Randomized Trial of Alternative HPV Vaccination Schedules in Males in a University Setting
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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
1. 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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Förenta staterna, 15261
- University of Pittsburgh
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Males age 18-26
Exclusion Criteria:
- 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
- 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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 12 months
Administration of 3rd dose at 12 months quadrivalent human papillomavirus vaccine
|
0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months
Andra namn:
0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months
Andra namn:
|
|
Aktiv komparator: 6 month
Administration of 3rd dose at 6 months quadrivalent human papillomavirus vaccine
|
0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months
Andra namn:
0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Immunogenicity After Dose 3
Tidsram: 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.
|
1 month after dose 3 (e.g., month 7 if third dose at 6months or month 13 if third dose at 12 months)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Compliance With 3rd Dose
Tidsram: at 3rd dose (i.e., at month 6 or month 12, depending on arm)
|
Determine the compliance of the men for the timing of the third dose.
|
at 3rd dose (i.e., at month 6 or month 12, depending on arm)
|
|
Safety Profile
Tidsram: 1 week after vaccination
|
Total proportion of side effects reported after any dose, compared by arm.
|
1 week after vaccination
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Richard K Zimmerman, MD MPH, University of Pittsburgh
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- Lin 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.
- Zimmerman 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IISP#38206
- PRO10070407 (Annan identifierare: University of Pittsburgh IRB)
- I#0021806 (Annan identifierare: University of Pittsburgh InfoEd)
Läkemedels- och apparatinformation, studiedokument
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