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Study on the Safety, Humoral Immune Response, and Memory B Cell Response Characteristics of Sequential 9-Valent HPV Vaccination

NCT07530679 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2026-04-15

No results posted yet for this study

Summary

This is a single-center, prospective, open-label, partially randomized, matched-controlled trial designed as a cohort study. The study plans to enroll 360 healthy female participants aged 18 to 45 years, divided into three groups: a three-dose sequential group, a two-dose sequential group, and a primary immunization group, with 120 participants in each group. All participants will be stratified by two age subgroups (18-26 years and 27-45 years) to ensure demographic balance across groups.

As blinding is not feasible in this study, a prospective, open-label, partially randomized, controlled trial design is adopted. A combination of randomized and non-randomized (i.e., partially randomized) enrollment methods is used to balance study feasibility with intergroup comparability.

Participants in the three-dose sequential group and the primary immunization group will receive one dose of the nine-valent HPV vaccine at months 0, 1, and 6, while those in the two-dose sequential group will receive the nine-valent HPV vaccine at months 0 and 6. Before the second and third doses, investigators must confirm that participants do not meet the criteria for early withdrawal or for postponement of the second and third doses. After each vaccination, a 30-minute safety observation will be conducted at the vaccination site to monitor for adverse events (AEs). Subsequently, the study visit procedures will be followed, including collection of solicited AEs within 7 days post-vaccination, unsolicited AEs within 30 days, and serious AEs (SAEs) throughout the study period. Participants will also complete other scheduled study visits, including safety observations and immunogenicity blood sampling at various time points before and after vaccination.

The study aims to evaluate the immune response characteristics and safety of sequential vaccination with different doses of the nine-valent HPV vaccine (three doses at 0, 1, 6 months and two doses at 0, 6 months) in healthy female participants who have previously completed vaccination with the bivalent HPV vaccine.

Conditions

  • Cervical Cancer Prevention

Interventions

BIOLOGICAL

9-valent HPV vaccination at months 0 and 6

Administer the 9-valent HPV vaccine at month 0 and month 6 according to the immunization schedule

BIOLOGICAL

9-valent HPV vaccination at months 0 , 1 and 6

Administer the 9-valent HPV vaccine at month 0, 1 and month 6 according to the immunization schedule

Sponsors & Collaborators

  • Jiangsu Province Centers for Disease Control and Prevention

    lead NETWORK

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-12
Primary Completion
2027-06-30
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07530679 on ClinicalTrials.gov