NCT00428337

Brief Summary

The purpose of this study is to determine the safety of and immune response to two experimental vaccines, designed for use in combination, for the prevention of HIV infection in healthy adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 hiv-infections

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

3 active sites

Status
completed

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

January 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

October 14, 2021

Status Verified

October 1, 2021

First QC Date

January 29, 2007

Last Update Submit

October 13, 2021

Conditions

HIV Infections

Keywords

HIV SeronegativityEP1233MVA-mBN32HIV Preventive Vaccine

Outcome Measures

Primary Outcomes (1)

  • Safety of vaccination, as measured by number of adverse events, local and systemic reactogenicity signs and symptoms, changes in electrocardiogram (ECG), cardiac troponin I levels, and differences in other safety laboratory measures

    Throughout study

Secondary Outcomes (3)

  • HIV-specific intracellular cytokine staining (ICS) assay and/or interferon-gamma ELISA responses

    At 2 weeks following the third and fourth injection

  • Vaccinia-specific neutralizing binding assays performed on serum samples from participants receiving the MVA vaccine

    At 2 weeks following the final vaccination

  • Self reports on social impact of participation in study

    Throughout study

Study Arms (3)

1

EXPERIMENTAL

Participants will receive one injection of DNA vaccine EP-1233 or placebo in each shoulder on Days 0 and 28 and one injection of MVA-mBN32 or placebo in each arm on Days 84 and 168

Biological: EP-1233Biological: MVA-mBN32

2

EXPERIMENTAL

Participants will receive one injection of DNA vaccine EP-1233 or placebo in each shoulder on Days 0, 28, 84, and 168

Biological: EP-1233

3

EXPERIMENTAL

Participants will receive one injection of MVA-mBN32 or placebo in each arm on Days 0, 28, 84, and 168

Biological: MVA-mBN32

Interventions

EP-1233BIOLOGICAL

DNA-HIV-recombinant vaccine

12
MVA-mBN32BIOLOGICAL

HIV-recombinant viral vaccine

13

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Good general health

You may not qualify if:

  • Previous receipt of smallpox vaccination
  • HIV-infected
  • Hepatitis B surface antigen positive
  • Participation in prior HIV vaccination trial
  • Immunosuppressive medications within 168 days prior to study entry
  • Receipt of blood products within 120 days of study entry
  • Receipt of live attenuated, medically indicated subunit, or killed (inactivated) vaccines within 30 days of study entry
  • Certain abnormal lab values
  • Pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

San Francisco Vaccine and Prevention CRS

San Francisco, California, 94102, United States

Location

Univ. of Rochester HVTN CRS

Rochester, New York, 14642, United States

Location

Vanderbilt Vaccine CRS

Nashville, Tennessee, 37232, United States

Location

Related Publications (4)

  • Dale CJ, Thomson S, De Rose R, Ranasinghe C, Medveczky CJ, Pamungkas J, Boyle DB, Ramshaw IA, Kent SJ. Prime-boost strategies in DNA vaccines. Methods Mol Med. 2006;127:171-97. doi: 10.1385/1-59745-168-1:171.

    PMID: 16988455BACKGROUND

  • Ostrowski MA, Yu Q, Yue FY, Liu J, Jones B, Gu XX, Loutfy M, Kovacs CM, Halpenny R. Why can't the immune system control HIV-1? Defining HIV-1-specific CD4+ T cell immunity in order to develop strategies to enhance viral immunity. Immunol Res. 2006;35(1-2):89-102. doi: 10.1385/IR:35:1:89.

    PMID: 17003512BACKGROUND

  • Rodriguez-Chavez IR, Allen M, Hill EL, Sheets RL, Pensiero M, Bradac JA, D'Souza MP. Current advances and challenges in HIV-1 vaccines. Curr HIV/AIDS Rep. 2006 Feb;3(1):39-47. doi: 10.1007/s11904-006-0007-0.

    PMID: 16522258BACKGROUND

  • Elizaga ML, Vasan S, Marovich MA, Sato AH, Lawrence DN, Chaitman BR, Frey SE, Keefer MC; MVA Cardiac Safety Working Group. Prospective surveillance for cardiac adverse events in healthy adults receiving modified vaccinia Ankara vaccines: a systematic review. PLoS One. 2013;8(1):e54407. doi: 10.1371/journal.pone.0054407. Epub 2013 Jan 17.

    PMID: 23349878DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Geoffrey Gorse

    Saint Louis University School of Medicine

    STUDY CHAIR

  • Christine Mhorag Hay

    University of Rochester

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2007

First Posted

January 30, 2007

Study Start

April 1, 2007

Study Completion

August 1, 2008

Last Updated

October 14, 2021

Record last verified: 2021-10

Locations

US(3)