Ongoing Trials of Preventive HIV Vaccines
Last updated: September 27, 2007
| Trial No. |
Sponsor Manufacturer |
Start Date | Sites (No.) | Vaccine(s) | Antigen | Clade | Comment |
| Phase III (Large-size trials in high-risk populations; test vaccine efficacy) | |||||||
| RV144 | WRAIR, AFRIMS, MoH; Aventis, VaxGen | October 2003 | Thailand (several) |
ALVAC vCP1521 AIDSVAX B/E |
env (E), gag/pol (B) env (B, E) |
B, E B, E |
16,000 healthy normal HIV negative adult volunteers |
| Phase II (Mid-size trials in low- & high-risk populations; test vaccine safety, immunogenicity) | |||||||
|
HVTN 502/ Merck 023 |
HVTN, Merck; Merck |
December 2004 | US (12), Canada (1), Peru (2), Dominican Republic (1), Haiti (1), Puerto Rico (1), Australia (1) | MRKAd5 HIV-1 gag/pol/nef | gag, pol, nef | B | To test whether cellular immune response generated by Merck’s vaccine is potent enough to impact infection with HIV in 1,500 at-risk volunteers |
|
ANRS VAC 18 |
ANRS; Aventis | September 2004 | France (6) | LIPO-5 | 5 lipopeptides containing CTL epitopes (from Gag, Pol, Nef) | B | CompareCD8 response of 3 doses of LIPO-5 versus placebo |
| IAVI 010 | IAVI; KAVI | February 2003 | UK; Kenya |
DNA.HIVA MVA.HIVA |
gag + 25 CTL epitopes gag + 25 CTL epitopes |
A A |
HIV-DNA +/-MVA boost |
| Phase I/II (Mid-sized trials in low-risk populations; test vaccine safety, immunogenicity) | |||||||
|
HVTN 042/ ANRS VAC 19 |
HVTN, ANRS; Aventis | June 2004 | US (13) |
LIPO-5 ALVAC-HIV (vCP1452) |
See above See above |
B B |
To evaluate safety and immunogenicity of LIPO-5 alone, vCP1452 alone, and ALVAC prime/LIPO-5 boost |
| GTU-MultiHIV | FIT Biotech | February 2004 | Finland | GTU-MultiHIV B clade | nef, rev, tat, gag, pol, env, CTL epitopes | B | Immunogenicity of GTU-MultiHIV clade B DNA after intradermal and intramuscular injection. |
| HVTN 052 | HVTN; Vical | December 2003 | US (10) | VRC-HIVDNA-009-00-VP |
gag, pol, nef env |
B A,B,C |
Phase IB, safety, immunogenicity of multiclade DNA Vaccine |
| N/A | UNSW; AVC | June 2003 | Australia |
pHIS-HIV-B rFPV-HIV-B |
gag, RT, rev, tat, vpu, env gag, RT, rev, tat, vpu, env |
B B |
DNA Vaccine + fowlpox boost |
| Phase I (Small trials in low-risk populations; test vaccine safety, immunogenicity) | |||||||
| IAVI C002 | IAVI; IDT | January 2005 | US (2) | ADMVA | env/gag-pol, nef-tat | C | Safety, immunogenicity of an MVA vector vaccine |
| HVTN 057 | NIAID, VRC | November 2004 | US (12) | VRC-HIVADV014-00-VP |
gag/pol
polyprotein env |
B A,B,C |
Safety, immune response to VRC-HIVADV014-00-VP, when given as a booster to already vaccinated adults (HVTN 052) |
| HVTN 059 | NIAID, AlphaVax | October 2004 | US (5), South Africa, Botswana | AVX101 (VEE) | gag | C | Safety, immunogenicity of an alphavirus replicon |
|
VRC 007 (04-I-0254) |
NIAID/VRC | August 2004 | US (1) | VRC-HIVDNA016-00-VP |
gag, pol, nef env |
B A, B, C |
Safety, immunogenicity of a 6-plasmid multiclade HIV-1 DNA vaccine |
| HVTN 055 | NIAID; Therion | July 2004 | US (6) |
TBC-M358 (MVA) TBC-M335 (MVA) TBC-F357 (FPV) TBC-F349 (FPV) |
env, gag tat, rev, nef, RT env, gag tat, rev, nef, RT |
B B B B |
Safety, immunogenicity of MVA-HIV and rFPV-HIV alone or in combination. |
|
ANRS VAC 16 |
ANRS; Biovector SA |
July 2004 | France (6) | LIPO-4T (LPHIV-1) | 4 lipopeptides containing CTL epitopes (from Gag, Pol-RT, Pol, Nef) | B | Safety and immunogenicity of lipopeptides LIPO-4T, by two administration routes. |
|
VRC 006 (04-I-0172) |
NIAID; GenVec | May 2004 | US | VRC-HIVADV014-00-VP |
gag/pol polyprotein env |
B A,B,C |
Safety, tolerability, immune response of a multiclade HIV adenoviral vector vaccine in uninfected adults. |
| N/A | AVANT; NIAID; WRAIR | May 2004 | US | LFn-p24 |
Anthrax-derived polypeptide LFn gag p24 protein |
B | 18 health volunteers. Aim: inducing strong and persistent HIV-1 gag specific CD8 T Cell responses. |
| HVTN 056 | NIAID, Wyeth | April 2004 | US (7) | HIV CTL MEP | CTL epitopes from env or gag | B | Safety of and immune response to a new HIV vaccine: HIV CTL MEP |
|
UMMS vaccine |
UMMS; ABL | April 2004 | US |
DNA Proteins |
gag + 5 env 5 recombinant gp120 |
A,B,C,E A,B,C,E |
DNA prime: 1 gag gene (C) + 5 env genes (A, 2 B, C, E). Boost: 5 gp120 (same isolates as DNA). Adjuvant: QS21. |
|
HVTN 050/ Merck 018 |
NIAID; Merck | September 2004 | Malawi, South Africa | MRKAd5 HIV-1 | gag | B | Replication defective Ad-5 vector |
| IAVI A001 | IAVI; Targeted Genetics | December 2003 | Belgium (2); Germany (2); India (1) | tgAAC09 AAV | gag, protease, rt | C | Recombinant AAV vector; single shot |
| IAVI C001 | IAVI; ADARC; Vical | December 2003 | US (2) | ADVAX DNA | gag, env, pol, nef, tat | C | Multi-gene approach |
| HVTN 049 | HVTN; Chiron | December 2003 | US (8) |
Gag and Env DNA/PLG Oligomeric gp140/MF59 |
gag, env DNA/PLG; Oligomeric gp140 |
B B |
Safety, Immunogenicity of DNA/PLG and env DNA/PLG prime, oligomeric gp140/MF59 boost |
| HVTN 044 | HVTN; Vical | December 2003 | US (3) | VRC-HIVDNA-009-00-VP |
gag, pol, nef env |
B A,B,C |
Safety, immunogenicity of of multiclade DNA Vaccine with IL-2/Ig DNA adjuvant |
| IAVI 011 |
IAVI, SAAVI IDT |
November 2003 | South Africa (2), UK (1), Switzerland (1) | MVA-HIVA | gag + 25 CTL epitopes | A | Dose response |
| EnvPro | St Jude's | September 2003 | US | EnvPro protein | gp140 | D | Purified env protein |
| ISS P-001 | ISS; Excell | August 2003 | Italy (4) | HIV-1 Tat protein | tat | B | Safety, immunogenicity of the recombinant HIV-1 Tat protein in healthy HIV-negative volunteers. |
| MRKAd5 + ALVAC | Merck; Aventis Pasteur | 2003 | US (17) | MRKAd5 HIV-1; ALVAC vCP205 |
gag env, gag, pol |
B | MRKAd5 HIV-1 prime, ALVAC vCP205 boost |
| HVTN 040 |
NIAID; SAAVI AlphaVAX |
July 2003 | US (4); South Africa (2) | AVX101 VEE | gag | C | Safety and immunogenicity of VEE vector |
|
ANRS VAC 14 |
ANRS; Aventis | June 2003 | France (2) | gp160MN/LAI-2 |
gp120 (MN strain), gp41 (LAI strain) |
B | Safety and immunogenicity, using several routes |
| HVTN 048 | NIAID; Epimmune | April 2003 | US (2); Botswana | EP HIV-1090 DNA | 21 CTL epitopes from gag, pol, env, nef, rev, vpr | B | Safety and immunogenicity |
|
VRC 004 (03-I-0022) |
NIAID/VRC; Vical | November 2002 | US | VRC-HIVDNA009-00-VP |
gag, pol,nef
(clade B); env (clades A, B, C) |
A, B, C | Safety and immunogenicity of a multiclade vaccine |
|
B011; RV 138 |
WRAIR; Aventis | July 2002 | US | ALVAC-HIV vCP205 | env, gag, pol | B | Response to vaccine subcutaneously (via dendtritic cells), intradermally, or intramuscularly |
|
VRC 004 (03-I-0022) |
NIAID/VRC; Vical | November 2002 | US | VRC-HIVDNA009-00-VP |
gag, pol,nef (clade B); env (clades A, B, C) |
A, B, C | Safety and immunogenicity of a multiclade vaccine |
|
B011; RV 138 |
WRAIR; Aventis | July 2002 | US | ALVAC-HIV vCP205 | env, gag, pol | B | Response to vaccine subcutaneously (via dendtritic cells), intradermally, or intramuscularly |
| N/A | Merck | 2002 | US | gag DNA | gag | B | Dose response |
| 01-I-0079 | NIAID/VRC; Vical | January 2001 | US | VRC4302 DNA | gag, pol | B | Dose and immune response |
| N/A | Merck | 2001 | US |
gag DNA Ad5 gag |
gag gag |
B B |
Evaluation of DNA vs. Ad5 prime + Ad5 boost |
| ABL: Advanced BioScience Laboratories, Inc.; ADARC: Aaron Diamond AIDS Research Center; AFRIMS: Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand, is a joint U.S.-Royal Thai Army Command; AlphaVax: AlphaVax Human Vaccines Inc.; ANRS: Agence Nationale de Recherche sur le SIDA; AVANT: AVANT Immunotherapeutics, Inc.; AVC: Australian Vaccine Consortium; Aventis: Aventis Pasteur; CAN: Canada; Chiron: Chiron Corporation; CTL: cytotoxic T-lymphocyte; Epimmune: Epimmune Inc.; Excell: Excell Biotech; GSK: GlaxoSmithKline; HVTN: HIV Vaccine Trials Network; IAVI: International AIDS Vaccine Initiative; IDT: Impfstoffwerk Dessau Tornau GmbH; ISS: Istituto Superiore di Sanità; KAVI: Kenyan AIDS Vaccine Initiative; MoH: Ministry of Health (Thailand); MRC: UK Medical Research Council; NIAID: U.S. National Institute Allergy and Infectious Diseases; NL: Netherlands; PACTG: Pediatric AIDS Clinical Trials Group; PR: Puerto Rico; SAAVI: South African AIDS Vaccine Initiative; St Jude’s: St Jude’s Childrens Hospital; Therion: Therion Biologics Corporation; TT: Tetanus Toxoid; UMMS: University of Massachusetts Medical School; UNSW: University of New South Wales; US: United States; UVRI: Uganda Virus Research Institute; VEE: Venezuelan equine encephalitis; Vical: Vical Inc.; VRC: Vaccine Research Center; WRAIR: Walter Reed Army Institute of Research | |||||||