STUDY NUMBER PROTOCOL DESCRIPTION AND
SPONSOR STATUS ACCRUAL INITIATED ACCRUAL COMPLETED Safety/immunogenicity of HIVAC-1e
recombinant vaccinia-env Bristol-Myers
Squibb/Oncogen in vaccinia-naive subjects; amended
to add booster dose of 640 µg VaxSyn
MicroGeneSys Chair: Graham; Sites: Vanderbilt,
Hopkins, Rochester, Saint Louis, Washington 11/88 1/92 Safety/immunogenicity of combination:
640 µg VaxSyn and HIVAC-1e in prior vaccinia
recipients Chair: Corey; Sites: Washington,
Saint Louis, Vanderbilt 3/91 9/91 Continued study of safety/immunogenicity
of HIVAC-1e plus VaxSyn (160 µg) volunteers
originally entered U. Washington Chair: Corey; Sites:
Washington 6/91 7/91 Safety/immunogenicity of VaxSyn 40 and
80 µg doses
MicroGeneSys Chair: Dolin; Sites: Rochester,
Baylor, Hopkins, Maryland, Saint Louis,
Vanderbilt 2/88 5/88 Safety/immunogenicity of VaxSyn
160 µg dose Chair: Dolin; Sites: Rochester,
Hopkins, Saint Louis, Vanderbilt, Washington 5/90 10/90 Safety/immunogenicity of VaxSyn
640 µg dose Chair: Dolin; Sites: Rochester,
Hopkins, Saint Louis, Vanderbilt, Washington 10/90 3/91 Safety/immunogenicity of 12.5 and
50 µg doses rgp160 vaccinia/vero cell-derived
IMMUNO-AG Chair: Belshe; Sites: Saint Louis,
Hopkins, Rochester, Vanderbilt, Washington 12/90 7/91 Safety/immunogenicity of 200 µg
dose rgp160 IMMUNO-AG, IIIB
strain Chair: Belshe; Sites: Saint Louis,
Hopkins, Rochester, Washington, Vanderbilt 7/92 10/92 Safety/immunogenicity of accelerated
schedules of rgp160 IMMUNO-AG Chair: Belshe; Sites: Saint Louis,
Hopkins, Vanderbilt 12/91 3/92 005: Two-part evaluation of
BIOCINE
Product: Safety of MTP-PE/MF59 adjuvant
emulsion Chair: Dolin; Sites:
Rochester 1/91 2/91 Safety/immunogenicity of 30 µg
ENV 2-3 in combination with MTP-PE/MF59 Chair: Dolin; Sites: Rochester,
Vanderbilt, Washington 3/91 10/91 Safety/immunogenicity of 100 µg
ENV 2-3 in combination with MF59 Chair: Dolin; Sites: Rochester,
Vanderbilt, Washington 10/91 11/91 Safety/immunogenicity of
Genentech
rgp120/HIV-1IIIB Chair: Clements-Mann; Sites: Hopkins,
Saint Louis 3/91 6/91 007: Three-part evaluation of
BIOCINE
Product: Safety/immunogenicity of SF-2 gp120
protein (CHO) with/without MTP-PE adjuvant in MF59
emulsion Chair: Graham; Sites: Vanderbilt,
Rochester, Washington 12/91 3/92 Safety/immunogenicity of five monthly
doses gp120 protein in MF59 Chair: Graham; Sites: Hopkins, Saint
Louis 2/92 3/92 Safety/immunogenicity of 200 µg
gp120 (CHO) with MF59 emulsion Chair: Graham; Sites: Vanderbilt,
Rochester, Washington 11/92 12/92 Safety/immunogenicity of HIVAC-1e
Bristol-Myers Squibb/Oncogen in combination
with a panel of recombinant HIV envelope vaccines in
non-vaccinia-naive subjects Chair: Corey; Sites: Washington,
Hopkins, Rochester, Saint Louis, Vanderbilt 7/92 1/93 Safety/immunogenicity of
Genentech MN rgp120/HIV-1 vaccine alone or
in combination with IIIB rgp120/HIV-1 Chair: Belshe; Sites: Saint Louis,
Rochester, Vanderbilt 3/92 7/92 Safety/immunogenicity of HIVAC-1e
Bristol-Myers Squibb/Oncogen in combination
with a panel of subunit recombinant vaccines in
vaccinia-negative subjects Chair: McElrath; Sites: Washington,
Hopkins, Rochester, Saint Louis, Vanderbilt 7/92 6/93 Safety/immunogenicity of United
Biomedical, Inc. SynVac HIV-1 octameric V3 peptide
vaccine Chair: Gorse; Sites: Saint Louis,
Rochester 2/93 6/93 Safety/immunogenicity of Pasteur
Merieux Connaught live recombinant canarypox-gp160
MN ALVAC vCP125 with Chiron/BIOCINE HIV-1
SF-2 rgp120 (CHO) Chair: Clements-Mann; Sites: Hopkins,
Rochester, Saint Louis, Vanderbilt,
Washington 5/93 8/93 Safety/immunogenicity of Pasteur
Merieux Connaught live recombinant canarypox-gp160
MN ALVAC vCP125 with Chiron/BIOCINE HIV-1
SF-2 rgp120 (CHO) Chair: Clements-Mann; Sites: Hopkins,
Rochester, Saint Louis, Vanderbilt,
Washington 10/93 6/94 Safety/immunogenicity of
IMMUNO-AG vaccinia/vero cell-derived HIV-1
MN recombinant envelope glycoprotein (rgp160) Chair: Gorse; Sites: Saint Louis,
Washington 4/93 7/93 Safety/immunogenicity of
IMMUNO-AG vaccinia/vero cell-derived HIV-1
MN recombinant envelope glycoprotein (rgp160) Chair: Gorse; Sites: Saint Louis,
Washington 11/95 3/95 Safety/immunogenicity of Therion
Biologics recombinant vaccinia HIV-1 IIIB
env/gag/pol vaccine (TBC-3B) Chair: Keefer; Sites: Rochester,
Saint Louis, Vanderbilt, Washington 4/94 7/94 Safety/immunogenicity of Therion
Biologics recombinant vaccinia HIV-1 IIIB
env/gag/pol vaccine (TBC-3B) and MN rgp120/HIV-1 in
combination with alum (VaxGen) Chair: Keefer; Sites: Rochester,
Alabama, Hopkins, Saint Louis, Vanderbilt,
Washington 4/97 1/98 Safety/immunogenicity of SF-2 rgp120
BIOCINE individually combined with seven
adjuvants Chair: McElrath; Sites: Washington,
Rochester, Saint Louis, Vanderbilt 6/93 10/93 Safety/immunogenicity of
Genentech MN rgp120 in combination with
QS21 adjuvant and/or alum Chair: McElrath; Sites: Washington,
Hopkins, Rochester, Saint Louis, Vanderbilt 6/93 11/93 Safety/immunogenicity of
Genentech MN rgp120 in combination with
QS21 adjuvant and/or alum Chair: McElrath; Sites: Washington,
Hopkins, Rochester, Saint Louis, Vanderbilt 6/94 3/95 Safety/immunogenicity of
Genentech low dose MN rsgp120 in
combination with QS21 adjuvant or alum Chairs: Evans/McElrath; Sites:
Alabama, Rochester, Saint Louis, Washington 11/96 7/97 Safety/immunogenicity of United
Biomedical, Inc. multivalent HIV-1 octameric V3
peptide immunogens Chair: Keefer; Sites: Rochester,
Hopkins 2/94 7/94 Safety/immunogenicity of United
Biomedical, Inc. microparticulate monovalent HIV-1
MN V3 peptide immunogen Chair: Lambert; Sites: Hopkins,
Alabama, Rochester 6/94 1/95 Safety/immunogenicity of British
Biotech PLC p17/p24:Ty VLP Chair: Spearman/Graham; Sites:
Vanderbilt, Alabama, Rochester, Washington 5/95 9/95 Safety/immunogenicity of
Wyeth-Lederle Vaccines and Pediatrics gp120
C4-V3 hybrid polyvalent peptide immunogen mixed in mineral
oil containing mannose mono-oleate (IFA) Chair: Graham; Sites: Vanderbilt,
Rochester, Washington 10/97 3/98 Safety/immunogenicity of United
Biomedical, Inc. prototype HIV synthetic gag
lipopeptide vaccine component, P3C541b Chair: Schwartz; Sites: Hopkins,
Vanderbilt, Washington 1/95 9/95 Safety/immunogenicity of Pasteur
Merieux Connaught live recombinant canarypox HIV
gp120, TM gp41, gag, protease, ALVAC-HIV vCP205, and
Chiron Vaccines HIV-1 SF-2 rgp120
(CHO) Chair: Corey; Sites: Washington,
Alabama, Hopkins, Rochester, Saint Louis,
Vanderbilt 5/95 11/95 Safety/immunogenicity of Pasteur
Merieux Connaught live recombinant canarypox
ALVAC-HIV (vCP205) [higher dosage than Protocol 022]
and Chiron Vaccines HIV-1 SF-2 rgp120
(CHO) Chair: Corey; Sites: Washington,
Alabama, Hopkins, Rochester, Saint Louis,
Vanderbilt 7/96 5/97 Safety/immunogenicity of parenteral
priming with UBI® HIV-1 MN octameric V3
peptide immunogen followed by oral boosting with
microparticulate monovalent HIV-1 MN octameric peptide
vaccine United Biomedical, Inc. Chair: Mulligan; Sites: Alabama,
Rochester, Washington 5/95 2/96 Safety/immunogenicity of Chiron
Vaccines recombinant envelope protein, HIV-1 SF-2
rgp120 combined with MF59 Chair: Corey; Sites: Washington,
Alabama, Hopkins, Rochester, Saint Louis,
Vanderbilt 9/95 1/96 Safety/immunogenicity of Pasteur
Merieux Connaught live recombinant canarypox HIV
gp120, TM gp41, gag, protease, other pol and nef epitopes,
ALVAC vCP300, and Chiron Vaccines SF-2
rgp120 (CHO) Chair: Keefer/Evans; Sites:
Rochester, Alabama, Hopkins, Saint Louis, Vanderbilt,
Washington 2/96 1/97 Safety/immunogenicity of Pasteur
Merieux Connaught live recombinant canarypox
ALVAC-HIV vCP205 delivered by alternative mucosal
routes Chair: Wright; Sites: Vanderbilt,
Alabama, Hopkins, Rochester, Saint Louis,
Washington 11/97 10/98 Safety/immunogenicity of
University of Maryland Center for Vaccine
Development orally administered live attenuated
recombinant S. typhi CVD 908 asd(pW57-asd+)
expressing LAI gp120 (VVG 203) and parenterally
administered VaxGen MN rgp120 in
alum Chair: Schwartz; Site:
Hopkins 12/97 5/99 Safety/immunogenicity of live recombinant
canarypox-HIV, ALVAC vCP205 Pasteur Merieux
Connaught and HIV-1 SF-2 rgp120 (CHO)
Chiron Vaccines to evaluate accelerated
vaccine schedules Chair: Belshe; Sites: Rochester,
Alabama, Saint Louis 7/96 12/96 Safety/immunogenicity of facilitated
Apollon HIV-1 env/gag/pol DNA vaccine
(APL-400-047) given intramuscularly by needle and syringe or
Bioject 2000® needle-free jet injection
system Chair: Mulligan; Sites: Alabama,
Rochester, Vanderbilt, Washington Part I: 7/97 Part II: 11/98 11/97 2/99 Evaluate the Chiron HIV-1 SF-2
recombinant p24 subunit vaccine administered as a novel
boost in "prime-boost" vaccination regimens with Pasteur
Merieux Connaught ALVAC-HIV vCP205 and Chiron
HIV-1 SF-2 rgp120 in MF59 Chair: Mulligan; Sites: Alabama,
Hopkins, Rochester, Saint Louis, Vanderbilt,
Washington 8/99 9/99 Safety/immunogenicity of Pasteur
Merieux Connaught live recombinant canarypox
ALVAC-HIV vCP205 combined with Immunex
GM-CSF Chair: Evans; Sites: Rochester,
Alabama, Hopkins, Vanderbilt 1/98 6/98 Safety/immunogenicity of Pasteur
Merieux Connaught live recombinant canarypox ALVAC-HIV
vaccines, vCP205, vCP1433 and vCP1452, alone and combined
with rgp160 MN/LAI-2 in PCPP Chair: Schwartz; Sites: Hopkins,
Alabama, Rochester, Saint Louis, Vanderbilt,
Washington Safety/immunogenicity of three live
recombinant canarypox ALVAC-HIV vaccines vCP205, vCP1433 and
vCP1452 Chair: Schwartz; Sites: Hopkins,
Alabama, Rochester, Saint Louis, Vanderbilt, Washington
11/99 Safety/immunogenicity of VaxGen
low dose MN rsgp 120 in combination with QS21 adjuvant and
low dose bivalent AIDSVAX TM B/E and MN rgp 120
in combination with QS21 and alum. Chair: Evans; Sites:
Rochester,Hopkins, Alabama, Saint Louis, Vanderbilt,
Washington Phase I trial to evaluate the memory
responses to a single boosting vaccination with Aventis
Pasteur ALVAC-HIV vCP205 in volunteers who have
previously received poxvirus-based vaccines Chair: Evans; Sites: Rochester,
Hopkins, Alabama, Saint Louis, Vanderbilt,
Washington 3/00 In progress Safety/immunogenicity of
IMMUNO-AG HIV-1 IIIB rgp160 in asymptomatic
HIV seropositive subjects Chair: Schwartz; Sites: Hopkins,
Saint Louis, Vanderbilt 6/92 2/93 Safety/immunogenicity of recombinant
envelope vaccine VaxSyn MicroGeneSys in
HIV-1 infected pregnant women Chairs: Graham/Lambert/Wright; Site:
Yale (ACTG site); AVEG Clinical Coordination:
Vanderbilt 5/93 3/94 103: Three-part evaluation of
BIOCINE Product:
Safety/immunogenicity of ENV 2-3 in combination with
MF59/MTP-PE in asymptomatic HIV seropositive
individuals Pilot Study: ENV 2-3 30 µg +
MTP-PE adjuvant with/without MF59 emulsion Chair: Corey; Sites: Washington,
Rochester 1/92 1/92 ENV 2-3 0 and 30 µg + MTP-PE
adjuvant 0 and 100 µg with/without MF59
emulsion Chair: Corey; Sites: Washington,
Rochester 3/92 9/92 ENV 2-3 0 and 30 µg + MTP-PE
adjuvant 100 µg with MF59 emulsion Chair: Corey; Sites: Washington,
Rochester 4/92 7/92 Safety/immunogenicity of HIV-1 MN rgp120
Genentech in HIV-1 infected pregnant
women Chairs: Lambert/Wright; Sites:
Hopkins, Rochester, Saint Louis, Vanderbilt, Washington,
UCSF (ACTG site) 5/93 1/95 Phase II safety/immunogenicity of
recombinant subunit HIV-1 envelope vaccines
BIOCINE rgp120 (CHO) in MF59
adjuvant and Genentech MN rgp120
in alum adjuvant Chairs: Corey/McElrath; Sites:
Washington, Hopkins, Rochester, Saint Louis,
Vanderbilt 12/92 12/93 Phase II safety/immunogenicity trial of
live recombinant canarypox-HIV ALVAC vCP205 Pasteur
Merieux Connaught with or without HIV-1 SF-2 rgp120
Chiron Vaccines Chairs: Belshe/Gorse; Sites: Saint
Louis, Alabama, Hopkins, Rochester, Vanderbilt, Washington
(also includes domestic HIVNET sites) 5/97 1/98 Evaluation of acute primary HIV-1
infection in participants in AVEG HIV-1 Phase I and II
vaccine trials to study emergent viral strains, strain
variation, viral load, immunological responses and natural
history of disease Chairs: Graham/McElrath; Sites:
Alabama, Hopkins, Rochester, Saint Louis, Vanderbilt,
Washington 7/94 8/95 Evaluation of virologic, immunologic, and
clinical parameters of participants in Phase I and II HIV-1
vaccine trials who develop HIV-1 infection subsequent to
enrollment in a trial Chairs: Graham/McElrath; Sites:
Alabama, Hopkins, Rochester, Saint Louis, Vanderbilt,
Washington 6/97 In progress
STUDY CHAIR; VEU PARTICIPANTS