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

NCT00393276 | Completed Phase 1

• 4 other identifiers: A5232101541R21AI066957-01ACTG A5232
• Study Type: interventional
• Target: 29
• Locations: 2 countries
• Sites: 12

Brief 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.

Conditions

HIV Infections; Hepatitis C

Keywords

Treatment Experienced; Treatment Naive; Immunizations

Outcome Measures

Primary Outcomes (3)

• B-cell humoral responses

  At Week 8

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

  At Week 8

• Dendritic cell, B-cell, and T-cell functional markers

  At Study Entry

Secondary Outcomes (5)

• B-cell functional marker

  At Week 6

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

  At Weeks 3 and 8

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

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

• CD4/CD8 and HCV genotype

  At Study entry

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

  At Study entry

Study Arms (3)

A

EXPERIMENTAL

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; Biological: Decavac

B

EXPERIMENTAL

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; Biological: Decavac

C

EXPERIMENTAL

HCV/HIV-coinfected as defined above in Arms A and B.

Biological: Twinrix; Biological: Decavac

Interventions

Twinrix BIOLOGICAL

Combined hepatitis A and hepatitis B immunization

A; B; C

Decavac BIOLOGICAL

Diphtheria and tetanus toxoid vaccine

A; B; C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections: collaborator

Study Sites (12)

UCSD Antiviral Research Center CRS

San Diego, California, 92103, United States

Location

Ucsf Aids Crs

San Francisco, California, 94110, United States

Location

University of Colorado Hospital CRS

Aurora, Colorado, 80045, United States

Location

IHV Baltimore Treatment CRS

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital Clinical Research Site (MGH CRS) CRS

Boston, Massachusetts, 02114, United States

Location

Columbia P&S CRS

New York, New York, 10032-3732, United States

Location

Duke Univ. Med. Ctr. Adult CRS

Durham, North Carolina, 27710, United States

Location

Case CRS

Cleveland, Ohio, 44106-5083, United States

Location

MetroHealth CRS

Cleveland, Ohio, 44109, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Trinity Health and Wellness Center CRS

Dallas, Texas, United States

Location

Puerto Rico AIDS Clinical Trials Unit CRS

San Juan, Puerto Rico

Location

Related Publications (3)

• 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.

  PMID: 12174359 BACKGROUND

• 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.

  PMID: 14562859 BACKGROUND

• 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.

  PMID: 10770916 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Hepatitis C

Interventions

twinrix; Diphtheria-Tetanus Vaccine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepatitis, Viral, Human; Flaviviridae Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Diphtheria Toxoid; Toxoids; Tetanus Toxoid; Vaccines, Combined

Study Officials

• Donald D. Anthony, MD, PhD

  Case Western Reserve University

  STUDY CHAIR

• Benigno Rodriguez, MD

  Division of Infectious Diseases, University Hospital of Cleveland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2006
• First Posted: October 27, 2006
• Study Start: August 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

US (11); PR (1)