Protocol #

Start Date

Sponsor , Funder, Developer

Trial Site(s)

Number of Participants

Vaccine(s)

Clade

PHASE III

RV 144

Oct-03

USMHRP, MoPH Thailand, Aventis, Vaxgen

Thailand

16,402

Prime: canarypox viral vector with env and gag-pol
Boost: Env protein (gp120 subunits)

B
 A/E

TEST-OF-CONCEPT

The two trials that follow, HVTN 503 and 502, stopped enrollment and immunizations, September 2007.
Follow-up and data collection continue. For more information visit: http://avac.org/pr_step_study.htm.

HVTN 503 (Phambili)

Feb-07

SAAVI, HVTN

South Africa

3,000

Adenovirus vector with gag, pol, nef

B

HVTN 502/ Merck 023 (Step study)

Dec-04

DAIDS, HVTN, Merck

US, Canada, Peru, Dominican Republic, Haiti, Puerto Rico, Australia, Brazil, Jamaica

801

Adenovirus vector with gag, pol, nef

B

PHASE II

HVTN 204

Sep-05

DAIDS, HVTN, VRC, Vical, GenVec

US, Brazil, South Africa, Haiti, Jamaica

480

Prime: DNA vaccine with gag, pol, nef + env
Boost: Adenovirus vector with gag, pol + env

A, B, C

PHASE I / II

EV 03/ANRS Vac20

June-07

European Commission, ANRS

UK, Germany, Switzerland, France

140

Prime: DNA vaccine with env plus gag, pol, nef
Boost: NYVAC-C

C

HIVIS 03

Dec-06

MUCHS, Karolinska Institute, SMI, Vecura, USMHRP

Tanzania

60

Prime: HIVIS DNA with env, gag, rev, RT
Boost: MVA-CMDR with env, gag, pol

A, B, C, A, E

RV 172

May-06

NIH, USMHRP, VRC

Kenya, Uganda, Tanzania

324

Prime: DNA vaccine with gag, pol, nef + env
Boost: Adenovirus vector with gag, pol + env

B
A, B, C

PHASE I

N/A

Dec-07

National Center for Disease Control and Prevention, the National Vaccine & Serum Institute, Peking Union Medical College Hospital

China

36

Replicating smallpox vector with HIV gene inserts

HVTN 070

Oct-07

NIAID, HVTN, UPenn/Wyeth

US

120

PENNVAX-B alone, in combination with IL-12, or with 2 different doses of IL-15

B

IAVI C004 / DHO-614

Oct-07

Rockefeller University, ADARC, Bill and Melinda Gates Foundation, Ichor Medical Systems, IAVI

US

40

ADVAX e/g + ADVAX p/n-t, by Ichor TriGrid™ in Vivo Electroporation

C

HVTN 072

Aug-07

NIAID, HVTN, VRC

US

17

DNA and Adenovirus 5 or 35 vectors, all with env in varying prime-boost combinations

A

HVTN 071
[As of Sept 07 enrollment and vaccinations have been discontinued]

Jul-07

NIAID, HVTN, Merck

US

35

Adenovirus 5, vector with gag, pol, nef

B

DVP-1
[Enrollment paused]

May-07

St. Jude’s Children’s Research Hospital

US

20

Prime-boost regimen with PolyEnv, EnvPro, EnvDNA

A, B, C
D, E

VRC 012

May-07

NIAID, VRC

US

35

HIV-1 adenovirus vector vaccine VRC-HIVADV027-00VP: dose escalation and prime-boost with an HIV-1 adenovirus vector vaccine, VRC-HIVADV038-00-VP

A

HVTN 067

Apr-07

NIAID, HVTN, Pharmexa-Epimmune, Bavarian Nordic

US

108

DNA Vaccine EP-1233 and Recombinant MVA-HIV Polytope Vaccine MVA-mBN32, Separately and in a Combined Prime-Boost Regimen

HVTN 069

Nov-06

NIAID, HVTN, VRC, NY Blood Center, IMPACTA

US, Peru

90

Prime: DNA vaccine with gag, pol, nef + env
Boost: Adenovirus 5 vector with gag, pol + env (intramuscularly, intradermally, subcutaneously)

A, B, C

HPTN 027

Oct-06

Makerere University, Johns Hopkins University, NIAID

Uganda

50

Canarypox viral vector with env and gag-pol

B

C86P1

Sep-06

SGUL, Richmond Pharmacology, Novartis Vaccines

UK

31

Prime: HIV gp140 with LTK63
Boost: HIV gp140 with MF59

B

VRC 011

Apr-06

NIAID, VRC

US

60

DNA vaccine with gag, pol, nef + env
or Adenovirus vector with gag, pol + env

A, B, C

HVTN 065

Apr-06

NIAID, HVTN, GeoVax

US

120

Prime: DNA plasmid with gag, pro, RT, env, tat, rev, vpu
Boost: MVA vector with gag, pol, env

B

HVRF-380- 131004

Mar-06

Moscow Institute of Immunology, Russian Federation Ministry of Education and Science

Russian Federation

15

VICHREPOL with polyoxidonium adjuvant

B

IAVI D001

Feb-06

IAVI, Therion

India

32

Modified vaccinia Ankara (MVA) viral vector with env, gag, tat-rev, nef-RT

C

HIVIS 02

Jan-06

Karolinska Institute, Swedish Institute for Infectious Disease Control, USMHRP

Sweden

38

Modified vaccinia Ankara (MVA) viral vector with env, gag, and pol to volunteers from HIVIS 01

A, E

RV 158

Nov-05

USMHRP, NIH

US, Thailand

48

Modified vaccinia Ankara (MVA) viral vector with gp160, gag and pol

A, E

HVTN 063

Sep-05

DAIDS, HVTN, Wyeth

US, Brazil

120

Prime: Genevax Gag-2692 +/- IL-15 DNA
Boost: Genevax Gag-2692 + IL-12 DNA or IL-15 DNA

B

HVTN 060

Aug-05

DAIDS, HVTN, Wyeth

US, Thailand

144

Prime: Genevax Gag-2692 +/- IL-12 DNA adjuvant
Boost: DNA plasmids with gag or RC529-SE and GM-CSF with env, gag, nef

B

EnvDNA

May-05

St. Jude’s Children’s Research Hospital

US

6

Recombinant HIV-1 multi-envelope DNA plasmid vaccine with env

A, B, C, D, E

VRC 008

Apr-05

NIAID, VRC

US

40

Prime: DNA vaccine with gag, pol, nef + env
Boost: Adenovirus vector with gag, pol + env

B
A, B, C

RV 156 A

Nov-04

NIAID, HVTN, VRC, USMHRP, Makerere U.

Uganda

30

VRC-HIVADV014-00-VP alone or as a boost to VRC-HIVDNA009-00-VP

A, B, C

HVTN 050/
Merck 018

Jan-04

NIAID, HVTN, Merck

Thailand, Brazil, Haiti, Puerto Rico, South Africa, US, Malawi, Peru

435

Adenovirus vector with gag

B

HVTN 049

Dec-03

DAIDS, HVTN, Chiron

US

96

Prime: DNA vaccine with gag, env attached to microparticles
Boost: Env protein (oligomeric gp140) + adjuvant (MF59)

B

EnvPro

Jun-03

St. Jude’s Children’s Research Hospital

US

9

Recombinant Purified HIV-1 Envelope Protein Vaccine

D

ADARC: Aaron Diamond AIDS Research Center
ANRS: Agence Nationale de Recherches sur le Sida (France)
DAIDS: Division of AIDS
EV: EuroVacc
HVTN: HIV Vaccine Trials Network
IAVI: International AIDS Vaccine Initiative
MoPH: Ministry of Public Health
MUCHS: Muhimbili University College of Health Sciences
NIAID: National Institute of Allergy and Infectious Diseases

NIH: National Institutes of Health
SAAVI: South African AIDS Vaccine Initiative
SGUL: St. George’s, University of London
SMI: Swedish Institute for Infectious Disease Control
UK MRC: United Kingdom Medical Research Council
USMHRP: United States Military HIV Research Program
VRC: Vaccine Research Center