Herpes SimplexPhase 3NCT00224471
Study to Compare Safety and Immunogenicity of Commercial Scale Consistency Lots of Herpes Simplex Vaccine
A Phase 3 study testing GSK208141 vaccine in people with Herpes Simplex, run by GlaxoSmithKline at 13 sites in 3 countries.
Trial summary
Evaluate, one month after the third dose, the lot-to-lot consistency of 3 different commercial scale production lots of the candidate vaccine in healthy HSV 1-/2- females aged 10-17 years, determined by ELISA. Absence in significant variation for both parameters among the tested lots was hypothesized. Read more about this study
- Who is it for?
- Ages 10 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Herpes Simplex
- What is being tested?
- GSK208141 vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 671 participants
- Where
- 13 sitesin 3 countries
- Study dates
- Dec 2003to Jan 2006
- 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 10 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy female between, and including, 10 and 17 years of age at the time of the first vaccination.
- Seronegative for HSV-1 and HSV-2 at screening
- Written informed assent obtained from the subject and written informed consent obtained from a parent or legal guardian of the subject prior to enrolment. If the subject is above the legal age of consent in her country, written informed consent will only be obtained from the subject.
- Subject must have a negative urine pregnancy test.
- Subject must be of non-childbearing potential, i.e. pre-menarcheal, or if of childbearing potential she must be abstinent or must be using an effective method of birth control for 30 days prior to vaccination, have a negative urine pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. Subjects who reach menarche during the study and therefore are of childbearing potential must agree to follow the same precautions.
- A subject who (or whose parents/guardian) the investigator believes can and will comply with the requirements of the protocol
Who cannot join
- Pregnant or lactating female.
- Female planning to become pregnant during the first eight months of the study
- Any previous history of, or current clinical signs or symptoms of oro-labial (cold sores), genital or non-genital HSV disease, such as swelling, papules, vesicles, pustules, ulcers, crusts, fissures, erythema, discharge, pain, burning, itching, tingling, or dysuria.
- Previous vaccination against herpes.
- History of erythema multiforme.
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
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- Planned administration/administration of a non-study vaccine within 30 days before and after the first dose of study vaccine with the following exceptions: Administration of routine meningococcal, hepatitis B, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus containing vaccine up to 8 days before the first dose of study vaccine is allowed.
- History of allergic disease or reactions likely to be exacerbated by any component of the study vaccines
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- History of a current acute or chronic autoimmune disease.
- History of any neurologic disorders or seizures, with the exception of a single febrile seizure during childhood.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history or physical examination.
- Acute disease at the time of enrolment
- Oral temperature ≥99.5°F (> 37.5°C) / axillary temperature ≥99.5°F (> 37.5°C) at the time of enrolment
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose or planned use during the study period
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
United States9 sites
GSK Investigational Site
Charleston, South Carolina, 29403
GSK Investigational Site
Cincinnati, Ohio, 45229
GSK Investigational Site
Fountain Valley, California, 92708
GSK Investigational Site
Galveston, Texas, 77555-0188
GSK Investigational Site
Golden, Colorado, 80401
GSK Investigational Site
Mesa, Arizona, 85201
GSK Investigational Site
Salt Lake City, Utah, 84109
GSK Investigational Site
Salt Lake City, Utah, 84121
GSK Investigational Site
Seattle, Washington, 98105
Canada3 sites
GSK Investigational Site
Beauport, Quebec, G1E 7G9
GSK Investigational Site
Edmonton, Alberta, T6G 2C8
GSK Investigational Site
Vancouver, British Columbia, V6H 3N1
About this study
Official title: A Phase III, Double-blind, Randomized, Study to Compare: 1) the Immunogenicity and Safety of 3 Commercial Scale Consistency Lots of GlaxoSmithKline (GSK) Biologicals' Herpes Simplex Candidate Vaccine in Healthy HSV-1 and -2 Seronegative (HSV 1-/2-) Female Subjects Aged 10 - 17 Years, and 2) Vaccine Immunogenicity in Healthy HSV 1-/2- Females Aged 10 - 17 Years With Healthy HSV 1-/2- Adult Females
Evaluate, one month after the third dose, the lot-to-lot consistency of 3 different commercial scale production lots of the candidate vaccine in healthy HSV 1-/2- females aged 10-17 years, determined by ELISA. Absence in significant variation for both parameters among the tested lots was hypothesized.
Read the detailed description
At month 0, 1 and 6, 3 groups of 184 subjects received each 3 doses of herpes simplex vaccine lot A, B or C, respectively. The study took 14 months to complete, including screening, and 6 visits were required. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
- Conditions
- Herpes Simplex
- Being tested
- GSK208141 vaccine
- Keywords
- Adolescents, Immunogenicity, Safety, 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.
GSK208141 vaccineBiological
Also called Herpes simplex vaccine
3 IM doses
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Biological: GSK208141 vaccine |
| Group B | Experimental | Not described Receives: Biological: GSK208141 vaccine |
| Group C | Experimental | Not described Receives: Biological: GSK208141 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-gD antibody titre in the entire cohort (10-17 yrs)
Measured: At month 7
Secondary outcomes (10)
Anti-gD antibody titre
Measured: At months 2 and 12
Anti-HSV neutralizing antibodies
Measured: At months 2, 7 and 12
Occurrence and intensity of solicited local symptoms. Resulting school absenteeism will also be evaluated.
Measured: Within 7 days after each vaccination
Occurrence, intensity, relationship to vaccination and resulting school absenteeism of solicited general symptoms
Measured: Within 7 days after each vaccination
Occurrence, intensity, relationship to vaccination and resulting school absenteeism of unsolicited adverse events
Measured: Within 30 days after any vaccination
Occurrence of new onset chronic diseases and other medically significant conditions, regardless of causal relationship to vaccination and intensity
Measured: Throughout the study
Occurrence and relationship to vaccination of SAEs
Measured: Throughout the study period
Anti-gD antibody titre in sera from HSV-042 subjects and in an equally sized subset of sera from adults from study 208141/039
Measured: At month 7
Seroconversion rate by anti-gD ELISA. in HSV-042 subjects and in an equally sized subset of adults from study 208141/039
Measured: At month 7
In the event that a cell-mediated immune correlate of protection is identified in study 208141/039: assessment of the immune correlate of protection in a random subset of HBV-042 subjects
Measured: At months 0, 2, 7, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startDec 2003
- Primary completionSep 2005
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 671 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
- NCT00224471
- Sponsor's protocol ID
- 208141/042
- Status last verified
- Sep 2016
- First submitted
- 21 Sep 2005
- Last updated
- 21 Sep 2016
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Double-blind, Randomized, Study to Compare: 1) the Immunogenicity and Safety of 3 Commercial Scale Consistency Lots of GlaxoSmithKline (GSK) Biologicals' Herpes Simplex Candidate Vaccine in Healthy HSV-1 and -2 Seronegative (HSV 1-/2-) Female Subjects Aged 10 - 17 Years, and 2) Vaccine Immunogenicity in Healthy HSV 1-/2- Females Aged 10 - 17 Years With Healthy HSV 1-/2- Adult Females
- ClinicalTrials.gov ID
- NCT00224471
- Acronym / sponsor ID
- 208141/042
- Conditions
- Herpes Simplex
- Keywords
- Adolescents, Immunogenicity, Safety, Herpes Simplex vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 671 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- Sep 2005 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 23 Sep 2005 (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.
Evaluate, one month after the third dose, the lot-to-lot consistency of 3 different commercial scale production lots of the candidate vaccine in healthy HSV 1-/2- females aged 10-17 years, determined by ELISA. Absence in significant variation for both parameters among the tested lots was hypothesized.
Detailed description
At month 0, 1 and 6, 3 groups of 184 subjects received each 3 doses of herpes simplex vaccine lot A, B or C, respectively. The study took 14 months to complete, including screening, and 6 visits were required. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: GSK208141 vaccine |
| Group B | Experimental | Biological: GSK208141 vaccine |
| Group C | Experimental | Biological: GSK208141 vaccine |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy female between, and including, 10 and 17 years of age at the time of the first vaccination.
- Seronegative for HSV-1 and HSV-2 at screening
- Written informed assent obtained from the subject and written informed consent obtained from a parent or legal guardian of the subject prior to enrolment. If the subject is above the legal age of consent in her country, written informed consent will only be obtained from the subject.
- Subject must have a negative urine pregnancy test.
- Subject must be of non-childbearing potential, i.e. pre-menarcheal, or if of childbearing potential she must be abstinent or must be using an effective method of birth control for 30 days prior to vaccination, have a negative urine pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. Subjects who reach menarche during the study and therefore are of childbearing potential must agree to follow the same precautions.
Key exclusion criteria (16 listed)
- Pregnant or lactating female.
- Female planning to become pregnant during the first eight months of the study
- Any previous history of, or current clinical signs or symptoms of oro-labial (cold sores), genital or non-genital HSV disease, such as swelling, papules, vesicles, pustules, ulcers, crusts, fissures, erythema, discharge, pain, burning, itching, tingling, or dysuria.
- Previous vaccination against herpes.
- 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 |
|---|---|---|
| GSK208141 vaccineAlso: Herpes simplex vaccine3 IM doses | Biological | Group A, Group B, Group C |
Primary outcome
Anti-gD antibody titre in the entire cohort (10-17 yrs)
Time frame: At month 7
10 secondary outcomes
Anti-gD antibody titre
Time frame: At months 2 and 12
Anti-HSV neutralizing antibodies
Time frame: At months 2, 7 and 12
Occurrence and intensity of solicited local symptoms. Resulting school absenteeism will also be evaluated.
Time frame: Within 7 days after each vaccination
Occurrence, intensity, relationship to vaccination and resulting school absenteeism of solicited general symptoms
Time frame: Within 7 days after each vaccination
Occurrence, intensity, relationship to vaccination and resulting school absenteeism of unsolicited adverse events
Time frame: Within 30 days after any vaccination
Occurrence of new onset chronic diseases and other medically significant conditions, regardless of causal relationship to vaccination and intensity
Time frame: Throughout the study
Occurrence and relationship to vaccination of SAEs
Time frame: Throughout the study period
Anti-gD antibody titre in sera from HSV-042 subjects and in an equally sized subset of sera from adults from study 208141/039
Time frame: At month 7
Seroconversion rate by anti-gD ELISA. in HSV-042 subjects and in an equally sized subset of adults from study 208141/039
Time frame: At month 7
In the event that a cell-mediated immune correlate of protection is identified in study 208141/039: assessment of the immune correlate of protection in a random subset of HBV-042 subjects
Time frame: At months 0, 2, 7, and 12
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 21 Sep 2016.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GSK208141 vaccine in people with Herpes Simplex, run by GlaxoSmithKline at 13 sites in 3 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 6 inclusion and 16 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 21 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada, 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 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?
Anti-gD antibody titre in the entire cohort (10-17 yrs) (time frame: At month 7). 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 21 Sep 2016.