Human Papillomavirus InfectionPhase 1/2NCT07888686
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
A Phase 1/2 study testing 10vHPV and Gardasil9 in people with Human Papillomavirus Infection, run by Serum Institute of India Pvt. Ltd. at 1 site in Australia.
Trial summary
Human papilloma virus (HPV) is the most common viral infection of the reproductive system and is spread through contact with infected genital skin, mucous membranes, or bodily fluids. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Infection
- What is being tested?
- 10vHPV and Gardasil9
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2026to Apr 2028
- Phase
- Phase 1/2
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females aged 18 to 25 years inclusive at Screening (Phase 1 Only)
- Males and females aged 26 to 45 years inclusive at Screening (Phase 2 Only)
- Willing and able to sign an Informed Consent Form (ICF)
- Good physical and mental health based on medical history, physical examination, clinical laboratory, electrocardiogram (ECG), and vital signs, as judged by the Investigator
- Participants willing and able to comply with the requirements of the Protocol
- Participants agree to refrain from strenuous exercise (including weightlifting) within 96 hours (4 days) prior to Screening, and each day of vaccine administration
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- Willing and able to comply with restrictions of nicotine use throughout the study is not permitted from within 48 hours [2days] prior to Screening, from Day 1 until Day 8, and within 48 hours [2 days] prior to the end of study [EoS/early termination [ET} visit)
- Male participants, if not surgically sterilised or have partners of the same sex, must agree to use highly effective contraception and not plan a pregnancy or donate sperm from Day 1 until 90 days after the last study visit.
- Female participants of childbearing potential who have fertile male sexual partners must agree to use highly effective contraception from Day 1 until 90 days after the last study visit.
Who cannot join
- Positive drug and/or alcohol screen at Screening and Day 1 (Phase 1 Only)
- Are vaccinated against HPV
- History of HPV infection and associated medical conditions (confirmed either clinically, serologically, or microbiologically) including history of abnormal Papanicolau test, HPV DNA test, abnormal cervical biopsy,or external genital warts, as reported by the participant
- History of administration of any investigational or non-registered product (drug or vaccine) 30 days prior to study vaccine administration on Day 1 or plan to participate in another study with investigational drug or vaccine prior to Day 30
- Any vaccination received 30 days before Screening or plan to receive a vaccination between Screening and Day 30
- Pregnant or lactating females or females planning to become pregnant or beast feed during the study
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- Any findings on medical examination deviating from normal and assessed as clinically relevant by the investigator
- A participant who has a body mass index (BMI) >35.0 kg/m2
- A participant who has skin markings in both deltoid areas, which prevents injection site reaction (ISR)assessment, in the opinion of the investigator
- History of alcohol abuse or drug addiction
- Positive screen for HBsAg, HBcAb, HCV antibodies, or HIV 1 and 2 antibodies
- History of a severe allergic reaction (e.g. anaphylaxis) after any vaccine or to any component (active substances or excipients) of the study vaccines
- History of major congenital defects or developmental disorders or genetic diseases as determined by medical history or clinical assessment
- History of thrombocytopenia or a bleeding disorder following an IM injection
- History or current evidence of any condition or therapy which might interfere with the participant's participation for the full duration of the study, evidence of suspected diseases, or is not in the best interest of the participants to participate, in the opinion of the investigator
- History of major surgery =30 days prior to study vaccination on Day 1. If the participant has had any surgery >30 days prior to the study vaccination on Day 1, the participant can be enrolled in the study at the discretion of the investigator
- Acute illness (moderate or severe) and/or fever (tympanic) (temperature ≥38.0°C) at the time of vaccination or during the 72 hours prior to the vaccination on Visit 2 (Day 1) should be delayed until the participant is fully recovered and fever-free
- History of receipt of a blood transfusion, other blood products, or immunoglobulins in 3 months prior to study vaccination, or planned receipt of blood products during the study period.
- Any confirmed or suspected congenital or acquired immunosuppressive, immunodeficient condition or autoimmune disease, based on medical history and physical examination.
- Family history of any medical conditions, that in the Investigator's opinion, could affect the trial outcomes.
- Chronic administration (defined as >14 days) of immunosuppressant or other immune modifying drugs(including topical calcineurin inhibitors) during the period starting 6 months prior to the study vaccine administration or planned during the study period up to Visit 4 (Day 30 [-2 to +14 days]).
- Any plans to permanently relocate from the area prior to the completion of the study or to leave for an extended period of time when study visits would be scheduled.
- Employee of any organisation associated with this study.
- History of clinically relevant drug and/or food allergies.
- History of alcohol consumption of more than 10 standard drinks/week and no more than 4 standard drinks on any one day within 3 months prior to Screening.
- Any physical, psychological, mental and/or social reason which in the opinion of the Investigator makes the participant unsuitable for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Doherty Clinical Trials Limited
East Melbourne, Victoria, 3002
Nicola Byrne, +61 03 9970 4200, nbyrne@dohertyclinicaltrials.com
James Molton
About this study
Official title: A Phase 1/2, Double-blinded, Randomised, Active Controlled, Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine in Comparison With Gardasil 9 Vaccine in Healthy Adults
Human papilloma virus (HPV) is the most common viral infection of the reproductive system and is spread through contact with infected genital skin, mucous membranes, or bodily fluids. This study will assess an experimental vaccine called 10 valent Human Papillomavirus Virus (10vHPV) for the safety, reactivity, and immune response, in healthy adults, compared to Gardasil 9.
There are two phases in this study - Phase 1 will include up to 36 healthy adults aged 18-25 years, Phase 2 will include 36 healthy adults aged 26-45 years. Participants will be randomised in a 2-to-1 ratio to receive either 10vHPV or Gardasil 9.
10vHPV or Gardasil 9 will be administered as a 0.5 mL single dose via intramuscular injection in the deltoid muscle of the upper arm. In Phase 1, participants will receive a single dose on Day 1, and in Phase 2, participants will receive a single dose on Day 1, 2 months, and 6 months.
- Conditions
- Human Papillomavirus Infection
- Being tested
- 10vHPV, Gardasil9
- Keywords
- HPV, Vaccine
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10vHPVBiological
10vHPV is manufactured by Serum Institute of India Pvt. Ltd and is a 10-valent recombinant VLP vaccine containing the major capsid (L1) protein
Gardasil9Biological
Gardasil9 is manufactured by Merck Sharp \& Dohme (MSD) and is a 9-valent recombinant VLP vaccine containing the major capsid (L1) protein
| Study group | Role | What they receive |
|---|---|---|
| 10vHPV Vaccine | Experimental | Not described Receives: Biological: 10vHPV |
| Gardasil9 | Active comparator | Not described Receives: Biological: Gardasil9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and reactogenicity of a single dose of 10vHPV vaccine in comparison with a single dose of Gardasil 9 vaccine in healthy adults aged 18 to 25 years in phase 1.
The incidence, severity and relationship of solicited AEs during 7-day, unsolicited and serious adverse events during 30-day follow-up period after administration of a single dose.
Measured: 30 days after vaccination
To assess the safety of 3 doses (administered at day 0, 60 and 180) of 10vHPV vaccine in comparison with 3 doses (administered at day 0, 60 and 180) of Gardasil 9 vaccine in healthy adults aged 26 to 45 years.
The incidence, severity and relationship of solicited AEs during 7-day after each vaccine dose, unsolicited and serious adverse events up to 30 days after the last dose .
Measured: 30 days after last dose
Secondary outcomes (2)
To assess immune response 30 days after vaccination with 10vHPV vaccine compared to Gardasil 9 in healthy adults aged 18 to 25 years.
Percentage of participants achieving seroconversion, Geometric mean titres (GMTs) for anti-HPV antibodies, Geometric mean fold rise (GMFR) on Day 30.
Measured: 30 days after vaccination
To assess immune response 30 days after 3rd vaccination with 10vHPV vaccine compared to Gardasil 9 in healthy adults aged 26 to 45 years.
Percentage of participants achieving seroconversion, GMTs for anti-HPV antibodies and GMFR on Day 30 post 3rd dose (Month 7)
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus InfectionStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Serum Institute of India Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hitt Sharma, Study director, Serum Institute of India Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888686
- Sponsor's protocol ID
- SII-10vHPV-01
- Status last verified
- Oct 2026
- First submitted
- 26 Sep 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Summary Results