Single dose HPV Immunobridging Study with NewVaccines I (SHINE I)
- Conditions
- CancerHPV Infection
- Registration Number
- PACTR202407768096289
- Lead Sponsor
- PATH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 1320
1. Females between the ages of =9 - <15 years for Cohort 1 and =15 - =20 years for Cohort 2 at time of randomization.
2. Healthy as defined by the absence of clinically significant medical condition, either acute or chronic,
as determined by medical history and clinical assessment.
3. Written informed consent obtained from the participant prior to randomization. For participants below the legal age of consent, written informed consent must be obtained from the participant’s parent(s)/legally authorized representative (LAR), and written informed assent must be obtained from the participant.
4. Anticipated ability and willingness to complete all study visits and evaluations.
5. Participant must be either of non-childbearing potential or, if of childbearing potential*, not breastfeeding and not pregnant (based on a negative urine pregnancy test at screening and on the day of vaccination), and must have been practicing adequate contraception (defined in Appendix III) for at least 21 days prior to vaccination and agrees to continue such precautions consistently through 2 months after vaccination, and agrees to not become pregnant through other means (e.g., artificial insemination and IVF) through 2 months after vaccination. *Female of childbearing potential is defined as having begun menstruation (achieved menarche) and not permanently infertile (e.g., due to bilateral tubal ligation, occlusion or removal, or post-total
hysterectomy, or post-bilateral ovariectomy).
6. Living within the catchment area of the study without plans to move during the conduct of the study.
1.Acute medical illnesses (temporary exclusions) should be evaluated, treated, and improved prior to study randomization and vaccination.
2.Known history of abnormal cervical cytology, abnormal cervical biopsy results, treatment for genital warts or other HPV-associated disease (prior screening is not required for eligibility assessment).
3.Participant reports more than 4 lifetime sexual partners prior to enrollment.
4.Current or former participation in HPV vaccine related research.
5.Prior receipt of any HPV vaccine, or planned administration of any HPV vaccine other than study vaccines during the study period.
6.Received an investigational product within 30 days prior to randomization.
7.Currently participating in or planning to participate in another clinical research trial involving investigational product during the conduct of this study.
8Received or plans to receive a licensed inactivated vaccine or allergy desensitization injections within 7 days prior to or after study vaccination or a live attenuated vaccine within 28 days prior to or after study vaccination.
9Contraindication to intramuscular injections or history of bleeding or coagulation disorder.
10.History of anaphylaxis or serious allergic reactions following receipt of any vaccines.
11.History of allergy or hypersensitivity to any components of the study vaccine or Gardasil 9 (e.g., yeast, polysorbate 80, aluminum).
12.Planned administration or receipt of any immunoglobulins or blood products within 6 months prior to randomization or during the study.
13.Immunosuppressive or immunodeficient condition
14.Immunosuppressive or immune modulating medications
15.Malignancy or autoimmune disease
16.Any condition that in the opinion of the investigator would pose a health risk to the participant if enrolled or could interfere with the evaluation of the study vaccine.
17.Medical condition that would interfere with or serves as a contraindication to protocol adherence or ability to give informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Immunoglobulin G (IgG) geometric mean concentration (GMC) against oncogenic HPV types (HPV-16, -18, -31, -33, -45, -52, and -58), in healthy girls 9–14 years of age, 24 months after vaccine administration for each study arm.;IgG GMC against oncogenic HPV types (HPV-16, -18, -31, -33, -45, -52, and -58), in healthy young women 15–20 years of age, 24 months after vaccine administration for each study arm.
- Secondary Outcome Measures
Name Time Method 1.Number and proportion of participants in each study arm reporting solicited adverse events (AEs) within 30 minutes and within seven days of vaccination.<br>2.Number and proportion of participants in each study arm reporting unsolicited adverse events within 30 days of vaccination.<br>3.Number and proportion of participants in each study arm reporting serious adverse events (SAEs) throughout study duration. <br>;IgG GMC against HPV types 6 and 11, 24 months after vaccine administration for each study arm.;For each HPV type, seropositivity rate, seroconversion rate, IgG antibody GMC and antibody geometric mean increase from baseline, at Month 6 and Month 24 following vaccine administration (all participants) and at Month 1 and Month 12 following vaccine administration (immunogenicity subset) for each study arm.