Prophylaxis Herpes SimplexPhase 1/2NCT00698490
Humoral and Cellular Immune Response of Herpes Simplex (gD) Candidate Vaccines From 2 Different Cell Lines
A Phase 1/2 study testing Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141 and Herpes simplex virus containing gD-Alum in people with Prophylaxis Herpes Simplex, run by GlaxoSmithKline at 1 site in Belgium.
Trial summary
The purpose of the study is to compare, in healthy HSV seronegative and HSV seropositive subjects, the humoral and cellular immune response of herpes simplex candidate vaccines containing gD from two different cell lines and using gD-Alum as control. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Prophylaxis Herpes Simplex
- What is being tested?
- Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141 and Herpes simplex virus containing gD-Alum
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 1995to Jan 1997
- Phase
- Phase 1/2
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 18 and 45 years of age
- Written informed consent
- Female volunteers must be using contraception and should avoid becoming pregnant for the duration of the vaccination course
- Serology: Groups 1, 3, 4 and 5: HSV-1 AND HSV-2 seronegative (by gD2 ELISA); Group 2: HSV seropositive by gD2 ELISA before entry
Who cannot join
- Any previous vaccination against Herpes simplex.
- Any previous administration of MPL.
- Pregnancy or lactation.
- Patient is immuno-compromised or is receiving immuno-modifying therapy of any kind.
- Clinical signs of acute or febrile illness at the time of entry into the study.
- Any administration of immunoglobulins during the vaccination course or within one month of vaccination.
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- Any vaccination within one week of study vaccination.
- Previous known hypersensitivity to vaccination or to any component of the vaccine.
- Simultaneous participation in any other clinical trial with an investigational drug or vaccine. Subjects currently in a follow-up period of a vaccine study can be included.
- Recent history of alcoholism or drug abuse (within the past 6 months).
- Life-threatening or serious cardiac (NYHA grades III-IV), gastrointestinal, hepatic, renal, hematological or immunological disorder which, in the opinion of the investigator, would preclude entry into the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Compare, in Healthy HSV Seronegative and HSV Seropositive Subjects, the Humoral and Cellular Immune Response of Herpes Simplex Candidate Vaccines Containing gD From Two Different Cell Lines and Using gD-Alum as Control
The purpose of the study is to compare, in healthy HSV seronegative and HSV seropositive subjects, the humoral and cellular immune response of herpes simplex candidate vaccines containing gD from two different cell lines and using gD-Alum as control.
Read the detailed description
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham.
- Conditions
- Prophylaxis Herpes Simplex
- Being tested
- Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141, Herpes simplex virus containing gD-Alum
- 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.
Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141Biological
Intramuscular injection, 3 doses, 2 different formulations
Herpes simplex virus containing gD-AlumBiological
Intramuscular injection, 3 doses
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | HSV-seronegative subjects Receives: Biological: Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141 |
| Group B | Experimental | HSV-seropositive subjects Receives: Biological: Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141 |
| Group C | Experimental | HSV-seronegative subjects Receives: Biological: Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141 |
| Group D | Experimental | HSV-seronegative subjects Receives: Biological: Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141 |
| Group E | Experimental | HSV-seronegative subjects Receives: Biological: Herpes simplex virus containing gD-Alum |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate in initially HSV-seronegative subjects the GMT's and the seroconversion rates of anti-gD2 antibodies (ELISA)
Measured: After the second and third doses of each vaccine
To evaluate in initially HSV-seronegative subjects, the GMT and the seropositivity rate of anti-HSV-2 neutralizing antibodies
To evaluate the cell-mediated immune (CMI) response (lymphoproliferation, secretion of interleukin 2 and γ interferon)
Measured: After the second and third dose of each vaccine formulation
To evaluate, in initially seronegative subjects and in initially seropositive subjects, the incidence and intensity of solicited local and general signs and symptoms
Measured: During 3 days after each dose of each vaccine
To evaluate in initially seropositive subjects, the GMT and the seropositivity rate of anti-gD2 antibodies (ELISA) and of anti-HSV-2 neutralizing antibodies
Measured: After 2 and 3 doses of vaccines
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 startAug 1995
- Primary completionJan 1997
- Study completionJan 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prophylaxis 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 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
- NCT00698490
- Sponsor's protocol ID
- 208141/015
- Status last verified
- Jun 2008
- First submitted
- 13 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 Compare, in Healthy HSV Seronegative and HSV Seropositive Subjects, the Humoral and Cellular Immune Response of Herpes Simplex Candidate Vaccines Containing gD From Two Different Cell Lines and Using gD-Alum as Control
- ClinicalTrials.gov ID
- NCT00698490
- Acronym / sponsor ID
- 208141/015
- Conditions
- Prophylaxis Herpes Simplex
- Keywords
- Herpes simplex, Herpes simplex candidate vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 1995
- Primary completion
- Jan 1997 (actual)
- Study completion
- Jan 1997 (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.
The purpose of the study is to compare, in healthy HSV seronegative and HSV seropositive subjects, the humoral and cellular immune response of herpes simplex candidate vaccines containing gD from two different cell lines and using gD-Alum as control.
Detailed description
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
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141HSV-seronegative subjects |
| Group B | Experimental | Biological: Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141HSV-seropositive subjects |
| Group C | Experimental | Biological: Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141HSV-seronegative subjects |
| Group D | Experimental | Biological: Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141HSV-seronegative subjects |
| Group E | Experimental | Biological: Herpes simplex virus containing gD-AlumHSV-seronegative subjects |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between 18 and 45 years of age
- Written informed consent
- Female volunteers must be using contraception and should avoid becoming pregnant for the duration of the vaccination course
- Serology: Groups 1, 3, 4 and 5: HSV-1 AND HSV-2 seronegative (by gD2 ELISA); Group 2: HSV seropositive by gD2 ELISA before entry
Key exclusion criteria (11 listed)
- Any previous vaccination against Herpes simplex.
- Any previous administration of MPL.
- Pregnancy or lactation.
- Patient is immuno-compromised or is receiving immuno-modifying therapy of any kind.
- Clinical signs of acute or febrile illness at the time of entry into the study.
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 |
|---|---|---|
| Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141Intramuscular injection, 3 doses, 2 different formulations | Biological | Group A, Group B, Group C, Group D |
| Herpes simplex virus containing gD-AlumIntramuscular injection, 3 doses | Biological | Group E |
Primary outcome
To evaluate in initially HSV-seronegative subjects the GMT's and the seroconversion rates of anti-gD2 antibodies (ELISA)
Time frame: After the second and third doses of each vaccine
To evaluate in initially HSV-seronegative subjects, the GMT and the seropositivity rate of anti-HSV-2 neutralizing antibodies
To evaluate the cell-mediated immune (CMI) response (lymphoproliferation, secretion of interleukin 2 and γ interferon)
Time frame: After the second and third dose of each vaccine formulation
To evaluate, in initially seronegative subjects and in initially seropositive subjects, the incidence and intensity of solicited local and general signs and symptoms
Time frame: During 3 days after each dose of each vaccine
To evaluate in initially seropositive subjects, the GMT and the seropositivity rate of anti-gD2 antibodies (ELISA) and of anti-HSV-2 neutralizing antibodies
Time frame: After 2 and 3 doses of vaccines
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.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141 and Herpes simplex virus containing gD-Alum in people with Prophylaxis Herpes Simplex, run by GlaxoSmithKline at 1 site in Belgium.
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 4 inclusion and 11 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 1 site in Belgium. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 evaluate in initially HSV-seronegative subjects the GMT's and the seroconversion rates of anti-gD2 antibodies (ELISA) (time frame: After the second and third doses of each vaccine). The study lists 5 primary outcomes in all. 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.