Trial Outcomes & Findings for A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013) (NCT NCT04490499)
NCT ID: NCT04490499
Last Updated: 2022-07-27
Results Overview
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.
COMPLETED
PHASE3
207 participants
Day 30
2022-07-27
Participant Flow
Approximately 200 planned to be enrolled and 207 were enrolled.
Participant milestones
| Measure |
HBVAXPRO™
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 Study
STARTED
|
207
|
|
Overall Study
Vaccinated
|
205
|
|
Overall Study
COMPLETED
|
205
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
HBVAXPRO™
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 Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013)
Baseline characteristics by cohort
| Measure |
HBVAXPRO™
n=207 Participants
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™).
|
|---|---|
|
Age, Continuous
|
8.4 years
STANDARD_DEVIATION 0.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
205 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
205 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
207 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 30Population: 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.
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.
Outcome measures
| Measure |
HBVAXPRO™
n=202 Participants
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™).
|
|---|---|
|
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™
|
99.5 Percentage of Participants
95% Confidence Interval 97.3 • Interval 97.3 to 100.0
|
SECONDARY outcome
Timeframe: Day 1 and Day 30Population: 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.
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.
Outcome measures
| Measure |
HBVAXPRO™
n=205 Participants
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™).
|
|---|---|
|
Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen
Day 1 Pre-challenge
|
9.63 mIU/mL
Interval 7.88 to 11.76
|
|
Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen
Day 30 Post-challenge
|
685.84 mIU/mL
Interval 605.67 to 776.63
|
Adverse Events
HBVAXPRO™
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER