Prophylaxis Herpes SimplexPhase 2NCT00697567
Evaluation of Immunogenicity, Reactogenicity and Safety of Herpes Simplex (gD) Candidate Vaccine With/Without Adjuvant
A Phase 2 study testing Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant and Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant in people with Prophylaxis Herpes Simplex, run by GlaxoSmithKline at 1 site in Belgium.
Trial summary
The purpose of the phase IIa study in healthy HSV seropositive and HSV seronegative adults is to evaluate the immunogenicity, reactogenicity and safety of herpes simplex (gD) candidate vaccine with or without adjuvant administered according to a 0, 1, 6 month schedule. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Prophylaxis Herpes Simplex
- What is being tested?
- Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant and Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 1992to Dec 1997
- Phase
- Phase 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 18 and 40 years of age
- Written informed consent
- Female volunteers must be using contraceptive and should avoid becoming pregnant for the duration of this study.
- Good clinical condition as evidenced by history taking and physical examination
Who cannot join
- History of persistent hepatic, renal, cardiac or respiratory diseases.
- Clinical signs of acute illness at the time of entry into the study.
- Seropositive for antibodies against the human immunodeficiency virus (HIV).
- Pregnancy, lactation.
- Treatment with corticosteroids or immunomodulating drugs.
- Simultaneous participation in another clinical trial.
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- Any previous history of allergy.
- Any concomitant vaccination or administration of immunoglobulin during the study period.
- Any abnormal laboratory value among the tests performed at screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study in Healthy HSV Positive and HSV Negative Adults to Evaluate the Immunogenicity, Reactogenicity and Safety of GSK Biologicals' Herpes Simplex (gD) Candidate Vaccine With or Without Adjuvant
The purpose of the phase IIa study in healthy HSV seropositive and HSV seronegative adults is to evaluate the immunogenicity, reactogenicity and safety of herpes simplex (gD) candidate vaccine with or without adjuvant administered according to a 0, 1, 6 month schedule.
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
- Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant, Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant
- Keywords
- Herpes simplex, Herpes simplex 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 GSK208141 - non-MPL-containing adjuvantBiological
Intramuscular injection, 3 doses
Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvantBiological
Intramuscular injection, 3 doses
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | HSV seropositive subjects Receives: Biological: Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant |
| Group B | Experimental | HSV seronegative subjects Receives: Biological: Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant |
| Group C | Experimental | HSV seropositive subjects Receives: Biological: Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant |
| Group D | Experimental | HSV seronegative subjects Receives: Biological: Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the immunogenicity of herpes simplex vaccine, with or without MPL, in healthy adult HSV seropositive and HSV seronegative volunteers
Measured: Days 0, 30, 60, 180 and 365 after vaccination
To evaluate the reactogenicity and safety of the MPL-containing and non-MPL-containing vaccine in healthy adult HSV seronegative and seropositive volunteers
Measured: Reactogenicity from day 0 to day 6 after vaccination. Safety from day 0 to day 365 after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2008 (estimated)
- Study startSep 1992
- Primary completionDec 1997
- Study completionDec 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 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
- NCT00697567
- Sponsor's protocol ID
- 208141/002
- Status last verified
- Jun 2008
- First submitted
- 12 Jun 2008
- Last updated
- 16 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study in Healthy HSV Positive and HSV Negative Adults to Evaluate the Immunogenicity, Reactogenicity and Safety of GSK Biologicals' Herpes Simplex (gD) Candidate Vaccine With or Without Adjuvant
- ClinicalTrials.gov ID
- NCT00697567
- Acronym / sponsor ID
- 208141/002
- Conditions
- Prophylaxis Herpes Simplex
- Keywords
- Herpes simplex, Herpes simplex vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 1992
- Primary completion
- Dec 1997 (actual)
- Study completion
- Dec 1997 (actual)
- First posted
- 16 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 phase IIa study in healthy HSV seropositive and HSV seronegative adults is to evaluate the immunogenicity, reactogenicity and safety of herpes simplex (gD) candidate vaccine with or without adjuvant administered according to a 0, 1, 6 month schedule.
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
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvantHSV seropositive subjects |
| Group B | Experimental | Biological: Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvantHSV seronegative subjects |
| Group C | Experimental | Biological: Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvantHSV seropositive subjects |
| Group D | Experimental | Biological: Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvantHSV seronegative subjects |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between 18 and 40 years of age
- Written informed consent
- Female volunteers must be using contraceptive and should avoid becoming pregnant for the duration of this study.
- Good clinical condition as evidenced by history taking and physical examination
Key exclusion criteria (9 listed)
- History of persistent hepatic, renal, cardiac or respiratory diseases.
- Clinical signs of acute illness at the time of entry into the study.
- Seropositive for antibodies against the human immunodeficiency virus (HIV).
- Pregnancy, lactation.
- Treatment with corticosteroids or immunomodulating drugs.
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 GSK208141 - non-MPL-containing adjuvantIntramuscular injection, 3 doses | Biological | Group A, Group B |
| Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvantIntramuscular injection, 3 doses | Biological | Group C, Group D |
Primary outcome
To evaluate the immunogenicity of herpes simplex vaccine, with or without MPL, in healthy adult HSV seropositive and HSV seronegative volunteers
Time frame: Days 0, 30, 60, 180 and 365 after vaccination
To evaluate the reactogenicity and safety of the MPL-containing and non-MPL-containing vaccine in healthy adult HSV seronegative and seropositive volunteers
Time frame: Reactogenicity from day 0 to day 6 after vaccination. Safety from day 0 to day 365 after vaccination
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 16 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 2 study testing Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant and Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant 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 9 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 16 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 phase mean?
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 the immunogenicity of herpes simplex vaccine, with or without MPL, in healthy adult HSV seropositive and HSV seronegative volunteers (time frame: Days 0, 30, 60, 180 and 365 after vaccination). The study lists 2 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 16 Jun 2008.