NCT06681636

Effector and Memory Immune Responses to HPV Vaccination in Vietnamese Women Post Virus Exposure

A Non-inferiority Study Comparing the Immunogenicity of a Standard or an Extended Three-dose Nonavalent Human Papillomavirus Vaccine Schedule Between High-risk Women Aged 18-26 Years and Age-matched Women in the General Population

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: National Institute of Hygiene and Epidemiology, Vietnam · Academic / Other
• Sex: Female
• Age: 18 Years – 26 Years
• Healthy volunteers: Accepted

Summary

A Study to evaluate if the 3 dose extended schedule (0-6-18 months) for the HPV vaccine Gardasil-9 provide similar immune responses and short term protection against HPV infection compared to the regular 3 dose schedule (0-2-6 months) in high risk women in Vietnam

Detailed description

Primary objective: To determine whether antibody geometric mean titer (GMT) to vaccine type HPV16 and HPV18 at 7 months (m) are non-inferior between female sex workers (FSW) aged 18-26 years who received the standard (0, 2m, 6m) and those received the extended 3-dose (at 0, 6m and 18m) 9vHPV schedule and age-matched non-FSW who received an extended 3-dose (at 0, 6m and 18m) 9vHPV schedule. This extended 3-dose schedule is in line with the recommended schedule by the vaccine manufacturer in Vietnam. Secondary objectives: 1. To compare antibody GMT at 2m, 7m, 18m and 19m between FSW who are HPV DNA+/seropositive with FSW who are HPV DNA-/seronegative at baseline. 2. To compare antibody GMT at 18m and 19m between FSW and non-FSW. 3. To determine cellular immune responses to HPV16 and 18 at baseline, 2m, 7m, 18m and 19m. 4. To measure incidence and 6m/12m/18m persistent HPV infection. Primary hypothesis: HPV antibody GMT to HPV16 and 18 in FSW is non-inferior to those of young women of the same age group (non-FSW) at 7m. Secondary hypothesis: 1. HPV antibody GMT are similar at 2m, 7m, 18m and 19m between FSW who are HPV DNA+/seropositive and HPV DNA-/seronegative at month 0. 2. HPV antibody GMT are similar at 18m and 19m between FSW and non-FSW who received the extended schedule. 3. Cellular immune responses to HPV16 and 18 are similar between FSW and non-FSW at 2m, 7m, 18m and 19m who received the extended schedule. 4. No new vaccine-type HPV infection in FSW and non-FSW in all groups at 6m, 12m, 18m.

Conditions

• HPV Infection
• Cervical Cancer
• Anogenital Cancer
• Anogenital Warts

Interventions

Type	Name	Description
BIOLOGICAL	Human papillomavirus 9-valent vaccine, Recombinant	HPV vaccine manufactured by MSD consisted of 9HPV types: 6,11,16,18,31,33, 45, 52,58

Timeline

• Start date: 2024-12-14
• Primary completion: 2026-10-31
• Completion: 2027-12-31
• First posted: 2024-11-08
• Last updated: 2024-11-08

Locations

3 sites across 2 countries: Australia, Vietnam