Safety of and Immune Response to the Experimental Preventive HIV Vaccine, EP HIV-1090, in Healthy, HIV-1 Uninfected Adults
NCT ID: NCT00141024
Last Updated: 2021-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
84 participants
INTERVENTIONAL
2006-01-31
2007-12-31
Brief Summary
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Detailed Description
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Participants will be enrolled in this study for 1 year. Group 4 participants will receive EP HIV-1090 or placebo at study entry and Months 1, 3, and 6. There will be 11 study visits that will occur at screening; study entry; and Months 0.5, 1, 1.5, 3, 3.5, 6, 6.5, 9, and 12. A physical exam and risk reduction/pregnancy prevention counseling will occur at each visit. Participants will be asked about their adverse experiences from vaccination at each visit. Blood and urine collection will occur at selected visits.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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1
Group 1 will receive 4 vaccinations of the EP-1043 vaccine or placebo. Vaccinations will be given at Months 0, 1, 3, and 6. This group was discontinued as of 12/26/06.
EP HIV-1043
Recombinant protein vaccine containing the 18 HIV proteins from HIV genes Pol, Vpu, and Gag.
The vaccine is provided in single-use 1.1-mL vials.
2
Group 2 will receive 4 vaccinations of the EP-1043 vaccine or placebo. Vaccinations will be given at Months 0, 1, 3, and 6. This group was discontinued as of 12/26/06.
EP HIV-1043
Recombinant protein vaccine containing the 18 HIV proteins from HIV genes Pol, Vpu, and Gag.
The vaccine is provided in single-use 1.1-mL vials.
3
In Part B, Group 3 will receive 4 vaccinations of either the EP-1043 vaccine or placebo. Vaccinations will occur at Months 0, 1, 3, and 6. This group was discontinued as of 12/26/06.
EP HIV-1043
Recombinant protein vaccine containing the 18 HIV proteins from HIV genes Pol, Vpu, and Gag.
The vaccine is provided in single-use 1.1-mL vials.
4
In Part B, Group 4 will receive 4 vaccinations of either the DNA vaccine EP-HIV-1090 or placebo. Vaccinations will occur at Months 0, 1, 3, and 6.
EP HIV-1090
DNA plasmid vaccine containing the genes Gag, Pol, Vpr, Nef, Rev, and Env. The vaccine is provided in single-use 1.1-mL vials.
5
In Part B, Group 5 will receive 4 vaccinations of either the protein vaccine EP-1043 plus DNA vaccine EP-HIV- 1090 or placebo. Vaccinations will occur at Months 0, 1, 3, and 6. This group was discontinued as of 12/26/06.
EP HIV-1043
Recombinant protein vaccine containing the 18 HIV proteins from HIV genes Pol, Vpu, and Gag.
The vaccine is provided in single-use 1.1-mL vials.
EP HIV-1090
DNA plasmid vaccine containing the genes Gag, Pol, Vpr, Nef, Rev, and Env. The vaccine is provided in single-use 1.1-mL vials.
Interventions
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EP HIV-1043
Recombinant protein vaccine containing the 18 HIV proteins from HIV genes Pol, Vpu, and Gag.
The vaccine is provided in single-use 1.1-mL vials.
EP HIV-1090
DNA plasmid vaccine containing the genes Gag, Pol, Vpr, Nef, Rev, and Env. The vaccine is provided in single-use 1.1-mL vials.
Eligibility Criteria
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Inclusion Criteria
* Have access to a participating HIV Vaccine Trials Unit (HVTU) and are willing to be followed for the duration of the study
* Willing to receive HIV test results
* Have understanding of the study
* Willing to use acceptable forms of contraception
* Negative pregnancy test
Exclusion Criteria
* Immunosuppressive medications within 168 days prior to first vaccination
* Blood products within 120 days prior to first vaccination
* Immunoglobulin within 60 days prior to first vaccination
* Live attenuated vaccines within 30 days prior to first vaccination
* Investigational research agents within 30 days prior to first vaccination
* Medically indicated subunit or killed vaccines within 14 days prior to first study vaccine administration, or allergy treatment with antigen injections within 30 days prior to first vaccination
* Current tuberculosis prophylaxis or therapy
* Clinically significant medical condition, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect current health
* Any medical, psychiatric, or social condition that would interfere with the study. More information about this criterion can be found in the protocol.
* Any job-related responsibility that would interfere with the study
* Serious adverse reaction to vaccines. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.
* Autoimmune disease or immunodeficiency
* Active syphilis infection unless the participant has completed full treatment for syphilis 6 months prior to enrollment
* Unstable asthma
* Diabetes mellitus type 1 or 2
* Thyroid disease or thyroidectomy requiring treatment
* Serious angioedema within 3 years prior to enrollment
* Uncontrolled hypertension
* Body mass index (BMI) of 40 or greater
* BMI of 35 or greater if the participant is older than 45 years, has systolic blood pressure greater than 140 mm Hg, has diastolic blood pressure greater than 90 mm Hg, smokes, or has known hyperlipidemia
* Bleeding disorder
* Malignancy unless it has been surgically removed and, in the opinion of the investigator, is not likely to recur during the study period
* Seizure disorder requiring medication within the 3 years prior to enrollment
* Absence of the spleen
* Mental illness that would interfere with the study
* Other conditions that, in the judgment of the investigator, would interfere with the study
* Pregnancy, breastfeeding, or plans to become pregnant
18 Years
50 Years
ALL
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Xia Jin, MD, PhD
Role: STUDY_CHAIR
University of Rochester
Jorge Sanchez, MD
Role: STUDY_CHAIR
Asociación Civil Impacta Salud y Educación (IMPACTA)
Locations
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San Francisco Vaccine and Prevention CRS
San Francisco, California, United States
Project Brave HIV Vaccine CRS
Baltimore, Maryland, United States
Univ. of Rochester HVTN CRS
Rochester, New York, United States
Countries
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References
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Esparza J, Osmanov S. HIV vaccines: a global perspective. Curr Mol Med. 2003 May;3(3):183-93. doi: 10.2174/1566524033479825.
Gaschen B, Taylor J, Yusim K, Foley B, Gao F, Lang D, Novitsky V, Haynes B, Hahn BH, Bhattacharya T, Korber B. Diversity considerations in HIV-1 vaccine selection. Science. 2002 Jun 28;296(5577):2354-60. doi: 10.1126/science.1070441.
Livingston BD, Newman M, Crimi C, McKinney D, Chesnut R, Sette A. Optimization of epitope processing enhances immunogenicity of multiepitope DNA vaccines. Vaccine. 2001 Sep 14;19(32):4652-60. doi: 10.1016/s0264-410x(01)00233-x.
McKinney DM, Skvoretz R, Livingston BD, Wilson CC, Anders M, Chesnut RW, Sette A, Essex M, Novitsky V, Newman MJ. Recognition of variant HIV-1 epitopes from diverse viral subtypes by vaccine-induced CTL. J Immunol. 2004 Aug 1;173(3):1941-50. doi: 10.4049/jimmunol.173.3.1941.
Wilson CC, McKinney D, Anders M, MaWhinney S, Forster J, Crimi C, Southwood S, Sette A, Chesnut R, Newman MJ, Livingston BD. Development of a DNA vaccine designed to induce cytotoxic T lymphocyte responses to multiple conserved epitopes in HIV-1. J Immunol. 2003 Nov 15;171(10):5611-23. doi: 10.4049/jimmunol.171.10.5611.
Jin X, Morgan C, Yu X, DeRosa S, Tomaras GD, Montefiori DC, Kublin J, Corey L, Keefer MC; NIAID HIV Vaccine Trials Network. Multiple factors affect immunogenicity of DNA plasmid HIV vaccines in human clinical trials. Vaccine. 2015 May 11;33(20):2347-53. doi: 10.1016/j.vaccine.2015.03.036. Epub 2015 Mar 25.
Other Identifiers
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10059
Identifier Type: REGISTRY
Identifier Source: secondary_id
HVTN 064
Identifier Type: -
Identifier Source: org_study_id