Prophylaxis for Herpes SimplexPhase 3NCT00698568
Safety Evaluation of Herpes Simplex Candidate Vaccine (gD2t) With Adjuvant in HSV Seropositive / Seronegative Subjects
A Phase 3 study testing Herpes simplex candidate vaccine- adjuvanted GSK 208141 in people with Prophylaxis for Herpes Simplex, run by GlaxoSmithKline at 47 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prophylaxis for Herpes Simplex
- What is being tested?
- Herpes simplex candidate vaccine- adjuvanted GSK 208141
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7,460 participants
- Where
- 47 sitesin 12 countries
- Study dates
- Oct 1996to Apr 1999
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 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
Who cannot join
- 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
Show all 20Show fewer
- 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
- Recent clinical history or evidence of significant hepatic disease
- History of a current acute or chronic auto immune disease.
- Recent clinical history or evidence of renal dysfunction
- Life-threatening or serious cardiac (NYHA grades III-IV), gastrointestinal, haematological or immunological disorder which, in the opinion of the investigator, would preclude entry into the study.
- Inability or unwillingness to comply with the protocol or not expected to complete the study period
Trial locations and contacts
47 sites in 12 countries.
47 sites in 12 countries
United States36 sites
GSK Clinical Trials Call Center
Albuquerque, New Mexico, 87108
GSK Clinical Trials Call Center
Atlanta, Georgia, 30033
GSK Clinical Trials Call Center
Atlanta, Georgia, 30342
GSK Clinical Trials Call Center
Austin, Texas, 78758
GSK Clinical Trials Call Center
Brooklyn, New York, 11203
GSK Clinical Trials Call Center
Bryan, Texas, 77802
GSK Clinical Trials Call Center
Charleston, South Carolina, 29425-3312
GSK Clinical Trials Call Center
Cincinnati, Ohio, 45229-3039
GSK Clinical Trials Call Center
Dallas, Texas, 75235-8889
GSK Clinical Trials Call Center
Denver, Colorado, 80262
GSK Clinical Trials Call Center
Des Moines, Iowa, 50309
GSK Clinical Trials Call Center
East Lyme, Connecticut, 06333
GSK Clinical Trials Call Center
Falls Church, Virginia, 22046
GSK Clinical Trials Call Center
Indianapolis, Indiana, 46202-5124
GSK Clinical Trials Call Center
La Jolla, California, 92037
GSK Clinical Trials Call Center
Lake Jackson, Texas, 77566
GSK Clinical Trials Call Center
Lansing, Michigan, 48824
GSK Clinical Trials Call Center
Louisville, Kentucky, 40292
GSK Clinical Trials Call Center
Middle Valley, California, 94941
GSK Clinical Trials Call Center
Mission, Kansas, 66202
GSK Clinical Trials Call Center
Nassau Bay, Texas, 77058
GSK Clinical Trials Call Center
Newton, Massachusetts, 02165
GSK Clinical Trials Call Center
Omaha, Nebraska, 68131
GSK Clinical Trials Call Center
Philadelphia, Pennsylvania, 19104
GSK Clinical Trials Call Center
Pittsburgh, Pennsylvania, 45241
GSK Clinical Trials Call Center
Portland, Oregon, 97210
GSK Clinical Trials Call Center
Poughkeepsie, New York, 12601
GSK Clinical Trials Call Center
Providence, Rhode Island, 02907
GSK Clinical Trials Call Center
Salt Lake City, Utah, 84132
GSK Clinical Trials Call Center
San Antonio, Texas, 78229
GSK Clinical Trials Call Center
San Diego, California, 92128
GSK Clinical Trials Call Center
Seattle, Washington, 98104
GSK Clinical Trials Call Center
St Louis, Missouri, 63139
GSK Clinical Trials Call Center
St Louis, Missouri, 63141
GSK Clinical Trials Call Center
Towson, Maryland, 21286
GSK Clinical Trials Call Center
Wenatchee, Washington, 98801
Australia1 site
GSK Clinical Trials Call Center
Sydney, New South Wales, 2000
About this study
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
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.
Read the detailed description
This study was monitored by a Data Safety Monitoring Board. At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham.
- Conditions
- Prophylaxis for Herpes Simplex
- Being tested
- Herpes simplex candidate vaccine- adjuvanted GSK 208141, Placebo
- Keywords
- Herpes simplex, Herpes simplex candidate vaccine
- Medical subject headings
- Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herpes simplex candidate vaccine- adjuvanted GSK 208141Biological
Intramuscular injection, 3 doses
PlaceboBiological
Intramuscular injection, 3 doses
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Biological: Herpes simplex candidate vaccine- adjuvanted GSK 208141 |
| Group B | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 0 through month 19
To evaluate the incidence and the types of the serious adverse experiences in both groups
Measured: 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
Measured: 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
Measured: At months 7 and 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startOct 1996
- Primary completionApr 1999
- Study completionApr 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prophylaxis for Herpes SimplexStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 7,460 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698568
- Sponsor's protocol ID
- 208141/016
- Status last verified
- Jun 2008
- First submitted
- 16 Jun 2008
- Last updated
- 17 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00698568
- Acronym / sponsor ID
- 208141/016
- Conditions
- Prophylaxis for Herpes Simplex
- Keywords
- Herpes simplex, Herpes simplex candidate vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,460 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 1996
- Primary completion
- Apr 1999 (actual)
- Study completion
- Apr 1999 (actual)
- First posted
- 17 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study was monitored by a Data Safety Monitoring Board. At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: Herpes simplex candidate vaccine- adjuvanted GSK 208141 |
| Group B | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 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
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herpes simplex candidate vaccine- adjuvanted GSK 208141Intramuscular injection, 3 doses | Biological | Group A |
| PlaceboIntramuscular injection, 3 doses | Biological | Group B |
Primary outcome
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
Time frame: During a 30-day period after each vaccination (AEs), during 7 months after study start (SAEs)
6 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
Time frame: 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
Time frame: 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
Time frame: Day 0 through month 19
To evaluate the incidence and the types of the serious adverse experiences in both groups
Time frame: 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
Time frame: 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
Time frame: At months 7 and 13
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2008.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
GlaxoSmithKline
47 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Herpes simplex candidate vaccine- adjuvanted GSK 208141 in people with Prophylaxis for Herpes Simplex, run by GlaxoSmithKline at 47 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Australia, Austria, Belgium, Canada and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: During a 30-day period after each vaccination (AEs), during 7 months after study start (SAEs)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2008; AzTrials last refreshed its copy on 8 Nov 2026.