Immunologic Memory (Supp. of ATN 024)

Phase 4

Completed

• Conditions: HIV Infections
• Interventions: Biological: Engerix B; Biological: Twinrix for ATN 025; Biological: Recombivax; Biological: Twinrix for ATN 024

• Registration Number: NCT00142753
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-08-31
• Study First Submitted QC: 2005-08-31
• Study First Posted: 2005-09-02
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2016-02
• Last Update Submitted: 2017-02-27
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A1: ATN 024 Energix-B Standard Adult Dose	Engerix B	-
B2: ATN 025 Twinrix	Twinrix for ATN 025	-
A2: ATN 024 Engerix-B Increased Adult Dose	Engerix B	-
B1: ATN 025 Recombivax	Recombivax	-
A3: ATN 024 Twinrix Standard Adult Dose	Twinrix for ATN 024	-

Primary Outcome Measures

Name	Time	Method
To measure interferon-γ (IFN-γ), interleukin -4 (IL-4), and interleukin-10 (IL-10) production in serologic responders and non-responders.	Before and one month after receipt of primary series of immunization.
To measure concentration of antibody-secreting cells in serologic responders and non-responders.	Before and one month after receipt of primary series of immunization.
To measure concentration of hepatitis B antibodies in serologic responders and non-responders.	1, 2, and 4 weeks after supplemental vaccine dose.

Secondary Outcome Measures

Name	Time	Method
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.	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.
To compare the rate of loss of antibody-secreting cells after vaccination through the end of the study in each vaccine arm.	Prior to immunization, 1 month after completion of primary immunization and at study exit.

Trial Locations

Locations (4)

University of California at San Francisco; 🇺🇸 San Franciso, California, United States

Children's Hosp Natinal Med Center; 🇺🇸 Washington, District of Columbia, United States

Childrens Hosp of Los Angeles; 🇺🇸 Los Angeles, California, United States

Tulane Med Center; 🇺🇸 New Orleans, Louisiana, United States