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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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The aims of this study are to determine:
Study subjects eligible for enrollment will:
The primary hypothesis is that the majority of young people will exhibit immune memory for hepatitis B in response to a booster dose of vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| birth, lower dose booster | Experimental | Adolescents who received their first dose of hepatitis B vaccine at or before day 7 of life who received a 10 ug dose of hepatitis B vaccine as a booster |
|
| birth, higher dose booster | Experimental | Adolescents who received their first dose of hepatitis B vaccine at or before day 7 of life who received a 20 ug dose of hepatitis B vaccine as a booster |
|
| 4 weeks, lower dose booster | Experimental | Adolescents who received their first dose of hepatitis B vaccine at or after 4 weeks of life who received a 10 ug dose of hepatitis B vaccine as a booster |
|
| 4 weeks, higher dose booster | Experimental | Adolescents who received their first dose of hepatitis B vaccine at or after 4 weeks of life who received a 20 ug dose of hepatitis B vaccine as a booster |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hepatitis B vaccine | Biological | 10 ug dose, one-time administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| anti-HBSAg titers | 13-15 days after enrollment and booster dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amy B Middleman, MD | Contact | 832-822-3664 | amym@bcm.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Children's Hospital | Recruiting | Houston | Texas | 77030 | United States | |
| Texas Children's Pediatric Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25643863 | Derived | Spradling PR, Kamili S, Xing J, Drobeniuc J, Hu DJ, Middleman AB. Response to challenge dose among young adults vaccinated for hepatitis B as infants: importance of detectable residual antibody to hepatitis B surface antigen. Infect Control Hosp Epidemiol. 2015 May;36(5):529-33. doi: 10.1017/ice.2015.6. Epub 2015 Feb 3. | |
| 24843060 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 18, 2022 | |
| Reset | Jun 6, 2022 | |
| Release | Apr 3, 2023 | |
| Reset | Apr 24, 2023 | |
| Release | Jun 20, 2023 | |
| Reset | Jul 10, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 18, 2022 | Jun 6, 2022 | |||
| Apr 3, 2023 |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| D017325 | Hepatitis B Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| hepatitis B vaccine | Biological | 20 ug dose, one-time administration |
|
|
| Recruiting |
| Houston |
| Texas |
| 77030 |
| United States |
| Middleman AB, Baker CJ, Kozinetz CA, Kamili S, Nguyen C, Hu DJ, Spradling PR. Duration of protection after infant hepatitis B vaccination series. Pediatrics. 2014 Jun;133(6):e1500-7. doi: 10.1542/peds.2013-2940. Epub 2014 May 19. |
| Apr 24, 2023 |
| Jun 20, 2023 | Jul 10, 2023 |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D045424 |
| Complex Mixtures |