Immunologic Memory (Supp. of ATN 024)

University of North Carolina (UNC)

Status and phase: Completed; Phase 4

Conditions: HIV Infections

Treatments: Biological: Engerix B; Biological: Twinrix for ATN 024; Biological: Recombivax; Biological: Twinrix for ATN 025

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00142753

ATN 048

Details and patient eligibility

About

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.

Full 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.

Enrollment: 95 patients

Sex: All

Ages: 12 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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95 participants in 5 patient groups

A1: ATN 024 Energix-B Standard Adult Dose

Active Comparator group

Treatment:

Biological: Engerix B

A2: ATN 024 Engerix-B Increased Adult Dose

Experimental group

Treatment:

Biological: Engerix B

A3: ATN 024 Twinrix Standard Adult Dose

Active Comparator group

Treatment:

Biological: Twinrix for ATN 024

B1: ATN 025 Recombivax

Experimental group

Treatment:

Biological: Recombivax

B2: ATN 025 Twinrix

Experimental group

Treatment:

Biological: Twinrix for ATN 025