search
Back to results

Safety of Recombinant HIV Vaccines in HIV Infected Young Adults on Stable Therapy

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
rMVA-HIV (env/gag [TBC-M358] + tat/rev/nef-RT [TBC-M335)])
rFPV-HIV (env/gag [TBC-F357] + tat/rev/nef-RT [TBC-F349])
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Treatment Experienced, HIV Therapeutic Vaccine

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: HIV-1 infected CD4 count of 350 cells/mm3 or greater If hepatitis B or C infected, infection must be chronic and stable Normal electrocardiogram (ECG) On stable HAART consisting of at least 3 different antiretrovirals from 2 different classes AND with a viral load of less than 100 copies/ml for at least 6 months prior to study entry Willing to use acceptable forms of contraception. Females enrolled in the study must use contraception for at least 21 days prior to first vaccination until the last study visit. Males enrolled in the study must use a condom from the first vaccination until one month after the last vaccination. Willing to follow all study requirements Available for follow-up for the duration of the study Exclusion Criteria: History of allergic reaction to eggs or egg products Known hypersensitivity to vaccine components Chemotherapy for active cancer in the 12 months prior to study entry Prior vaccination with any HIV-1 vaccine Prior vaccination against smallpox Prior vaccinia immunization Any immunization within 1 month of study screening History of or known active heart disease including myocardial infarction, angina pectoris, congestive heart failure, cardiomyopathy, pericarditis, stroke or transient ischemic attack, chest pain or shortness of breath with activity such as walking upstairs, mitral valve prolapse, or other heart conditions under a doctor's care Immunomodulatory agents, gamma globulin, or investigational agents within 6 months of study entry Systemic steroids, including nonprescription street steroids, within 6 months of study entry Documented or suspected serious bacterial infection, metabolic illness, cancer, or immediate life-threatening condition Any clinically significant diseases other than HIV infection or clinically significant findings during study screening that, in the investigator's opinion, may interfere with the study Current alcohol or drug abuse that, in the investigator's opinion, may interfere with the study Pregnancy or breastfeeding

Sites / Locations

  • Children's Hospital Los Angeles NICHD CRS
  • Usc La Nichd Crs
  • Univ. of Colorado Denver NICHD CRS
  • Chicago Children's CRS
  • Univ. of Maryland Baltimore NICHD CRS
  • Columbia IMPAACT CRS
  • DUMC Ped. CRS
  • St. Jude/UTHSC CRS
  • Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

All participants in this study will receive two injections of the rMVA-HIV vaccine and the rFPV-HIV vaccine

Outcomes

Primary Outcome Measures

Development of any adverse events of Grade 3 or higher
Development of adverse events of Grade 3 or higher attributed to the study vaccines
Viral breakthrough to greater than 1,000 copies/ml

Secondary Outcome Measures

Full Information

First Posted
April 5, 2005
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
search

1. Study Identification

Unique Protocol Identification Number
NCT00107549
Brief Title
Safety of Recombinant HIV Vaccines in HIV Infected Young Adults on Stable Therapy
Official Title
A Phase I, Open-Label Study to Evaluate the Safety and Tolerability of Recombinant HIV-1 Vaccines in HIV-1 Infected Young Adults With Control of HIV-1 Replication and on Stable Highly Active Antiretroviral Therapy (HAART)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine the safety of two recombinant HIV vaccines in HIV infected young adults on stable anti-HIV therapy.
Detailed Description
By helping to control viral replication, HAART has dramatically improved the prognosis for HIV infected individuals. However, because of extensive side effects, some of which may be acute and life-threatening, many patients find it difficult to tolerate a HAART regimen. HAART-associated long-term morbidity or mortality contribute to this difficulty. Administering an HIV therapeutic vaccine might allow HIV infected individuals to delay or interrupt treatment, avoiding the side effects associated with antiretroviral exposure. This study will evaluate the safety of two injections of two recombinant therapeutic vaccines in HIV infected young adults who are currently on stable HAART. This study will last 72 weeks. All participants will receive two rMVA vaccines (env/gag and tat/rev/nef-RT) at study entry and at Week 4 and two rFPV vaccines (env/gag and tat/rev/nef-RT) at Weeks 8 and 24. Safety will be assessed immediately after each immunization and at 1 hour and 48 hours postimmunization. There will be 16 study visits over 72 weeks. A physical exam, blood collection, and administration of an adherence module will occur at most visits. An electrocardiogram (ECG) will occur at study entry and Weeks 2 and 10. Urine collection will occur at study entry and Weeks 4, 8, and 24.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Treatment Experienced, HIV Therapeutic Vaccine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
All participants in this study will receive two injections of the rMVA-HIV vaccine and the rFPV-HIV vaccine
Intervention Type
Biological
Intervention Name(s)
rMVA-HIV (env/gag [TBC-M358] + tat/rev/nef-RT [TBC-M335)])
Intervention Description
Recombinant experimental therapeutic vaccine using the modified vaccinia Ankara vector given at study entry and Week 4
Intervention Type
Biological
Intervention Name(s)
rFPV-HIV (env/gag [TBC-F357] + tat/rev/nef-RT [TBC-F349])
Intervention Description
Recombinant experimental therapeutic vaccine using fowlpox vector given at Weeks 8 and 24
Primary Outcome Measure Information:
Title
Development of any adverse events of Grade 3 or higher
Time Frame
Throughout study
Title
Development of adverse events of Grade 3 or higher attributed to the study vaccines
Time Frame
Throughout study
Title
Viral breakthrough to greater than 1,000 copies/ml
Time Frame
During the first 24 weeks of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV-1 infected CD4 count of 350 cells/mm3 or greater If hepatitis B or C infected, infection must be chronic and stable Normal electrocardiogram (ECG) On stable HAART consisting of at least 3 different antiretrovirals from 2 different classes AND with a viral load of less than 100 copies/ml for at least 6 months prior to study entry Willing to use acceptable forms of contraception. Females enrolled in the study must use contraception for at least 21 days prior to first vaccination until the last study visit. Males enrolled in the study must use a condom from the first vaccination until one month after the last vaccination. Willing to follow all study requirements Available for follow-up for the duration of the study Exclusion Criteria: History of allergic reaction to eggs or egg products Known hypersensitivity to vaccine components Chemotherapy for active cancer in the 12 months prior to study entry Prior vaccination with any HIV-1 vaccine Prior vaccination against smallpox Prior vaccinia immunization Any immunization within 1 month of study screening History of or known active heart disease including myocardial infarction, angina pectoris, congestive heart failure, cardiomyopathy, pericarditis, stroke or transient ischemic attack, chest pain or shortness of breath with activity such as walking upstairs, mitral valve prolapse, or other heart conditions under a doctor's care Immunomodulatory agents, gamma globulin, or investigational agents within 6 months of study entry Systemic steroids, including nonprescription street steroids, within 6 months of study entry Documented or suspected serious bacterial infection, metabolic illness, cancer, or immediate life-threatening condition Any clinically significant diseases other than HIV infection or clinically significant findings during study screening that, in the investigator's opinion, may interfere with the study Current alcohol or drug abuse that, in the investigator's opinion, may interfere with the study Pregnancy or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Coleen K. Cunningham, MD
Organizational Affiliation
Pediatric Infectious Diseases, Duke University
Official's Role
Study Chair
Facility Information:
Facility Name
Children's Hospital Los Angeles NICHD CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Usc La Nichd Crs
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Univ. of Colorado Denver NICHD CRS
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80218-1088
Country
United States
Facility Name
Chicago Children's CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Univ. of Maryland Baltimore NICHD CRS
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Columbia IMPAACT CRS
City
New York
State/Province
New York
Country
United States
Facility Name
DUMC Ped. CRS
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
St. Jude/UTHSC CRS
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105-2794
Country
United States
Facility Name
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
City
San Juan
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
15544457
Citation
Caputo A, Gavioli R, Ensoli B. Recent advances in the development of HIV-1 Tat-based vaccines. Curr HIV Res. 2004 Oct;2(4):357-76. doi: 10.2174/1570162043350986.
Results Reference
background
PubMed Identifier
14604567
Citation
Cosma A, Nagaraj R, Buhler S, Hinkula J, Busch DH, Sutter G, Goebel FD, Erfle V. Therapeutic vaccination with MVA-HIV-1 nef elicits Nef-specific T-helper cell responses in chronically HIV-1 infected individuals. Vaccine. 2003 Dec 8;22(1):21-9. doi: 10.1016/s0264-410x(03)00538-3.
Results Reference
background
PubMed Identifier
9811759
Citation
Kent SJ, Zhao A, Best SJ, Chandler JD, Boyle DB, Ramshaw IA. Enhanced T-cell immunogenicity and protective efficacy of a human immunodeficiency virus type 1 vaccine regimen consisting of consecutive priming with DNA and boosting with recombinant fowlpox virus. J Virol. 1998 Dec;72(12):10180-8. doi: 10.1128/JVI.72.12.10180-10188.1998.
Results Reference
background
PubMed Identifier
15039533
Citation
Mwau M, Cebere I, Sutton J, Chikoti P, Winstone N, Wee EG, Beattie T, Chen YH, Dorrell L, McShane H, Schmidt C, Brooks M, Patel S, Roberts J, Conlon C, Rowland-Jones SL, Bwayo JJ, McMichael AJ, Hanke T. A human immunodeficiency virus 1 (HIV-1) clade A vaccine in clinical trials: stimulation of HIV-specific T-cell responses by DNA and recombinant modified vaccinia virus Ankara (MVA) vaccines in humans. J Gen Virol. 2004 Apr;85(Pt 4):911-919. doi: 10.1099/vir.0.19701-0.
Results Reference
background
PubMed Identifier
15544450
Citation
Pancharoen C, Ananworanich J, Thisyakorn U. Immunization for persons infected with human immunodeficiency virus. Curr HIV Res. 2004 Oct;2(4):293-9. doi: 10.2174/1570162043351084.
Results Reference
background
PubMed Identifier
19605490
Citation
Shiu C, Cunningham CK, Greenough T, Muresan P, Sanchez-Merino V, Carey V, Jackson JB, Ziemniak C, Fox L, Belzer M, Ray SC, Luzuriaga K, Persaud D; Pediatric AIDS Clinical Trials Group P1059 Team. Identification of ongoing human immunodeficiency virus type 1 (HIV-1) replication in residual viremia during recombinant HIV-1 poxvirus immunizations in patients with clinically undetectable viral loads on durable suppressive highly active antiretroviral therapy. J Virol. 2009 Oct;83(19):9731-42. doi: 10.1128/JVI.00570-09. Epub 2009 Jul 15.
Results Reference
derived

Learn more about this trial

Safety of Recombinant HIV Vaccines in HIV Infected Young Adults on Stable Therapy

We'll reach out to this number within 24 hrs