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

• Status: Withdrawn
• Trial end date: 2025-04-30
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: PharmaJet, Inc.
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)

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.