Uterine Cervical DysplasiaNCT03763565

Effectiveness of HPV Vaccine in Thai Adult Women

An observational study of Uterine Cervical Dysplasia and Papillomavirus Vaccines, run by Mahidol University at 5 sites in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Background: The majority of the burden of HPV-related cervical cancer is in developing countries while most of the effectiveness reports of HPV vaccination are currently coming from developed countries. Also, currently many adult women are left without either HPV vaccination or cervical cancer screening. Read more about this study

Who is it for?: Ages 25 to 53 years, women only
Conditions the study is for: Uterine Cervical Dysplasia, Papillomavirus Vaccines
What is being tested?: Bivalent or Quadrivalent HPV vaccines
Type of treatment: Vaccines
How many people: 993 participants
Where: 5 sitesThailand
Study dates: 1 Nov 2018to 1 Jul 2019
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 53 years
Women only
Adult

Study population: Vaccinated group: Thai women who received at least one dose of HPV vaccination, either by bivalent or quadrivalent HPV vaccine when they were 20-45 years old at least 5 years ago from the current enrollment time Control group: Women who did not receive any HPV vaccination, but received Pap smear result (conventional or liquid-based) when they were 20-45 years at least 5 years ago from the current enrollment time

Who may be able to join

(vaccinated group)
Thai women aged 20-45 years at the time of HPV vaccination
Received at least 1 dose of bivalent or quadrivalent HPV vaccine at least 5 years ago
Willing to provide written informed consent and receive Pap smear \& HPV genotyping (only for those who need specimen collection for cervical cytology and HPV genotyping result)
(control group)
Thai women without history of HPV vaccination
Received Pap smear result at their ages 20-45 years at least 5 years ago
Willing to provide written informed consent and receive Pap smear \& HPV genotyping (only for those who need specimen collection for cervical cytology and HPV genotyping result)

Who cannot join

Known pregnancy
History of hysterectomy or excisional treatment of the cervix
Known increased risk of bleeding
Not willing to provide written informed consent

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Thailand5 sites

Bumrungrad International Hospital
Bangkok, 10110
King Chulalongkorn Memorial Hospital
Bangkok, 10330
National Cancer Institute, Thailand
Bangkok, 10400
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University,
Bangkok, 10400
Siriraj Hospital, Mahidol University
Bangkok, 10700

Other trials in Thailand

About this study

Official title: Effectiveness of HPV Vaccine Among Women Age Equal or More Than 20 Years

Background: The majority of the burden of HPV-related cervical cancer is in developing countries while most of the effectiveness reports of HPV vaccination are currently coming from developed countries. Also, currently many adult women are left without either HPV vaccination or cervical cancer screening. Effectiveness data of currently available HPV vaccines among adult women in developing countries are needed for women and healthcare workers and policy makers to best protect women from cervical cancer.
Primary Study Objective:
To determine the effectiveness bivalent and quadrivalent HPV vaccines in reduction of cervical dysplasia (Low-grade Squamous Intraepithelial Lesion or worse; LSIL+) attributable to HPV types 16 or 18 after at least 5 years of vaccination among Thai women vaccinated at their ages 20-45 years with at least one dose of the HPV vaccine
Secondary Study Objectives:
To measure the effectiveness of currently available bivalent and quadrivalent HPV vaccines in reducing the prevalence of HPV 16 or 18
To measure the effectiveness of HPV vaccines in reducing any abnormal Pap smear result (ASC-US+)
To compare the effectiveness of HPV vaccines according to the number of doses immunized
To find out risk factor(s) for HPV 16 or 18-related cervical dysplasia in this cohort
To assess the prevalence of other high-risk HPV types in vaccinated and non-vaccinated group
To determine direct and/or indirect cost of HPV vaccination
The hypothesis to be tested: At least one dose of vaccination with bi- or quadri-valent HPV vaccine will reduce the prevalence of LSIL+ attributable to HPV 16/18 by 80% after at least 5 years of vaccination.
Materials and Methods: This study will be a retrospective matched cohort study. Data is to be collected either by from samples for Pap and HPV test and/or HPV 16/18 genotyping of the recruited participants, or from existing medical records. HPV vaccinated women at their ages 20-45 years (vaccinated group) and women received Pap smear at their ages 20-45 years without vaccination (control group) will be included in the study. Pap smear and HPV test and/or HPV 16/18 typing result of 2 groups will be compared after ≥ 5 years of vaccination or baseline Pap smear. Those who don't have Pap smear results ≥ 5 years after vaccination or ≥ 5 years after the baseline Pap smear will be offered for a Pap smear and HPV 16/18 typing

Conditions: Uterine Cervical Dysplasia, Papillomavirus Vaccines
Being tested: Bivalent or Quadrivalent HPV vaccines, Control group
Medical subject headings: Uterine Cervical Dysplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bivalent or Quadrivalent HPV vaccinesBiological
Vaccination with at least one dose of Bivalent or Quadrivalent HPV vaccines at least 5 years ago at the ages of 20-45 years
Control groupOther
Thai women who did not receive HPV vaccination, either by bivalent or quadrivalent HPV vaccine but have received Pap smear at their ages 20-45 years at least 5 years ago from the current enrollment time

Study groups in NCT03763565
Study group	Role	What they receive
Vaccinated group		Thai women who received at least one dose HPV vaccination at least 5 years ago, either by Bivalent or Quadrivalent HPV vaccines when they were 20-45 years old Receives: Biological: Bivalent or Quadrivalent HPV vaccines
Control group		Thai women who did not receive HPV vaccination, either by bivalent or quadrivalent HPV vaccine but have received Pap smear at their ages 20-45 years at least 5 years ago from the current enrollment time Receives: Other: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

Occurrence of Low-grade squamous intraepithelial lesion or worse (LSIL+) associated with HPV 16 or 18
LSIL or worse, including Atypical Glandular Cells, High-grade squamous intraepithelial lesion, Cervical intraepithelial neoplasia (CIN) grade 1-3, and cervical cancer which are associated with either HPV 16 or 18
Measured: Sample collection in the project is single 1 day time for participants who received vaccination at least 5 years ago.

Secondary outcomes (1)

Cost-effectiveness of bivalent and quadrivalent HPV vaccination
Direct and and indirect cost survey interview associated with HPV vaccination and its cost-effectiveness
Measured: Interview for direct and indirect cost survey will be single 1 day time for a participant.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 20181 Jul 2019

First posted4 Dec 2018
Study start1 Nov 2018
Primary completion1 Jul 2019
Study completion1 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Uterine Cervical DysplasiaStudies of the same condition, open and under way.
More trials run by Mahidol UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 993 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03763565
Sponsor's protocol ID: HPV 021
Other IDs: 2561.1/13
Status last verified: Jun 2023
First submitted: 3 Dec 2018
Last updated: 5 Jun 2023
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Uterine Cervical Dysplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of HPV Vaccine Among Women Age Equal or More Than 20 Years
ClinicalTrials.gov ID: NCT03763565
Acronym / sponsor ID: HPV 021
Conditions: Uterine Cervical Dysplasia, Papillomavirus Vaccines
Study type: Observational
Recruitment status: Completed
Enrolment: 993 participants (actual)
Lead sponsor: Mahidol UniversityUniversity, hospital or other
Collaborators: National Vaccine Institute, Thailand, Chulalongkorn University, National Cancer Institute, Thailand, Bumrungrad International Hospital, Siriraj Hospital
Study start: 1 Nov 2018 (actual)
Primary completion: 1 Jul 2019 (actual)
Study completion: 1 Jul 2019 (actual)
First posted: 4 Dec 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Background: The majority of the burden of HPV-related cervical cancer is in developing countries while most of the effectiveness reports of HPV vaccination are currently coming from developed countries. Also, currently many adult women are left without either HPV vaccination or cervical cancer screening. Effectiveness data of currently available HPV vaccines among adult women in developing countries are needed for women and healthcare workers and policy makers to best protect women from cervical cancer.
Primary Study Objective:
To determine the effectiveness bivalent and quadrivalent HPV vaccines in reduction of cervical dysplasia (Low-grade Squamous Intraepithelial Lesion or worse; LSIL+) attributable to HPV types 16 or 18 after at least 5 years of vaccination among Thai women vaccinated at their ages 20-45 years with at least one dose of the HPV vaccine
Secondary Study Objectives:
To measure the effectiveness of currently available bivalent and quadrivalent HPV vaccines in reducing the prevalence of HPV 16 or 18
To measure the effectiveness of HPV vaccines in reducing any abnormal Pap smear result (ASC-US+)
To compare the effectiveness of HPV vaccines according to the number of doses immunized
To find out risk factor(s) for HPV 16 or 18-related cervical dysplasia in this cohort
To assess the prevalence of other high-risk HPV types in vaccinated and non-vaccinated group
To determine direct and/or indirect cost of HPV vaccination
The hypothesis to be tested: At least one dose of vaccination with bi- or quadri-valent HPV vaccine will reduce the prevalence of LSIL+ attributable to HPV 16/18 by 80% after at least 5 years of vaccination.
Materials and Methods: This study will be a retrospective matched cohort study. Data is to be collected either by from samples for Pap and HPV test and/or HPV 16/18 genotyping of the recruited participants, or from existing medical records. HPV vaccinated women at their ages 20-45 years (vaccinated group) and women received Pap smear at their ages 20-45 years without vaccination (control group) will be included in the study. Pap smear and HPV test and/or HPV 16/18 typing result of 2 groups will be compared after ≥ 5 years of vaccination or baseline Pap smear. Those who don't have Pap smear results ≥ 5 years after vaccination or ≥ 5 years after the baseline Pap smear will be offered for a Pap smear and HPV 16/18 typing

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Vaccinated group	–	Biological: Bivalent or Quadrivalent HPV vaccinesThai women who received at least one dose HPV vaccination at least 5 years ago, either by Bivalent or Quadrivalent HPV vaccines when they were 20-45 years old
Control group	–	Other: Control groupThai women who did not receive HPV vaccination, either by bivalent or quadrivalent HPV vaccine but have received Pap smear at their ages 20-45 years at least 5 years ago from the current enrollment time

Who may qualify

Ages: 25 to 53 years
Sex: Female only
Age groups: Adult
Study population: Vaccinated group: Thai women who received at least one dose of HPV vaccination, either by bivalent or quadrivalent HPV vaccine when they were 20-45 years old at least 5 years ago from the current enrollment time Control group: Women who did not receive any HPV vaccination, but received Pap smear result (conventional or liquid-based) when they were 20-45 years at least 5 years ago from the current enrollment time

Key inclusion criteria (8 listed)

(vaccinated group)
Thai women aged 20-45 years at the time of HPV vaccination
Received at least 1 dose of bivalent or quadrivalent HPV vaccine at least 5 years ago
Willing to provide written informed consent and receive Pap smear \& HPV genotyping (only for those who need specimen collection for cervical cytology and HPV genotyping result)
(control group)

Key exclusion criteria (4 listed)

Known pregnancy
History of hysterectomy or excisional treatment of the cervix
Known increased risk of bleeding
Not willing to provide written informed consent

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bivalent or Quadrivalent HPV vaccinesVaccination with at least one dose of Bivalent or Quadrivalent HPV vaccines at least 5 years ago at the ages of 20-45 years	Biological	Vaccinated group
Control groupThai women who did not receive HPV vaccination, either by bivalent or quadrivalent HPV vaccine but have received Pap smear at their ages 20-45 years at least 5 years ago from the current enrollment time	Other	Control group

Primary outcome

Occurrence of Low-grade squamous intraepithelial lesion or worse (LSIL+) associated with HPV 16 or 18
Time frame: Sample collection in the project is single 1 day time for participants who received vaccination at least 5 years ago.
LSIL or worse, including Atypical Glandular Cells, High-grade squamous intraepithelial lesion, Cervical intraepithelial neoplasia (CIN) grade 1-3, and cervical cancer which are associated with either HPV 16 or 18

1 secondary outcome

Cost-effectiveness of bivalent and quadrivalent HPV vaccination
Time frame: Interview for direct and indirect cost survey will be single 1 day time for a participant.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.

Related trials for Uterine Cervical Dysplasia

RecruitingObservational study
Role of Liquid Biopsies in HPV-associated Cancer Treatment Monitoring
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Punnee Pitisuttithum study chair

Mahidol University

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Uterine Cervical Dysplasia and Papillomavirus Vaccines, run by Mahidol University at 5 sites in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of Low-grade squamous intraepithelial lesion or worse (LSIL+) associated with HPV 16 or 18 (time frame: Sample collection in the project is single 1 day time for participants who received vaccination at least 5 years ago.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03763565.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.