NCT00083603

Brief Summary

The purpose of this study is to evaluate the safety of and immune response to two HIV vaccine formulations, rMVA-HIV and rFPV-HIV, alone and in combination, in HIV uninfected adults.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for phase_1 hiv-infections

Timeline
Completed

Started Sep 2004

Typical duration for phase_1 hiv-infections

Geographic Reach
2 countries

6 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

May 26, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 27, 2004

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2004

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

October 14, 2021

Status Verified

October 1, 2021

First QC Date

May 26, 2004

Last Update Submit

October 13, 2021

Conditions

HIV Infections

Keywords

HIV SeronegativityHIV Preventive VaccineVaccinia vectorPox vector

Outcome Measures

Primary Outcomes (2)

  • Safety and tolerability, as judged by local and systemic reactogenicity signs and symptoms, laboratory measures, and adverse events

    After each injection and 12 months after the first injection

  • Immunogenicity, as judged by qualitative HIV-1-specific T-cell responses

    At Days 98 and 210

Study Arms (16)

1

EXPERIMENTAL

rFPV-HIV vaccine administered as two separate 1-mL intramuscular injections, with rFPV-HIV env/gag into the left deltoid, rFPV-HIV tat/rev/nef-RT into the right deltoid at Days 0, 28, 84, 140, and 196

Biological: rFPV-HIV (rFPV-HIV env/gag + rFPV-HIV tat/rev/nef-RT)

2

PLACEBO COMPARATOR

Empty TBC-FPV vector administered as two separate 1-mL intramuscular injections, one into each deltoid at Days 0, 28, 84, 140, and 196

Biological: Empty TBC-FPV

3

EXPERIMENTAL

rMVA-HIV env/gag and rMVA-HIV tat/rev/nef-RT administered as two separate 1-mL intramuscular injections, with rMVA-HIV env/gag into the left deltoid, rMVA-HIV tat/rev/nef-RT into the right deltoid at Days 0, 28; rFPV-HIV env/gag and rFPV-HIV tat/rev/nef-RT administered as two separate 1-mL intramuscular injections, with rFPV-HIV env/gag into the left deltoid, rFPV-HIV tat/rev/nef-RT into the right deltoid at Days 84, 140, and 196

Biological: rMVA-HIV (rMVA-HIV env/gag + rMVA-HIV tat/rev/nef-RT)Biological: rFPV-HIV (rFPV-HIV env/gag + rFPV-HIV tat/rev/nef-RT)

4

PLACEBO COMPARATOR

Empty TBC-MVA vector administered in each deltoid on Days 0, 28; empty TBC-FPV vector administered in each deltoid on Days 84, 140, and 196

Biological: Empty TBC-FPVBiological: TBC-MVA and TBC-FPV

5

EXPERIMENTAL

rMVA-HIV env/gag and rMVA-HIV tat/rev/nef-RT administered as two separate 1-mL intramuscular injections, with rMVA-HIV env/gag into the left deltoid, rMVA-HIV tat/rev/nef-RT into the right deltoid at Days 0, 28; rFPV-HIV env/gag and rFPV-HIV tat/rev/nef-RT administered as two separate 1-mL intramuscular injections, with rFPV-HIV env/gag into the left deltoid, rFPV-HIV tat/rev/nef-RT into the right deltoid at Days 84, 140, and 196

Biological: rFPV-HIV (rFPV-HIV env/gag + rFPV-HIV tat/rev/nef-RT)Biological: rMVA-HIV (rMVA-HIV env/gag + rMVA-HIV tat/rev/nef-RT)

6

PLACEBO COMPARATOR

Empty TBC-MVA vector administered in each deltoid Days 0, 28; empty TBC-FPV vector administered in each deltoid Days 84, 140, and 196

Biological: Empty TBC-FPVBiological: TBC-MVA and TBC-FPV

7

EXPERIMENTAL

rMVA-HIV env/gag and rMVA-HIV tat/rev/nef-RT administered as two separate 1-mL intramuscular injections, with rMVA-HIV env/gag into the left deltoid, rMVA-HIV tat/rev/nef-RT into the right deltoid at Days 0, 28; rFPV-HIV env/gag and rFPV-HIV tat/rev/nef-RT administered as two separate 1-mL intramuscular injections, with rFPV-HIV env/gag into the left deltoid, rFPV-HIV tat/rev/nef-RT into the right deltoid at Days 84, 140, and 196

Biological: rFPV-HIV (rFPV-HIV env/gag + rFPV-HIV tat/rev/nef-RT)Biological: rMVA-HIV (rMVA-HIV env/gag + rMVA-HIV tat/rev/nef-RT)

8

PLACEBO COMPARATOR

Empty TBC-MVA vector administered in each deltoid Days 0, 28; empty TBC-FPV vector administered in each deltoid Days 84, 140, and 196

Biological: Empty TBC-FPVBiological: TBC-MVA and TBC-FPV

9

EXPERIMENTAL

rMVA-HIV env/gag and rMVA-HIV tat/rev/nef-RT administered as two separate 1-mL intramuscular injections, with rMVA-HIV env/gag into the left deltoid, rMVA-HIV tat/rev/nef-RT into the right deltoid at Days 0, 28, 84, 140, 196

Biological: rMVA-HIV (rMVA-HIV env/gag + rMVA-HIV tat/rev/nef-RT)

10

PLACEBO COMPARATOR

Empty TBC-MVA vector administered in each deltoid Days 0, 28, 84, 140, 196

Biological: TBC-MVA and TBC-FPV

11

EXPERIMENTAL

rFPV-HIV vaccine administered as two separate 1-mL intramuscular injections, with rFPV-HIV env/gag into the left deltoid, rFPV-HIV tat/rev/nef-RT into the right deltoid at Days 0, 28, 84, 140, and 196

Biological: rFPV-HIV (rFPV-HIV env/gag + rFPV-HIV tat/rev/nef-RT)

12

PLACEBO COMPARATOR

Empty TBC-FPV vector administered as two separate 1-mL intramuscular injections, one into each deltoid at Days 0, 28, 84, 140, and 196

Biological: Empty TBC-FPV

13

EXPERIMENTAL

rMVA-HIV env/gag and rMVA-HIV tat/rev/nef-RT administered as two separate 1-mL intramuscular injections, with rMVA-HIV env/gag into the left deltoid, rMVA-HIV tat/rev/nef-RT into the right deltoid at Days 0, 28; rFPV-HIV env/gag and rFPV-HIV tat/rev/nef-RT administered as two separate 1-mL intramuscular injections, with rFPV-HIV env/gag into the left deltoid, rFPV-HIV tat/rev/nef-RT into the right deltoid at Days 84, 140, and 196

Biological: rFPV-HIV (rFPV-HIV env/gag + rFPV-HIV tat/rev/nef-RT)Biological: rMVA-HIV (rMVA-HIV env/gag + rMVA-HIV tat/rev/nef-RT)

14

PLACEBO COMPARATOR

Empty TBC-MVA vector administered in each deltoid Days 0, 28; empty TBC-FPV vector administered in each deltoid Days 84, 140, and 196

Biological: Empty TBC-FPVBiological: TBC-MVA and TBC-FPV

15

EXPERIMENTAL

rMVA-HIV env/gag and rMVA-HIV tat/rev/nef-RT administered as two separate 1-mL intramuscular injections, with rMVA-HIV env/gag into the left deltoid, rMVA-HIV tat/rev/nef-RT into the right deltoid at Days 0, 28, 84, 140, 196

Biological: rMVA-HIV (rMVA-HIV env/gag + rMVA-HIV tat/rev/nef-RT)

16

PLACEBO COMPARATOR

Empty TBC-MVA vector administered in each deltoid Days 0, 28, 84, 140, 196

Biological: TBC-MVA and TBC-FPV

Interventions

rMVA-HIV (rMVA-HIV env/gag + rMVA-HIV tat/rev/nef-RT)BIOLOGICAL

rMVA 10\^7 pfu /2mL administered in each deltoid

3
rFPV-HIV (rFPV-HIV env/gag + rFPV-HIV tat/rev/nef-RT)BIOLOGICAL

Vaccines administered as two separate 1-mL intramuscular injections, with rFPV-HIV env/gag into the left deltoid, rFPV-HIV tat/rev/nef-RT into the right deltoid

11113357
Empty TBC-FPVBIOLOGICAL

Empty FPV 10\^9 pfu/2mL administered as two separate 1 mL intramuscular injections, one into each deltoid.

12142468
TBC-MVA and TBC-FPVBIOLOGICAL

Empty MVA 10\^7 pfu/2mL administered into each deltoid

4

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • HIV uninfected within 8 weeks prior to first vaccination
  • Blood pressure 140/90 or less upon enrollment
  • Good general health
  • Willing to receive HIV test results
  • Understand the vaccination procedure
  • Negative for hepatitis B surface antigen
  • Negative for anti-hepatitis C virus antibodies (anti-HCV) or negative for HCV PCR if anti-HCV is positive
  • Willing to use acceptable forms of contraception
  • Willing to be followed for the duration of the study
  • Have access to a participating HIV vaccine trial site

You may not qualify if:

  • HIV vaccines or placebos in prior HIV vaccine trial
  • Previously received Avipox vaccine
  • Previously received Vaccinia vaccine
  • 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
  • Hypersensitivity to egg products
  • Past or present cardiac disease
  • Two or more of the following cardiac risk factors: history of fasting LDL greater than 160 mg/dl; first degree relative who had heart condition, excluding hypertension; cigarette smoking
  • ECG with clinically significant findings (e.g., conduction disturbance, repolarization abnormality, significant atrial or ventricular arrhythmia, frequent atrial or ventricular ectopy, ST elevation consistent with ischemia, evidence of past or evolving myocardial infarction)
  • Serious adverse reaction to vaccines. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Alabama Vaccine CRS

Birmingham, Alabama, 35294-2041, United States

Location

Saint Louis Univ. School of Medicine, HVTU

St Louis, Missouri, 63110-2500, United States

Location

Univ. of Rochester HVTN CRS

Rochester, New York, 14642, United States

Location

FHCRC/UW Vaccine CRS

Seattle, Washington, 98104, United States

Location

Projeto Praça Onze/Hesfa Crs

Rio de Janeiro, Brazil

Location

Sao Paulo HVTU - CRT DST/AIDS CRS

São Paulo, Brazil

Location

Related Publications (9)

  • Amara RR, Villinger F, Altman JD, Lydy SL, O'Neil SP, Staprans SI, Montefiori DC, Xu Y, Herndon JG, Wyatt LS, Candido MA, Kozyr NL, Earl PL, Smith JM, Ma HL, Grimm BD, Hulsey ML, Miller J, McClure HM, McNicholl JM, Moss B, Robinson HL. Control of a mucosal challenge and prevention of AIDS by a multiprotein DNA/MVA vaccine. Science. 2001 Apr 6;292(5514):69-74. doi: 10.1126/science.1058915.

    PMID: 11393868BACKGROUND

  • Blanchard TJ, Alcami A, Andrea P, Smith GL. Modified vaccinia virus Ankara undergoes limited replication in human cells and lacks several immunomodulatory proteins: implications for use as a human vaccine. J Gen Virol. 1998 May;79 ( Pt 5):1159-67. doi: 10.1099/0022-1317-79-5-1159.

    PMID: 9603331BACKGROUND

  • Hanke T, McMichael AJ, Mwau M, Wee EG, Ceberej I, Patel S, Sutton J, Tomlinson M, Samuel RV. Development of a DNA-MVA/HIVA vaccine for Kenya. Vaccine. 2002 May 6;20(15):1995-8. doi: 10.1016/s0264-410x(02)00085-3.

    PMID: 11983261BACKGROUND

  • Kent SJ, Zhao A, Best SJ, Chandler JD, Boyle DB, Ramshaw IA. Enhanced T-cell immunogenicity and protective efficacy of a human immunodeficiency virus type 1 vaccine regimen consisting of consecutive priming with DNA and boosting with recombinant fowlpox virus. J Virol. 1998 Dec;72(12):10180-8. doi: 10.1128/JVI.72.12.10180-10188.1998.

    PMID: 9811759BACKGROUND

  • Stratov I, DeRose R, Purcell DF, Kent SJ. Vaccines and vaccine strategies against HIV. Curr Drug Targets. 2004 Jan;5(1):71-88. doi: 10.2174/1389450043490686.

    PMID: 14738219BACKGROUND

  • Ramjee G, Kapiga S, Weiss S, Peterson L, Leburg C, Kelly C, Masse B; HPTN 055 Study Team. The value of site preparedness studies for future implementation of phase 2/IIb/III HIV prevention trials: experience from the HPTN 055 study. J Acquir Immune Defic Syndr. 2008 Jan 1;47(1):93-100. doi: 10.1097/QAI.0b013e31815c71f7.

    PMID: 17984760RESULT

  • 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

  • Walsh SR, Seaman MS, Grandpre LE, Charbonneau C, Yanosick KE, Metch B, Keefer MC, Dolin R, Baden LR. Impact of anti-orthopoxvirus neutralizing antibodies induced by a heterologous prime-boost HIV-1 vaccine on insert-specific immune responses. Vaccine. 2012 Dec 17;31(1):114-9. doi: 10.1016/j.vaccine.2012.10.093. Epub 2012 Nov 7.

    PMID: 23142302DERIVED

  • Keefer MC, Frey SE, Elizaga M, Metch B, De Rosa SC, Barroso PF, Tomaras G, Cardinali M, Goepfert P, Kalichman A, Philippon V, McElrath MJ, Jin X, Ferrari G, Defawe OD, Mazzara GP, Montefiori D, Pensiero M, Panicali DL, Corey L; NIAID HIV Vaccine Trials Network. A phase I trial of preventive HIV vaccination with heterologous poxviral-vectors containing matching HIV-1 inserts in healthy HIV-uninfected subjects. Vaccine. 2011 Feb 24;29(10):1948-58. doi: 10.1016/j.vaccine.2010.12.104. Epub 2011 Jan 7.

    PMID: 21216311DERIVED

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

  • Michael Keefer, MD

    University of Rochester

    STUDY CHAIR

  • Sharon Frey, MD

    St. Louis University School of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2004

First Posted

May 27, 2004

Study Start

September 1, 2004

Study Completion

August 1, 2007

Last Updated

October 14, 2021

Record last verified: 2021-10

Locations

US(4)BR(2)