Safety and Immunogenicity of HPV Vaccine Administered Intradermally and Intramuscularly Via Needle-Free Injection System

March 21, 2024 updated by: PharmaJet, Inc.

Safety and Immunogenicity of Human Papillomavirus Quadrivalent Vaccine Administered Intradermally and Intramuscularly Via Needle-Free Injection System

The goal of this clinical trial is to evaluate the safety and immunogenicity of an HPV Vaccine (Gardasil) delivered by intramuscular needle-free injection and intradermal needle-free injection. The main question it aims to answer is:

  • Is intramuscular and intradermal needle-free injection of Gardasil safe?
  • Does intramuscular and intradermal needle-free vaccination with Gardasil illicit an immune response?

Participants will:

  • Receive Gardasil by intramuscular needle-free injection, intradermal needle-free injection, or needle and syringe injection.
  • Provide blood samples
  • Complete physical exams
  • Complete diaries

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

480

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Bandung, Indonesia
        • Universitas Padjadjaran
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cissy Kartasasmita, dr., M.Sc, Sp.AK, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Female between the age of 12 years and 13 years, inclusive. (Female 7th grade junior high school students in Indonesia)
  • Clinically healthy, as established by medical history and physical examination before entering the study.
  • Not pregnant at the time of vaccination.
  • Able to provide informed consent and assent.
  • Able to comply with the study.

Exclusion Criteria:

  • Previous vaccination against HPV.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days prior to study enrollment, or planned use during the study period.
  • Administration of any vaccine within 30 days prior the study enrollment, or within 30 days of study vaccination visits.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the study enrollment, or planned use during the study period.
  • Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination.
  • History of allergic disease, suspected allergy, or reactions likely to be exacerbated by any component of vaccine, including yeast.
  • History of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, autoimmune disease. Participants with medically stable, well controlled autoimmune disease may be permitted.
  • Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection.
  • Received immunoglobulins and/or blood product within 90 days preceding enrollment, or planned use during the study period.
  • Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., axillary temperature <37.5°C.
  • Any condition that may interfere with ability to comply with trial procedures, as assessed by the Investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1: Intradermal needle-free injection
Fractional dose (2 x 0.1 mL injections) intradermal administration of Gardasil® using PharmaJet Tropis® Needle-Free Injection System.
Drug: Gardasil
Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Pre-filled syringe, 0.5mL dose volume
Other Names:
  • Gardasil PFS, 0.5mL
Drug: Gardasil
Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Needle-free intramuscular injection, 0.5mL dose volume
Other Names:
  • Gardasil vial, 0.5mL
Drug: Gardasil
Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Needle-free intradermal injection, 0.2mL dose volume
Other Names:
  • Gardasil vial, 0.2mL
Device: PharmaJet Tropis® Needle-Free Injection System
0.1mL dose injection
Other Names:
  • Tropis
Experimental: 2: Intramuscular needle-free injection
Full dose (0.5 mL injection) intramuscular administration of Gardasil® using PharmaJet Stratis® Needle-Free Injection System
Drug: Gardasil
Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Pre-filled syringe, 0.5mL dose volume
Other Names:
  • Gardasil PFS, 0.5mL
Drug: Gardasil
Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Needle-free intramuscular injection, 0.5mL dose volume
Other Names:
  • Gardasil vial, 0.5mL
Drug: Gardasil
Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Needle-free intradermal injection, 0.2mL dose volume
Other Names:
  • Gardasil vial, 0.2mL
Device: PharmaJet Stratis® Needle-Free Injection System
0.5mL dose injection
Other Names:
  • Stratis
Active Comparator: 3: Needle and syringe
Full dose (0.5 mL injection) intramuscular administration of Gardasil® using needle and syringe
Drug: Gardasil
Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Pre-filled syringe, 0.5mL dose volume
Other Names:
  • Gardasil PFS, 0.5mL
Drug: Gardasil
Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Needle-free intramuscular injection, 0.5mL dose volume
Other Names:
  • Gardasil vial, 0.5mL
Drug: Gardasil
Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Needle-free intradermal injection, 0.2mL dose volume
Other Names:
  • Gardasil vial, 0.2mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety of fractional dose intradermal administration of Gardasil using PharmaJet Tropis® Needle-Free Injection System
Time Frame: Day 0 through Day 210
Day 0 through Day 210
Immunogenicity of fractional dose intradermal administration of Gardasil using PharmaJet Tropis® Needle-Free Injection System
Time Frame: 28 days following each vaccination
28 days following each vaccination
Safety of full dose intramuscular administration of Gardasil using PharmaJet Stratis® Needle-Free Injection System
Time Frame: Day 0 through Day 210
Day 0 through Day 210
Immunogenicity of full dose intramuscular administration of Gardasil using PharmaJet Stratis® Needle-Free Injection System
Time Frame: 28 days following each vaccination
28 days following each vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
Non-inferior immunogenicity of intradermal administration of Gardasil using PharmaJet Tropis® Needle-Free Injection System compared to full dose intramuscular administration of Gardasil using needle and syringe
Time Frame: 28 days following each vaccination
28 days following each vaccination
Non-inferior immunogenicity of intramuscular administration of Gardasil using PharmaJet Stratis® Needle-Free Injection System compared to full dose intramuscular administration of Gardasil using needle and syringe
Time Frame: 28 days following each vaccination
28 days following each vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PharmaJet, Inc.

Collaborators

National Cancer Institute (NCI)
National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 31, 2024

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

November 16, 2023

First Submitted That Met QC Criteria

November 16, 2023

First Posted (Actual)

November 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • HPV-PJ-01
  • 1R44CA261326-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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