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
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
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Pennsylvania
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Pittsburgh, Pennsylvania, États-Unis, 15261
- University of Pittsburgh
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
Autres noms:
0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months
Autres noms:
|
|
Comparateur actif: 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
Autres noms:
0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Immunogenicity After Dose 3
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Compliance With 3rd Dose
Délai: 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
Délai: 1 week after vaccination
|
Total proportion of side effects reported after any dose, compared by arm.
|
1 week after vaccination
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Richard K Zimmerman, MD MPH, University of Pittsburgh
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IISP#38206
- PRO10070407 (Autre identifiant: University of Pittsburgh IRB)
- I#0021806 (Autre identifiant: University of Pittsburgh InfoEd)
Informations sur les médicaments et les dispositifs, documents d'étude
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produit fabriqué et exporté des États-Unis.
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