Clinical trial NCT06142461: Safety and Immunogenicity of HPV Vaccine Administered Intradermally and Intramuscularly Via Needle-Free Injection System
Official title: Safety and Immunogenicity of Human Papillomavirus Quadrivalent Vaccine Administered Intradermally and Intramuscularly Via Needle-Free Injection System
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Vaccine Reaction
Lead sponsor: PharmaJet, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2023-11-21
Enrollment: 0
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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.

Primary outcomes:
measure: Safety of fractional dose intradermal administration of Gardasil using PharmaJet Tropis® Needle-Free Injection System
timeFrame: Day 0 through Day 210
measure: Immunogenicity of fractional dose intradermal administration of Gardasil using PharmaJet Tropis® Needle-Free Injection System
timeFrame: 28 days following each vaccination
measure: Safety of full dose intramuscular administration of Gardasil using PharmaJet Stratis® Needle-Free Injection System
timeFrame: Day 0 through Day 210
measure: Immunogenicity of full dose intramuscular administration of Gardasil using PharmaJet Stratis® Needle-Free Injection System
timeFrame: 28 days following each vaccination
Secondary outcomes:
measure: 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
timeFrame: 28 days following each vaccination
measure: 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
timeFrame: 28 days following each vaccination
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Universitas Padjadjaran
Study officials:
References: