HPVPhase 2NCT00260039
Broad Spectrum HPV Vaccine Dose Ranging Study (V502-001)
A Phase 2 study testing Comparator: Gardasil, Comparator: octavalent HPV Vaccine - dose formulation 1 and Comparator: octavalent HPV Vaccine - dose formulation 2 in people with HPV and Cervical Cancer, run by Merck Sharp & Dohme LLC.
Trial summary
This dose-ranging study is to evaluate an investigational vaccine with the following objectives: (1) To demonstrate that the vaccine is well-tolerated in women (2) To evaluate immune responses in women who are between 16 and 23 years of age at enrollment. Read more about this study
- Who is it for?
- Ages 16 to 23 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV, Cervical Cancer, Premalignancy Anogenital Warts
- What is being tested?
- Comparator: Gardasil, Comparator: octavalent HPV Vaccine - dose formulation 1 and Comparator: octavalent HPV Vaccine - dose formulation 2
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- No sites listed yet
- Study dates
- Dec 2005to Aug 2007
- 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 16 to 23 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Lifetime history of 0-4 sexual partners
Who cannot join
- History of abnormal PAP test or abnormal cervical biopsy result; history of external genital/vaginal warts; history of positive HPV test
About this study
Official title: A Randomized, International, Double-Blinded (With In-House Blinding), GARDASIL-Controlled, Dose-Ranging Study of Octavalent Human Papillomavirus (HPV) L1 Virus-like Particle (VLP) Vaccine Administered to 16- to 23- Year-Old Women
This dose-ranging study is to evaluate an investigational vaccine with the following objectives: (1) To demonstrate that the vaccine is well-tolerated in women (2) To evaluate immune responses in women who are between 16 and 23 years of age at enrollment.
- Conditions
- HPV, Cervical Cancer, Premalignancy Anogenital Warts
- Being tested
- Comparator: Gardasil, Comparator: octavalent HPV Vaccine - dose formulation 1, Comparator: octavalent HPV Vaccine - dose formulation 2, Comparator: octavalent HPV Vaccine - dose formulation 3
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparator: GardasilBiological
0.5 mL intramuscular injection administered at Day 1, Month 2 and Month 6
Comparator: octavalent HPV Vaccine - dose formulation 1Biological
0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6
Comparator: octavalent HPV Vaccine - dose formulation 2Biological
0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6
Comparator: octavalent HPV Vaccine - dose formulation 3Biological
0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Gardasil Receives: Biological: Comparator: Gardasil |
| 2 | Experimental | HPV VLP vaccine -Dose regimen 1 Receives: Biological: Comparator: octavalent HPV Vaccine - dose formulation 1 |
| 3 | Experimental | HPV VLP vaccine -Dose regimen 2 Receives: Biological: Comparator: octavalent HPV Vaccine - dose formulation 2 |
| 4 | Experimental | HPV VLP vaccine -Dose regimen 3 Receives: Biological: Comparator: octavalent HPV Vaccine - dose formulation 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The octavalent HPV VLP vaccine, when administered in a 3-dose regimen, induces acceptable responses for specific HPV types at 4 weeks Post dose 3. Immune responses measured by an HPV competitive Luminex immunoassay.
Measured: 4 weeks post dose 3 injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionAug 2007
- Study completionAug 2007
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 HPVStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- 680 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260039
- Sponsor's protocol ID
- V502-001
- Other IDs
- 2005_086
- Status last verified
- Jun 2015
- First submitted
- 28 Nov 2005
- Last updated
- 8 Jun 2015
- Results posted
- No
Publications
Luxembourg A, Brown D, Bouchard C, Giuliano AR, Iversen OE, Joura EA, Penny ME, Restrepo JA, Romaguera J, Maansson R, Moeller E, Ritter M, Chen J. Phase II studies to select the formulation of a multivalent HPV L1 virus-like particle (VLP) vaccine. Hum Vaccin Immunother. 2015;11(6):1313-22. doi: 10.1080/21645515.2015.1012010.
PubMed 25912208
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, International, Double-Blinded (With In-House Blinding), GARDASIL-Controlled, Dose-Ranging Study of Octavalent Human Papillomavirus (HPV) L1 Virus-like Particle (VLP) Vaccine Administered to 16- to 23- Year-Old Women
- ClinicalTrials.gov ID
- NCT00260039
- Acronym / sponsor ID
- V502-001
- Conditions
- HPV, Cervical Cancer, Premalignancy Anogenital Warts
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 680 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 1 Dec 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.
This dose-ranging study is to evaluate an investigational vaccine with the following objectives: (1) To demonstrate that the vaccine is well-tolerated in women (2) To evaluate immune responses in women who are between 16 and 23 years of age at enrollment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Biological: Comparator: GardasilGardasil |
| 2 | Experimental | Biological: Comparator: octavalent HPV Vaccine - dose formulation 1HPV VLP vaccine -Dose regimen 1 |
| 3 | Experimental | Biological: Comparator: octavalent HPV Vaccine - dose formulation 2HPV VLP vaccine -Dose regimen 2 |
| 4 | Experimental | Biological: Comparator: octavalent HPV Vaccine - dose formulation 3HPV VLP vaccine -Dose regimen 3 |
Who may qualify
- Ages
- 16 to 23 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Lifetime history of 0-4 sexual partners
Key exclusion criteria (1 listed)
- History of abnormal PAP test or abnormal cervical biopsy result; history of external genital/vaginal warts; history of positive HPV test
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 |
|---|---|---|
| Comparator: Gardasil0.5 mL intramuscular injection administered at Day 1, Month 2 and Month 6 | Biological | 1 |
| Comparator: octavalent HPV Vaccine - dose formulation 10.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6 | Biological | 2 |
| Comparator: octavalent HPV Vaccine - dose formulation 20.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6 | Biological | 3 |
| Comparator: octavalent HPV Vaccine - dose formulation 30.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6 | Biological | 4 |
Primary outcome
The octavalent HPV VLP vaccine, when administered in a 3-dose regimen, induces acceptable responses for specific HPV types at 4 weeks Post dose 3. Immune responses measured by an HPV competitive Luminex immunoassay.
Time frame: 4 weeks post dose 3 injection
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 8 Jun 2015.
- Background: PubMed 25912208Luxembourg A, Brown D, Bouchard C, Giuliano AR, Iversen OE, Joura EA, Penny ME, Restrepo JA, Romaguera J, Maansson R, Moeller E, Ritter M, Chen J. Phase II studies to select the formulation of a multivalent HPV L1 virus-like particle (VLP) vaccine. Hum Vaccin Immunother. 2015;11(6):1313-22. doi: 10.1080/21645515.2015.1012010.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Comparator: Gardasil, Comparator: octavalent HPV Vaccine - dose formulation 1 and Comparator: octavalent HPV Vaccine - dose formulation 2 in people with HPV and Cervical Cancer, run by Merck Sharp & Dohme LLC.
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 1 inclusion and 1 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 8 Jun 2015. 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 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?
The octavalent HPV VLP vaccine, when administered in a 3-dose regimen, induces acceptable responses for specific HPV types at 4 weeks Post dose 3. Immune responses measured by an HPV competitive Luminex immunoassay. (time frame: 4 weeks post dose 3 injection). 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 NCT00260039, 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 8 Jun 2015.