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

PharmaJet

Status and phase: Withdrawn; Phase 2

Conditions: Vaccine Reaction

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

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT06142461

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

HPV-PJ-01

Details and patient eligibility

About

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

Sex: Female

Ages: 12 to 13 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 3 patient groups

1: Intradermal needle-free injection

Experimental group

Description:

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

Treatment:

Drug: Gardasil

Drug: Gardasil

Drug: Gardasil

Device: PharmaJet Tropis® Needle-Free Injection System

2: Intramuscular needle-free injection

Experimental group

Description:

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

Treatment:

Device: PharmaJet Stratis® Needle-Free Injection System

Drug: Gardasil

Drug: Gardasil

Drug: Gardasil

3: Needle and syringe

Active Comparator group

Description:

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

Treatment:

Drug: Gardasil

Drug: Gardasil

Drug: Gardasil