Human Papillomavirus InfectionNCT00572832
Randomized Trial of Alternative Quadrivalent Human Papilloma Virus (HPV) Vaccination Schedules in a University Setting
A study testing Quadrivalent human papillomavirus vaccine on-time administration and Quadrivalent human papillomavirus vaccine delayed administration in people with Human Papillomavirus Infection, run by University of Pittsburgh at 1 site in United States.
Trial summary
This is a randomized, open label trial of HPV (human papilloma virus) vaccine, 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 23 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Infection
- What is being tested?
- Quadrivalent human papillomavirus vaccine on-time administration and Quadrivalent human papillomavirus vaccine delayed administration
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Aug 2009
- 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 23 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-23 year old college females who are planning to return to the university for the next fall semester.
Who cannot join
- Pregnancy or planned pregnancy.
- Prior receipt of HPV vaccine.
- Greater than four lifetime sexual partners.
- Immunosuppression.
- Anti-coagulant therapy.
- Breastfeeding.
- History of abnormal pap smear.
- Allergy to vaccine components.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
This is a randomized, open label trial of HPV (human papilloma virus) vaccine, 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 vaccine at 6 months or vaccine at 12 months.
Blood will be drawn for titers twice from all participants: pre-dose 1 and one month post third dose. We hypothesize that 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.
Read the detailed description
The recommendations for HPV vaccine include catch-up of women 18 to 26 years old. Given that a large percentage of women in this age group are attending college, a good place to access them would be through the student health services on college campuses. However, the HPV vaccine schedule of 0, 2, and 6 months is likely to be difficult to implement in a college calendar year and the immunogenicity of alternative schedules is unknown. If the immunogenicity of an altered schedule is good, then higher vaccination rates may be achievable.
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
- Conditions
- Human Papillomavirus Infection
- Being tested
- Quadrivalent human papillomavirus vaccine on-time administration, Quadrivalent human papillomavirus vaccine delayed administration
- Keywords
- Human Papillomavirus Vaccine
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadrivalent human papillomavirus vaccine on-time administrationBiological
Also called Gardasil
The vaccine is given in three doses: Dose 1; dose 2 given 60 days later; dose 3 given six months after dose 1.
Quadrivalent human papillomavirus vaccine delayed administrationBiological
Also called Gardasil
The vaccine is given in three doses: Dose 1; dose 2 given 60 days later; dose 3 given 12 months after dose 1.
| Study group | Role | What they receive |
|---|---|---|
| 6 mon. 3rd dose of quadrivalent human papillomavirus vaccine | Active comparator | Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months. Receives: Biological: Quadrivalent human papillomavirus vaccine on-time administration |
| 12 mon. 3rd dose of quadrivalent human papillomavirus vaccine | Active comparator | Receipt of three doses of quadrivalent human papillomavirus vaccine on a delayed schedule of 0,2, and 12 months. Receives: Biological: Quadrivalent human papillomavirus vaccine delayed administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Antibody Titers Following the Third Dose of Human Papilloma Virus (HPV) Vaccine by Virus Type and by Administration Schedule
Geomtric mean antibody titers were assessed 1 month following the third dose of human papilloma virus vaccine. Persons with baseline antibody titers that were positive to a particular type were deleted from the analysis for that particular type so that the outcome is excludes those with baseline positives (thus, sample size varies by type). Responses were compared between the two groups after dose 3 by type.
Measured: 1 month post-dose 3 (i.e., 7 months for standard schedule and 13 months for alternative schedule)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2007 (estimated)
- Study startSep 2007
- Primary completionApr 2009
- Study completionAug 2009
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 (1)Papers the sponsor has linked to this study.
- Other trials for Human Papillomavirus InfectionStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Investigators
- Richard K. Zimmerman, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00572832
- Sponsor's protocol ID
- 32090
- Status last verified
- Aug 2010
- First submitted
- 11 Dec 2007
- Last updated
- 17 Aug 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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 20629576
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Alternative Quadrivalent Human Papilloma Virus (HPV) Vaccination Schedules in a University Setting
- ClinicalTrials.gov ID
- NCT00572832
- Acronym / sponsor ID
- 32090
- Conditions
- Human Papillomavirus Infection
- Keywords
- Human Papillomavirus Vaccine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Sep 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 13 Dec 2007 (estimated)
- Results
- Posted 25 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, open label trial of HPV (human papilloma virus) vaccine, 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 vaccine at 6 months or vaccine at 12 months.
Blood will be drawn for titers twice from all participants: pre-dose 1 and one month post third dose. We hypothesize that 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.
Detailed description
The recommendations for HPV vaccine include catch-up of women 18 to 26 years old. Given that a large percentage of women in this age group are attending college, a good place to access them would be through the student health services on college campuses. However, the HPV vaccine schedule of 0, 2, and 6 months is likely to be difficult to implement in a college calendar year and the immunogenicity of alternative schedules is unknown. If the immunogenicity of an altered schedule is good, then higher vaccination rates may be achievable.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6 mon. 3rd dose of quadrivalent human papillomavirus vaccine | Active comparator | Biological: Quadrivalent human papillomavirus vaccine on-time administrationReceipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months. |
| 12 mon. 3rd dose of quadrivalent human papillomavirus vaccine | Active comparator | Biological: Quadrivalent human papillomavirus vaccine delayed administrationReceipt of three doses of quadrivalent human papillomavirus vaccine on a delayed schedule of 0,2, and 12 months. |
Who may qualify
- Ages
- 18 to 23 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-23 year old college females who are planning to return to the university for the next fall semester.
Key exclusion criteria (8 listed)
- Pregnancy or planned pregnancy.
- Prior receipt of HPV vaccine.
- Greater than four lifetime sexual partners.
- Immunosuppression.
- Anti-coagulant therapy.
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 vaccine on-time administrationAlso: GardasilThe vaccine is given in three doses: Dose 1; dose 2 given 60 days later; dose 3 given six months after dose 1. | Biological | 6 mon. 3rd dose of quadrivalent human papillomavirus vaccine |
| Quadrivalent human papillomavirus vaccine delayed administrationAlso: GardasilThe vaccine is given in three doses: Dose 1; dose 2 given 60 days later; dose 3 given 12 months after dose 1. | Biological | 12 mon. 3rd dose of quadrivalent human papillomavirus vaccine |
Primary outcome
Geometric Mean Antibody Titers Following the Third Dose of Human Papilloma Virus (HPV) Vaccine by Virus Type and by Administration Schedule
Time frame: 1 month post-dose 3 (i.e., 7 months for standard schedule and 13 months for alternative schedule)
Geomtric mean antibody titers were assessed 1 month following the third dose of human papilloma virus vaccine. Persons with baseline antibody titers that were positive to a particular type were deleted from the analysis for that particular type so that the outcome is excludes those with baseline positives (thus, sample size varies by type). Responses were compared between the two groups after dose 3 by type.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: 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.
Related trials for Human Papillomavirus Infection
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
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 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 on-time administration and Quadrivalent human papillomavirus vaccine delayed administration in people with Human Papillomavirus Infection, 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 8 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 17 Aug 2010. 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 25 Feb 2010). 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?
Geometric Mean Antibody Titers Following the Third Dose of Human Papilloma Virus (HPV) Vaccine by Virus Type and by Administration Schedule (time frame: 1 month post-dose 3 (i.e., 7 months for standard schedule and 13 months for alternative schedule)). 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 NCT00572832, 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 17 Aug 2010.