A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccinatio

Phase 1

• Conditions: ong-term protection against HBV infection; MedDRA version: 20.0Level: LLTClassification code 10019743Term: Hepatitis B virus (HBV)System Organ Class: 100000004848; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-000126-26-FI
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-01
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Is healthy (based on a review of medical history and targeted physical examination) based on the clinical judgment of the investigator
2. Has participated in Protocol V419-007 and received a 3 + 1 Vaxelis® schedule or participated in Protocol V419-008 and received a 2 + 1 Vaxelis® schedule
3. Is male or female, 8 years to 10 years of age, at the time of signing the informed consent/assent
4. The participant (or legally acceptable representative if applicable) provides written informed consent/assent for the study
Are the trial subjects under 18? yes
Number of subjects for this age range: 200
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Has a history of diagnosis (clinical, serological, or microbiological) of HBV infection
2. Has a known or suspected impairment of immunological function (eg, HIV,splenectomy)
3. Has a known hypersensitivity to any component of the study vaccine
4. Has a known or suspected blood dyscrasias, leukemia, lymphomas of any type or other malignant neoplasms affecting the haematopoietic and lymphatic system
5. Has a bleeding disorder contraindicating intramuscular vaccinations
6. Had a recent febrile illness (defined as oral temperature =38.1°C [=100.5°F]; axillary temperature =37.8°C [=100.0°F]) occurring within 72 hours prior to receipt of study vaccine
7. Has received any hepatitis B vaccine after participation in Protocol V419-007 or V419-008
8. Is receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease
9. Meets one or more of the following systemic steroid exclusion criteria:
a. Has received any dose of systemic steroids within 7 days prior to entering study
b. Is expected to require systemic steroids =20 mg/day for =5 consecutive days through the course of the participant’s participation in the study
10. Has received any licensed, non-live vaccine within the 14 days before receipt of study vaccine or is scheduled to receive any licensed, non-live vaccine within 30 days following receipt of any study vaccine. Exception: Inactivated influenza vaccine may be administered but must be given at least 7 days before receipt of any study vaccine or at least 15 days after receipt of any study vaccine
11. Has received any licensed live vaccine within 30 days before receipt of study vaccine or is scheduled to receive any live vaccine within 30 days following receipt of any study vaccine
12. Has received a blood transfusion or blood products, including immunoglobulins within the 6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine. Autologous blood transfusions are not considered an exclusion criterion
13. Has participated in another clinical study of an investigational product within 2 months before study vaccination at Visit 1 (Day 1) or plans to participate anytime during the duration of the current clinical study. Participants enrolled in observational studies may be included; these will be reviewed on a case-by-case basis for approval by the Sponsor
14. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1. To evaluate the proportion of participants with a protective hepatitis B surface antibodies (anti-HBs) level of =10 mIU/mL at 30 days post challenge (Day 30) with HBVAXPRO™ ;Secondary Objective: 1. To evaluate anti-HBs geometric mean concentrations (GMCs) pre-challenge on Day 1 and 30 days post-challenge with HBVAXPRO™ ;Primary end point(s): 1. Percentage of participants with anti-HBs =10 mIU/mL 30 days after HBVAXPRO™;Timepoint(s) of evaluation of this end point: 1. Day 30

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Anti-HB GMCs prior to HBVAXPRO™<br>2. Anti-HB GMCs 30 days post-HBVAXPRO™;Timepoint(s) of evaluation of this end point: 1. Day 1<br>2. Day 30