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

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT03183492
Collaborator
(none)
0
1
8.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Havrix®
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Long-term Persistence of Hepatitis A Immunity in Healthy Adults Vaccinated as Part of a Hepatitis A Universal Mass Vaccination Program
Anticipated Study Start Date :
May 7, 2018
Anticipated Primary Completion Date :
Jan 28, 2019
Anticipated Study Completion Date :
Jan 28, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: HAV Group

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®
One challenge dose of Havrix® administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
Other Names:
  • GSK Biologicals' inactivated hepatitis A vaccine
  • Outcome Measures

    Primary Outcome Measures

    1. Evaluation of immunity to hepatitis A in terms of anti-HAV (Antibodies against Hepatitis A virus) seropositivity status. [At the pre-challenge time-point (Day 1)]

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

    2. Evaluation of immunity to hepatitis A in terms of anti-HAV antibody concentrations. [At the pre-challenge time-point (Day 1)]

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

    Secondary Outcome Measures

    1. 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]

      Anti-HAV anamnestic response to the challenge dose is defined as: At least a 4-fold increase in anti-HAV antibody concentrations in subjects seropositive at the pre-challenge time-point. Anti-HAV antibody concentrations at least 4 time the assay cut-off (i.e.60 mIU/mL) in subjects seronegative at the pre-challenge time-point.

    2. 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]

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

    3. 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]

      Immunogenicity will be assessed in terms of GMC of anti-HAV antibody concentrations.

    4. Occurrence of solicited local and general symptoms. [During the 4-day (Days 1-4) follow-up period after the challenge dose]

      The following local (injection-site) AEs will be solicited: Pain at injection site, Redness at injection site, Swelling at injection site. The following general AEs will be solicited: Fatigue, Fever*, Gastrointestinal symptoms**, Headache. *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. **Gastrointestinal symptoms include nausea, vomiting, diarrhea and/or abdominal pain. The AEs will be categorized depending on their intensity into the following grades: (mild) = An AE which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. (moderate) = An AE which is sufficiently discomforting to interfere with normal everyday activities. (severe) = An AE which prevents normal, everyday activities.

    5. 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]

      Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

    6. Occurrence of Serious Adverse Events (SAEs). [After the challenge dose up to the study end (Days 1-31)]

      SAEs to be assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity or a congenital anomaly/birth defect in the offspring of a study subject.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 19 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 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

    Exclusion Criteria:
    • 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • GlaxoSmithKline

    Investigators

    • Study Director: GSK Clinical Trials, GlaxoSmithKline

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    GlaxoSmithKline
    ClinicalTrials.gov Identifier:
    NCT03183492
    Other Study ID Numbers:
    • 116762
    First Posted:
    Jun 12, 2017
    Last Update Posted:
    Mar 2, 2018
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by GlaxoSmithKline
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 2, 2018