Phase 4
N=49
Immune Response of Healthy Subjects Who Received Neonatal Vaccination Course With Engerix™-B Vaccine.
Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT00774995 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcome: Primary: Number of Subjects With an Anamnestic Response to a Challenge Dose of Hepatitis B Virus (HBV) Vaccine as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). — 8; 13; 6; 14 Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- EngerixTM-B (Biological)
- Age
- Adult · 19+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With an Anamnestic Response to a Challenge Dose of Hepatitis B Virus (HBV) Vaccine as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). |
8; 13; 6; 14 | — |
| PRIMARY Number of Subjects With an Anamnestic Response to a Challenge Dose of Hepatitis B Virus (HBV) Vaccine as Measured by ChemiLuminescence ImmunoAssay (CLIA). |
7; 11; 5; 12 | — |
| SECONDARY Number of Subjects With Anti-Hepatitis B Surface (HBs) Antibody Concentrations Above Cut-off Values as Measured by ELISA. |
8; 14; 6; 15; 8; 13 | — |
| SECONDARY Number of Subjects With Anti-Hepatitis B Surface (HBs) Antibody Concentrations Above Cut-off Values as Measured by CLIA. |
7; 12; 6; 15; 7; 12 | — |
| SECONDARY Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by ELISA. |
2852.1; 163.8; 1420.2; 515.5 | — |
| SECONDARY Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by CLIA. |
1831.6; 165.6; 1335.2; 454.1 | — |
| SECONDARY Number of Subjects Experiencing Any, Grade 3 and Related to Vaccination Unsolicited Symptoms. |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects That Experienced Serious Adverse Events (SAEs) |
0; 0; 0; 0 | — |
Summary
This study will evaluate the immune response of healthy subjects who received neonatal vaccination course with GSK Biologicals' Engerix™-B vaccine, approximately 20 years ago. The presence of immune memory against hepatitis B surface antigen (HBsAg) in these subjects will be investigated by the administration of a challenge dose of hepatitis B vaccine and the comparison of their antibody concentration before and one month after vaccination.
This protocol posting deals with objectives & outcome measures of the booster phase. No new subjects will be recruited during this booster phase of the study.
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female who received the complete neonatal primary vaccination course of Engerix™-B in the 103860/273 primary study approximately 20 years earlier.
- Anti-HBs antibody concentrations less than the specified value at the last available follow-up time-point.
- Written informed consent obtained from the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- If the subject is female, she must be of non-childbearing potential,or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination.
Exclusion Criteria
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the Engerix™-B challenge dose, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs within six months prior to challenge dose administration.
- Planned administration/ administration of a vaccine not foreseen by the study protocol starting from 30 days before the challenge dose and ending 30 days after.
- Administration of a hepatitis B vaccine outside the context of this study between the follow-up time-point at which anti-HBs antibody concentrations was less than the specified value and the current challenge dose study visit.
- 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 product
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Acute disease at the time of enrolment.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Administration of immunoglobulins and/or any blood products within the three months preceding the challenge dose visit or planned administration during the study period.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
Data sourced from ClinicalTrials.gov (NCT00774995). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.