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

HIV Infections Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00107549
• Other study ID #: P1059
• Secondary ID: 10051PACTG P1059
• Status: Completed
• Phase: Phase 1
• Est. completion date: February 2009

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Biological:
• rMVA-HIV (env/gag [TBC-M358] + tat/rev/nef-RT [TBC-M335)])
Recombinant experimental therapeutic vaccine using the modified vaccinia Ankara vector given at study entry and Week 4
• rFPV-HIV (env/gag [TBC-F357] + tat/rev/nef-RT [TBC-F349])
Recombinant experimental therapeutic vaccine using fowlpox vector given at Weeks 8 and 24

Locations

Country	Name	City	State
Puerto Rico	Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS	San Juan
United States	Univ. of Colorado Denver NICHD CRS	Aurora	Colorado
United States	Univ. of Maryland Baltimore NICHD CRS	Baltimore	Maryland
United States	Chicago Children's CRS	Chicago	Illinois
United States	DUMC Ped. CRS	Durham	North Carolina
United States	Children's Hospital Los Angeles NICHD CRS	Los Angeles	California
United States	Usc La Nichd Crs	Los Angeles	California
United States	St. Jude/UTHSC CRS	Memphis	Tennessee
United States	Columbia IMPAACT CRS	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (5)

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. Review. — View Citation

Cosma A, Nagaraj R, Bühler 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. — View 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. — View 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. — View Citation

Pancharoen C, Ananworanich J, Thisyakorn U. Immunization for persons infected with human immunodeficiency virus. Curr HIV Res. 2004 Oct;2(4):293-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of any adverse events of Grade 3 or higher		Throughout study
Primary	Development of adverse events of Grade 3 or higher attributed to the study vaccines		Throughout study
Primary	Viral breakthrough to greater than 1,000 copies/ml		During the first 24 weeks of study

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