San Francisco, California 94102

  • HIV Infections

Purpose:

The purpose of the study is to determine the safety of and immune response to the investigational HIV vaccine, EP HIV-1090, in HIV uninfected adults.


Study summary:

The worldwide HIV/AIDS epidemic may only be controlled through the development of a safe and effective vaccine that will prevent HIV infection. DNA vaccines are inexpensive to construct, readily produced in large quantities, and stable for long periods of time. EP HIV-1090 is a DNA HIV CTL vaccine; the proteins for which its genes code are designed to interact with CD8 cells (CTL) and cause CD8 cell proliferation. The DNA plasmids in EP HIV-1090 code for proteins conserved among HIV subtypes A, B, C, D, F, and G, which encompass the HLA subtypes of 85% of the worldwide general population. 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.


Criteria:

Note: Groups 1, 2, 3, and 5 have permanently discontinued enrollment per the 12/26/06 letter of amendment. Inclusion Criteria: - Good general health - 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: - HIV vaccines in a prior HIV vaccine trial - 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


Study is Available At:


Original ID:

HVTN 064


NCT ID:

NCT00141024


Secondary ID:

10059


Study Acronym:


Brief Title:

Safety of and Immune Response to the Experimental Preventive HIV Vaccine, EP HIV-1090, in Healthy, HIV-1 Uninfected Adults


Official Title:

A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of the Recombinant Protein Vaccine EP-1043 and the DNA Vaccine EP HIV-1090 Given Alone or in Combination in Healthy, HIV-1-Uninfected Adult Participants


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute of Allergy and Infectious Diseases (NIAID)


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

5


Number of Groups:

0


Total Enrollment:

84


Enrollment Type:

Actual


Overall Contact Information

Official Name:Xia Jin, MD, PhD
Study Chair
University of Rochester

Study Dates

Start Date:January 2006
Completion Date:December 2007
Completion Type:Actual
Primary Completion Date:December 2007
Primary Completion Type:Actual
Verification Date:June 2016
Last Changed Date:June 28, 2016
First Received Date:August 30, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Social impacts as assessed by negative experiences or problems reported by the participants
Time Frame:Throughout the study
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Immunogenicity as assessed by HIV-specific cellular responses assessed by interferon-gamma ELISpot assays and intracellular cytokine staining
Time Frame:Throughout the study
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Safety as assessed by local and systemic reactogenicity signs and symptoms, laboratory measures, and adverse and serious experiences
Time Frame:After each injection and for 12 months following the first injection
Safety Issues:True

Study Interventions

Intervention Type:Biological
Name:EP HIV-1043
Description: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.
Arm Name:1
Intervention Type:Biological
Name:EP HIV-1090
Description:DNA plasmid vaccine containing the genes Gag, Pol, Vpr, Nef, Rev, and Env. The vaccine is provided in single-use 1.1-mL vials.
Arm Name:4

Study Arms

Study Arm Type:Experimental
Arm Name:5
Description: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.
Study Arm Type:Experimental
Arm Name:4
Description: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.
Study Arm Type:Experimental
Arm Name:3
Description: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.
Study Arm Type:Experimental
Arm Name:2
Description: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.
Study Arm Type:Experimental
Arm Name:1
Description: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.

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Allergy and Infectious Diseases (NIAID)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.
PMID:14607970
Reference Type:Reference
Citation: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.
PMID:15265928
Reference Type:Reference
Citation: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.
PMID:11535313
Reference Type:Reference
Citation: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. Review.
PMID:12089434
Reference Type:Reference
Citation:Esparza J, Osmanov S. HIV vaccines: a global perspective. Curr Mol Med. 2003 May;3(3):183-93. Review.
PMID:12699356

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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