Vaccine ReactionPhase 2NCT06142461
Safety and Immunogenicity of HPV Vaccine Administered Intradermally and Intramuscularly Via Needle-Free Injection System
A Phase 2 study testing Gardasil, PharmaJet Stratis® Needle-Free Injection System and PharmaJet Tropis® Needle-Free Injection System in people with Vaccine Reaction, run by PharmaJet, Inc. at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 13 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaccine Reaction
- What is being tested?
- Gardasil, PharmaJet Stratis® Needle-Free Injection System and PharmaJet Tropis® Needle-Free Injection System
- Type of treatment
- Vaccines, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIndonesia
- Study dates
- 31 May 2024to 30 Apr 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 13 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Immunogenicity of Human Papillomavirus Quadrivalent Vaccine Administered Intradermally and Intramuscularly Via Needle-Free Injection System
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
- Being tested
- Gardasil, PharmaJet Stratis® Needle-Free Injection System, PharmaJet Tropis® Needle-Free Injection System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GardasilDrug
Also called Gardasil PFS, 0.5mL
Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Pre-filled syringe, 0.5mL dose volume
GardasilDrug
Also called Gardasil vial, 0.5mL
Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Needle-free intramuscular injection, 0.5mL dose volume
GardasilDrug
Also called Gardasil vial, 0.2mL
Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Needle-free intradermal injection, 0.2mL dose volume
PharmaJet Stratis® Needle-Free Injection SystemDevice
Also called Stratis
0.5mL dose injection
PharmaJet Tropis® Needle-Free Injection SystemDevice
Also called Tropis
0.1mL dose injection
| Study group | Role | What they receive |
|---|---|---|
| 1: Intradermal needle-free injection | Experimental | Fractional dose (2 x 0.1 mL injections) intradermal administration of Gardasil® using PharmaJet Tropis® Needle-Free Injection System. Receives: Drug: Gardasil; Device: PharmaJet Tropis® Needle-Free Injection System |
| 2: Intramuscular needle-free injection | Experimental | Full dose (0.5 mL injection) intramuscular administration of Gardasil® using PharmaJet Stratis® Needle-Free Injection System Receives: Drug: Gardasil; Device: PharmaJet Stratis® Needle-Free Injection System |
| 3: Needle and syringe | Active comparator | Full dose (0.5 mL injection) intramuscular administration of Gardasil® using needle and syringe Receives: Drug: Gardasil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of fractional dose intradermal administration of Gardasil using PharmaJet Tropis® Needle-Free Injection System
Measured: Day 0 through Day 210
Immunogenicity of fractional dose intradermal administration of Gardasil using PharmaJet Tropis® Needle-Free Injection System
Measured: 28 days following each vaccination
Safety of full dose intramuscular administration of Gardasil using PharmaJet Stratis® Needle-Free Injection System
Measured: Day 0 through Day 210
Immunogenicity of full dose intramuscular administration of Gardasil using PharmaJet Stratis® Needle-Free Injection System
Measured: 28 days following each vaccination
Secondary outcomes (2)
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
Measured: 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
Measured: 28 days following each vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start31 May 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Why it stopped: Change in landscape of HPV treatment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaJet, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142461
- Sponsor's protocol ID
- HPV-PJ-01
- Other IDs
- 1R44CA261326-01A1
- Status last verified
- May 2024
- First submitted
- 16 Nov 2023
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Human Papillomavirus Quadrivalent Vaccine Administered Intradermally and Intramuscularly Via Needle-Free Injection System
- ClinicalTrials.gov ID
- NCT06142461
- Acronym / sponsor ID
- HPV-PJ-01
- Conditions
- Vaccine Reaction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in landscape of HPV treatment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PharmaJet, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 31 May 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1: Intradermal needle-free injection | Experimental | Drug: Gardasil, Device: PharmaJet Tropis® Needle-Free Injection SystemFractional dose (2 x 0.1 mL injections) intradermal administration of Gardasil® using PharmaJet Tropis® Needle-Free Injection System. |
| 2: Intramuscular needle-free injection | Experimental | Drug: Gardasil, Device: PharmaJet Stratis® Needle-Free Injection SystemFull dose (0.5 mL injection) intramuscular administration of Gardasil® using PharmaJet Stratis® Needle-Free Injection System |
| 3: Needle and syringe | Active comparator | Drug: GardasilFull dose (0.5 mL injection) intramuscular administration of Gardasil® using needle and syringe |
Who may qualify
- Ages
- 12 to 13 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GardasilAlso: Gardasil PFS, 0.5mLHuman Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Pre-filled syringe, 0.5mL dose volume | Drug | 3: Needle and syringe |
| GardasilAlso: Gardasil vial, 0.5mLHuman Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Needle-free intramuscular injection, 0.5mL dose volume | Drug | 2: Intramuscular needle-free injection |
| GardasilAlso: Gardasil vial, 0.2mLHuman Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Needle-free intradermal injection, 0.2mL dose volume | Drug | 1: Intradermal needle-free injection |
| PharmaJet Stratis® Needle-Free Injection SystemAlso: Stratis0.5mL dose injection | Device | 2: Intramuscular needle-free injection |
| PharmaJet Tropis® Needle-Free Injection SystemAlso: Tropis0.1mL dose injection | Device | 1: Intradermal needle-free injection |
Primary outcome
Safety of fractional dose intradermal administration of Gardasil using PharmaJet Tropis® Needle-Free Injection System
Time frame: Day 0 through Day 210
Immunogenicity of fractional dose intradermal administration of Gardasil using PharmaJet Tropis® Needle-Free Injection System
Time frame: 28 days following each vaccination
Safety of full dose intramuscular administration of Gardasil using PharmaJet Stratis® Needle-Free Injection System
Time frame: Day 0 through Day 210
Immunogenicity of full dose intramuscular administration of Gardasil using PharmaJet Stratis® Needle-Free Injection System
Time frame: 28 days following each vaccination
2 secondary outcomes
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
Time frame: 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
Time frame: 28 days following each vaccination
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gardasil, PharmaJet Stratis® Needle-Free Injection System and PharmaJet Tropis® Needle-Free Injection System in people with Vaccine Reaction, run by PharmaJet, Inc. at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of fractional dose intradermal administration of Gardasil using PharmaJet Tropis® Needle-Free Injection System (time frame: Day 0 through Day 210). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.