Herpes SimplexPhase 1NCT00698893
Evaluation of Safety of Candidate gD Vaccine, With or Without MPL in Healthy Herpes Simplex Virus-positive Adults
A Phase 1 study testing Herpes simplex candidate (gD) vaccine GSK208141 in people with Herpes Simplex, run by GlaxoSmithKline.
Trial summary
The purpose of the study is to evaluate the safety and reactogenicity of candidate gD vaccine, with or without MPL, in HSV-seropositive subjects. The immune response elicited in these subjects will also be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Herpes Simplex
- What is being tested?
- Herpes simplex candidate (gD) vaccine GSK208141
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 1 May 1992to 1 Jul 1992
- Phase
- Phase 1
- 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
- Seropositive for antibodies against HSV
- Female volunteers must have been using contraceptives for at least 2 months before the entry and should avoid becoming pregnant for the duration of this study.
- Good physical condition as established by physical examination and history taking at the time of entry
Who cannot join
- Any abnormal laboratory value among the tests performed at screening.
- History of persistent hepatic, renal, cardiac or respiratory diseases
- Clinical signs of acute illness at the time of entry into the study.
- Previous history of asthma or hypersensitivity to drugs.
- Seropositive for antibodies against the human immunodeficiency virus
- Pregnancy and lactation.
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- Treatment with corticosteroids or immunomodulating drugs.
- Simultaneous participation in another clinical trial.
- Administration of any other vaccine or immunoglobulins during the study period
About this study
Official title: An Open Study in Healthy Herpes Simplex Virus (HSV)-Positive Adults to Evaluate the Safety of GSK Biologicals' Candidate gD Vaccine, With or Without 3D MPL
The purpose of the study is to evaluate the safety and reactogenicity of candidate gD vaccine, with or without MPL, in HSV-seropositive subjects. The immune response elicited in these subjects will also be evaluated.
Read the detailed description
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
- Conditions
- Herpes Simplex
- Being tested
- Herpes simplex candidate (gD) vaccine GSK208141
- Keywords
- Herpes simplex, Herpes simplex candidate (gD) 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 (gD) vaccine GSK208141Biological
Intramuscular injection, 2 doses, 2 different formulations (with and without MPL)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Biological: Herpes simplex candidate (gD) vaccine GSK208141 |
| Group B | Experimental | Not described Receives: Biological: Herpes simplex candidate (gD) vaccine GSK208141 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the vaccine safety by repeated physical examination and by recording all local and general signs/symptoms
Measured: Throughout the study
Measurement of haematology/biochemical parameters on blood samples
Measured: Throughout the study
Vaccine reactogenicity by soliciting of local and general signs/symptoms
Measured: On the day of vaccination and the subsequent 7 days
Vaccine immunogenicity by 6 measurements of anti-HSV antibodies
Measured: From day 0 to day 45 following vaccination
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 start1 May 1992
- Primary completion1 Jul 1992
- Study completion1 Jul 1992
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698893
- Sponsor's protocol ID
- 208141/001
- Status last verified
- Jun 2017
- First submitted
- 13 Jun 2008
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049.
PubMed 18845199
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Study in Healthy Herpes Simplex Virus (HSV)-Positive Adults to Evaluate the Safety of GSK Biologicals' Candidate gD Vaccine, With or Without 3D MPL
- ClinicalTrials.gov ID
- NCT00698893
- Acronym / sponsor ID
- 208141/001
- Conditions
- Herpes Simplex
- Keywords
- Herpes simplex, Herpes simplex candidate (gD) vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 May 1992 (actual)
- Primary completion
- 1 Jul 1992 (actual)
- Study completion
- 1 Jul 1992 (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 evaluate the safety and reactogenicity of candidate gD vaccine, with or without MPL, in HSV-seropositive subjects. The immune response elicited in these subjects will also be evaluated.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: Herpes simplex candidate (gD) vaccine GSK208141 |
| Group B | Experimental | Biological: Herpes simplex candidate (gD) vaccine GSK208141 |
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
- Seropositive for antibodies against HSV
- Female volunteers must have been using contraceptives for at least 2 months before the entry and should avoid becoming pregnant for the duration of this study.
- Good physical condition as established by physical examination and history taking at the time of entry
Key exclusion criteria (9 listed)
- Any abnormal laboratory value among the tests performed at screening.
- History of persistent hepatic, renal, cardiac or respiratory diseases
- Clinical signs of acute illness at the time of entry into the study.
- Previous history of asthma or hypersensitivity to drugs.
- Seropositive for antibodies against the human immunodeficiency virus
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 (gD) vaccine GSK208141Intramuscular injection, 2 doses, 2 different formulations (with and without MPL) | Biological | Group A, Group B |
Primary outcome
To evaluate the vaccine safety by repeated physical examination and by recording all local and general signs/symptoms
Time frame: Throughout the study
Measurement of haematology/biochemical parameters on blood samples
Time frame: Throughout the study
Vaccine reactogenicity by soliciting of local and general signs/symptoms
Time frame: On the day of vaccination and the subsequent 7 days
Vaccine immunogenicity by 6 measurements of anti-HSV antibodies
Time frame: From day 0 to day 45 following 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 2 Jun 2017.
- Background: PubMed 18845199Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049.
- Results for study 208141/001 can be found on the GSK Clinical Study RegisterLink provided by the sponsor.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Herpes simplex candidate (gD) vaccine GSK208141 in people with Herpes Simplex, run by GlaxoSmithKline.
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 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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 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.
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 vaccine safety by repeated physical examination and by recording all local and general signs/symptoms (time frame: Throughout the study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00698893, which also lists 1 linked publication.
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 2 Jun 2017.