Effector and Memory Immune Responses to HPV Vaccination in Vietnamese Women Post Virus Exposure (HPV9vxFSW)

National Institute of Hygiene and Epidemiology (NIHE)

Status and phase: Not yet enrolling; Phase 2

Conditions: Anogenital Cancer; Anogenital Warts; HPV Infection; Cervical Cancer

Treatments: Biological: Human papillomavirus 9-valent vaccine, Recombinant

Study type: Interventional

Funder types: Other

Identifiers

NCT06681636

HPV9-VINIF2427

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 26 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Is between the reporting ages of 18-26 years at the time of recruitment.
• Engage in commercial sex in the last 6m (for FSW group) or have engaged in sexual activity (non-FSWs)
• Willing and able to give written informed consent.
• Willing to complete the follow-up requirements of the study.

Exclusion criteria

Participants meeting any of the following criteria will be excluded from the trial:

• Pregnant or possibly pregnant
• Has received any HPV vaccine previously
• Has an axillary temperate greater than 38°C
• Known allergies to any vaccine component
• incapacity to provide consent
• Currently receiving immunosuppressive medication or anti-cancer chemotherapy.
• Known HIV infection.
• Known Congenital immune deficiency syndrome.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 3 patient groups

Group 1 FSW

Experimental group

Description:

100 FSWs aged 18-26 years receiving 3 doses of Gardasil-9 vaccine at 0-6-18 months

Treatment:

Biological: Human papillomavirus 9-valent vaccine, Recombinant

Group 2 non-FSW

Active Comparator group

Description:

100 non-FSW aged 18-26 years receiving 3 doses of Gardasil-9 vaccine at 0-6-18 months

Treatment:

Biological: Human papillomavirus 9-valent vaccine, Recombinant

Group 3 FSW

Active Comparator group

Description:

100 FSW aged 18-26 years receiving 3 doses of Gardasil-9 vaccine at 0-2-6 months

Treatment:

Biological: Human papillomavirus 9-valent vaccine, Recombinant