Safety of and Immune Response to a Hepatitis B Virus Vaccine Given With a Booster (CpG7909 ODN) in HIV Infected and HIV Uninfected People

NCT ID: NCT00100633

Last Updated: 2008-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2007-10-31

Brief Summary

The purpose of the study is to determine the safety of and immune response to a hepatitis B virus vaccine series given with a boosting agent, CpG7909 oligodeoxynucleotides (ODN), in HIV infected and HIV uninfected individuals who previously failed to develop a response to hepatitis B vaccine.

Study hypothesis: Administration of CpG7909 ODN together with recombinant hepatitis B vaccine will result in increased frequency and magnitude of response to vaccine in individuals who have previously failed to mount a response to vaccination, and that in HIV infected subjects with detectable plasma viremia, it will lead to the enhancement of HIV-specific responses.

Detailed Description

As HIV disease progresses in HIV infected people, their immune responses to infectious and other foreign invaders becomes weaker; in particular, the cellular (T-cell) immune response is particularly affected by HIV. A boosting agent called CpG7909 ODN may be an ideal adjuvant for vaccines given to HIV infected people, because it may help elicit an increased CD8 T-cell response. This study will evaluate the safety of and immune response to a hepatitis B virus vaccine series given with CpG7909 ODN in HIV infected and uninfected people.

There will be three groups in this study; participants will be stratified by baseline CD4 counts and viral load. Within each group, participants will be randomly assigned to receive 3 injections of hepatitis B vaccine with CpG7909 ODN or 3 injections of hepatitis B vaccine alone. Injections will be given at study entry and Months 1 and 6. There will be 10 study visits; a physical exam and blood collection will occur at each visit.

Conditions

HIV Infections; Hepatitis B

Keywords

Hepatitis B Vaccine; Treatment Experienced; Treatment Naive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

CpG7909 oligodeoxynucleotides (ODN)

Intervention Type: DRUG

Hepatitis B virus vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• HIV-1 infection
• If receiving combination antiretroviral therapy (ART), must have been on ART for at least 3 months prior to study entry. Patients who anticipate a change in treatment (either initiating ART or stopping ART) in the next 7 months are not eligible.
• CD4 count of 250 cells/mm3 or greater
• Negative HBsAb, HBsAg, and HBcAb
• Willing to use acceptable forms of contraception while on study treatment and for 24 weeks after study treatment has ended

• HIV uninfected
• Negative HBsAb, HBsAg, and HBcAb
• Willing to use acceptable forms of contraception while on study treatment and for 24 weeks after study treatment has ended

Exclusion Criteria

• Cancer. Participants with squamous cell or basal cell skin cancer are not excluded.
• Autoimmune disease
• Immunosuppressive medications. People who use or have used corticosteroid nasal sprays are not excluded. People who have received fewer than 2 weeks of systemic corticosteroids with the last dose over a month prior to study entry are not excluded.
• Any medical or psychiatric condition or occupational responsibilities that may interfere with the study
• Immunomodulator or investigational agent therapy within 30 days prior to study entry
• Allergy/sensitivity to study drugs or their formulations, including thimerosal
• Current drug or alcohol use that, in the opinion of the investigator, would interfere with the study
• Active hepatitis C virus infection, as indicated by serum antibodies to HCV AND detectable HCV RNA in plasma
• Blood clotting abnormalities
• Any other condition that, in the opinion of the investigator, might interfere with the study
• Pregnancy or breastfeeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Case Western Reserve University

Principal Investigators

Michael M. Lederman, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

University Hospitals of Cleveland

Cleveland, Ohio, United States

Countries

United States

References

Jiang JQ, Patrick A, Moss RB, Rosenthal KL. CD8+ T-cell-mediated cross-clade protection in the genital tract following intranasal immunization with inactivated human immunodeficiency virus antigen plus CpG oligodeoxynucleotides. J Virol. 2005 Jan;79(1):393-400. doi: 10.1128/JVI.79.1.393-400.2005.

Reference Type: BACKGROUND

PMID: 15596832 (View on PubMed)

Schlaepfer E, Audige A, von Beust B, Manolova V, Weber M, Joller H, Bachmann MF, Kundig TM, Speck RF. CpG oligodeoxynucleotides block human immunodeficiency virus type 1 replication in human lymphoid tissue infected ex vivo. J Virol. 2004 Nov;78(22):12344-54. doi: 10.1128/JVI.78.22.12344-12354.2004.

Reference Type: BACKGROUND

PMID: 15507621 (View on PubMed)

Other Identifiers

P01AI055793

Identifier Type: NIH

Identifier Source: secondary_id

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P01AI055793

Identifier Type: NIH

Identifier Source: org_study_id

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