NCT00574600

Brief Summary

The purpose of this study is to evaluate the safety of and immune response to an experimental DNA HIV vaccine followed by boosting with an experimental modified vaccinia HIV vaccine (MVA) in HIV uninfected adults.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 hiv-infections

Timeline
Completed

Started Nov 2008

Longer than P75 for phase_1 hiv-infections

Geographic Reach
2 countries

4 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

December 13, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2007

Completed
11 months until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

October 14, 2021

Status Verified

October 1, 2021

Enrollment Period

1.9 years

First QC Date

December 13, 2007

Last Update Submit

October 13, 2021

Conditions

HIV Infections

Keywords

HIV SeronegativityHIV Preventive Vaccine

Outcome Measures

Primary Outcomes (1)

  • Signs and symptoms of local and systemic reactogenicity, laboratory measures of safety, and adverse events

    Measured throughout study

Secondary Outcomes (2)

  • T-cell responses as detected by HIV-1 specific interferon-gamma/interleukin-2 intracellular cytokine staining

    Measured 2 weeks following the fourth and fifth vaccinations

  • HIV-1-specific neutralizing and binding antibody assays

    Measured 2 weeks following the fourth and fifth vaccinations

Study Arms (2)

Vaccine

EXPERIMENTAL

SAAVI DNA-C2 administered as 1 ml intramuscularly in either deltoid at study entry and Months 1 and 2; SAAVI MVA-C administered as 0.5 ml intramuscularly in either deltoid at Months 4 and 5

Biological: SAAVI DNA-C2 vaccineBiological: SAAVI MVA-C vaccine

Placebo

PLACEBO COMPARATOR

Placebo administered at Months 0, 1, 2, 4 and 5

Biological: Placebo

Interventions

SAAVI DNA-C2 vaccineBIOLOGICAL

DNA vaccine

Vaccine
SAAVI MVA-C vaccineBIOLOGICAL

Boost vaccine

Vaccine
PlaceboBIOLOGICAL

Placebo vaccine

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Laboratory test results within specified ranges \[complete blood count, chemistries, cardiac troponin T, urinalysis\]
  • Good general health
  • HIV-1 and -2 uninfected
  • Have access to a participating HIV Vaccine Trials Unit (HVTU) and willing to be followed for the duration of the study
  • Willing to receive HIV test results
  • Negative hepatitis B surface antigen
  • Negative hepatitis C virus (HCV) antibodies OR negative HCV PCR if anti-HCV test is positive
  • Willing to use acceptable forms of contraception from at least 21 days prior to enrollment through the duration of the study

You may not qualify if:

  • History of vaccination against smallpox
  • HIV vaccines in prior HIV vaccine trial
  • Immunosuppressive medications within 168 days prior to first study vaccination
  • Blood products within 120 days prior to first study vaccination
  • Immunoglobulin within 60 days prior to first study vaccination
  • Live attenuated vaccines within 30 days prior to first study vaccination or scheduled within 14 days after other vaccination (e.g., measles, mumps, and rubella \[MMR\]; oral polio vaccine \[OPV\]; varicella; yellow fever; influenza vaccine in nasal form)
  • Investigational research agents within 30 days prior to first study vaccination
  • Any vaccines that are not live attenuated vaccines within 14 days prior to first study vaccination
  • Allergy treatment with antigen injections within 30 days prior to first vaccination or scheduled within 14 days after vaccination
  • Received investigational research agents within 30 days prior to first vaccination
  • Current tuberculosis (TB) prophylaxis or therapy
  • Recreational cocaine or methamphetamine use within the last 12 months prior to first study vaccination
  • Clinically significant medical condition, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect current health. More information about this criterion can be found in the protocol.
  • Any medical, psychiatric, social, or job-related condition that would interfere with the study
  • Serious adverse reaction to vaccines. Participants who have had an adverse reaction to pertussis vaccine as a child are not excluded.
  • +20 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Brigham and Women's Hospital Vaccine CRS (BWH VCRS)

Boston, Massachusetts, 02115-6110, United States

Location

Fenway Health (FH) CRS

Boston, Massachusetts, 02215-4302, United States

Location

Soweto HVTN CRS

Johannesburg, Gauteng, 1862, South Africa

Location

Emavundleni CRS

Cape Town, Western Cape, 7750, South Africa

Location

Related Publications (4)

  • Hanke T, McMichael AJ, Dorrell L. Clinical experience with plasmid DNA- and modified vaccinia virus Ankara-vectored human immunodeficiency virus type 1 clade A vaccine focusing on T-cell induction. J Gen Virol. 2007 Jan;88(Pt 1):1-12. doi: 10.1099/vir.0.82493-0.

    PMID: 17170430BACKGROUND

  • Verrier F, Burda S, Belshe R, Duliege AM, Excler JL, Klein M, Zolla-Pazner S. A human immunodeficiency virus prime-boost immunization regimen in humans induces antibodies that show interclade cross-reactivity and neutralize several X4-, R5-, and dualtropic clade B and C primary isolates. J Virol. 2000 Nov;74(21):10025-33. doi: 10.1128/jvi.74.21.10025-10033.2000.

    PMID: 11024131BACKGROUND

  • Williamson C, Morris L, Maughan MF, Ping LH, Dryga SA, Thomas R, Reap EA, Cilliers T, van Harmelen J, Pascual A, Ramjee G, Gray G, Johnston R, Karim SA, Swanstrom R. Characterization and selection of HIV-1 subtype C isolates for use in vaccine development. AIDS Res Hum Retroviruses. 2003 Feb;19(2):133-44. doi: 10.1089/088922203762688649.

    PMID: 12639249BACKGROUND

  • Gray GE, Mayer KH, Elizaga ML, Bekker LG, Allen M, Morris L, Montefiori D, De Rosa SC, Sato A, Gu N, Tomaras GD, Tucker T, Barnett SW, Mkhize NN, Shen X, Downing K, Williamson C, Pensiero M, Corey L, Williamson AL. Subtype C gp140 Vaccine Boosts Immune Responses Primed by the South African AIDS Vaccine Initiative DNA-C2 and MVA-C HIV Vaccines after More than a 2-Year Gap. Clin Vaccine Immunol. 2016 Jun 6;23(6):496-506. doi: 10.1128/CVI.00717-15. Print 2016 Jun.

    PMID: 27098021DERIVED

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

  • Glenda Gray

    University of the Witswatersrand

    STUDY CHAIR

  • Kenneth Mayer

    Fenway Community Health

    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

December 13, 2007

First Posted

December 17, 2007

Study Start

November 1, 2008

Primary Completion

October 1, 2010

Study Completion

January 1, 2013

Last Updated

October 14, 2021

Record last verified: 2021-10

Locations

ZA(2)US(2)