A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013)
Study Details
Study Description
Brief Summary
The purpose of this study is to demonstrate the durability of protection against hepatitis B virus (HBV) infection approximately 8-9 years after vaccination with Vaxelis®. This is an estimation study, and no formal hypothesis testing was performed.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HBVAXPRO™ Healthy children vaccinated approximately 8-9 years previously with a 2- or 3-dose infant series and toddler dose of Vaxelis® who will receive a single dose of Hepatitis B vaccine challenge (HBVAXPRO™). |
Biological: HBVAXPRO™
Single 0.5 mL intramuscular dose
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With a Protective Hepatitis B Surface Antibody Level of ≥10 Milli International Units/mL (mIU/mL) at 30 Days Post-Challenge With HBVAXPRO™ [Day 30]
Participant serum samples were collected for analysis with an enhanced chemiluminescence (ECi) assay to determine the concentration of antibodies to hepatitis B surface antigen (HBsAg). Response rate was the percentage of participants with a protective hepatitis B surface antibody (anti-HBs) level of ≥ 10 mIU/mL at Day 30 post-challenge.
Secondary Outcome Measures
- Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen [Day 1 and Day 30]
Participant serum samples will be assessed with an ECi assay for anti-HBs geometric mean concentrations (GMCs) pre-challenge on Day 1 and 30 days post-challenge with HBVAXPRO™ in mIU/mL.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Is healthy (based on a review of medical history and targeted physical examination) based on the clinical judgment of the investigator.
-
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.
-
The participant (or legally acceptable representative if applicable) provides written informed consent/assent for the study.
Exclusion Criteria:
-
Has a history of diagnosis (clinical, serological, or microbiological) of HBV infection.
-
Has a known or suspected impairment of immunological function (e.g., human immunodeficiency virus (HIV), splenectomy).
-
Has a known hypersensitivity to any component of the study vaccine.
-
Has a known or suspected blood dyscrasias, leukemia, lymphomas of any type or other malignant neoplasms affecting the haematopoietic and lymphatic system.
-
Has a bleeding disorder contraindicating intramuscular vaccinations.
-
Has received any hepatitis B vaccine after participation in Protocol V419-007 or V419-008.
-
Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tampereen yliopisto Kokkolan rokotetutkimusklinikka ( Site 0009) | Kokkola | Mellersta Osterbotten | Finland | 67100 |
| 2 | Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0001) | Tampere | Pirkanmaa | Finland | 33100 |
| 3 | Seinajoki Vaccine Research Center ( Site 0010) | Seinajoki | Pohjanmaa | Finland | 60100 |
| 4 | Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0004) | Oulu | Pohjois-Pohjanmaa | Finland | 90220 |
| 5 | Porin rokotetutkimusklinikka ( Site 0008) | Pori | Satakunta | Finland | 28100 |
| 6 | Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0007) | Espoo | Uusimaa | Finland | 02230 |
| 7 | Tampereen yliopisto Etelä-Helsingin rokotetutkimusklinikka ( Site 0005) | Helsinki | Uusimaa | Finland | 00100 |
| 8 | Ita-Helsingin Rokotetutkimuskeskus ( Site 0006) | Helsinki | Uusimaa | Finland | 00930 |
| 9 | Tampereen yliopisto Järvenpään rokotetutkimusklinikka ( Site 0003) | Jarvenpaa | Uusimaa | Finland | 04400 |
| 10 | Tampereen yliopisto Turun rokotetutkimusklinikka ( Site 0002) | Turku | Varsinais-Suomi | Finland | 20520 |
Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
More Information
Publications
None provided.- V419-013
- V419-013
- 2020-000126-26
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Approximately 200 planned to be enrolled and 207 were enrolled. |
| Arm/Group Title | HBVAXPRO™ |
|---|---|
| Arm/Group Description | Healthy children vaccinated approximately 8-9 years previously with a 2- or 3-dose infant series and toddler dose of Vaxelis® who received a single dose of Hepatitis B vaccine challenge (HBVAXPRO™). |
| Period Title: Overall Study | |
| STARTED | 207 |
| Vaccinated | 205 |
| COMPLETED | 205 |
| NOT COMPLETED | 2 |
Baseline Characteristics
| Arm/Group Title | HBVAXPRO™ |
|---|---|
| Arm/Group Description | Healthy children vaccinated approximately 8-9 years previously with a 2- or 3-dose infant series and toddler dose of Vaxelis® who received a single dose of Hepatitis B vaccine challenge (HBVAXPRO™). |
| Overall Participants | 207 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
8.4
(0.5)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
97
46.9%
|
| Male |
110
53.1%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
2
1%
|
| Not Hispanic or Latino |
205
99%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
205
99%
|
| More than one race |
2
1%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (Count of Participants) | |
| Finland |
207
100%
|
Outcome Measures
| Title | Percentage of Participants With a Protective Hepatitis B Surface Antibody Level of ≥10 Milli International Units/mL (mIU/mL) at 30 Days Post-Challenge With HBVAXPRO™ |
|---|---|
| Description | Participant serum samples were collected for analysis with an enhanced chemiluminescence (ECi) assay to determine the concentration of antibodies to hepatitis B surface antigen (HBsAg). Response rate was the percentage of participants with a protective hepatitis B surface antibody (anti-HBs) level of ≥ 10 mIU/mL at Day 30 post-challenge. |
| Time Frame | Day 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population consisted of all enrolled participants without deviations from the protocol (i.e., did not receive study vaccine, use of prohibited medicine/vaccine, or blood sample collected outside of analysis window) that may substantially affect the results of the immunogenicity endpoint. |
| Arm/Group Title | HBVAXPRO™ |
|---|---|
| Arm/Group Description | Healthy children vaccinated approximately 8-9 years previously with a 2- or 3-dose infant series and toddler dose of Vaxelis® who received a single dose of Hepatitis B vaccine challenge (HBVAXPRO™). |
| Measure Participants | 202 |
| Number (95% Confidence Interval) [Percentage of Participants] |
99.5
(97.3)
48.1%
|
| Title | Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen |
|---|---|
| Description | Participant serum samples will be assessed with an ECi assay for anti-HBs geometric mean concentrations (GMCs) pre-challenge on Day 1 and 30 days post-challenge with HBVAXPRO™ in mIU/mL. |
| Time Frame | Day 1 and Day 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population consisted of all enrolled participants without deviations from the protocol (i.e., did not receive study vaccine, use of prohibited medicine/vaccine, or blood sample collected outside of analysis window) that may substantially affect the results of the immunogenicity endpoint. |
| Arm/Group Title | HBVAXPRO™ |
|---|---|
| Arm/Group Description | Healthy children vaccinated approximately 8-9 years previously with a 2- or 3-dose infant series and toddler dose of Vaxelis® who received a single dose of Hepatitis B vaccine challenge (HBVAXPRO™). |
| Measure Participants | 205 |
| Day 1 Pre-challenge |
9.63
|
| Day 30 Post-challenge |
685.84
|
Adverse Events
| Time Frame | Up to Day 30 | |
|---|---|---|
| Adverse Event Reporting Description | The analysis population included all participants who received study vaccine and had safety follow-up data after the vaccination. The all-cause mortality analysis population included all enrolled participants. Per protocol, reported non-serious adverse events only include non-serious adverse events that lead to study discontinuation. | |
| Arm/Group Title | HBVAXPRO™ | |
| Arm/Group Description | Healthy children vaccinated approximately 8-9 years previously with a 2- or 3-dose infant series and toddler dose of Vaxelis® who received a single dose of Hepatitis B vaccine challenge (HBVAXPRO™). | |
All Cause Mortality |
||
| HBVAXPRO™ | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/207 (0%) | |
Serious Adverse Events |
||
| HBVAXPRO™ | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/205 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| HBVAXPRO™ | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/205 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Results Point of Contact
| Name/Title | Senior Vice President, Global Clinical Development |
|---|---|
| Organization | Merck Sharp & Dohme Corp. |
| Phone | 1-800-672-6372 |
| ClinicalTrialsDisclosure@merck.com |
- V419-013
- V419-013
- 2020-000126-26