NCT00698568|CompletedPhase 3

Safety Evaluation of Herpes Simplex Candidate Vaccine (gD2t) With Adjuvant in HSV Seropositive / Seronegative Subjects

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

GlaxoSmithKline ClinicalTrials.gov

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1 other identifier

208141/016

Study Type

interventional

Target

7,460

Locations

11 countries

Sites

Timeline

RegisteredJun 2008

StartedOct 1996

CompletionApr 1999

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

7,460

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Oct 1996

Geographic Reach

11 countries

46 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.5 years study duration

Study Start

First participant enrolled

October 1, 1996

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 1999

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 1999

Completed

9.2 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2008

Completed

1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2008

Completed

Last Updated

June 17, 2008

Status Verified

June 1, 2008

Enrollment Period

2.5 years

First QC Date

June 16, 2008

Last Update Submit

June 16, 2008

Conditions

Prophylaxis for Herpes Simplex

Keywords

Herpes simplex, Herpes simplex candidate vaccine

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (6)

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
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
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
Day 0 through month 19
To evaluate the incidence and the types of the serious adverse experiences in both groups
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
Before vaccination, and one month and 7 months after vaccination
+1 more secondary outcomes

Study Arms (2)

Group A

EXPERIMENTAL

Biological: Herpes simplex candidate vaccine- adjuvanted GSK 208141

Group B

PLACEBO COMPARATOR

Biological: Placebo

Interventions

Herpes simplex candidate vaccine- adjuvanted GSK 208141BIOLOGICAL

Intramuscular injection, 3 doses

Group A

PlaceboBIOLOGICAL

Intramuscular injection, 3 doses

Group B

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

years of age and over at the time of first vaccination
Written informed consent
Females of childbearing potential must have a negative pregnancy test at enrollment and prior to each vaccination and be using an accepted method of birth control

You may not qualify if:

Any previous history of or current clinical signs or symptoms of genital herpes disease.
Any previous vaccination against herpes simplex.
Any previous administration of MPL.
History of herpetic keratitis.
History of erythema multiforme.
Female subjects who are pregnant, lactating or planning a pregnancy before one month after the last vaccine dose
Patient is immuno-compromised or is receiving immuno-modifying therapy of any kind. Topical corticoid therapy is allowed.
HIV positive at the time of enrollment
Clinical signs of acute or febrile illness at the time of entry into the study.
Any continuous suppressive antiviral oral therapy within the 6 months prior to entry.
Any administration of immunoglobulins during the vaccination course or within one month prior to the first vaccination.
Any vaccine administration less than one week before or after a study vaccination.
Previous known hypersensitivity to vaccination or to any component of the vaccine.
Simultaneous participation in any other clinical trial of an investigational drug or vaccine concurrent with this study or during the period beginning 30 days prior to entry into the study or 5 half-lives of the drug
Recent history of alcoholism or drug abuse
+5 more criteria

Contact the study team to confirm eligibility.