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Comparaison de la réponse immunitaire de 2 vs 3 doses de VPH (27-45 ans)

4 novembre 2026 mis à jour par: The University of Texas Medical Branch, Galveston

Comparaison de la réponse immunitaire après l'administration de 2 à 3 doses du vaccin contre le VPH 9-valent approuvé par la FDA chez les femmes de 27 à 45 ans

The goal of this clinical trial is to compare a 2-dose and 3-dose series of 9vHPV vaccine among 27-45-year-old females to assess if 2 doses elicit a noninferior immune response. Participants will be randomized 1:1 to either the 2-dose group or the 3-dose group and asked to provide 4 blood samples over a period of 12 months. All 2-dose participants will be offered a 3rd dose after the final blood draw,12 months after their initial vaccination.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Description détaillée

The investigators are studying an alternate dosing regimen of an approved drug (9vHPV vaccine) in the population for which it is approved. The vaccine is approved for individuals ages 9-45 years old and participants in this study will be 27-45 years of age. The purpose of the study is to examine the immune response of 2 doses of 9vHPV vaccine. The current recommendation is to administer the vaccine in 3 doses (administered at 0, 1-2 months and 6 months) to those 15-45 years of age, but only 2 doses (administered at 0 and 6 months) if the vaccine series is initiated before age 15. The investigators will conduct a randomized study to determine if 2 doses of elicit a similar immune response to that of a standard 3 dose series in individuals 27-45 years of age. Participants in the study group will receive 2 doses of at 0 and 6 months. Participants in the control group will receive 3 doses of 9vHPV vaccine at 0, 2 months, and 6 months. All participants (target accrual n=618) will have 5 mLs of blood drawn at 0, 1, 7, and 12 months. Following the 12-month blood draw, participants randomized to 2-doses will be offered the 3rd dose. Potential participants will be recruited through the University of Texas Medical Branch (UTMB) clinics and surrounding community, and will be screened for inclusion/exclusion criteria. Eligible patients will sign an informed written consent. At their baseline visit, participants will have their blood drawn, be randomized into either the study or control group, and receive their first dose of the HPV vaccine. All participants will receive compensation administered through a ClinCard following each of the 4 blood draws.

Type d'étude

Interventionnel

Inscription (Réel)

618

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Texas
      • Galveston, Texas, États-Unis, 77555
        • University of Texas Medical Branch

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

27 ans à 45 ans (Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Femelle

La description

Inclusion criteria:

  1. Females 27-45 years old.
  2. Ability to give informed consent.
  3. Has not received any prior doses of the HPV vaccine. This will be verified by the person and state registry (Immtrac), as well as the person's electronic medical record.
  4. Reliable telephone access for the duration of the project.
  5. Can read and speak in either English or Spanish.
  6. Identified source of funding for vaccine such as Medicaid, private health insurance, Texas Healthy Women program, etc.
  7. Reports consistent use of reliable birth control and plans to continue its use through study month 13.

Exclusion criteria:

  1. Currently pregnant or plans to become pregnant or donate eggs in the next 13 months. Any subjects with positive pregnancy tests at the initial visit will be disqualified from the study and advised to seek prenatal care.
  2. Has an immunodeficiency or autoimmune disease such as HIV infection, lymphoma, leukemia, lupus, rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition.
  3. Currently receiving treatment or medication that can suppress immune function including radiation therapy, chemotherapy, cyclosporin, leflunomide (Arava), TNF-α antagonists, monoclonal antibody therapies (including rituximab [Rituxan]), intravenous gamma globulin (IVIG), antilymphocyte sera, other therapy known to interfere with the immune response, or systemic corticosteroids (by mouth or intramuscular injection). Those using or have used steroids that are inhaled, placed in the eye, applied on the skin, or injected into the joint/soft tissue will be considered eligible for the study.
  4. History of splenectomy
  5. Known allergies to any vaccine components, including aluminum, yeast or Benzonase.
  6. Febrile at ≥100°F in the 24 hours prior to vaccination. The patients may be rescheduled for a later date.
  7. History of thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
  8. History of >10 sexual partners in their lifetime at time of enrollment
  9. Plans to move out of the Galveston/Houston area in the 13 months following study entry.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Females, 3-dose standard

Three doses of the 9-valent HPV vaccine to be administered to the comparison group (27-45 years of age) at 0, 2, and 6 months.
Biologique: 9-valent HPV vaccine, 3 doses standard timing

This will be the comparison group for the 2-dose group.
Expérimental: Females, 2-dose alternative

Two doses of the 9-valent HPV vaccine to be administered to the experimental group (27-45 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
Biologique: 9-valent HPV vaccine, 2 doses alternate timing

Evaluate 2 doses of the 9-valent HPV vaccine across a 12-month period following the 1st dose among 27-45-year-old females.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Short-term human papillomavirus (HPV) type-specific antibody response for type HPV-6
Délai: Month 1

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-6, measured as number of participants.
Month 1
Short-term human papillomavirus (HPV) type-specific antibody response for type HPV-6
Délai: Month 7

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-6, measured as number of participants.
Month 7
Short-term human papillomavirus (HPV) type-specific antibody response for type HPV-6
Délai: Month 12

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-6, measured as number of participants.
Month 12
Short-term HPV type-specific antibody response for type HPV-11
Délai: Month 1

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-11, measured as number of participants.
Month 1
Short-term HPV type-specific antibody response for type HPV-11
Délai: Month 7

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-11, measured as number of participants.
Month 7
Short-term HPV type-specific antibody response for type HPV-11
Délai: Month 12

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-11, measured as number of participants.
Month 12
Short-term HPV type-specific antibody response for type HPV-16
Délai: Month 1

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-16, measured as number of participants.
Month 1
Short-term HPV type-specific antibody response for type HPV-16
Délai: Month 7

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-16, measured as number of participants.
Month 7
Short-term HPV type-specific antibody response for type HPV-16
Délai: Month 12

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-16, measured as number of participants.
Month 12
Short-term HPV type-specific antibody response for type HPV-18
Délai: Month 1

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-18, measured as number of participants.
Month 1
Short-term HPV type-specific antibody response for type HPV-18
Délai: Month 7

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-18, measured as number of participants.
Month 7
Short-term HPV type-specific antibody response for type HPV-18
Délai: Month 12

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-18, measured as number of participants.
Month 12
Short-term HPV type-specific antibody response for type HPV-31
Délai: Month 1

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-31, measured as number of participants.
Month 1
Short-term HPV type-specific antibody response for type HPV-31
Délai: Month 7

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-31, measured as number of participants.
Month 7
Short-term HPV type-specific antibody response for type HPV-31
Délai: Month 12

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-31, measured as number of participants.
Month 12
Short-term HPV type-specific antibody response for type HPV-33
Délai: Month 1

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-33, measured as number of participants.
Month 1
Short-term HPV type-specific antibody response for type HPV-33
Délai: Month 7

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-33, measured as number of participants.
Month 7
Short-term HPV type-specific antibody response for type HPV-33
Délai: Month 12

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-33, measured as number of participants.
Month 12
Short-term HPV type-specific antibody response for type HPV-45
Délai: Month 1

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-45, measured as number of participants.
Month 1
Short-term HPV type-specific antibody response for type HPV-45
Délai: Month 7

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-45, measured as number of participants.
Month 7
Short-term HPV type-specific antibody response for type HPV-45
Délai: Month 12

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-45, measured as number of participants.
Month 12
Short-term HPV type-specific antibody response for type HPV-52
Délai: Month 1

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-52, measured as number of participants.
Month 1
Short-term HPV type-specific antibody response for type HPV-52
Délai: Month 7

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-52, measured as number of participants.
Month 7
Short-term HPV type-specific antibody response for type HPV-52
Délai: Month 12

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-52, measured as number of participants.
Month 12
Short-term HPV type-specific antibody response for type HPV-58
Délai: Month 1

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-58, measured as number of participants.
Month 1
Short-term HPV type-specific antibody response for type HPV-58
Délai: Month 7

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-58, measured as number of participants.
Month 7
Short-term HPV type-specific antibody response for type HPV-58
Délai: Month 12

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-58, measured as number of participants.
Month 12

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

The University of Texas Medical Branch, Galveston

Collaborateurs

Cancer Prevention Research Institute of Texas

Les enquêteurs

  • Chercheur principal: Abbey B Berenson, MD, PhD, University of Texas

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

18 janvier 2023

Achèvement primaire (Estimé)

1 août 2027

Achèvement de l'étude (Estimé)

1 août 2028

Dates d'inscription aux études

Première soumission

19 décembre 2022

Première soumission répondant aux critères de contrôle qualité

21 décembre 2022

Première publication (Réel)

5 janvier 2023

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 22-0243

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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