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Porównanie odpowiedzi immunologicznej 2 vs 3 dawek HPV (27-45 lat)

4 listopada 2026 zaktualizowane przez: The University of Texas Medical Branch, Galveston

Porównanie odpowiedzi immunologicznej po podaniu 2 vs. 3 dawek zatwierdzonej przez FDA 9-walentnej szczepionki HPV wśród kobiet w wieku 27-45 lat

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.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

618

Faza

  • Faza 4

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Texas
      • Galveston, Texas, Stany Zjednoczone, 77555
        • University of Texas Medical Branch

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

27 lat do 45 lat (Dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Kobieta

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: 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.
Biologiczny: 9-valent HPV vaccine, 3 doses standard timing

This will be the comparison group for the 2-dose group.
Eksperymentalny: 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.
Biologiczny: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Short-term human papillomavirus (HPV) type-specific antibody response for type HPV-6
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

The University of Texas Medical Branch, Galveston

Współpracownicy

Cancer Prevention Research Institute of Texas

Śledczy

  • Główny śledczy: Abbey B Berenson, MD, PhD, University of Texas

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

18 stycznia 2023

Zakończenie podstawowe (Szacowany)

1 sierpnia 2027

Ukończenie studiów (Szacowany)

1 sierpnia 2028

Daty rejestracji na studia

Pierwszy przesłany

19 grudnia 2022

Pierwszy przesłany, który spełnia kryteria kontroli jakości

21 grudnia 2022

Pierwszy wysłany (Rzeczywisty)

5 stycznia 2023

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

4 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 22-0243

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Tak

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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