{ "generatedAt": "2026-09-28T15:55:00.540Z", "note": "HerpesVaccinations.com open data, licensed CC BY 4.0 (https://creativecommons.org/licenses/by/4.0/) — reuse freely with attribution to HerpesVaccinations.com. Editorial status is our sourced reading of the evidence; registry facts come from ClinicalTrials.gov with their own date. Not medical advice. See https://herpesvaccinations.com/methodology/", "candidates": [ { "slug": "bcht-hsv-2-mrna", "url": "https://herpesvaccinations.com/candidates/bcht-hsv-2-mrna/", "name": "BCHT HSV-2 mRNA vaccine", "aka": [], "developer": "Changchun BCHT Biotechnology Co.", "platform": "mRNA", "hsvTarget": "HSV-2", "approach": "unclear", "phase": "phase 1", "cautionary": false, "status": "A Phase 1 dose-escalation trial started in 2025 and is enrolling by invitation, with primary completion listed for 2027; no results are posted.", "nctIds": [ "NCT07330440" ], "lastUpdated": "2026-09-27", "sources": [ { "title": "ClinicalTrials.gov registry search for BCHT HSV mRNA vaccine (searched 2026-09-27)", "publisher": "ClinicalTrials.gov", "url": "https://clinicaltrials.gov/search?intr=BCHT%20HSV%20mRNA%20vaccine", "date": "searched 2026-09-27" }, { "title": "A Phase I, Dose-escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of an mRNA Vaccine Against Herpes Simplex Virus Type 2 (HSV-2) in Healthy Participants Aged 18-55 Years, Stratified by Serostatus (NCT07330440)", "publisher": "ClinicalTrials.gov", "url": "https://clinicaltrials.gov/study/NCT07330440", "date": "record updated 2026-01-09" } ] }, { "slug": "bnt163", "url": "https://herpesvaccinations.com/candidates/bnt163/", "name": "BNT163", "aka": [], "developer": "BioNTech SE", "platform": "mRNA", "hsvTarget": "HSV-2", "approach": "prophylactic", "phase": "phase 1", "cautionary": false, "status": "First-in-human Phase 1 trial ongoing (active, not recruiting). Started December 2022; estimated primary completion October 2026. No efficacy data published.", "nctIds": [ "NCT05432583" ], "lastUpdated": "2026-06-30", "sources": [ { "title": "A Clinical Trial to Study the Safety, Tolerability, and Immune Responses After Vaccination With an Investigational Vaccine Designed to Prevent Genital Herpes Lesions (NCT05432583)", "publisher": "ClinicalTrials.gov", "url": "https://clinicaltrials.gov/study/NCT05432583", "date": "Active, not recruiting (as of 2026)" }, { "title": "BioNTech Starts Phase 1 Clinical Trial for Prophylactic Herpes Simplex Virus-2 Vaccine Candidate BNT163", "publisher": "BioNTech SE (press release)", "url": "https://investors.biontech.de/news-releases/news-release-details/biontech-starts-phase-1-clinical-trial-prophylactic-herpes", "date": "December 2022" }, { "title": "Safety and Immunogenicity of BNT163, a Trivalent mRNA HSV Vaccine Candidate for Genital Herpes (abstract P-105)", "publisher": "Open Forum Infectious Diseases (IDWeek 2025)", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC12793109/", "date": "October 2025" } ] }, { "slug": "g103", "url": "https://herpesvaccinations.com/candidates/g103/", "name": "G103", "aka": [], "developer": "Sanofi Pasteur, a Sanofi Company (lead sponsor of NCT04222985)", "platform": "protein subunit", "hsvTarget": "HSV-2", "approach": "therapeutic", "phase": "phase 1", "cautionary": false, "status": "The likely registry record for its human trial (NCT04222985, a Sanofi Pasteur Phase 1 study in adults with recurrent genital herpes, which does not name G103) is listed as terminated for business reasons after its first part, with no results posted; as of the 2026-09-28 registry search, no record has an ongoing status.", "nctIds": [ "NCT04222985" ], "lastUpdated": "2026-09-28", "sources": [ { "title": "ClinicalTrials.gov registry search for G103 (searched 2026-09-28)", "publisher": "ClinicalTrials.gov", "url": "https://clinicaltrials.gov/search?intr=G103", "date": "searched 2026-09-28" }, { "title": "Safety and Efficacy of 4 Investigational HSV 2 Vaccines Administered by Intramuscular Route in Adults With Recurrent Genital Herpes Caused by HSV 2 (NCT04222985)", "publisher": "ClinicalTrials.gov", "url": "https://clinicaltrials.gov/study/NCT04222985", "date": "record updated 2022-10-25" }, { "title": "Safety and immunogenicity of investigational herpes simplex virus-2 vaccines in adults with recurrent genital infection", "publisher": "Vaccine", "url": "https://doi.org/10.1016/j.vaccine.2025.127821", "date": "2025" }, { "title": "Nonclinical safety evaluation of two vaccine candidates for herpes simplex virus type 2 to support combined administration in humans", "publisher": "Journal of applied toxicology : JAT", "url": "https://doi.org/10.1002/jat.4404", "date": "2023" }, { "title": "A novel HSV-2 subunit vaccine induces GLA-dependent CD4 and CD8 T cell responses and protective immunity in mice and guinea pigs", "publisher": "Vaccine", "url": "https://doi.org/10.1016/j.vaccine.2015.10.137", "date": "2016" } ] }, { "slug": "gen-003", "url": "https://herpesvaccinations.com/candidates/gen-003/", "name": "GEN-003", "aka": [], "developer": "Genocea Biosciences", "platform": "protein subunit", "hsvTarget": "HSV-2", "approach": "therapeutic", "phase": "discontinued", "cautionary": false, "status": "Reached Phase 2 with positive results on viral shedding and genital lesions. Genocea discontinued the program in September 2017 to focus on cancer immunotherapy. Development has not resumed.", "nctIds": [ "NCT01667341", "NCT02114060", "NCT02300142", "NCT02515175", "NCT03146403" ], "lastUpdated": "2026-09-27", "sources": [ { "title": "Effects of Different Doses of GEN-003, a Therapeutic Vaccine for Genital HSV-2, on Viral Shedding and Lesions: Results of a Randomized Placebo-Controlled Trial (NCT02114060)", "publisher": "The Journal of Infectious Diseases (via PubMed Central)", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC7191615/", "date": "2019" }, { "title": "A Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of a Maintenance Dose of GEN-003 in Subjects With Genital Herpes (NCT03146403)", "publisher": "ClinicalTrials.gov", "url": "https://clinicaltrials.gov/study/NCT03146403", "date": "registry record" }, { "title": "Genocea discontinues HSV-2 candidate GEN-003", "publisher": "BioCentury", "url": "https://www.biocentury.com/article/289815/genocea-discontinues-hsv-2-candidate-gen-003", "date": "September 2017" }, { "title": "Bombs Away: Genocea's Herpes Vaccine Goes Down In Flames", "publisher": "American Council on Science and Health", "url": "https://www.acsh.org/news/2017/09/25/bombs-away-genoceas-herpes-vaccine-goes-down-flames-11874", "date": "September 2017" } ] }, { "slug": "gsk4108771a", "url": "https://herpesvaccinations.com/candidates/gsk4108771a/", "name": "GSK4108771A", "aka": [], "developer": "GlaxoSmithKline", "platform": "other", "hsvTarget": "unclear", "approach": "unclear", "phase": "phase 1", "cautionary": false, "status": "A Phase 1 dose-escalation trial of GSK4108771A was terminated in 2021 to enable development of an enhanced version of the vaccine; as of the 2026-09-27 registry search, no record found has an ongoing status.", "nctIds": [ "NCT04762511" ], "lastUpdated": "2026-09-27", "sources": [ { "title": "ClinicalTrials.gov registry search for GSK4108771A (searched 2026-09-27)", "publisher": "ClinicalTrials.gov", "url": "https://clinicaltrials.gov/search?intr=GSK4108771A", "date": "searched 2026-09-27" }, { "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 (NCT04762511)", "publisher": "ClinicalTrials.gov", "url": "https://clinicaltrials.gov/study/NCT04762511", "date": "record updated 2021-06-28" }, { "title": "A Phase I/II, Observer-blind, Randomised, Placebo-controlled, Multi-country Study to Evaluate Reactogenicity, Safety, Immune Response, and Efficacy of an HSV-targeted Immunotherapy in Healthy Participants Aged 18-40 Years or in Participants Aged 18-60 Years With Recurrent Genital Herpes (NCT05298254)", "publisher": "ClinicalTrials.gov", "url": "https://clinicaltrials.gov/study/NCT05298254", "date": "record updated 2025-09-08" } ] }, { "slug": "herpevac-gd2-gsk", "url": "https://herpesvaccinations.com/candidates/herpevac-gd2-gsk/", "name": "Herpevac (gD2 subunit, GSK)", "aka": [ "gD-Alum/MPL", "Herpevac Trial for Women" ], "developer": "GlaxoSmithKline", "platform": "protein subunit", "hsvTarget": "HSV-2", "approach": "prophylactic", "phase": "discontinued", "cautionary": false, "status": "Completed Phase 3 (the 'Herpevac Trial for Women', ~8,300 participants). It did not prevent HSV-2 genital disease, though it unexpectedly showed ~58% efficacy against HSV-1 genital disease. The program was not advanced.", "nctIds": [ "NCT00057330" ], "lastUpdated": "2026-06-30", "sources": [ { "title": "Efficacy Results of a Trial of a Herpes Simplex Vaccine (Belshe et al.)", "publisher": "New England Journal of Medicine", "url": "https://www.nejm.org/doi/full/10.1056/NEJMoa1103151", "date": "January 2012" }, { "title": "Phase III Study to Assess the Prophylactic Efficacy and Safety of gD-Alum/MPL Vaccine in Young Women Seronegative for HSV-1 and HSV-2 (NCT00057330)", "publisher": "ClinicalTrials.gov", "url": "https://clinicaltrials.gov/study/NCT00057330", "date": "Completed 2009" }, { "title": "Blocking HSV-2 Glycoprotein E Immune Evasion as an Approach To Enhance Efficacy of a Subunit Antigen Vaccine for Genital Herpes", "publisher": "Journal of Virology", "url": "https://journals.asm.org/doi/10.1128/jvi.01130-14", "date": "2014" } ] }, { "slug": "herpv", "url": "https://herpesvaccinations.com/candidates/herpv/", "name": "HerpV", "aka": [ "AG-707" ], "developer": "Agenus", "platform": "protein subunit", "hsvTarget": "HSV-2", "approach": "therapeutic", "phase": "phase 2", "cautionary": false, "status": "A Phase 2a trial in adults with recurrent genital herpes was completed in 2015 with results posted on the registry; as of the 2026-09-27 registry search, no record naming HerpV has an ongoing status.", "nctIds": [ "NCT01687595" ], "lastUpdated": "2026-09-27", "sources": [ { "title": "ClinicalTrials.gov registry search for HerpV (searched 2026-09-27)", "publisher": "ClinicalTrials.gov", "url": "https://clinicaltrials.gov/search?intr=HerpV", "date": "searched 2026-09-27" }, { "title": "A Phase 2a, Multicenter, Double-blinded, Randomized, 2-Period Trial to Evaluate the Effect of HerpV Administered in Combination With the Stimulon® Adjuvant QS-21 on Viral Shedding in Adults With Recurrent Genital Herpes (NCT01687595)", "publisher": "ClinicalTrials.gov", "url": "https://clinicaltrials.gov/study/NCT01687595", "date": "record updated 2021-07-13" }, { "title": "Toward the Eradication of Herpes Simplex Virus: Vaccination and Beyond", "publisher": "Viruses", "url": "https://doi.org/10.3390/v16091476", "date": "2024" }, { "title": "Safety and immunogenicity of long HSV-2 peptides complexed with rhHsc70 in HSV-2 seropositive persons", "publisher": "Vaccine", "url": "https://doi.org/10.1016/j.vaccine.2011.09.046", "date": "2011" }, { "title": "A heat shock protein based polyvalent vaccine targeting HSV-2: CD4(+) and CD8(+) cellular immunity and protective efficacy", "publisher": "Vaccine", "url": "https://doi.org/10.1016/j.vaccine.2011.07.011", "date": "2011" } ] }, { "slug": "hsv529", "url": "https://herpesvaccinations.com/candidates/hsv529/", "name": "HSV529", "aka": [ "dl5-29" ], "developer": "Sanofi Pasteur (trials run with NIAID and Fred Hutchinson Cancer Center)", "platform": "replication-defective live", "hsvTarget": "HSV-2", "approach": "both", "phase": "phase 1", "cautionary": false, "status": "Two Phase 1 trials completed (2013–2018). A 2020–2021 Sanofi trial that appears to be the one combining HSV529 with the protein vaccine G103 was terminated for business reasons after its first part; no active HSV529 trial is listed on ClinicalTrials.gov.", "nctIds": [ "NCT01915212", "NCT02571166", "NCT04222985" ], "lastUpdated": "2026-09-28", "sources": [ { "title": "A Randomized, Double-Blinded, Placebo-Controlled, Phase 1 Study of a Replication-Defective Herpes Simplex Virus (HSV) Type 2 Vaccine, HSV529, in Adults With or Without HSV Infection", "publisher": "The Journal of Infectious Diseases", "url": "https://doi.org/10.1093/infdis/jiz225", "date": "2019" }, { "title": "Phase I Study of the Safety of a Replication-Defective Herpes Simplex Virus-2 Vaccine, HSV529 (NCT01915212)", "publisher": "ClinicalTrials.gov", "url": "https://clinicaltrials.gov/study/NCT01915212", "date": "record updated 2026-09-01" }, { "title": "Phase I Study of the Genital Immune Response to Live, Attenuated HSV529 Vaccine in HSV-2 Seropositive Adults (NCT02571166)", "publisher": "ClinicalTrials.gov", "url": "https://clinicaltrials.gov/study/NCT02571166", "date": "record updated 2019-01-14" }, { "title": "Safety and Efficacy of 4 Investigational HSV 2 Vaccines in Adults With Recurrent Genital Herpes Caused by HSV 2 (NCT04222985)", "publisher": "ClinicalTrials.gov", "url": "https://clinicaltrials.gov/study/NCT04222985", "date": "record updated 2022-10-25" }, { "title": "Safety and immunogenicity of investigational herpes simplex virus-2 vaccines in adults with recurrent genital infection", "publisher": "Vaccine", "url": "https://doi.org/10.1016/j.vaccine.2025.127821", "date": "2025" }, { "title": "Expansion of the HSV-2-specific T cell repertoire in skin after immunotherapeutic HSV-2 vaccine", "publisher": "JCI Insight", "url": "https://doi.org/10.1172/jci.insight.179010", "date": "2024" }, { "title": "Immunogenicity, protective efficacy, and non-replicative status of the HSV-2 vaccine candidate HSV529 in mice and guinea pigs", "publisher": "PLOS ONE", "url": "https://doi.org/10.1371/journal.pone.0121518", "date": "2015" } ] }, { "slug": "mrna-1608", "url": "https://herpesvaccinations.com/candidates/mrna-1608/", "name": "mRNA-1608", "aka": [ "mRNA-1608-P101" ], "developer": "Moderna (ModernaTX, Inc.)", "platform": "mRNA", "hsvTarget": "HSV-2", "approach": "therapeutic", "phase": "discontinued", "cautionary": false, "status": "Phase 1/2 trial completed April 2025 with positive interim data. Moderna announced in November 2025 that it will not advance the program to Phase 3, ending development.", "nctIds": [ "NCT06033261" ], "lastUpdated": "2026-06-30", "sources": [ { "title": "A Study of mRNA-1608, a Herpes Simplex Virus-2 (HSV-2) Therapeutic Candidate Vaccine, in Healthy Adults With Recurrent HSV-2 Genital Herpes (NCT06033261)", "publisher": "ClinicalTrials.gov", "url": "https://clinicaltrials.gov/study/NCT06033261", "date": "Completed April 2025" }, { "title": "mRNA-1608, an mRNA-Based Therapeutic Genital Herpes Vaccine Candidate: Interim Safety, Immunogenicity and Clinical Endpoint Results from a Phase 1/2 Trial (abstract 642)", "publisher": "Open Forum Infectious Diseases (IDWeek 2025)", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC12792503/", "date": "October 2025" }, { "title": "Moderna Cans 3 mRNA Vaccines, Secures $1.5B Loan in Quest for 10% Growth", "publisher": "BioSpace", "url": "https://www.biospace.com/business/moderna-cans-3-mrna-vaccines-secures-1-5b-loan-in-quest-for-10-growth", "date": "November 2025" } ] }, { "slug": "ppjv7630", "url": "https://herpesvaccinations.com/candidates/ppjv7630/", "name": "pPJV7630", "aka": [], "developer": "PowderMed", "platform": "DNA", "hsvTarget": "HSV-2", "approach": "therapeutic", "phase": "phase 1", "cautionary": false, "status": "Two Phase 1 trials were completed by 2006 with no results posted on the registry; as of the 2026-09-27 registry search, no record naming pPJV7630 has an ongoing status.", "nctIds": [ "NCT00274300", "NCT00310271" ], "lastUpdated": "2026-09-27", "sources": [ { "title": "ClinicalTrials.gov registry search for pPJV7630 (searched 2026-09-27)", "publisher": "ClinicalTrials.gov", "url": "https://clinicaltrials.gov/search?intr=pPJV7630", "date": "searched 2026-09-27" }, { "title": "A Phase I, Two-Center, Open-Label, Dose-Escalating Study to Investigate the Safety, Tolerability and Immunogenicity of pPJV7630, a Therapeutic DNA Vaccine for Herpes Simplex Virus Type 2 (HSV-2), in Patients With Recurrent Genital Herpes Caused by HSV-2 (NCT00274300)", "publisher": "ClinicalTrials.gov", "url": "https://clinicaltrials.gov/study/NCT00274300", "date": "record updated 2007-01-29" }, { "title": "A Phase I Study Assessing Safety and Tolerability of a DNA Vaccine With a DNA Encoded Immunostimulator , Administered by Particle Mediated Epidermal Delivery Using the PowderMed ND10 Delivery System in HSV-2 Seronegative Healthy Volunteers (NCT00310271)", "publisher": "ClinicalTrials.gov", "url": "https://clinicaltrials.gov/study/NCT00310271", "date": "record updated 2008-11-21" } ] }, { "slug": "theravax-rational-vaccines", "url": "https://herpesvaccinations.com/candidates/theravax-rational-vaccines/", "name": "Theravax / Profavax (Rational Vaccines)", "aka": [ "Theravax HSV-2", "Profavax", "Halford live-attenuated HSV" ], "developer": "Rational Vaccines (William Halford)", "platform": "live-attenuated", "hsvTarget": "both", "approach": "both", "phase": "discontinued", "cautionary": true, "status": "CAUTIONARY / DISCREDITED — not a legitimate candidate. Tested in an unlicensed, unregistered offshore trial in 2016 without ethical (IRB) or FDA oversight. It prompted an FDA criminal investigation and university findings of serious regulatory noncompliance. The program is defunct.", "nctIds": [], "lastUpdated": "2026-06-30", "sources": [ { "title": "Peter Thiel sponsors offshore testing of herpes vaccine, sidestepping U.S. safety rules", "publisher": "PBS NewsHour", "url": "https://www.pbs.org/newshour/health/peter-thiel-sponsors-offshore-testing-herpes-vaccine-sidestepping-u-s-safety-rules", "date": "2017" }, { "title": "FDA Launches Criminal Investigation into Rational Vaccines Over Unauthorized Herpes Research", "publisher": "BioSpace", "url": "https://www.biospace.com/fda-launches-criminal-investigation-into-rational-vaccines-over-unauthorized-herpes-research", "date": "2018" }, { "title": "Before heading offshore, dubious herpes vaccine trial carried out on people in U.S.", "publisher": "Fierce Pharma", "url": "https://www.fiercepharma.com/vaccines/before-heading-offshore-dubious-herpes-vaccine-trial-carried-out-people-u-s", "date": "2017" } ] }, { "slug": "upenn-trivalent-mrna", "url": "https://herpesvaccinations.com/candidates/upenn-trivalent-mrna/", "name": "Trivalent gC2/gD2/gE2 mRNA (UPenn)", "aka": [ "Friedman–Weissman trivalent", "UPenn HSV-2 trivalent mRNA-LNP" ], "developer": "University of Pennsylvania (Friedman & Weissman labs); licensed to BioNTech", "platform": "mRNA", "hsvTarget": "HSV-2", "approach": "prophylactic", "phase": "preclinical", "cautionary": false, "status": "Academic preclinical program. Strong protection in animal models (mice, guinea pigs, non-human primates). Its clinical development is BioNTech's BNT163, now in a Phase 1 trial.", "nctIds": [], "lastUpdated": "2026-06-30", "sources": [ { "title": "Nucleoside-modified mRNA encoding HSV-2 glycoproteins C, D, and E prevents clinical and subclinical genital herpes", "publisher": "Science Immunology (Awasthi, Friedman, et al.)", "url": "https://www.science.org/doi/10.1126/sciimmunol.aaw7083", "date": "2019" }, { "title": "Trivalent nucleoside-modified mRNA vaccine yields durable memory B cell protection against genital herpes in preclinical models", "publisher": "Journal of Clinical Investigation", "url": "https://www.jci.org/articles/view/152310", "date": "2021" }, { "title": "Safety and Immunogenicity of BNT163, a Trivalent mRNA HSV Vaccine Candidate for Genital Herpes (abstract P-105)", "publisher": "Open Forum Infectious Diseases (IDWeek 2025)", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC12793109/", "date": "October 2025" } ] }, { "slug": "vcl-hb01", "url": "https://herpesvaccinations.com/candidates/vcl-hb01/", "name": "VCL-HB01", "aka": [], "developer": "Vical", "platform": "DNA", "hsvTarget": "HSV-2", "approach": "therapeutic", "phase": "phase 2", "cautionary": false, "status": "A Phase 2 trial in adults with symptomatic genital HSV-2 was completed in 2018 with no results posted on the registry; as of the 2026-09-27 registry search, no record naming VCL-HB01 has an ongoing status.", "nctIds": [ "NCT02030301", "NCT02837575" ], "lastUpdated": "2026-09-27", "sources": [ { "title": "ClinicalTrials.gov registry search for VCL-HB01 (searched 2026-09-27)", "publisher": "ClinicalTrials.gov", "url": "https://clinicaltrials.gov/search?intr=VCL-HB01", "date": "searched 2026-09-27" }, { "title": "A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Phase 1/2 Trial to Evaluate the Safety and Efficacy of Herpes Simplex Virus, Type 2 Therapeutic DNA Vaccines in Symptomatic HSV-2-Seropositive Adults (NCT02030301)", "publisher": "ClinicalTrials.gov", "url": "https://clinicaltrials.gov/study/NCT02030301", "date": "record updated 2019-02-27" }, { "title": "A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Safety and Efficacy of Herpes Simplex Virus, Type 2 (HSV-2) Therapeutic DNA Vaccine in Adults With Symptomatic Genital HSV-2 Infection (NCT02837575)", "publisher": "ClinicalTrials.gov", "url": "https://clinicaltrials.gov/study/NCT02837575", "date": "record updated 2019-02-27" } ] } ] }