Clincosm LogoSign in Get a demo

An Exploratory Open-Label Clinical Trial Evaluating the Immunogenicity of the 9-valent 2-dose HPV Vaccination Regimen

Sponsor
Boston Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04206813
Collaborator
Merck Sharp & Dohme LLC (Industry)
360
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
15
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this study is to explore and evaluate whether a 2-dose schedule of Gardasil 9 among young and mid-adult women 16-45 years of age is generally safe and immunogenic, with an antibody response that is not inferior to that observed of a 3-dose schedule of Gardasil 9 among women aged 16-26 years old. The investigators thought that having a 2-dose vaccination regimen for individuals 16 to 45 would provide a more robust dataset than those of 27 to 45 years old.

Condition or Disease Intervention/Treatment Phase
  • Drug: Gardasil 9 2 dose regimen
  • Drug: Gardasil 9 3 dose regimen
  • Drug: Gardasil 9 rescue dose
 Phase 4

Detailed Description

The investigators will identify potential eligible subjects from the Boston Medical Center (BMC) Clinical Data Warehouse from the following BMC clinics: Pediatrics, Adolescent Medicine, Family Medicine, Obstetric/ Gynecology (OB/GYN), and Women's Health/Adult Primary Care. The research team will mail a recruitment opt-out letter signed by the principal investigator to the participant along with a study flyer. The recruitment letter will inform the participant that a research member may contact them via phone within two week to provide more information regarding the study.

Participants opting-in will be called and interviewed with the study recruitment script and eligibility will be determined. Eligible participants who agree to participate (in-person or over the phone), will be scheduled to come to the Boston University (BU) General Clinical Research Unit (GCRU) to complete the consent process. At the baseline visit participants will be assigned into the appropriate group (control vs. intervention) based on their age.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
360 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The control group will have 120 subjects will receive a 3-dose regimen as recommended by Center for Disease Control (CDC) given at 0, 2 and 6 months. The intervention group will have 240 subjects who will receive a modified 3-dose regimen given at 0, 6, and 12 months. Both groups will have HPV titers drawn at Visit 1 (pre-vaccination) and Visit 7 (after three doses for the Control group and 2 doses for the Intervention group).The control group will have 120 subjects will receive a 3-dose regimen as recommended by Center for Disease Control (CDC) given at 0, 2 and 6 months. The intervention group will have 240 subjects who will receive a modified 3-dose regimen given at 0, 6, and 12 months. Both groups will have HPV titers drawn at Visit 1 (pre-vaccination) and Visit 7 (after three doses for the Control group and 2 doses for the Intervention group).
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
An Open-Label Clinical Trial Evaluating the Immunogenicity of the 9vHPV Vaccination Regimen Over 6 Months Among Women Aged 16 to 45 Years Old, An Exploratory Immunogenicity Study
Actual Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

240 eligible women will receive a 2-dose regimen of Gardasil 9 at (0 and 6 months, followed by a rescue 3rd dose at month 12)

Drug: Gardasil 9 2 dose regimen
a 2-dose regimen of Gardasil 9 at 0 and 6 months
Other Names:
  • Human Papillomavirus 9-valent Vaccine, Recombinant

    • Drug: Gardasil 9 rescue dose
    A rescue dose of Gardasil 9 will be given at 12 months
    Other Names:
  • Human Papillomavirus 9-valent Vaccine, Recombinant

    		•
    Active Comparator: Control group

    120 eligible women will receive the standard 3-dose regimen of Gardasil 9 at (0, 2, 6 months)

    Drug: Gardasil 9 3 dose regimen
    standard 3-dose regimen of Gardasil 9 at 0, 2, 6 months
    Other Names:
  • Human Papillomavirus 9-valent Vaccine, Recombinant

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in immunogenicity of Gardasil 9 [baseline and 7 months]

      Immunogenicity will be measured by serum antibodies assessed by ELISA to the nine HPV types (anti-HPV 6/11/16/18/31/33/45/ 52/58 where positive anti-HPV serum levels are defined as >30, >16, >20, >24, >10, >8, >8, >8, or >8 milli Merck units (mMU)/mL respectively).

    2. Change in geometric mean titers ratios [baseline and 7 months]

      The geometric mean titers (GMT) ratios will be determined by a post-vaccination geometric mean titer (GMT) ratio with a pre-stated analysis of variance model (95% Confidence Interval lower bound >0.5).

    Secondary Outcome Measures

    1. Number of participants with HPV seropositivity at day 1 [day 1]

      The number of participant who test positive in mili Unit (nMU) which will be will be defined as anti-HPV 6/11/16/18/31/33/45/ 52/58 positive if her anti-HPV serum level is >30, >16, >20, >24, >10, >8, >8, >8, or >8 milli Merck units (mMU)/mL for the 9 types, respectively. The serum testing will be under the direction of Merck research lab.

    2. Number of participants with HPV seropositivity at month 7 [month 7]

      The number of participant who test positive in mili Unit (nMU) which will be will be defined as anti-HPV 6/11/16/18/31/33/45/ 52/58 positive if her anti-HPV serum level is >30, >16, >20, >24, >10, >8, >8, >8, or >8 milli Merck units (mMU)/mL for the 9 types, respectively. The serum testing will be under the direction of Merck research lab.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Women receiving care at Boston Medical Center
    Exclusion Criteria:

    • Currently pregnant

    • Prior HPV vaccination

    • A history of severe allergic reaction, including known allergy to any vaccine component, specially severe allergic to yeast

    • Immunocompromised/previous immunosuppressive therapy

    • Thrombocytopenia or other coagulation disorder

    • Currently breastfeeding

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Boston Medical Center Boston Massachusetts United States 02118

    Sponsors and Collaborators

    • Boston Medical Center
    • Merck Sharp & Dohme LLC

    Investigators

    • Principal Investigator: Natalie Joseph, MD MPH, Boston Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Boston Medical Center
    ClinicalTrials.gov Identifier:
    NCT04206813
    Other Study ID Numbers:
    • H-39051
    First Posted:
    Dec 20, 2019
    Last Update Posted:
    Dec 20, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Boston Medical Center
    Gardasil
    Immunogenicity
    9-valent 2-dose HPV vaccination
    9-valent 3-dose HPV vaccination
    Additional relevant MeSH terms:
    Papillomavirus Infections
    Vaccines

    Study Results

    No Results Posted as of Dec 20, 2021