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NCT06184230 Clinical Trial

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

Hepatitis A Clinical Trial

Official title:
Open Label Study to Assess the ~32-Year Persistence of Hepatitis A Antibody Among Participants in the Pivotal, Double-Blind, Placebo-Controlled Efficacy Study of VAQTA (Study 023-001)

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06184230
Other study ID # Study 023-Persistence
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date January 2024
Est. completion date June 2025

Study information
Verified date December 2023
Source Best Healthcare Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 300
Est. completion date June 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Hepatitis A Vaccine
Hepatitis A Vaccine

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Best Healthcare Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Persistence of Antibody Hepatitis A antibody 32 Years
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