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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
| GlaxoSmithKline | INDUSTRY |
| Aclin Laboratory | OTHER |
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Hepatitis B virus infection is a common occurrence among patients with HIV. Effective vaccines are available, but there's some uncertainty regarding specific dosages, specially among those who have not responded to an initial vaccination. The purpose of this study is to determine the effectiveness of a simplified immunization schedule compared to a high-dose one.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recombinant Hepatitis B Virus Vaccine (High Dose) | Experimental | Patients allocated to this arm will receive three doses of 40mcg each of recombinant hepatitis B vaccine (Engerix-B (R)). Doses will be administered at 0, 1 and 2 months. |
|
| Recombinant Hepatitis B Virus Vaccine (Standard Dose) | Active Comparator | Patients allocated to this arm will receive three doses of 20mcg each of recombinant hepatitis B vaccine (Engerix-B (R)). Doses will be administered at 0, 1 and 2 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Hepatitis B Virus Vaccine | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serologic Response | Number of participants with positive hepatitis B surface antigen (HBsAg) antibodies 4 to 8 weeks after completion of the vaccination schemes. | 4-8 weeks After Exposure |
| Measure | Description | Time Frame |
|---|---|---|
| Local Reactions to Vaccine | Number of participants presenting dermatologic reactions to the vaccine up to one week after exposure. | One Week after Exposure |
| Systemic Reactions to the Vaccine | Number of participants presenting any systemic adverse reaction attributable to vaccination. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco Fuster, MD | Hospital Gustavo Fricke, Viña del Mar, Chile | Principal Investigator |
| Jose I Vargas, MD | Escuela de Medicina, Universidad de ValparaÃso, Chile | Principal Investigator |
| Daniela Jensen, MD | Escuela de Medicina, Universidad de ValparaÃso | Principal Investigator |
| Felipe T Martinez, MD | Centro de Investigaciones Biomédicas, Escuela de Medicina, Universidad de ValparaÃso | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Gustavo Fricke | Viña del Mar | Valparaiso | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34424307 | Derived | Vargas JI, Jensen D, Martinez F, Sarmiento V, Peirano F, Acuna P, Provoste F, Bustos V, Cornejo F, Fuster A, Acuna M, Fuster F, Soto S, Estay D, Jensen W, Ahumada R, Arab JP, Soza A, Fuster F. Comparative Efficacy of a High-Dose vs Standard-Dose Hepatitis B Revaccination Schedule Among Patients With HIV: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2120929. doi: 10.1001/jamanetworkopen.2021.20929. |
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| 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 |
|---|---|
| C075654 | Engerix-B |
| C023768 | halofantrine |
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| One Week after Exposure |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |