CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 8,323 enrolled
Drug / intervention
HSV vaccine or SB208141, GSK Biologicals' glycoprotein D (gD)-Alum/3-deacylated form of Monophosphoryl Lipid A (MPL) candidate genital herpes vaccine +1 morebiological
Likely dose
HSV gD-Alum/MPL vaccine administered intramuscularly in non-dominant deltoid; specific dose per injection not stated in provided textAI-extracted
Key inclusion· 4
  • ✓Female aged 18-30 years at first vaccination
  • ✓HSV-1 and HSV-2 seronegative confirmed by Western blot
  • ✓Not pregnant and using highly effective contraception for 30 days prior to vaccination and 2 months after vaccination series completion
  • ✓Free of obvious health problems on medical history and clinical examination
Key exclusion· 8
  • ✕Pregnant or nursing female
  • ✕Clinical signs or symptoms of current oro-labial, genital or non-genital HSV disease (swelling, papules, vesicles, pustules, ulcers, crusts, fissures, erythema, discharge, pain, burning, itching, tingling or dysuria)
  • ✕History of confirmed oro-labial, genital or non-genital HSV disease or infection
  • ✕Previous vaccination against herpes

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00057330
NCT00057330Phase 3Completed
CompareCT.gov

A Double-Blind, Randomized, Controlled Phase III Study to Assess the Prophylactic Efficacy and Safety of gD-Alum/MPL Vaccine in the Prevention of Genital Herpes Disease in Young Women Who Are HSV-1 and -2 Seronegative

GlaxoSmithKline·interventional·Posted Apr 1, 2003·Updated Aug 27, 2018

In Brief

A Phase 3 clinical trial evaluating HSV vaccine or SB208141, GSK Biologicals' glycoprotein D (gD)-Alum/3-deacylated form of Monophosphoryl Lipid A (MPL) candidate genital herpes vaccine and Havrix™, GlaxoSmithKline (GSK) Biologicals' licensed Hepatitis A vaccine for Herpes Simplex Infection. Completed, enrolled 8,323 participants across 75 sites in 2 countries.

Detailed Summary

The primary purpose of this study is to see if a herpes vaccine may prevent genital herpes disease in women who are not infected. The study will enroll approximately 7550 healthy women. These women will be randomly assigned to 1 of 2 possible study groups: herpes vaccine (experimental group) or hepatitis A vaccine (control group). Participants will receive their assigned vaccine at 0, 1, and 6 months. Participants will have 9 scheduled study visits and additional unscheduled visits for an evaluation of herpes if it is suspected. Participants will be involved in study related procedures for up to 20 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHerpes Simplex Infection
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 1, 2003
Enrollment StartJan 14, 2003
Primary CompletionAug 22, 2009
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 23.3 years ago

Interventions

HSV vaccine or SB208141, GSK Biologicals' glycoprotein D (gD)-Alum/3-deacylated form of Monophosphoryl Lipid A (MPL) candidate genital herpes vaccinebiological

the vaccine was administered intramuscularly in the non-dominant deltoid

Havrix™, GlaxoSmithKline (GSK) Biologicals' licensed Hepatitis A vaccinebiological

the vaccine was administered intramuscularly in the non-dominant deltoid