Quadrivalent HPV VaccineNCT01184079
Randomized Trial of Alternative HPV Vaccination Schedules in Males in a University Setting
A study testing quadrivalent human papillomavirus vaccine in people with Quadrivalent HPV Vaccine and Human Papillomavirus Vaccine, run by University of Pittsburgh at 1 site in United States.
Trial summary
The investigators propose a randomized, open label trial of the immunogenicity of HPV vaccine among males 18-24 years old, comparing an on-time administration of the third dose with delayed administration of the third dose. All participants would receive the first and second doses according to schedule. Read more about this study
- Who is it for?
- Ages 18 to 26 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Quadrivalent HPV Vaccine, Human Papillomavirus Vaccine
- What is being tested?
- quadrivalent human papillomavirus vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to May 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 26 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males age 18-26
Who cannot join
- Hospitalization within the past year
- Previous HPV vaccination
- >/=5 sexual partners (i.e., insertive intercourse) No other drug studies within 30 days of proposed HPV vaccination
- History of genital warts
- Immunosuppression
- Other vaccines within 8 days of proposed HPV vaccination
Show all 10Show fewer
- Hypersensitivity to yeast or HPV vaccine components
- Known autoimmune disorders
- Receipt of immunoglobulins or blood product within 90 days of enrollment (may defer until 90 days completed)
- Serious Adverse Reaction to HPV vaccine
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
About this study
The investigators propose a randomized, open label trial of the immunogenicity of HPV vaccine among males 18-24 years old, comparing an on-time administration of the third dose with delayed administration of the third dose. All participants would receive the first and second doses according to schedule. They would be randomized to either Dose 3 at 6 months or Dose 3 at 12 months.
Hypothesis: The Geometric mean titers in the 12 month test group (T) are non-inferior to the usual timing control group (C):
H0: δ ≤ -δ0 versus H1: δ > -δ0 where δ = log (GMTT )- log (GMTC) and δ0 is the pre-specified non-inferiority margin
Read the detailed description
- Specific Aims and Overview: The investigators propose a randomized, open label trial of HPV vaccine among males 18-24 years old, comparing an on-time administration of the third dose with delayed administration of the third dose. All participants would receive the first and second doses according to schedule. They would be randomized to either Dose 3 at 6 months or Dose 3 at 12 months.
Blood would be drawn for titers at twice from all participants: pre-dose 1 and one month post Dose 3.
No cytology studies or DNA studies will be conducted.
1.1 Aims:
- Determine if delay in the third dose is immunologically non-inferior to the standard administration schedule (1 month post-dose 3).
- Determine the side effect profile of a delayed third dose, in comparison to the standard schedule.
- Determine the preference and compliance of the men for the timing of the third dose.
1.2 Hypothesis for non- inferiority:
The GMTs in the test group (T) are non-inferior to the usual timing control group (C):
H0: δ ≤ -δ0 versus H1: δ > -δ0 where δ = log (GMTT )- log (GMTC) and δ0 is the pre-specified non-inferiority margin.
- Being tested
- quadrivalent human papillomavirus vaccine
- Keywords
- human papillomavirus vaccine L1, type 6,11,16,18, HPV Vaccines, HPV L1 vaccine, quadrivalent 6,11,16,18
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quadrivalent human papillomavirus vaccineBiological
Also called Gardasil
0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months
quadrivalent human papillomavirus vaccineBiological
Also called Gardasil
0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months
| Study group | Role | What they receive |
|---|---|---|
| 12 months | Experimental | Administration of 3rd dose at 12 months quadrivalent human papillomavirus vaccine Receives: Biological: quadrivalent human papillomavirus vaccine |
| 6 month | Active comparator | Administration of 3rd dose at 6 months quadrivalent human papillomavirus vaccine Receives: Biological: quadrivalent human papillomavirus vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity After Dose 3
Geometric mean titer (GMT) and 95% confidence intervals around titer 1 month after dose 3 in per protocol population, comparing the two groups.
Measured: 1 month after dose 3 (e.g., month 7 if third dose at 6months or month 13 if third dose at 12 months)
Secondary outcomes (2)
Compliance With 3rd Dose
Determine the compliance of the men for the timing of the third dose.
Measured: at 3rd dose (i.e., at month 6 or month 12, depending on arm)
Safety Profile
Total proportion of side effects reported after any dose, compared by arm.
Measured: 1 week after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2010 (estimated)
- Study startOct 2010
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Quadrivalent HPV VaccineStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Richard Zimmerman, University of Pittsburgh
- Investigators
- Richard K Zimmerman, MD MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184079
- Sponsor's protocol ID
- IISP#38206
- Other IDs
- PRO10070407, I#0021806
- Status last verified
- Feb 2014
- First submitted
- 11 Aug 2010
- Last updated
- 27 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Zimmerman RK, Nowalk MP, Lin CJ, Fox DE, Ko FS, Wettick E, Cost G, Hand L, Hayes J, Michaels M. Randomized trial of an alternate human papillomavirus vaccine administration schedule in college-aged women. J Womens Health (Larchmt). 2010 Aug;19(8):1441-7. doi: 10.1089/jwh.2009.1753.
PubMed 20629576Lin CJ, Zimmerman RK, Nowalk MP, Huang HH, Raviotta JM. Randomized controlled trial of two dosing schedules for human papillomavirus vaccination among college age males. Vaccine. 2014 Feb 3;32(6):693-9. doi: 10.1016/j.vaccine.2013.11.098. Epub 2013 Dec 14.
PubMed 24342252Zimmerman RK, Lin CJ, Raviotta JM, Nowalk MP. Do vitamin D levels affect antibody titers produced in response to HPV vaccine? Hum Vaccin Immunother. 2015;11(10):2345-9. doi: 10.1080/21645515.2015.1062955.
PubMed 26176493
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Alternative HPV Vaccination Schedules in Males in a University Setting
- ClinicalTrials.gov ID
- NCT01184079
- Acronym / sponsor ID
- IISP#38206
- Keywords
- human papillomavirus vaccine L1, type 6,11,16,18, HPV Vaccines, HPV L1 vaccine, quadrivalent 6,11,16,18
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Oct 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 18 Aug 2010 (estimated)
- Results
- Posted 26 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose a randomized, open label trial of the immunogenicity of HPV vaccine among males 18-24 years old, comparing an on-time administration of the third dose with delayed administration of the third dose. All participants would receive the first and second doses according to schedule. They would be randomized to either Dose 3 at 6 months or Dose 3 at 12 months.
Hypothesis: The Geometric mean titers in the 12 month test group (T) are non-inferior to the usual timing control group (C):
H0: δ ≤ -δ0 versus H1: δ > -δ0 where δ = log (GMTT )- log (GMTC) and δ0 is the pre-specified non-inferiority margin
Detailed description
- Specific Aims and Overview: The investigators propose a randomized, open label trial of HPV vaccine among males 18-24 years old, comparing an on-time administration of the third dose with delayed administration of the third dose. All participants would receive the first and second doses according to schedule. They would be randomized to either Dose 3 at 6 months or Dose 3 at 12 months.
Blood would be drawn for titers at twice from all participants: pre-dose 1 and one month post Dose 3.
No cytology studies or DNA studies will be conducted.
1.1 Aims:
- Determine if delay in the third dose is immunologically non-inferior to the standard administration schedule (1 month post-dose 3).
- Determine the side effect profile of a delayed third dose, in comparison to the standard schedule.
- Determine the preference and compliance of the men for the timing of the third dose.
1.2 Hypothesis for non- inferiority:
The GMTs in the test group (T) are non-inferior to the usual timing control group (C):
H0: δ ≤ -δ0 versus H1: δ > -δ0 where δ = log (GMTT )- log (GMTC) and δ0 is the pre-specified non-inferiority margin.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12 months | Experimental | Biological: quadrivalent human papillomavirus vaccineAdministration of 3rd dose at 12 months quadrivalent human papillomavirus vaccine |
| 6 month | Active comparator | Biological: quadrivalent human papillomavirus vaccineAdministration of 3rd dose at 6 months quadrivalent human papillomavirus vaccine |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Males age 18-26
Key exclusion criteria (10 listed)
- Hospitalization within the past year
- Previous HPV vaccination
- >/=5 sexual partners (i.e., insertive intercourse) No other drug studies within 30 days of proposed HPV vaccination
- History of genital warts
- Immunosuppression
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 |
|---|---|---|
| quadrivalent human papillomavirus vaccineAlso: Gardasil0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months | Biological | 12 months |
| quadrivalent human papillomavirus vaccineAlso: Gardasil0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months | Biological | 6 month |
Primary outcome
Immunogenicity After Dose 3
Time frame: 1 month after dose 3 (e.g., month 7 if third dose at 6months or month 13 if third dose at 12 months)
Geometric mean titer (GMT) and 95% confidence intervals around titer 1 month after dose 3 in per protocol population, comparing the two groups.
2 secondary outcomes
Compliance With 3rd Dose
Time frame: at 3rd dose (i.e., at month 6 or month 12, depending on arm)
Safety Profile
Time frame: 1 week after vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20629576Zimmerman RK, Nowalk MP, Lin CJ, Fox DE, Ko FS, Wettick E, Cost G, Hand L, Hayes J, Michaels M. Randomized trial of an alternate human papillomavirus vaccine administration schedule in college-aged women. J Womens Health (Larchmt). 2010 Aug;19(8):1441-7. doi: 10.1089/jwh.2009.1753.
- Results publication: PubMed 24342252Lin CJ, Zimmerman RK, Nowalk MP, Huang HH, Raviotta JM. Randomized controlled trial of two dosing schedules for human papillomavirus vaccination among college age males. Vaccine. 2014 Feb 3;32(6):693-9. doi: 10.1016/j.vaccine.2013.11.098. Epub 2013 Dec 14.
- Derived from this study: PubMed 26176493Zimmerman RK, Lin CJ, Raviotta JM, Nowalk MP. Do vitamin D levels affect antibody titers produced in response to HPV vaccine? Hum Vaccin Immunother. 2015;11(10):2345-9. doi: 10.1080/21645515.2015.1062955.
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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.
Richard K Zimmerman, MD MPH principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing quadrivalent human papillomavirus vaccine in people with Quadrivalent HPV Vaccine and Human Papillomavirus Vaccine, run by University of Pittsburgh at 1 site in United States.
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 10 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 27 Mar 2014. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Immunogenicity After Dose 3 (time frame: 1 month after dose 3 (e.g., month 7 if third dose at 6months or month 13 if third dose at 12 months)). 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 NCT01184079, which also lists 3 linked publications.
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 27 Mar 2014.