Hepatitis B
Conditions
Brief summary
This is a study to evaluate immunogenicity, safety, and tolerability of 2XP HEPTAVAX™-II compared with the 1XP HEPTAVAX™-II in healthy Japanese young adults.
Detailed description
2XP HEPTAVAX™-II is manufactured using a modified process in which the composition of the amorphous aluminum hydroxyphosphate sulfate adjuvant has been modified by increasing the phosphate content by approximately 2-fold. Thus the modified process HEPTAVAX™-II is referred to as 2XP HEPTAVAX™-II.
Interventions
BIOLOGICAL2XP HEPTAVAX™-II SC
BIOLOGICAL1XP HEPTAVAX™-II SC
BIOLOGICAL2XP HEPTAVAX™-II IM
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
To receive the first study vaccination, Participants should meet all inclusion criteria. * Participants provide written informed consent for the trial. The Participant may also provide consent for Future Biomedical Research. However, the Participant may participate in the main trial without participating in Future Biomedical Research. * Participant is Japanese male or female, between 20 to 35 years of age on the day of the first study vaccination. * Participant is determined to be in general good health based on the medical history taken on Day 1 prior to receiving the first injection of the vaccine. Any underlying chronic illness must be documented to be in stable condition. * For females, a negative urine pregnancy test just prior to vaccination on Day 1.
Exclusion criteria
To receive the first study vaccination, Participants should not have any
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Receiving Subcutaneous Vaccination Who Achieved Seroprotection | Month 7 | Blood samples were collected for anti-hepatitis B antibody assays. Seroprotection was defined as ≥10 mIU/mL anti-hepatitis B antibody. |
| Percentage of Participants With Injection-site Adverse Events | Up to 15 days after each vaccination | Participants were evaluated for injection-site adverse events using MedDRA version 15.1 |
| Percentage of Participants With Pyrexia Adverse Events | Up to 15 days after each vaccination | Participants were evaluated for pyrexia adverse events using MedDRA version 15.1. Pyrexia (fever) was defined as an oral temperature ≥37.8°C ( ≥100.0°F). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| V232-2XP SC 2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6 | 309 |
| V232-1XP SC 1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6 | 308 |
| V232-2XP IM 2XP HEPTAVAX™-II vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6 | 104 |
| Total | 721 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 | 0 |
| Overall Study | Lost to Follow-up | 10 | 9 | 7 |
| Overall Study | Physician Decision | 0 | 3 | 1 |
| Overall Study | Pregnancy | 2 | 2 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 17 | 2 |
Baseline characteristics
| Characteristic | V232-2XP SC | V232-1XP SC | V232-2XP IM | Total |
|---|---|---|---|---|
| Age, Continuous | 27.3 Years STANDARD_DEVIATION 4.7 | 26.8 Years STANDARD_DEVIATION 4.6 | 26.9 Years STANDARD_DEVIATION 4.9 | 27.1 Years STANDARD_DEVIATION 4.7 |
| Sex: Female, Male Female | 169 Participants | 144 Participants | 48 Participants | 361 Participants |
| Sex: Female, Male Male | 140 Participants | 164 Participants | 56 Participants | 360 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 239 / 309 | 225 / 308 | 69 / 104 |
| serious Total, serious adverse events | 1 / 309 | 2 / 308 | 0 / 104 |
Outcome results
Primary
Percentage of Participants Receiving Subcutaneous Vaccination Who Achieved Seroprotection
Blood samples were collected for anti-hepatitis B antibody assays. Seroprotection was defined as ≥10 mIU/mL anti-hepatitis B antibody.
Time frame: Month 7
Population: The per protocol population consisted of all randomized participants who met enrollment criteria, did not violate the protocol, were seronegative at Baseline, and had vaccination and blood collection. Seroprotection was evaluated only for participants receiving vaccine subcutaneously; intramuscular vaccination was evaluated for safety only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V232-2XP SC | Percentage of Participants Receiving Subcutaneous Vaccination Who Achieved Seroprotection | 90.1 Percentage of participants |
| V232-1XP SC | Percentage of Participants Receiving Subcutaneous Vaccination Who Achieved Seroprotection | 82.5 Percentage of participants |
95% CI: [1.9, 13.6]Miettinen & Nurminen
Primary
Percentage of Participants With Injection-site Adverse Events
Participants were evaluated for injection-site adverse events using MedDRA version 15.1
Time frame: Up to 15 days after each vaccination
Population: All randomized participants who received at least 1 vaccination were included in the analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V232-2XP SC | Percentage of Participants With Injection-site Adverse Events | 76.4 Percentage of participants |
| V232-1XP SC | Percentage of Participants With Injection-site Adverse Events | 71.4 Percentage of participants |
| V232-2XP IM | Percentage of Participants With Injection-site Adverse Events | 65.4 Percentage of participants |
p-value: 0.16295% CI: [-2, 11.9]Miettinen & Nurminen
p-value: 0.02895% CI: [1.1, 21.6]Miettinen & Nurminen
p-value: 0.24695% CI: [-4, 16.8]Miettinen & Nurminen
Primary
Percentage of Participants With Pyrexia Adverse Events
Participants were evaluated for pyrexia adverse events using MedDRA version 15.1. Pyrexia (fever) was defined as an oral temperature ≥37.8°C ( ≥100.0°F).
Time frame: Up to 15 days after each vaccination
Population: All randomized participants who received at least 1 vaccination were included in the analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V232-2XP SC | Percentage of Participants With Pyrexia Adverse Events | 3.2 Percentage of participants |
| V232-1XP SC | Percentage of Participants With Pyrexia Adverse Events | 3.9 Percentage of participants |
| V232-2XP IM | Percentage of Participants With Pyrexia Adverse Events | 4.8 Percentage of participants |
p-value: 0.65995% CI: [-3.8, 2.4]Miettinen & Nurminen
p-value: 0.45995% CI: [-7.7, 2.2]Miettinen & Nurminen
p-value: 0.68695% CI: [-7.1, 3]Miettinen & Nurminen