Immunologic Memory (Supp. of ATN 024) - Full Text View

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Biological: Engerix B Biological: Twinrix for ATN 024 Biological: Recombivax Biological: Twinrix for ATN 025	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Hepatitis Hepatitis B Memory

Drug Information available for: Recombivax HB

U.S. FDA Resources

Further study details as provided by Westat:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]
To measure concentration of hepatitis B antibodies in serologic responders and non-responders. [ Time Frame: 1, 2, and 4 weeks after supplemental vaccine dose. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]


Enrollment:	95
Study Start Date:	August 2005
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A1: ATN 024 Energix-B Standard Adult Dose	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. Other Name: There are no other names.
Experimental: A2: ATN 024 Engerix-B Increased Adult Dose	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. Other Name: There are no other names.
Active Comparator: A3: ATN 024 Twinrix Standard Adult Dose	Biological: 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. Other Name: There are no other names.
Experimental: B1: ATN 025 Recombivax	Biological: 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. Other Name: There are no other names.
Experimental: B2: ATN 025 Twinrix	Biological: 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. Other Name: There are no other names.

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.

Eligibility


Ages Eligible for Study:	12 Years to 25 Years (Child, Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142753

Locations


United States, California
Childrens Hosp of Los Angeles
Los Angeles, California, United States, 90027
University of California at San Francisco
San Franciso, California, United States, 94118
United States, District of Columbia
Children's Hosp Natinal Med Center
Washington, District of Columbia, United States, 20010
United States, Louisiana
Tulane Med Center
New Orleans, Louisiana, United States, 70112

Sponsors and Collaborators

Westat

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators


Study Chair:	Stephen Obaro, MBBS, PhD	ATN

More Information

Additional Information:

(Website for the Adolescent Trials Network for HIV/AIDS Interventions) This link exits the ClinicalTrials.gov site


Responsible Party:	Westat
ClinicalTrials.gov Identifier:	NCT00142753 History of Changes
Other Study ID Numbers:	ATN 048
Study First Received:	August 31, 2005
Last Updated:	February 29, 2016
Health Authority:	United States: Federal Government

Keywords provided by Westat:


Hepatitis B vaccines HIV-infected adolescents Hepatitis B infection

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

ClinicalTrials.gov processed this record on September 23, 2016