Comparison of Three Hepatitis B Vaccination Regimens in HIV-Positive Youth
This study has been completed.
Sponsor:
Collaborators:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00106964
First received: April 1, 2005
Last updated: May 12, 2010
Last verified: December 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Hepatitis B is a contagious virus that can damage a person's liver. It can be prevented by vaccination, but for many HIV-positive people, the vaccines do not help them achieve adequate protection against this virus. In an attempt to improve response to vaccination and achieve protection from hepatitis B, this trial will compare the immune system response to 3 hepatitis B vaccine regimens in HIV-positive adolescents 12 through 24 years of age.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infection Hepatitis B |
Biological: Engerix-B 20 mcg Biological: Engerix-B 40 mcg Biological: Twinrix 720 EIA HAV Ag plus 20 mcg HBsAg |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Randomized, Open-Label Trial of Three Hepatitis B Vaccination Schemas in HIV-Positive Youth |
Resource links provided by NLM:
Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Primary Outcome Measures:
- Determine sero-response to hepatitis B vaccine in HIV+ youth four weeks following standard adult dosing regimen versus two alternate regimens [ Time Frame: Week 28; follow-up in weeks 48 and 72 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Determine the safety of 3 hepatitis B vaccine regimens in HIV+ youth. [ Time Frame: Telephone contact 3 and 7 days after vaccine; evaluation of any symptoms at wks 4, 24, and 28; follow-up through wk 72. ] [ Designated as safety issue: Yes ]
- Determine the duration of response in HIV+ youth [ Time Frame: Entry through Week 72 ] [ Designated as safety issue: No ]
- Explore the virologic and immunologic factors that are related to sero-response (sub group analysis) [ Time Frame: Entry through Week 72 ] [ Designated as safety issue: No ]
- Assess the impact that missing data might have had on the results of the primary analysis [ Time Frame: Entry through Week 72, data analysis after study closure ] [ Designated as safety issue: No ]
| Enrollment: | 371 |
| Study Start Date: | January 2004 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Standard dose (20 mcg) of Hepatitis B vaccine.
|
Biological: Engerix-B 20 mcg
A single dose of 1 mL (20 mcg/mL) will be administered in the deltoid muscle at Entry, Weeks 4 and 24.
|
|
Active Comparator: 2
40 mcg of Hepatitis B vaccine
|
Biological: Engerix-B 40 mcg
A single dose of 2 mL (20 mcg/mL) will be administered in the deltoid muscle at Entry, Week 4 and 24.
|
|
Active Comparator: 3
20 mgc of Twinrix
|
Biological: Twinrix 720 EIA HAV Ag plus 20 mcg HBsAg
Arm 3: 720 ELU HAV Ag, 20 mcg HBsAg/ml: A single dose of 1 mL will be administered in the deltoid muscle. |
Detailed Description:
Suboptimal response to hepatitis B vaccination in HIV+ adults and children has been well documented in the literature. Given the importance of preventing HBV (hepatitis B virus) co-infection in HIV+ youth and the poor response rates in this population, this study will attempt to improve the immediate and long-term sero-response rates by undertaking a randomized, open-label trial of three hepatitis B vaccination schemas, as follows:
- standard adult dosing of HBV-only vaccine: Engerix-B 20 mcg at Entry, Week 4 and Week 24
- increased adult dosing of HBV-only vaccine: Engerix-B 40 mcg at Entry, Week 4 and Week 24
- standard adult dosing of combined HBV/HAV vaccine: Twinrix 720 EIA HAV Ag plus 20 mcg HBsAg at Entry, Week 4 and Week 24.
This study will also describe the safety of administration of an increased dose of the hepatitis B vaccine in this population. In general, patients undergoing dialysis who have received the dosing regimen recommended for immunocompromised individuals have tolerated the vaccine series well.
Design: This is a stratified, block-randomized, open-label trial of three hepatitis B vaccination schemas in HIV-infected and HBV-uninfected youth. Once randomized, there will be a total of 6 study visits in a 72 week period. Vaccination will occur at Entry, Week 4 and Week 24. Primary sero-response will be evaluated at Week 28 and sustainability of response will be evaluated at Weeks 48 and 72 for those who achieve a primary antibody response of >= 10 IU/ml. Primary non-responders (antibody response of < 10 IU/ml) will be provided with a booster vaccine using the increased-dose Engerix-B vaccine at Week 48 and evaluated for responsiveness at Week 72.
Eligibility| Ages Eligible for Study: | 12 Years to 24 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Documented HIV+
- Age 12 to < 25 years
- History of no or one hepatitis B vaccination
- Not pregnant.
- Females engaging in sexual intercourse must be willing to practice an approved method of birth control throughout the completion of the vaccine phase of the study.
Exclusion Criteria:
- History of > 1 hepatitis B vaccination
- Serologic evidence of past or present hepatitis B infection: anti-HBsAg, HBs-Ag or anti-HBcAg
- Previous allergic reaction to hepatitis A or B vaccinations or to yeast, thimerosal or aluminum.
- Active opportunistic infection or current treatment for known or suspected active serious bacterial infection at the pre-entry exam.
Presence of any known grade >= 3 clinical or laboratory toxicity at the time of pre-entry per toxicity tables.
- Anticipation of long-term corticosteroid therapy or within 3 months preceding study randomization. Use of non-steroidal, anti-inflammatory agents and inhaled or topical corticosteroids are allowed.
- Receipt of any restricted medicine listed in the protocol section 8.1.3 within 3 months preceding randomization.
- Receipt of immune globulin product or plasma product within 6 months preceding randomization
- Receipt of licensed blood product or transfusion or any licensed vaccine within 4 weeks preceding randomization.
- Known or suspected diseases of the immune system, other than HIV, or treatment for a malignancy within 3 months of randomization.
- Other serious, acute or chronic medical or surgical conditions must be approved by the protocol chair.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00106964
Locations
| United States, California | |
| Childrens Hosp of Los Angeles | |
| Los Angeles, California, United States, 90054 | |
| University of California at San Francisco | |
| San Fransisco, California, United States, 94118 | |
| United States, District of Columbia | |
| Children's Hosp Natinal Med Center | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Louisiana | |
| Tulane Med Center | |
| New Orleans, Louisiana, United States, 70112 | |
| Brazil | |
| Federal University of Minas Gerais | |
| Belo Horizonte, MG, Brazil, 30130-100 | |
| Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto/USP | |
| Ribeirao Preto, SP, Brazil, 14049-900 | |
| Instituto de Infectologia Emilio Ribas | |
| Sao Paulo, SP, Brazil, 01246-900 | |
| Ippmg-Ufrj | |
| Rio de Janeiro, Brazil, 21941590 | |
| Hospital dos Sevidores do Estado | |
| Rio de Janeiro, Brazil, 20221-903 | |
| South Africa | |
| Tygerberg Hospital | |
| Bellville, Cape Town, South Africa, 7505 | |
| Harriet Shezi Childrens Clinic Chris Hani Baragwanth Hospital | |
| Johannesburg, Gauteng, South Africa, 2013 | |
Sponsors and Collaborators
Investigators
| Study Chair: | Patricia Flynn, MD | St. Jude Children's Research Hospital |
| Principal Investigator: | Patricia Emmanuel, MD | University of South Florida, Peds. Div. of Infectious Disease |
| Principal Investigator: | Diane M. Straub, MD | University of South Florida, Peds. Div. of Infectious Disease |
| Principal Investigator: | Jorge Lujuan-Ziberman, MD | University of South Florida, Peds. Div. of Infectious Disease |
| Principal Investigator: | Lawrence D'Angelo, MD | Children's National Medical Center, Div. of Aldol & Young Adult Medicine |
| Principal Investigator: | Carleen Townsend-Akpan, CPNP | Children's National Medical Center, Div. of Aldol & Young Adult Medicine |
| Principal Investigator: | Jaime Martinez, MD | John H. Stroger Jr. Hospital |
| Principal Investigator: | Lisa Henry- Reid, MD | John H. Stroger Jr. Hospital |
| Principal Investigator: | Irma Febo, MD | University Pediatric Hospital |
| Principal Investigator: | LLeana Blasini, MD | University Pediatric Hospital |
| Principal Investigator: | Donna Futterman, MD | Montefiore Medical Center |
| Principal Investigator: | Marina Catallozzi, MD | Montifiore Medical Center |
| Principal Investigator: | Linda Levin, MD | Mount Sinai School of Medicine |
| Principal Investigator: | Barbara Moscicki, MD | Univ. of California at San Franciso |
| Principal Investigator: | Coco Auerswald, MD | Univ. of California at San Franciso |
| Principal Investigator: | Sue Ellen Abdalian, MD | Tulane Medical Center |
| Principal Investigator: | Ligia Peralta, MD | University of Maryland |
| Principal Investigator: | Lawrence Friedman, MD | University of Miami |
| Principal Investigator: | Ana Puga, MD | Children's Diagnostic & Treatment Center |
| Principal Investigator: | Stephen Spector, MD | University of California, San Diego |
| Principal Investigator: | Rolando M Viani, MD | University of California, San Diego |
More Information
Additional Information:
No publications provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | James Korelitz, PhD, Adolescent Trials Network |
| ClinicalTrials.gov Identifier: | NCT00106964 History of Changes |
| Other Study ID Numbers: | ATN 024 |
| Study First Received: | April 1, 2005 |
| Last Updated: | May 12, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
Hepatitis B vaccines HIV-infected adolescents Hepatitis B infection (negative) |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Hepatitis Hepatitis A Hepatitis B HIV Seropositivity Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections Hepadnaviridae Infections DNA Virus Infections |
ClinicalTrials.gov processed this record on February 28, 2013
