Hepatitis A
Conditions
Keywords
Israel, Universal Mass Vaccination, Havrix®, Hepatitis A, Healthy adults, Long term persistence, Toddlers
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.
Interventions
BIOLOGICALHavrix®
One challenge dose of Havrix® administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 19 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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: 1. (mild) = An AE which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. 2. (moderate) = An AE which is sufficiently discomforting to interfere with normal everyday activities. 3. (severe) = An AE which prevents normal, everyday activities. |
| 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. |
| 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. |
| 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. |
| 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 . |
Outcome results
None listed