An interventional study of Quadrivalent human papillomavirus vaccine on-time administration and Quadrivalent human papillomavirus vaccine delayed administration in Human Papillomavirus Infection, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to female participants aged 18 Years to 23 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-08-17.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Prevention
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.
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:
495 studies on the registry are indexed under Papillomavirus Infections; 125 are open to participants now.
This study's enrollment of 200 is close to the median of 202 across 332 interventional studies indexed under Papillomavirus Infections.
Browse Papillomavirus Infections studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.
Biological: Quadrivalent human papillomavirus vaccine on-time administration
Receipt of three doses of quadrivalent human papillomavirus vaccine on a delayed schedule of 0,2, and 12 months.
Biological: Quadrivalent human papillomavirus vaccine delayed administration
The vaccine is given in three doses: Dose 1; dose 2 given 60 days later; dose 3 given six months after dose 1.
Also known as: Gardasil
The vaccine is given in three doses: Dose 1; dose 2 given 60 days later; dose 3 given 12 months after dose 1.
Also known as: Gardasil
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.
Time frame: 1 month post-dose 3 (i.e., 7 months for standard schedule and 13 months for alternative schedule)
Two hundred young women from the university community who met the eligibility criteria were recruited at the Student Health Service.
| Milestone | 6 Month Standard Schedule | 12 Month Alternative Group |
|---|---|---|
| Started | 100 | 100 |
| Completed | 100 | 88 |
| Not completed | 0 | 12 |
| Withdrew: Lost to follow-up | 0 | 11 |
| Withdrew: Pregnancy | 0 | 1 |
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.
| milliMerck units per mL | 6 Month Standard Schedule | 12 Month Alternative Group |
|---|---|---|
| Type 6 | 1894 (1564 to 2194) | 4221 (2930 to 5416) |
| Type 11 | 1773 (1261 to 2252) | 5623 (3939 to 7208) |
| Type 16 | 5534 (3875 to 7093) | 11832 (8165 to 15223) |
| Type 18 | 1225 (1038 to 1396) | 2052 (1138 to 2959) |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 6 Month Standard Schedule | — | 0/100 (0%) | 57/100 (57%) |
| 12 Month Alternative Group | — | 0/100 (0%) | 55/100 (55%) |
| Event | 6 Month Standard Schedule | 12 Month Alternative Group |
|---|---|---|
| Soreness at the injection siteSkin and subcutaneous tissue disorders | 57/100 | 55/100 |
| syncopeGeneral disorders | 1/100 | 0/100 |
| Age, Categorical(Participants) | 6 Month Standard Schedule | 12 Month Alternative Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 100 | 100 | 200 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | 6 Month Standard Schedule | 12 Month Alternative Group | Total |
|---|---|---|---|
| Mean | 20.3 ± 1.3 | 20.1 ± 1.4 | 20.2 ± 1.3 |
| Sex: Female, Male(Participants) | 6 Month Standard Schedule | 12 Month Alternative Group | Total |
|---|---|---|---|
| Female | 100 | 100 | 200 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 6 Month Standard Schedule | 12 Month Alternative Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 5 | 2 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 8 | 8 | 16 |
| White | 83 | 89 | 172 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 1 | 5 |
| Region of Enrollment(participants) | 6 Month Standard Schedule | 12 Month Alternative Group | Total |
|---|---|---|---|
| United States | 100 | 100 | 200 |
| Body Mass Index(kg/m^2) | 6 Month Standard Schedule | 12 Month Alternative Group | Total |
|---|---|---|---|
| Mean | 24.2 ± 4.7 | 24.5 ± 5.1 | 24.3 ± 4.9 |
This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.
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