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Not Yet Recruiting NCT07888686

Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine

Conditions: Human Papillomavirus Infection

Sex: All
Ages: 18 Years – 45 Years
Healthy volunteers: Yes
Phase: PHASE1, PHASE2
Enrollment: 72
Sponsor: Serum Institute of India Pvt. Ltd.

Location: Doherty Clinical Trials Limited East Melbourne Victoria

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. 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.

Eligibility Criteria

Inclusion Criteria: * 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 * 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. Exclusion Criteria: * 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 * 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.

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Source: ClinicalTrials.gov (NCT07888686). StuddyBuddy aggregates publicly available trial information.