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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06681636




Registration number
NCT06681636
Ethics application status
Date submitted
5/11/2024
Date registered
8/11/2024

Titles & IDs
Public title
Effector and Memory Immune Responses to HPV Vaccination in Vietnamese Women Post Virus Exposure
Scientific title
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
Secondary ID [1] 0 0
HPV9-VINIF2427
Universal Trial Number (UTN)
Trial acronym
HPV9vxFSW
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HPV Infection 0 0
Cervical Cancer 0 0
Anogenital Cancer 0 0
Anogenital Warts 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Human papillomavirus 9-valent vaccine, Recombinant

Experimental: Group 1 FSW - 100 FSWs aged 18-26 years receiving 3 doses of Gardasil-9 vaccine at 0-6-18 months

Active comparator: Group 2 non-FSW - 100 non-FSW aged 18-26 years receiving 3 doses of Gardasil-9 vaccine at 0-6-18 months

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


Treatment: Other: Human papillomavirus 9-valent vaccine, Recombinant
HPV vaccine manufactured by MSD consisted of 9HPV types: 6,11,16,18,31,33, 45, 52,58
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Comparison between antibody responses after the 3rd dose ofregular vaccine schedules among FSW and after the 2nd dose of the extended schedule
Timepoint [1] 0 0
7 months from the first doses
Secondary outcome [1] 0 0
Comparison of antibody responses after each doses among FSW according to HPV infection status pre-vaccination
Timepoint [1] 0 0
19 months after the 1st doses
Secondary outcome [2] 0 0
Comparison of antibody response after 3 doses of extended schedule between FSW and non-FSW
Timepoint [2] 0 0
19 month after the first doses
Secondary outcome [3] 0 0
Celular response after each vaccine dose
Timepoint [3] 0 0
19 months after the 1st dose
Secondary outcome [4] 0 0
HPV persistent during 19 month or more among vaccines
Timepoint [4] 0 0
at least 19 months after the first dose

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
26 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
14/12/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Murdoch Children Research Institute - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
Vietnam
State/province [1] 0 0
Hai Phong

Funding & Sponsors
Primary sponsor type
Other
Name
National Institute of Hygiene and Epidemiology, Vietnam
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Murdoch Childrens Research Institute
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
CENTER FOR SUPPORTING COMMUNITY DEVELOPMENT INITIATIVES
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Hai phong Center for Disease Control
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Hong T Duong, MD, PhD
Address 0 0
National Institute of Hygiene and Epidemiology, Vietnam
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trang V Nguyen, PhD
Address 0 0
Country 0 0
Phone 0 0
84902028181
Fax 0 0
Email 0 0
nvt@nihe.org.vn
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will not be shared. Results will be reported as grouped data


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents



Results not provided in https://clinicaltrials.gov/study/NCT06681636