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

Phase 2

Withdrawn

• Conditions: Vaccine Reaction
• Interventions: Drug: Gardasil; Device: PharmaJet Tropis® Needle-Free Injection System; Device: PharmaJet Stratis® Needle-Free Injection System

• Registration Number: NCT06142461
• Lead Sponsor: PharmaJet, Inc.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-16
• Study First Submitted QC: 2023-11-16
• Study First Posted: 2023-11-21
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-24
• Study Start: 2024-05-31
• Primary Completion: 2024-12-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1: Intradermal needle-free injection	Gardasil	Fractional dose (2 x 0.1 mL injections) intradermal administration of Gardasil® using PharmaJet Tropis® Needle-Free Injection System.
3: Needle and syringe	Gardasil	Full dose (0.5 mL injection) intramuscular administration of Gardasil® using needle and syringe
1: Intradermal needle-free injection	PharmaJet Tropis® Needle-Free Injection System	Fractional dose (2 x 0.1 mL injections) intradermal administration of Gardasil® using PharmaJet Tropis® Needle-Free Injection System.
2: Intramuscular needle-free injection	Gardasil	Full dose (0.5 mL injection) intramuscular administration of Gardasil® using PharmaJet Stratis® Needle-Free Injection System
2: Intramuscular needle-free injection	PharmaJet Stratis® Needle-Free Injection System	Full dose (0.5 mL injection) intramuscular administration of Gardasil® using PharmaJet Stratis® Needle-Free Injection System

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Universitas Padjadjaran; 🇮🇩 Bandung, Indonesia