Immunologic Memory (Supp. of ATN 024)

HIV Infections Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00142753
• Other study ID #: ATN 048
• Status: Completed
• Phase: Phase 4
• First received: August 31, 2005
• Last updated: February 27, 2017
• Start date: August 2005
• Est. completion date: November 2007

Study information

• Verified date: February 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

Intervention

Biological:
• Engerix B
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.
• Twinrix for ATN 024
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.
• Recombivax
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.
• Twinrix for ATN 025
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.

Locations

Country	Name	City	State
United States	Childrens Hosp of Los Angeles	Los Angeles	California
United States	Tulane Med Center	New Orleans	Louisiana
United States	University of California at San Francisco	San Franciso	California
United States	Children's Hosp Natinal Med Center	Washington	District of Columbia

Sponsors (4)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure interferon-? (IFN-?), 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.
Primary	To measure concentration of hepatitis B antibodies in serologic responders and non-responders.		1, 2, and 4 weeks after supplemental vaccine dose.
Primary	To measure concentration of antibody-secreting cells in serologic responders and non-responders.		Before and one month after receipt of primary series of immunization.
Secondary	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.
Secondary	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.

External Links

•   (Website for the Adolescent Trials Network for HIV/AIDS Interventions)