Determining Responses to Two Different Vaccines in HIV and HCV Infected Individuals
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ClinicalTrials.gov Identifier: NCT00393276 |
Recruitment Status
:
Completed
First Posted
: October 27, 2006
Last Update Posted
: December 9, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Hepatitis C | Biological: Twinrix Biological: Decavac | Phase 1 |
Individuals with HCV and HIV coinfection are especially hard to treat, and as a result, account for a high rate of deaths each year. Because HCV and HIV share transmission routes, HCV/HIV coinfection is common. Liver disease has emerged as a significant cause of death in individuals coinfected with HCV and HIV. Currently, the mechanisms by which HCV and HIV interact in HCV/HIV-coinfected individuals, including how these infections affect immune responses, are poorly understood. Research suggests that vaccination may prevent other comorbidities associated with HCV/HIV coinfection; however, responses to new vaccine antigens have been shown to be impaired in HCV or HIV-infected individuals. The purpose of this study is to identify the innate and adaptive immune defects present in HCV-infected, HIV-infected, and HCV/HIV-coinfected individuals. This study will evaluate whether these innate and adaptive immune defects predict responses to HBV neoantigen in the form of both a diphtheria/tetanus toxoid immunization (Decavac)and a hepatitis A-hepatitis B immunization (Twinrix).
This study will last approximately 24 weeks. Participants will be stratified to one of three arms, based on their HCV and HIV status:
- Arm A will enroll HCV-infected individuals who are HIV-uninfected
- Arm B will enroll HIV-infected individuals who are HCV-uninfected
- Arm C will enroll HCV/HIV-coinfected individuals
Arms B and C will open for enrollment before Arm A. Opening of enrollment for Arm A will be determined by the accrual progress of Arms B and C as evaluated by the ACTG Scientific Agenda Steering committee.
All participants will receive Decavac vaccination on Day 0, and a Twinrix vaccination on Days 0, 7, and 21. Study visits will occur around Days 0, 7, and 21, and at Weeks 6, 8, 12, and 24; all visits will include medical and medication history, blood collection, and a physical exam. Medication to treat HCV or HIV will not be provided by the study.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 29 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Optimizing Vaccine Responsiveness in HIV-1 and HCV Infections by Identifying Determinants of Responsiveness: A Pilot Study |
Study Start Date : | August 2007 |
Actual Primary Completion Date : | July 2009 |
Actual Study Completion Date : | July 2009 |
Arm | Intervention/treatment |
---|---|
Experimental: A
HCV-infected defined as a positive result using polymerase chain reaction (PCR) without previous HCV-based therapy and without the presence of Child's B or C cirrhosis. These participants will be HIV-uninfected.
|
Biological: Twinrix
Combined hepatitis A and hepatitis B immunization
Biological: Decavac
Diphtheria and tetanus toxoid vaccine
|
Experimental: B
HIV-infected and ARV naive, with a CD4 cell count of 300 cells/mm3 or greater, with no prior or current opportunistic infection, and with no indication for HIV therapy. These participants will be HCV-uninfected.
|
Biological: Twinrix
Combined hepatitis A and hepatitis B immunization
Biological: Decavac
Diphtheria and tetanus toxoid vaccine
|
Experimental: C
HCV/HIV-coinfected as defined above in Arms A and B.
|
Biological: Twinrix
Combined hepatitis A and hepatitis B immunization
Biological: Decavac
Diphtheria and tetanus toxoid vaccine
|
- B-cell humoral responses [ Time Frame: At Week 8 ]
- T-cell responses as reflected by hepatitis B and tetanus antibody titers [ Time Frame: At Week 8 ]
- Dendritic cell, B-cell, and T-cell functional markers [ Time Frame: At Study Entry ]
- B-cell functional marker [ Time Frame: At Week 6 ]
- T-cell responses to hepatitis A, hepatitis B, and tetanus antigens [ Time Frame: At Weeks 3 and 8 ]
- Longitudinal serum antibody titers to hepatitis A, hepatitis B, and tetanus (B-cell responses) [ Time Frame: At Study Entry and Weeks 1, 3, 6, 8, 12, and 24 ]
- CD4/CD8 and HCV genotype [ Time Frame: At Study entry ]
- Baseline antibody status for hepatitis B core antigen (anti-HBc) [ Time Frame: At Study entry ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria for Arm A Participants:
- HCV-infected
- HIV-uninfected
Inclusion Criteria for Arm B Participants:
- HIV-infected
- HCV-uninfected
- CD4 count greater than or equal to 300 cells/mm3 within 60 days prior to study entry
Inclusion Criteria for Arm C Participants:
- HIV-infected
- HCV-infected
Inclusion Criteria for All Participants:
- Documented hepatitis B virus (HBV) antibody status. If anti-HBV core antibody positive, documented HBV negative test within 30 days prior to study entry is required.
- Willing to use acceptable forms of contraception for the duration of the study and for 24 weeks after the last vaccination
Exclusion Criteria for Arm A Participants:
- Concurrent or recent treatment for HCV infection (within the past three months)
Exclusion Criteria for Arm B Participants:
- Current, prior, or clinical need for antiretroviral therapy (within the past three months prior to study entry)
- Opportunistic infection other than HCV
Exclusion Criteria for Arm C Participants:
- Concurrent or recent treatment for HCV infection (within the past three months)
- Current, prior, or clinical need for antiretroviral therapy (within the past three months prior to study entry). More information on this criterion can be found in the protocol.
- Opportunistic infection other than HCV
Exclusion Criteria for All Participants:
- History of exposure to hepatitis A vaccine, hepatitis B vaccine, or combined hepatitis A-hepatitis B vaccines
- Immunomodulatory agents for 7 days or more within 30 days prior to study entry. More information on this criterion can be found in the protocol.
- Concurrent immunizations (e.g., influenza, pneumococcal, other vaccine)within 3 days prior to study entry
- Active or recent (in the last six months prior to study entry) CDC Category C event. More information on this criterion can be found in the protocol
- Systemic anticancer chemotherapy or radiation within 24 weeks prior to study entry, or anticipated need to begin such treatment
- Past or current immunologically-mediated disease. More information on this criterion can be found in the protocol.
- Current bacterial infection requiring treatment, therapy, or hospitalization within 1 week prior to study entry
- Serious illness requiring systemic treatment and/or hospitalization. Participants who complete therapy or are clinically stable on therapy for at least 14 days prior to study entry are not excluded.
- Current uncontrolled seizure disorders
- Active bleeding varices, or Child's B or C cirrhosis. More information on this criterion can be found in the protocol.
- Serious bleeding disorder that poses a risk to a participant for intramuscular injections
- Known allergy or sensitivity to study vaccines or their formulations
- Current drug or alcohol use that, in the opinion of the investigator, interferes with study participation
- Pregnant or breastfeeding
- Use of systemic investigational agents within 30 days prior to entry
- History of any hepatitis A vaccine within one year

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00393276
United States, California | |
UCSD Antiviral Research Center CRS | |
San Diego, California, United States, 92103 | |
Ucsf Aids Crs | |
San Francisco, California, United States, 94110 | |
United States, Colorado | |
University of Colorado Hospital CRS | |
Aurora, Colorado, United States, 80045 | |
United States, Maryland | |
IHV Baltimore Treatment CRS | |
Baltimore, Maryland, United States, 21201 | |
United States, Massachusetts | |
Massachusetts General Hospital Clinical Research Site (MGH CRS) CRS | |
Boston, Massachusetts, United States, 02114 | |
United States, New York | |
Columbia P&S CRS | |
New York, New York, United States, 10032-3732 | |
United States, North Carolina | |
Duke Univ. Med. Ctr. Adult CRS | |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
Case CRS | |
Cleveland, Ohio, United States, 44106-5083 | |
MetroHealth CRS | |
Cleveland, Ohio, United States, 44109 | |
The Ohio State University Medical Center | |
Columbus, Ohio, United States, 43210 | |
United States, Texas | |
Trinity Health and Wellness Center CRS | |
Dallas, Texas, United States | |
Puerto Rico | |
Puerto Rico AIDS Clinical Trials Unit CRS | |
San Juan, Puerto Rico |
Study Chair: | Donald D. Anthony, MD, PhD | Case Western Reserve University | |
Study Chair: | Benigno Rodriguez, MD | Division of Infectious Diseases, University Hospital of Cleveland |
Publications:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00393276 History of Changes |
Other Study ID Numbers: |
A5232 10154 ( Registry Identifier: DAIDS ES Registry Number ) 1R21AI066957-01 ( U.S. NIH Grant/Contract ) ACTG A5232 |
First Posted: | October 27, 2006 Key Record Dates |
Last Update Posted: | December 9, 2014 |
Last Verified: | December 2014 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Treatment Experienced Treatment Naive Immunizations |
Additional relevant MeSH terms:
Infection Hepatitis C HIV Infections Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections Hepatitis Liver Diseases Digestive System Diseases |
Lentivirus Infections Retroviridae Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |