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)
| Registry | NCT06184230 |
|---|---|
| Status | Unknown |
| Phase | Phase 4 |
| Study type | Interventional; na, single group, masking: none, basic science |
| Enrollment | 300 (Estimated) |
| Sponsor | Best Healthcare Inc. (Other) |
| Conditions | Hepatitis A |
| Interventions | Hepatitis A Vaccine (Biological) |
| Dates | start 2024-01-01 (estimated), primary completion 2025-03-01 (estimated), completion 2025-06-01 (estimated), first posted 2023-12-28, last updated 2023-12-28 |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Revaccinated at 32 Years | Other | Biological: Hepatitis A Vaccine |
Sex: All, ages: 18 Years to any
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.