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Completed

NCT Number: NCT00142753

Immunologic Memory (Supp. of ATN 024)

This is an exploratory, laboratory-based evaluation of cellular immune response to immunization with hepatitis B surface antigen in HIV-infected and HIV-uninfected adolescents. This is a substudy of ATN 024 and ATN 025. This substudy will compare cellular immune response in responders and nonresponders to immunization and also evaluate the relationship of these factors to the persistence of known correlates of serologic protection for the hepatitis B virus.

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Key information

Conditions

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

Age range

12 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Childrens Hosp of Los Angeles, Los Angeles, California, United States

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About this study

This substudy will enroll volunteers from participants of ATN 024 and ATN 025. Participants in ATN 024 are HIV-infected youths aged 12-24 years while participants in ATN 025 are HIV-uninfected youths aged 12-17 years. These youths must also be negative for HBV core antibody, HBV surface antigen, and HBV surface antibody to be eligible.

Blood will be drawn from study participants prior to immunization, 1 month after completion of primary immunization and at study exit (week 72 for ATN 024 and week 76 for ATN 025) for cytokine assays and enumeration of antibody-secreting cells. In addition, the antibody to HBV surface antigen will be determined 2 and 4 weeks after supplemental immunization in nonresponders to the primary series and at study exit.

This laboratory substudy is designed to evaluate some aspects of cellular immune response to hepatitis B vaccination that are directly related to the generation and durability of antibody response to HBV surface antigen in HIV-infected and HIV-uninfected adolescents. Cytokine production by peripheral mononuclear cells will be determined following in-vitro stimulation, and antibody-secreting cells will be enumerated.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects that are eligible for participation in ATN 024 and ATN 025 are eligible for ATN 048. Subjects consented for ATN 024 or ATN 025 should be consented for ATN 048 at the same time. A written informed assent/consent must be obtained from the subject along with written parental/legal guardian permission as determined by the local IRB before any study-related procedures are performed.

Treatment and study plan

Engerix B

Biological

Standard adult dose for A1; increased adult dose for A2. Doses at Entry, Weeks 4 and 24. Non-responders (<10 IU/mL of antibody at week 28/4 weeks after dose #3) will receive Engerix-B increased adult dose at Week 48.

Other names: There are no other names.

Twinrix for ATN 024

Biological

Standard adult dosage, taken at Entry, Weeks 4 and 24. Non-responders (<10 IU/mL of antibody at week 28/4 weeks after dose #3) will receive Engerix-B increased adult dose at week 48.

Other names: There are no other names.

Recombivax

Biological

Dosage at entry and week 24; non-responders ((<10 IU/mL of antibody at week 28/4 weeks after dose #3) will receive 3rd dose of Recombivax during weeks 48-72.

Other names: There are no other names.

Twinrix for ATN 025

Biological

Doses at Entry and Week 24. Non-responders (<10 IU/mL of antibody at week 28/4 weeks after dose #3) will receive a dose of Recombivax during week 48-72.

Other names: There are no other names.

Primary outcomes

  1. To measure interferon-γ (IFN-γ), interleukin -4 (IL-4), and interleukin-10 (IL-10) production in serologic responders and non-responders.

    Time frame: Before and one month after receipt of primary series of immunization.

  2. To measure concentration of hepatitis B antibodies in serologic responders and non-responders.

    Time frame: 1, 2, and 4 weeks after supplemental vaccine dose.

  3. To measure concentration of antibody-secreting cells in serologic responders and non-responders.

    Time frame: Before and one month after receipt of primary series of immunization.

Secondary outcomes

  1. Measure whether the profile of cytokine secretion or the number of antibody-secreting cells can be used as a predictor of anamnestic response to a supplemental vaccine dose following serologic nonresponse to a primary series of immunization.

    Time frame: Prior to immunization, 1 month after primary immunization, at study exit (week 72 for ATN 024; week 76 for ATN 025); at 2 & 4 weeks after supplemental immunization in nonresponders, & at study exit for ATN 024 subjects.

  2. To compare the rate of loss of antibody-secreting cells after vaccination through the end of the study in each vaccine arm.

    Time frame: Prior to immunization, 1 month after completion of primary immunization and at study exit.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Correlates of HBV-Specific B Cell Memory Following Vaccination in HIV-Infected Adolescents and HIV-Uninfected Adolescents: A Substudy of ATN 024 and ATN 025

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 2, 2005
Registry last updated
Feb 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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