The Current Landscape of Herpes Vaccine and Drug Development (as of 2025)

작성자: Specta

The Current Landscape of Herpes Vaccine and Drug Development (as of 2025)

A visual depicting the current state of herpes vaccine development.

1. GSK3943104 – Development Halted Before Phase 3

After analyzing key data from the Phase 2 trial, GSK3943104 failed to meet its primary efficacy endpoints.
As a result, GSK has halted advancement into Phase 3 for this HSV therapeutic vaccine.

2. Moderna – mRNA-1608

Purpose: To reduce viral shedding of HSV-2.
This is not a curative vaccine, but aims to decrease recurrences and viral load in infected individuals.

The Phase 1/2 clinical study evaluating the safety, immunogenicity, and potential clinical benefit of mRNA-1608 was completed in May 2025, with individual participant data shared with volunteers.
An official topline report is expected by late 2025.

Some trial participants have reported fewer outbreaks after vaccination.
If results remain promising, the program may advance to Phase 2b or Phase 3, though progress depends heavily on funding availability.

Assuming steady financial support:

Phase 2b/3 initiation: 2026
Phase 3 completion: 2028
Regulatory review and potential approval: 2029–2030

3. Rational Vaccines – RVx-201

Type: Live-attenuated HSV-2 vaccine
Purpose: To reactivate the immune system in already-infected patients, reducing recurrence and symptom severity.
(Not curative; aims at long-term control.)

Animal studies demonstrated safety, strong immune responses, and ~45% reduction in recurrences.
Human clinical trials (Phase 1) have not yet begun, but IND submission is being prepared.

Estimated timeline (assuming smooth development):

Phase 1 (Safety): 2026 – 2027
Phase 2 (Dose/Efficacy): 2028 – 2030
Phase 3 (Large-scale validation): 2031 – 2033
Regulatory approval: 2033 – 2034

4. BioNTech – BNT163

Purpose: Preventive vaccine against genital herpes, mainly targeting HSV-2.
It is prophylactic, designed to protect non-infected individuals (e.g., partners of HSV-2 carriers).
While primarily preventive, it might offer partial benefit for infected patients by boosting immunity.

Expected timeline (assuming smooth progress):

Phase 1 (Safety): Late 2026 – Early 2027
Phase 2 (Dose/Efficacy): 2027 – 2029
Phase 3 (Large-scale): 2029 – 2031 or 2032
Market approval: 2033 – 2035

5. Changchun Baike Biotechnology – LVRNA101

Purpose: Preventive vaccine targeting genital HSV-2 infection.
It has recently received clinical trial approval in China.

Expected timeline:

Phase 1: 2025 – 2026
Phase 2: 2026 – 2028
Phase 3: 2028 – 2031
Market launch: ~2031 – 2033 (with potential early approval in China)

6. Sanofi (HSV529) + Immune Design (G103)

Both vaccines were tested individually and in combination (Immune Design has since been acquired by Sanofi).

Purpose:
Originally preventive (HSV529) but now repurposed for therapy, in combination with G103 to help reduce recurrence, alleviate symptoms, and lower transmission risk among HSV-2 patients.

Phase 1b/2a completed in 2025.
While immune responses improved with the combined regimen, the small sample size prevents definitive conclusions.
Both vaccines showed strong safety profiles, supporting possible larger-scale studies.

Projected timeline:

Phase 2: 2026 – 2028
Phase 3: 2028 – 2031
Market approval: 2033 – 2034

💊 Antiviral Drug Development

Beyond vaccines, next-generation antivirals such as Pritelivir and ABI-5366 are under development.
These agents demonstrate significantly stronger antiviral effects than acyclovir-based drugs.

ABI-5366 (Assembly Bio)

Oral, long-acting helicase-primase inhibitor
May require dosing only once a week or even once a month

Reported clinical outcomes (Phase 1b):

HSV-2 viral shedding rate ↓ 94 %
High-titer shedding (>10⁴ copies/mL) ↓ 98 %
Genital lesion rate ↓ 94 %

By contrast, daily acyclovir reduces shedding by about 40–60 %.

Assuming successful development (currently in Phase 2b):

Phase 2 completion: 2026
Phase 3: 2028
Regulatory approval: Early 2030s

🧬 Toward a Cure – Latent Virus Elimination

Researchers are also exploring curative approaches that target latent HSV.

One early human trial, NCT04560790, involves a CRISPR-based in vivo gene-editing therapy for HSV-1–related corneal disease (Herpetic Stromal Keratitis, HSK).
Three patients received localized CRISPR injections into the cornea.
After ~18 months of follow-up, HSV-1 DNA was undetectable, and no off-target edits were observed.
However, this study was small and uncontrolled, and long-term safety and durability remain to be proven.

So far, human clinical applications have been limited to HSK cases, but the results are encouraging.

While a commercial cure within 5–7 years remains unlikely, curative approaches could realistically emerge within 10–20 years — possibly sooner, given the rapid progress in gene editing, nanodelivery, immune-cell reprogramming, and synthetic biology.

Just as cancer survival rates have dramatically improved over the last decade, continuous biomedical and AI-driven innovation may accelerate breakthroughs even in persistent viral infections like HSV.

🌤️ Outlook

Although herpes is not a life-threatening disease, improving prevention and transmission control can make a major difference for patients and their partners.

If the efficacy of ABI-5366 (94 % viral suppression with weekly or monthly dosing) is confirmed in Phase 2/3 trials, it could revolutionize HSV management, providing a much simpler and more effective alternative to daily antivirals.

✅ Summary:

No approved cure yet, but multiple vaccines and drugs are advancing.
Moderna’s mRNA-1608 and Assembly Bio’s ABI-5366 are the most promising near-term candidates.
CRISPR-based therapies offer the first realistic path to a cure — likely within the next 10–20 years if research continues to accelerate.