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

NCT00141024 | Completed Phase 1

• 2 other identifiers: HVTN 06410059
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

HIV Infections

Keywords

HIV Seronegativity; HIV Preventive Vaccine

Outcome Measures

Primary Outcomes (1)

• Safety as assessed by local and systemic reactogenicity signs and symptoms, laboratory measures, and adverse and serious experiences

  After each injection and for 12 months following the first injection

Secondary Outcomes (2)

• Immunogenicity as assessed by HIV-specific cellular responses assessed by interferon-gamma ELISpot assays and intracellular cytokine staining

  Throughout the study

• Social impacts as assessed by negative experiences or problems reported by the participants

  Throughout the study

Study Arms (5)

1

EXPERIMENTAL

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.

Biological: EP HIV-1043

2

EXPERIMENTAL

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.

Biological: EP HIV-1043

3

EXPERIMENTAL

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.

Biological: EP HIV-1043

4

EXPERIMENTAL

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.

Biological: EP HIV-1090

5

EXPERIMENTAL

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.

Biological: EP HIV-1043; Biological: EP HIV-1090

Interventions

EP HIV-1043 BIOLOGICAL

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.

1; 2; 3; 5

EP HIV-1090 BIOLOGICAL

DNA plasmid vaccine containing the genes Gag, Pol, Vpr, Nef, Rev, and Env. The vaccine is provided in single-use 1.1-mL vials.

4; 5

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (3)

San Francisco Vaccine and Prevention CRS

San Francisco, California, 94102-6033, United States

Location

Project Brave HIV Vaccine CRS

Baltimore, Maryland, 21201, United States

Location

Univ. of Rochester HVTN CRS

Rochester, New York, 14642-0001, United States

Location

Related Publications (6)

• Esparza J, Osmanov S. HIV vaccines: a global perspective. Curr Mol Med. 2003 May;3(3):183-93. doi: 10.2174/1566524033479825.

  PMID: 12699356 BACKGROUND

• 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.

  PMID: 12089434 BACKGROUND

• 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.

  PMID: 11535313 BACKGROUND

• 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.

  PMID: 15265928 BACKGROUND

• 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.

  PMID: 14607970 BACKGROUND

• 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.

  PMID: 25820067 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Xia Jin, MD, PhD

  University of Rochester

  STUDY CHAIR

• Jorge Sanchez, MD

  Asociación Civil Impacta Salud y Educación (IMPACTA)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2005
• First Posted: September 1, 2005
• Study Start: January 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: October 14, 2021

Record last verified: 2021-10

Locations

US (3)