Table 1.

Summary of prior phase 3 human trials

Study population	Antigen & adjuvant	Primary endpoint	Outcome	Concerns and observations
HSV-2 seronegative discordant couples, HSV-2 seronegatives at STD clinics [30]	gB2, gD2 & MF59	Time to genital infection (culture or seroconversion)	5-month delay in onset of genital infection; by 1 year, no benefit	Durability problematic; accuracy of serology in vaccinated subjects undefined
Discordant couples: double seronegative or any serostatus [31]	gD2 & MPL/alum	Genital disease (lesions, culture+ or PCR+, & seroconversion)	Subset analysis: Efficacious in double seronegative women	Follow up study did not reproduce results [18]; concerns whether vaccine effective in men or HSV-1 seropositive women
Double seronegative women [18]	gD2 & MPL/alum	Genital lesions (signs & symptoms & culture+ or seroconversion)	Efficacious against HSV-1 but not HSV-2	Neutralizing antibody titers low and not durable; gD2 ELISA titers correlated with HSV-1 protection