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Therapeutic Vaccine for Genital Herpes Simplex Virus-2 Infection: Findings From a Randomized Trial
David I Bernstein1, Anna Wald2, Terri Warren3
1Cincinnati Children's Hospital Medical Center, University of Cincinnati, Ohio, USA.
The Journal of Infectious Diseases
|March 23, 2017
Summary
GEN-003, a therapeutic vaccine for genital herpes simplex virus type 2 (HSV-2), significantly reduced viral shedding and lesion rates in clinical trials. The vaccine demonstrated an acceptable safety profile and stimulated immune responses.
Area of Science:
- Infectious Diseases
- Vaccinology
- Immunology
Background:
- Genital herpes simplex virus type 2 (HSV-2) infection is characterized by recurrent lesions and frequent viral shedding.
- GEN-003 is an investigational therapeutic vaccine comprising HSV-2 glycoproteins and an adjuvant, designed to mitigate HSV-2 recurrence.
Purpose of the Study:
- To evaluate the safety and efficacy of GEN-003 in reducing genital HSV-2 shedding and lesion rates.
- To assess the immunogenicity of GEN-003 by measuring antibody and T-cell responses.
Main Methods:
- A randomized, placebo-controlled trial involving individuals with genital herpes.
- Participants received three intramuscular doses of GEN-003 (10 µg, 30 µg, or 100 µg), antigens without adjuvant, or placebo.
- Genital swabs and lesion monitoring were conducted to assess viral shedding and lesion occurrence.
Main Results:
- GEN-003 was well-tolerated, with reactogenicity linked to the adjuvant but not antigen dose.
- Significant reductions in genital HSV-2 shedding rates were observed for the 30 µg and 100 µg doses of GEN-003 compared to baseline.
- Genital lesion rates were also significantly reduced following immunization with the 30 µg and 100 µg doses.
Conclusions:
- GEN-003 exhibits an acceptable safety profile and effectively stimulates humoral and cellular immune responses.
- GEN-003 at 30 µg and 100 µg doses demonstrated efficacy in reducing genital HSV shedding and lesion rates, offering a potential therapeutic option for HSV-2.
