Immunogenicity and Persistence of GlaxoSmithKline (GSK) Biologicals' Havrix® in Healthy Adult Subjects Vaccinated at Infancy Under the Hepatitis A Universal Mass Vaccination (UMV) Program in Israel

NCT03183492 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 116762
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate the persistence, immunogenicity and safety of Havrix® (hepatitis A vaccine) in adults primed in infancy. The enrolled subjects will be assessed for circulating antibodies against hepatitis A and will also receive a challenge dose of Havrix Adult vaccine. In the present study, the anamnestic response will be assessed 30 days after the challenge dose.

Conditions

Hepatitis A

Keywords

Israel; Universal Mass Vaccination; Havrix®; Hepatitis A; Healthy adults; Long term persistence; Toddlers

Outcome Measures

Primary Outcomes (2)

• Evaluation of immunity to hepatitis A in terms of anti-HAV (Antibodies against Hepatitis A virus) seropositivity status.

  A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value of 15mIU/mL.

  At the pre-challenge time-point (Day 1)

• Evaluation of immunity to hepatitis A in terms of anti-HAV antibody concentrations.

  Immunogenicity will be assessed in terms of Geometric Mean Concentration (GMC) of anti-HAV antibody concentrations.

  At the pre-challenge time-point (Day 1)

Secondary Outcomes (6)

• Evaluation of immunity to hepatitis A in terms of anti-HAV anamnestic response to hepatitis A vaccine challenge dose.

  30 days (Day 31) after challenge dose

• Evaluation of immunity to hepatitis A in terms of anti-HAV seropositivity status in response to hepatitis A vaccine challenge dose.

  30 days (Day 31) after challenge dose

• Evaluation of immunity to hepatitis A in terms of anti-HAV antibody concentrations in response to hepatitis A vaccine challenge dose.

  30 days (Day 31) after challenge dose

• Occurrence of solicited local and general symptoms.

  During the 4-day (Days 1-4) follow-up period after the challenge dose

• Occurrence of unsolicited symptoms, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification.

  During the 31-day (Days 1-31) follow-up period after the challenge dose

Study Arms (1)

HAV Group

EXPERIMENTAL

Subjects who were vaccinated under UMV with 2 doses of Havrix® Junior at infancy and will receive a single challenge dose of Havrix Adult at Visit 1 (Day 1).

Biological: Havrix®

Interventions

Havrix® BIOLOGICAL

One challenge dose of Havrix® administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Also known as: GSK Biologicals' inactivated hepatitis A vaccine

HAV Group

Eligibility Criteria

• Age: 18 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol
• Written informed consent obtained from the subject prior to performing any study specific procedure
• A male or female subject aged 18 to 19 years at the time of enrolment (up to but excluding the 20th birthday)
• Documented administration of 2 doses of Havrix® Junior in the second year of life
• Healthy subjects as established by medical history and clinical examination before entering into the study
• Female subjects of childbearing potential may be enrolled in the study, if the subject:
• has practiced adequate contraception for 30 days prior to study vaccine administration, and has a negative pregnancy test on the day of vaccine administration, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the study vaccine administration

You may not qualify if:

• Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the dose of study vaccine (Day 29 to Day1), or planned use during the study period
• Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe
• Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed
• Administration of long-acting immune-modifying drugs at any time during the study entry
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product
• Administration of any hepatitis A vaccine dose, with the exception of the two doses of routine toddler vaccination for the subjects
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine
• Planned enrolment in the Israel Defense Forces within 30 days of study enrolment or activity that would prohibit the subject to return for Visit 2
• Acute disease and/or fever at the time of enrolment Fever is defined as temperature ≥38.0°C / 100.4°F. The preferred location for measuring temperature in this study will be the oral cavity Subjects with a minor illness without fever may be enrolled at the discretion of the investigator
• Pregnant or lactating female
• Female planning to become pregnant or planning to discontinue contraceptive precautions

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Hepatitis A

Interventions

Hepatitis A Vaccines

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 12, 2017
• Study Start: May 7, 2018
• Primary Completion: January 28, 2019
• Study Completion: January 28, 2019
• Last Updated: March 2, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share