NCT06184230

Brief Summary

The goal of this clinical trial is to evaluate the persistence of Hepatitis A antibody \~32 years post vaccination in healthy adults. The questions this study will answer are: 1) how long antibody persists and 2) The immune response to an additional dose of vaccine among those with no detectable antibody. Participants will be asked to provide a blood specimen. Those with no detectable antibody will be offered an additional dose of vaccine. The kinetics of antibody response in this population will be summarized.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2024

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 28, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

December 28, 2023

Status Verified

December 1, 2023

Enrollment Period

1.2 years

First QC Date

December 14, 2023

Last Update Submit

December 14, 2023

Conditions

Hepatitis A

Outcome Measures

Primary Outcomes (1)

  • Persistence of Antibody

    Hepatitis A antibody

    32 Years

Study Arms (1)

Revaccinated at 32 Years

OTHER
Biological: Hepatitis A Vaccine

Interventions

Hepatitis A VaccineBIOLOGICAL

Hepatitis A Vaccine

Revaccinated at 32 Years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consent obtained
  • Participated in original hepatitis A study in 1991
  • No detectable hepatitis A antibody \~32 years after study start

You may not qualify if:

  • Receipt of any dose of hepatitis A vaccine other than the hepatitis A vaccine used in the initial studies
  • History of hepatitis A
  • Receipt of blood transfusion or blood products, including immunoglobulins, within the past 6 months.
  • Receipt of any vaccine within the 14 days before receipt of the additional dose of hepatitis A vaccine or scheduled to receive any vaccine within 30 days after receipt of a booster dose of vaccine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis A

Interventions

Hepatitis A Vaccines

Condition Hierarchy (Ancestors)

Hepatitis, Viral, HumanVirus DiseasesInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2023

First Posted

December 28, 2023

Study Start

January 1, 2024

Primary Completion

March 1, 2025

Study Completion

June 1, 2025

Last Updated

December 28, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share