Persistence of Hepatitis A Antibody in Healthy Adults ~32... | NCT06184230

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

NCT06184230

Sponsor

Best Healthcare Inc.

Status

Unknown status

Last Update Posted

Dec 28, 2023Actual

Enrollment

300Estimated

Phase

Phase 4

Conditions

Hepatitis A

Interventions

Hepatitis A Vaccine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2024Estimated

Primary Completion Date

Mar 2025Estimated

Completion Date

Jun 2025Estimated

First Submitted Date

Dec 14, 2023

First Submission Date that Met QC Criteria

Dec 14, 2023

First Posted Date

Dec 28, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2023

Last Update Posted Date

Dec 28, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Revaccinated at 32 Years	Other		Biological: Hepatitis A Vaccine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hepatitis A Vaccine	Biological	Hepatitis A Vaccine	Revaccinated at 32 Years

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Persistence of Antibody	Hepatitis A antibody	32 Years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_ICF	Yes	No	Yes	Study Protocol and Informed Consent Form	Oct 24, 2023	Dec 14, 2023	Prot_ICF_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D006506	Hepatitis A

Ancestor Terms

ID	Term
D006525	Hepatitis, Viral, Human
D014777	Virus Diseases
D007239	Infections
D004769	Enterovirus Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D022362	Hepatitis A Vaccines

Ancestor Terms

ID	Term
D014761	Viral Hepatitis Vaccines
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products

Browse Leaves

Not provided

Browse Branches

Not provided