Safety of Recombinant HIV Vaccines in HIV Infected Young Adults on Stable Therapy
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)
3 other identifiers
interventional
20
2 countries
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 hiv-infections
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2005
CompletedFirst Posted
Study publicly available on registry
April 6, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedNovember 1, 2021
October 1, 2021
April 5, 2005
October 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Development of any adverse events of Grade 3 or higher
Throughout study
Development of adverse events of Grade 3 or higher attributed to the study vaccines
Throughout study
Viral breakthrough to greater than 1,000 copies/ml
During the first 24 weeks of study
Study Arms (1)
1
EXPERIMENTALAll participants in this study will receive two injections of the rMVA-HIV vaccine and the rFPV-HIV vaccine
Interventions
Recombinant experimental therapeutic vaccine using the modified vaccinia Ankara vector given at study entry and Week 4
Recombinant experimental therapeutic vaccine using fowlpox vector given at Weeks 8 and 24
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Children's Hospital Los Angeles NICHD CRS
Los Angeles, California, 90027, United States
Usc La Nichd Crs
Los Angeles, California, 90033, United States
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, 80218-1088, United States
Chicago Children's CRS
Chicago, Illinois, 60614, United States
Univ. of Maryland Baltimore NICHD CRS
Baltimore, Maryland, United States
Columbia IMPAACT CRS
New York, New York, United States
DUMC Ped. CRS
Durham, North Carolina, United States
St. Jude/UTHSC CRS
Memphis, Tennessee, 38105-2794, United States
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, Puerto Rico
Related Publications (6)
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.
PMID: 15544457BACKGROUNDCosma 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.
PMID: 14604567BACKGROUNDKent 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.
PMID: 9811759BACKGROUNDMwau 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.
PMID: 15039533BACKGROUNDPancharoen 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.
PMID: 15544450BACKGROUNDShiu 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.
PMID: 19605490DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Coleen K. Cunningham, MD
Pediatric Infectious Diseases, Duke University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2005
First Posted
April 6, 2005
Study Completion
February 1, 2009
Last Updated
November 1, 2021
Record last verified: 2021-10