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

Best Healthcare Inc.

Status and phase: Not yet enrolling; Phase 4

Conditions: Hepatitis A

Treatments: Biological: Hepatitis A Vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT06184230

Study 023-Persistence

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Revaccinated at 32 Years

Other group

Treatment:

Biological: Hepatitis A Vaccine