Last updated: 11/07/2018 13:04:26

Safety evaluation of Herpes Simplex candidate vaccine (gD2t) with adjuvant in HSV seropositive / seronegative subjects

GSK study ID

208141/016

See study documents

Clinicaltrials.gov ID

NCT00698568

EudraCT ID

Not applicable

EU CT Number

Not applicable

Trial status

Study complete

Overview

Eligibility

Locations

Study documents

Results summary

Plain language summaries

Additional information

Trial overview

Official title: Study to evaluate the safety of GSK Biologicals’ Herpes Simplex candidate vaccine (gD2t) with MPL in HSV seropositive or seronegative subjects without genital herpes disease

Trial description: This study will evaluate, versus a placebo, the safety of Herpes simplex candidate vaccine with adjuvant in initially HSV seropositive or seronegative subjects who have no genital herpes disease.

Primary purpose:

Prevention

Trial design:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Allocation:

Randomized

Primary outcomes:

To compare between herpes simplex vaccine and placebo recipients the general safety of the vaccine by recording all the unsolicited adverse experiences and all serious adverse experiences

Timeframe: During a 30-day period after each vaccination (AEs), during 7 months after study start (SAEs)

Secondary outcomes:

To compare between vaccine and placebo recipients the incidence and severity of the reactogenicity as measured by recording the local reactions and the general symptoms

Timeframe: On the day of each vaccination and on the following 3 days

To compare between vaccine and placebo recipients the effect on the haematological and biochemical parameters in subjects from 20% of the centers in each country

Timeframe: At day -90 to day -7, and at month 7 and month 13

To compare between vaccine and placebo recipients the effect on pre-existing herpes simplex virus infection by recording the frequency and severity of all herpes simplex clinical episodes

Timeframe: Day 0 through month 19

To evaluate the incidence and the types of the serious adverse experiences in both groups

Timeframe: Month 7 to month 19

To evaluate the humoral immune response to the vaccine by measuring the anti-gD2 antibodies in a subset of vaccine and placebo recipients from each of the serostatus groups

Timeframe: Before vaccination, and one month and 7 months after vaccination

To compare the anti-gD2 antibody responses between the subsets of HSV double seronegative and HSV-1 seropositive only vaccine recipients

Timeframe: At months 7 and 13

Interventions:

Biological/vaccine: Herpes simplex candidate vaccine- adjuvanted GSK 208141

Biological/vaccine: Placebo

Enrollment:

7460

Primary completion date:

1999-30-04

Observational study model:

Not applicable

Time perspective:

Not applicable

Clinical publications:

Bernstein D et al. (2005) Safety and Immunogenicity of Glycoprotein D—Adjuvant Genital Herpes Vaccine. Clin Infect Dis. 40(9):1271-1281.

Tavares F et al. (2013) Meta-analysis of pregnancy outcomes in pooled randomized trials on a prophylactic adjuvanted glycoprotein D subunit Herpes Simplex Virus vaccine. Vaccine. 31(13):1759-1764. doi: 10.1016/j.vaccine.2013.01.002.

Verstraeten T et al. (2008) Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 26(51):6630–6638.

Medical condition

Prophylaxis for herpes simplex

Product

Herpes Simplex Vaccine

Collaborators

Not applicable

Study date(s)

October 1996 to April 1999

Type

Interventional

Phase

Participation criteria

Sex

Female & Male

Age

18+ years

Accepts healthy volunteers

Yes

18 years of age and over at the time of first vaccination
Written informed consent

Any previous history of or current clinical signs or symptoms of genital herpes disease.
Any previous vaccination against herpes simplex.