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NCT Number: NCT04206813

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

HPV Infection Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

16 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gardasil 9 2 dose regimen

Drug

a 2-dose regimen of Gardasil 9 at 0 and 6 months

Other names: Human Papillomavirus 9-valent Vaccine, Recombinant

Gardasil 9 3 dose regimen

Drug

standard 3-dose regimen of Gardasil 9 at 0, 2, 6 months

Other names: Human Papillomavirus 9-valent Vaccine, Recombinant

Gardasil 9 rescue dose

Drug

A rescue dose of Gardasil 9 will be given at 12 months

Other names: Human Papillomavirus 9-valent Vaccine, Recombinant

Primary outcomes

  1. Change in immunogenicity of Gardasil 9

    Time frame: 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

    Time frame: 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 outcomes

  1. Number of participants with HPV seropositivity at day 1

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Dec 20, 2019
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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