Herpevac (gD2 subunit, GSK)
Also known as: gD-Alum/MPL, Herpevac Trial for Women
discontinued GlaxoSmithKline
Last updated:
| Developer | GlaxoSmithKline |
|---|---|
| Platform | protein subunit |
| HSV target | HSV-2 |
| Approach | prophylactic |
| Phase | discontinued |
| 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. |
| Trials | NCT00057330 |
A prophylactic protein-subunit vaccine from GlaxoSmithKline built around HSV-2 glycoprotein D. In a large Phase 3 trial published in 2012, it failed to prevent genital disease caused by HSV-2 — its intended target — but unexpectedly reduced HSV-1 genital disease by about 58%. This HSV-1 versus HSV-2 split became an influential lesson in the field. The program was not taken further.
What it is
Herpevac was a prophylactic (preventive) protein-subunit vaccine developed by GlaxoSmithKline. It was built around a single HSV-2 protein — glycoprotein D (gD2) — combined with two adjuvants, alum and MPL. The idea was that antibodies against gD2 would stop the virus from entering cells and thereby prevent genital herpes.
Where it stands
Herpevac was tested in a large Phase 3 trial, the “Herpevac Trial for Women” (NCT00057330), enrolling about 8,300 women who were seronegative for both HSV-1 and HSV-2. The results, published in the New England Journal of Medicine in 2012, were pivotal — and instructive about the distinctions this site emphasizes:
- Against HSV-2 genital disease — the vaccine’s actual target — it was not effective (about 20% efficacy, not statistically significant).
- Against HSV-1 genital disease it was unexpectedly protective, with roughly 58% efficacy.
Later laboratory work suggested why: HSV-2’s gC2 and gE2 proteins blunt the antibody response that gD2 alone provokes, whereas HSV-1’s equivalents do not. This helped motivate the multi-protein (trivalent) designs that came after. GSK did not advance Herpevac, so the program is inactive. It stands as evidence that a vaccine can succeed against one herpes type while failing against another — which is exactly why HSV-1 and HSV-2 must never be treated as interchangeable.
Registry snapshot
HerpeVac Trial for Young Women
- Registry status
- Completed
- Phase
- phase 3
- Enrollment
- 8,323 (actual)
- Lead sponsor
- GlaxoSmithKline
- Started
- Jan 14, 2003
- Primary completion
- Aug 22, 2009
Registry record last updated Aug 27, 2018.
Sources
- Efficacy Results of a Trial of a Herpes Simplex Vaccine (Belshe et al.)
- 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)
- Blocking HSV-2 Glycoprotein E Immune Evasion as an Approach To Enhance Efficacy of a Subunit Antigen Vaccine for Genital Herpes