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

NCT06142461 | Withdrawn Phase 2 DMC

• 2 other identifiers: HPV-PJ-011R44CA261326-01A1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vaccine Reaction

Outcome Measures

Primary Outcomes (4)

• Safety of fractional dose intradermal administration of Gardasil using PharmaJet Tropis® Needle-Free Injection System

  Day 0 through Day 210

• Immunogenicity of fractional dose intradermal administration of Gardasil using PharmaJet Tropis® Needle-Free Injection System

  28 days following each vaccination

• Safety of full dose intramuscular administration of Gardasil using PharmaJet Stratis® Needle-Free Injection System

  Day 0 through Day 210

• Immunogenicity of full dose intramuscular administration of Gardasil using PharmaJet Stratis® Needle-Free Injection System

  28 days following each vaccination

Secondary Outcomes (2)

• 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

  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

  28 days following each vaccination

Study Arms (3)

1: Intradermal needle-free injection

EXPERIMENTAL

Fractional dose (2 x 0.1 mL injections) intradermal administration of Gardasil® using PharmaJet Tropis® Needle-Free Injection System.

Drug: Gardasil; Device: PharmaJet Tropis® Needle-Free Injection System

2: Intramuscular needle-free injection

EXPERIMENTAL

Full dose (0.5 mL injection) intramuscular administration of Gardasil® using PharmaJet Stratis® Needle-Free Injection System

Drug: Gardasil; Device: PharmaJet Stratis® Needle-Free Injection System

3: Needle and syringe

ACTIVE COMPARATOR

Full dose (0.5 mL injection) intramuscular administration of Gardasil® using needle and syringe

Drug: Gardasil

Interventions

Gardasil DRUG

Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Pre-filled syringe, 0.5mL dose volume

Also known as: Gardasil PFS, 0.5mL

3: Needle and syringe

PharmaJet Stratis® Needle-Free Injection System DEVICE

0.5mL dose injection

Also known as: Stratis

2: Intramuscular needle-free injection

PharmaJet Tropis® Needle-Free Injection System DEVICE

0.1mL dose injection

Also known as: Tropis

1: Intradermal needle-free injection

Eligibility Criteria

• Age: 12 Years - 13 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PharmaJet, Inc.: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Universitas Padjadjaran

Bandung, Indonesia

Location

MeSH Terms

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Open-label vaccination. Serology samples for immunogenicity assessment are blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 21, 2023
• Study Start: May 31, 2024
• Primary Completion: December 30, 2024
• Study Completion: April 30, 2025
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)