NCT06901362

Brief Summary

This study is a cross-sectional study. The study aims to determine the levels of immunity against hepatitis B virus and varicella-zoster virus in medical students.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
401

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 28, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

December 23, 2025

Status Verified

April 1, 2025

Enrollment Period

5 months

First QC Date

March 22, 2025

Last Update Submit

December 16, 2025

Conditions

Keywords

hepatitis B virusvaricella-zoster virusvaccinationimmunizing programmedical students

Outcome Measures

Primary Outcomes (2)

  • The seroprevalence of hepatitis B virus

    The immunity level against the hepatitis B virus is assessed.

    From enrollment to the end of treatment at 6 months

  • The seroprevalence of varicella-zoster virus

    The immunity level against varicella-zoster virus is assessed.

    From enrollment to the end of treatment at 6 months

Secondary Outcomes (2)

  • The vaccination rate of hepatitis B virus

    From enrollment to the end of treatment at 6 months

  • The vaccination rate of varicella-zoster virus

    From enrollment to the end of treatment at 6 months

Study Arms (1)

Medical students

Medical students aged 18 years or older

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Medical students aged 18 years or older are included.

You may qualify if:

  • Medical students
  • Age 18 years or older

You may not qualify if:

  • Known cases of hepatitis B virus infection
  • Known cases of varicella-zoster virus infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Narongkorn Saiphoklang

Pathum Thani, Changwat Pathum Thani, 12120, Thailand

Location

Related Publications (12)

  • Techasathit W, Ratanasuwan W, Sonjai A, Sangsiriwut K, Anekthananon T, Suwanagool S. Vaccination against hepatitis B virus: are Thai medical students sufficiently protected? J Med Assoc Thai. 2005 Mar;88(3):329-34.

  • Baer G, Bonhoeffer J, Schaad UB, Heininger U. Seroprevalence and immunization history of selected vaccine preventable diseases in medical students. Vaccine. 2005 Mar 14;23(16):2016-20. doi: 10.1016/j.vaccine.2004.03.073.

  • Balbi O, Baldi S, Rizza S, Pietroiusti A, Perrone S, Coppeta L. Seroprevalence survey for Varicella among healthcare workers and medical students in Italy. Hum Vaccin Immunother. 2021 Feb 1;17(2):372-376. doi: 10.1080/21645515.2020.1771989. Epub 2020 Jul 9.

  • Pourakbari B, Shahbaznezhad L, Parvaneh N, Nikkhah S, Mahmoudi S, Teymuri M, Alyari A, Mamishi S. Seroepidemiology of Varicella Zoster Virus among children, adolescents and medical students in a referral children medical center, Tehran, Iran. Iran J Microbiol. 2012 Sep;4(3):136-8.

  • Sheek-Hussein M, Hashmey R, Alsuwaidi AR, Al Maskari F, Amiri L, Souid AK. Seroprevalence of measles, mumps, rubella, varicella-zoster and hepatitis A-C in Emirati medical students. BMC Public Health. 2012 Dec 5;12:1047. doi: 10.1186/1471-2458-12-1047.

  • Cardenas-Perea ME, Gomez-Conde E, Santos-Lopez G, Perez-Contreras I, Diaz-Orea MA, Gandara-Ramirez JL, Cruz Y Lopez OR, Marquez-Dominguez L, Sosa-Jurado F. Hepatitis B surface antibodies in medical students from a public university in Puebla, Mexico. Hum Vaccin Immunother. 2016 Jul 2;12(7):1857-62. doi: 10.1080/21645515.2016.1151587. Epub 2016 May 12.

  • Sartorelli P, Occhialini F, Miceli R, Pietronigro A, Bianciardi L, Salini C, Messina G. The seroprevalence of the hepatitis B virus in Italian medical students after 3 decades since the introduction of universal vaccination. Int J Occup Med Environ Health. 2022 Feb 15;35(1):75-80. doi: 10.13075/ijomeh.1896.01835. Epub 2021 Aug 25.

  • Tesfa T, Hawulte B, Tolera A, Abate D. Hepatitis B virus infection and associated risk factors among medical students in eastern Ethiopia. PLoS One. 2021 Feb 19;16(2):e0247267. doi: 10.1371/journal.pone.0247267. eCollection 2021.

  • Rathi A, Kumar V, Majhi J, Jain S, Lal P, Singh S. Assessment of knowledge, attitude, and practices toward prevention of hepatitis B infection among medical students in a high-risk setting of a newly established medical institution. J Lab Physicians. 2018 Oct-Dec;10(4):374-379. doi: 10.4103/JLP.JLP_93_18.

  • Yoda T, Katsuyama H. Analysis of antibody-negative medical students after hepatitis B vaccination in Japan. Hum Vaccin Immunother. 2021 Mar 4;17(3):852-856. doi: 10.1080/21645515.2020.1788309. Epub 2020 Aug 5.

  • Bianchi FP, Tafuri S, Larocca AMV, Germinario CA, Stefanizzi P. Long -term persistence of antibodies against varicella in fully immunized healthcare workers: an Italian retrospective cohort study. BMC Infect Dis. 2021 May 25;21(1):475. doi: 10.1186/s12879-021-06180-x.

  • Phattraprayoon N, Kakheaw J, Soonklang K, Cheirsilpa K, Ungtrakul T, Auewarakul C, Mahanonda N. Duration of Hepatitis B Vaccine-Induced Protection among Medical Students and Healthcare Workers following Primary Vaccination in Infancy and Rate of Immunity Decline. Vaccines (Basel). 2022 Feb 10;10(2):267. doi: 10.3390/vaccines10020267.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for measuring immunity levels against the hepatitis B virus and varicella-zoster virus.

MeSH Terms

Conditions

Hepatitis BChickenpox

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesVaricella Zoster Virus InfectionHerpesviridae Infections

Study Officials

  • Narongkorn Saiphoklang, MD

    Thammasat University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 22, 2025

First Posted

March 28, 2025

Study Start

April 1, 2025

Primary Completion

August 31, 2025

Study Completion

November 30, 2025

Last Updated

December 23, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

IPD and documents will be available for sharing immediately after publication for a period of 2 years.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
IPD and documents will be available for sharing immediately after publication for a period of 2 years.
Access Criteria
All researchers will be able to access the IPD and supporting information via the repository website without restriction.

Locations