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Sammenligning af immunrespons af 2 vs 3 HPV-doser (27-45 år gammel)

4. november 2026 opdateret af: The University of Texas Medical Branch, Galveston

Sammenligning af immunresponset efter administration af 2 versus 3 doser af den FDA-godkendte 9-Valent HPV-vaccine blandt kvinder i alderen 27-45 år

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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

618

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Texas
      • Galveston, Texas, Forenede Stater, 77555
        • University of Texas Medical Branch

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

27 år til 45 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv 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.
Biologisk: 9-valent HPV vaccine, 3 doses standard timing

This will be the comparison group for the 2-dose group.
Eksperimentel: 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.
Biologisk: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Short-term human papillomavirus (HPV) type-specific antibody response for type HPV-6
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The University of Texas Medical Branch, Galveston

Samarbejdspartnere

Cancer Prevention Research Institute of Texas

Efterforskere

  • Ledende efterforsker: Abbey B Berenson, MD, PhD, University of Texas

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

18. januar 2023

Primær færdiggørelse (Anslået)

1. august 2027

Studieafslutning (Anslået)

1. august 2028

Datoer for studieregistrering

Først indsendt

19. december 2022

Først indsendt, der opfyldte QC-kriterier

21. december 2022

Først opslået (Faktiske)

5. januar 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 22-0243

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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