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

NCT ID: NCT06142461

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2025-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1: Intradermal needle-free injection

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

Group Type: EXPERIMENTAL

Gardasil

Intervention Type: DRUG

Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Needle-free intradermal injection, 0.2mL dose volume

PharmaJet Tropis® Needle-Free Injection System

Intervention Type: DEVICE

0.1mL dose injection

2: Intramuscular needle-free injection

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

Group Type: EXPERIMENTAL

Gardasil

Intervention Type: DRUG

Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Needle-free intramuscular injection, 0.5mL dose volume

PharmaJet Stratis® Needle-Free Injection System

Intervention Type: DEVICE

0.5mL dose injection

3: Needle and syringe

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

Group Type: ACTIVE_COMPARATOR

Gardasil

Intervention Type: DRUG

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

Interventions

Gardasil

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

Intervention Type: DRUG

Gardasil

Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Needle-free intramuscular injection, 0.5mL dose volume

Intervention Type: DRUG

Gardasil

Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Needle-free intradermal injection, 0.2mL dose volume

Intervention Type: DRUG

PharmaJet Stratis® Needle-Free Injection System

0.5mL dose injection

Intervention Type: DEVICE

PharmaJet Tropis® Needle-Free Injection System

0.1mL dose injection

Intervention Type: DEVICE

Other Intervention Names

Gardasil PFS, 0.5mL; Gardasil vial, 0.5mL; Gardasil vial, 0.2mL; Stratis; Tropis

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

PharmaJet, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitas Padjadjaran

Bandung, , Indonesia

Countries

Indonesia

Other Identifiers

1R44CA261326-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HPV-PJ-01

Identifier Type: -

Identifier Source: org_study_id