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Persistence of Hepatitis A Antibody in Healthy Adults ~32 Years Post Vaccination.

NCT ID: NCT06184230

Last Updated: 2023-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis A

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Revaccinated at 32 Years

Group Type OTHER

Hepatitis A Vaccine

Intervention Type BIOLOGICAL

Hepatitis A Vaccine

Interventions

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Hepatitis A Vaccine

Hepatitis A Vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Best Healthcare Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Provided Documents

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Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

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Study 023-Persistence

Identifier Type: -

Identifier Source: org_study_id