consists of a first-dose escalation part, focusing on safety evaluations and assessing the optimal dose-response at various dose levels. The trial's second Part is designed to expand the safety characterization of the selected BNT163 dosing for a more comprehensive assessment of the impact of pre-existing immunity to HSV-1 and -2 on safety and BNT163-induced immune responses. The ClinicalTrials.gov Identifier is NCT05432583, with an estimated study completion date of October 2026.

Currently, available HSV therapies only reduce the severity and frequency of symptoms, says the U.S. Centers for Disease Control and Prevention (CDC). As of April 2025, the U.S. Food and Drug Administration (FDA) and other agencies have not authorized any herpes vaccine.

Based in Mainz, Germany, Biopharmaceutical New Technologies (BioNTech S.E.) (Nasdaq: BNTX) is a next-generation immunotherapy company pioneering novel therapies for cancer and other serious diseases.

BNT163 Indication

HSV-1 and HSV-2 viruses cause two highly prevalent viral infections, according to the World Health Organization (WHO). Both viruses are highly contagious and can also be transmitted during childbirth. As neurotropic and neuroinvasive viruses, HSV-1 and -2 persist in the body by hiding from the immune system in the cell bodies of neurons, where they reside lifelong and thus cannot be eradicated with current treatments. Once acquired, HSV persists lifelong in the body with recurring symptomatic outbreaks. HSV-1 is mainly transmitted by oral contact and causes lesions around the mouth, but in some cases, it also leads to genital infections and respective lesions.

HSV-2 is a sexually transmitted disease that causes genital herpes. Therefore, infections with HSV-2 further increase the risk of acquiring and transmitting HIV infections. According to the WHO, approximately 500 million people globally are estimated to be affected by genital infections caused by HSV-2, with painful genital lesions, an increased risk for meningitis, and high levels of emotional distress. Moreover, HSV-2 infection increases the risk of acquiring HIV infection by approximately threefold. In addition, co-infections with both HIV and HSV-2 increase the likelihood of transmitting HIV to others, says the WHO.

BioNTech - University of Pennsylvania

In 2018, Penn and BioNTech entered into a research collaboration and license agreement to develop novel mRNA vaccine candidates for the prevention and treatment of various infectious diseases. As a result, the Perelman School of Medicine at the University of Pennsylvania has licensed some intellectual property related to the BNT163 vaccine candidate to BioNTech. Additionally, the University receives sponsored research funding from BioNTech, associated with the preclinical development of the BNT163 vaccine candidate. As inventors of specific intellectual property related to the BNT163 vaccine candidate, some of the scientists involved in the preclinical development of the vaccine and Penn may receive additional financial benefits under the BioNTech license in the future. The Penn (BNT163-01) research study is being conducted to determine the optimal dose of the investigational vaccine, BNT163, and to assess its safety and tolerability.

BNT163 Herpes Vaccine News

February 23, 2023 - Herpes Vaccines Focus on mRNA.

December 21, 2022 - "This program is part of our strategy to help address diseases with a high unmet medical need and of global health relevance by combining our new technologies, such as mRNA, and our expertise in immune engineering," said Prof. Özlem Türeci, M.D., Chief Medical Officer and Co-Founder of BioNTech, in a press release. "BNT163 is based on three non-infectious mRNA-encoded HSV-2 glycoproteins. We aim to induce a broad immune response against multiple antivirus antigens and mobilize various immune effectors to support virus neutralization and clearance."

November 5, 2018 - BioNTech AG, a rapidly growing biotechnology company focused on the development of immunotherapies for the precise and individualized treatment of cancer and prevention of infectious diseases, and the University of Pennsylvania (Penn), Philadelphia, USA, today announced that they have entered into a strategic research collaboration. The exclusive, multi-year partnership aims to develop novel nucleoside-modified mRNA vaccine candidates for the prevention and treatment of various infectious diseases.

BNT163 Herpes Vaccine Clinical Trials

Phase 1 study: ClinicalTrials.gov Identifier: NCT05432583 - This exploratory trial will have two parts. While Part A will focus on safety evaluations, vaccine-induced immune responses, specifically neutralizing antibodies, will also be analyzed to assess whether there is a dose-response relationship. The trial will expand the safety characterization for a BNT163 dose selected based on Part A data and enable a more comprehensive assessment of the impact of pre-existing immunity to HSV-1 and -2 on the safety and BNT163-induced immune responses after one selected (higher) dose of BNT163 than could be done during the dose escalation performed in Part A.