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AzTrials

HIV InfectionsPhase 1NCT00393276

Determining Responses to Two Different Vaccines in HIV and HCV Infected Individuals

A Phase 1 study testing Twinrix and Decavac in people with HIV Infections and Hepatitis C, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Infection with either HIV or hepatitis C virus (HCV) affects immune system responses. The purpose of this study is to investigate the immune responses to two different vaccine formulations in HIV-infected, HCV-infected, and HCV/HIV- coinfected individuals. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
HIV Infections, Hepatitis C
What is being tested?
Twinrix and Decavac
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
12 sitesin 2 countries
Study dates
Aug 2007to Jul 2009
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • HCV-infected
  • HIV-uninfected
  • HIV-infected
  • HCV-uninfected
  • CD4 count greater than or equal to 300 cells/mm3 within 60 days prior to study entry
  • HIV-infected
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  • HCV-infected
  • 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

Who cannot join

  • 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)
  • Opportunistic infection other than HCV
  • 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
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  • 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

Trial locations and contacts

12 sites in 2 countries.

12 sites in 2 countries

United States11 sites

  • University of Colorado Hospital CRS

    Aurora, Colorado, 80045

  • IHV Baltimore Treatment CRS

    Baltimore, Maryland, 21201

  • Massachusetts General Hospital Clinical Research Site (MGH CRS) CRS

    Boston, Massachusetts, 02114

  • Case CRS

    Cleveland, Ohio, 44106-5083

  • MetroHealth CRS

    Cleveland, Ohio, 44109

  • The Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Trinity Health and Wellness Center CRS

    Dallas, Texas

  • Duke Univ. Med. Ctr. Adult CRS

    Durham, North Carolina, 27710

  • Columbia P&S CRS

    New York, New York, 10032-3732

  • UCSD Antiviral Research Center CRS

    San Diego, California, 92103

  • Ucsf Aids Crs

    San Francisco, California, 94110

Other trials in United States

Puerto Rico1 site

  • Puerto Rico AIDS Clinical Trials Unit CRS

    San Juan

Other trials in Puerto Rico

About this study

Official title: Optimizing Vaccine Responsiveness in HIV-1 and HCV Infections by Identifying Determinants of Responsiveness: A Pilot Study

Infection with either HIV or hepatitis C virus (HCV) affects immune system responses. The purpose of this study is to investigate the immune responses to two different vaccine formulations in HIV-infected, HCV-infected, and HCV/HIV- coinfected individuals.

Read the detailed description

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.

Being tested
Twinrix, Decavac
Keywords
Treatment Experienced, Treatment Naive, Immunizations
Medical subject headings
HIV Infections, Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TwinrixBiological

    Combined hepatitis A and hepatitis B immunization

  • DecavacBiological

    Diphtheria and tetanus toxoid vaccine

Study groups in NCT00393276
Study groupRoleWhat they receive
AExperimentalHCV-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.
Receives: Biological: Twinrix; Biological: Decavac
BExperimentalHIV-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.
Receives: Biological: Twinrix; Biological: Decavac
CExperimentalHCV/HIV-coinfected as defined above in Arms A and B.
Receives: Biological: Twinrix; Biological: Decavac

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. B-cell humoral responses

    Measured: At Week 8

  2. T-cell responses as reflected by hepatitis B and tetanus antibody titers

    Measured: At Week 8

  3. Dendritic cell, B-cell, and T-cell functional markers

    Measured: At Study Entry

Secondary outcomes (5)

  1. B-cell functional marker

    Measured: At Week 6

  2. T-cell responses to hepatitis A, hepatitis B, and tetanus antigens

    Measured: At Weeks 3 and 8

  3. Longitudinal serum antibody titers to hepatitis A, hepatitis B, and tetanus (B-cell responses)

    Measured: At Study Entry and Weeks 1, 3, 6, 8, 12, and 24

  4. CD4/CD8 and HCV genotype

    Measured: At Study entry

  5. Baseline antibody status for hepatitis B core antigen (anti-HBc)

    Measured: At Study entry

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2006 (estimated)
  2. Study startAug 2007
  3. Primary completionJul 2009
  4. Study completionJul 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00393276
Sponsor's protocol ID
A5232
Other IDs
10154, 1R21AI066957-01, ACTG A5232
Status last verified
Oct 2021
First submitted
25 Oct 2006
Last updated
1 Nov 2021
Results posted
No

Publications

  • Maier I, Wu GY. Hepatitis C and HIV co-infection: a review. World J Gastroenterol. 2002 Aug;8(4):577-9. doi: 10.3748/wjg.v8.i4.577.

    PubMed 12174359

  • Rockstroh JK. Management of hepatitis B and C in HIV co-infected patients. J Acquir Immune Defic Syndr. 2003 Sep;34 Suppl 1:S59-65. doi: 10.1097/00126334-200309011-00009.

    PubMed 14562859

  • Sulkowski MS, Mast EE, Seeff LB, Thomas DL. Hepatitis C virus infection as an opportunistic disease in persons infected with human immunodeficiency virus. Clin Infect Dis. 2000 Apr;30 Suppl 1:S77-84. doi: 10.1086/313842.

    PubMed 10770916

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Twinrix and Decavac in people with HIV Infections and Hepatitis C, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

B-cell humoral responses (time frame: At Week 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00393276, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.

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