Immune-Based Therapies &
Preventive Technologies Pipeline Tables
Preventive Technologies Pipeline Tables
- Preventive Vaccines
- Microbicides
- Pre-Exposure Prophylaxis (PrEP)
- Therapeutic Vaccines
- Cytokine & Immunomodulators
- Gene Therapies
Table 1. Preventive Vaccines Pipeline
| Product | Type | Manufacturer | Status |
| ALVAC vCP1521 | Canarypox vector encoding: HIV-1 CRF01_AE env, subtype B gag, the protease-encoding portion of the pol gene and a synthetic polypeptide encompassing several known CD8 T-cell epitopes from the Nef and Pol proteins | Aventis Pasteur | Phase III Phase I (in infants) |
| ALVAC vCP1452 | Canarypox vector encoding portions of subtype B HIV-1 env, gag, pol and a synthetic polypeptide encompassing several known CD8 T-cell epitopes from the Nef and Pol proteins | Aventis Pasteur | Phase II |
| AIDSVAX B/E (booster only) | Recombinant gp120 envelope protein | VaxGen | Phase III |
| MRKAd5 | Adenovirus serotype 5 vector containing gag/pol/nef genes from HIV-1 subtype B | Merck | Phase IIb |
| LIPO-5 | 5 lipopeptides containing CTL epitopes (from Gag, Pol and Nef proteins) | ANRS; Aventis | Phase II |
| GTU-Multi-HIV | DNA vaccine containing nef, rev, tat, gag, pol, env, and CTL epitopes | FIT Biotech | Phase I/II |
| pHIS-HIV-B rFPV-HIV-B | DNA vaccine + fowlpox boost containing gag, rev, tat, vpu, and truncated env genes from HIV-1 subtype B | University of New South Wales, Australia, Virax | Phase I/II |
| ADMVA | MVA vector containing env/gag-pol, and nef-tat genes from HIV-1 subtype C | Aaron Diamond AIDS Research Center (ADARC), IAVI, IDT | Phase I |
| GSK Protein HIV Vaccine | Recombinant Tat, Nef, and gp120 proteins in ASO2A adjuvant | GlaxoSmithKline | Phase I |
| VRC-HIVADV014-00-VP | Adenovirus serotype 5 vector containing gag/pol genes from HIV-1 subtype B and env genes from subtypes A, B, and C | NIH Vaccine Research Center | Phase II |
| AdVax 101 (VEE) | Venezuelan Equine Encephalitis virus vector containing the gag gene from HIV-1 subtype C | AlphaVax | Phase I |
| VRC-HIVDNA016-00-VP | Six separate DNA plasmids containing gag, pol, and nef genes from HIV-1 subtype B, and env genes from subtypes A, B, and C | NIH Vaccine Research Center | Phase II |
| TBC-M358 (MVA) TBC-M335 (MVA) TBC-F357 (FPV) TBC-F349 (FPV) | MVA and fowlpox vectors encoding env, gag, tat, rev, nef, and reverse transcriptase genes from HIV-1 subtype B | NIAID, Therion | Phase I |
| LIPO-4T (LPHIV-1) | 4 lipopeptides containing CTL epitopes (from gag, pol-RT, pol, and nef) | ANRS, Biovector SA | Phase I |
| LFn-p24 | Anthrax-derived polypeptide LFn Gag p24 protein | AVANT, NIAID, WRAIR | Phase I |
| HIV CTL MEP + RC529-SE and GM-CSF adjuvants | DNA vaccine containing CTL epitopes from env or gag | NIAID, Wyeth | Phase I |
| DNA + Protein Vaccine Combination | DNA vaccine containing a gag gene (from HIV-1 subtype C) and 5 env genes (from subtypes A, C, and E + two from subtype B), plus a protein boost using recombinant gp120 proteins from the same 5 isolates that supplied the env genes for the DNA component | University of Massachusetts Medical School, Advanced BioScience Laboratories, Inc. | Phase I |
| tgAAC09 AAV | Adeno-associated virus vector containing gag, protease, and reverse transcriptase genes from HIV-1 subtype C | Targeted Genetics, IAVI | Phase II |
| ADVAX DNA | DNA vaccine containing gag, env, pol, nef, and tat genes from HIV-1 subtype C | IAVI, ADARC, Vical | Phase I |
| DNA/PLG Oligomeric gp140/MF59 | DNA vaccine containing gag and env genes from HIV-1 subtype B, plus a protein boost containing a gp140 protein also from subtype B | Chiron | Phase I |
| VRC-HIVDNA-009-00-VP | DNA vaccine containing gag, pol, and nef genes from HIV-1 subtype B, and env genes from subtypes A, B, and C, together with an adjuvant gene encoding an IL-2 fusion protein | VRC, HVTN, Vical | Phase I |
| PolyEnv1 | Vaccinia viruses expressing 23 different env genes | St. Jude Children's Research Hospital | Phase I |
| EnvDNA | DNA vaccine encoding multiple env genes | St. Jude Children's Research Hospital | Phase I |
| ISS P-001 | Recombinant Tat protein from HIV-1 subtype B | ISS, Excell | Phase I |
| EP HIV-1090 DNA EP-1043 | DNA vaccine containing 21 CTL epitopes from gag, pol, env, nef, rev, and vpr (HIV-1 subtype B) + recombinant protein vaccine designed to induce CD4 T cell responses | NIAID, Epimmune | Phase I |
| HIV DNA vaccine + IL-12 | DNA vaccines encoding HIV-1 subtype B gag and IL-12 | NIAID, Wyeth | Phase I |
| HIV DNA vaccine + IL-15 | DNA vaccines encoding HIV-1 subtype B gag and IL-15 | NIAID, Wyeth | Phase I |
| pGA2/JS7 DNA MVA/HIV62 | DNA prime and MVA booster vaccines encoding gag, pol and env from HIV-1 subtype B | NIAID, Geovax | Phase I |
| SCBaL/M9 Soluble subunit protein | Oral vaccine utilizing salmonella typhi encoding gp120-CD4, subunit protein vaccine containing the same gp120-CD4 protein | Institute of Human Virology | Phase I |
Table 2. Microbicides Pipeline
| Product | Type | Manufacturer | Status |
| Carraguard® | Adsorption inhibitor | Population Council | Phase III |
| Cellulose sulfate (Ushercell®) | Adsorption inhibitor | Global Microbicide Project | Phase III |
| PRO 2000/5 Gel | Adsorption inhibitor | Indevus Pharmaceutical, Inc. | Phase III, Phase II/IIb (with BufferGel), Phase II (with tenofovir) |
| Savvy (C31G) | Surfactant | Cellegy Pharmaceuticals | Phase III |
| BufferGel™ | Acid-buffering agent | Reprotect, LLC | Phase II/IIb (with PRO2000) |
| Lactin-V | Vaginal defense enhancer | Osel, Inc. | Phase II |
| Protected Lactobacilli in combination with BZK | Acid-buffering agent/surfactant | Biofem, Inc. | Phase II |
| Tenofovir/PMPA Gel | Reverse transcriptase inhibitor | Gilead Sciences, Inc. | Phase II/IIb (alone and with PRO2000) |
| Invisible Condom | Entry/fusion inhibitor | Laval University (Division of Microbiology) | Phase I/II |
| ACIDFORM Gel | Acid-buffering agent | Global Microbicide Project | Phase I |
| Cellulose acetate 1,2-benzenedicarboxylate (cellulose acetate/CAP) | Adsorption inhibitor | Lindsey F. Kimball Research Institute, Dow Pharma | Phase I |
| Lime Juice | Acid-buffering agent | University of Melbourne | Phase I |
| TMC120 | Reverse transcriptase inhibitor | International Partnership for Microbicides (IPM) | Phase I |
| UC-781 | Reverse transcriptase inhibitor | Biosyn, Inc. | Phase I |
| VivaGel (SPL7013 gel) | Entry/fusion inhibitor | Starpharma Ltd. | Phase I |
| PC 815 (Carraguard + MIV-150) | Combination adsorption inhibitor/reverse transcriptase inhibitor | Population Council | Phase I |
Table 3. Pre-Exposure Prophylaxis (PrEP) Pipeline
| Product | Type | Manufacturer | Status |
| Tenofovir (Viread, TDF) | Nucleotide reverse transcriptase inhibitor | Gilead | Phase II |
| Truvada (FTC, TDF) | Combined nucleoside and nucleotide reverse transcriptase inhibitors | Gilead | Phase II |
Table 4. Therapeutic HIV Vaccines Pipeline
| Product | Type | Manufacturer | Status |
| ALVAC (vCP1452) | Canarypox vector encoding env, gag, the protease-encoding portion of the pol gene and CTL epitopes from the nef and pol gene products | Aventis Pasteur | Phase II |
| Lipopeptides | Peptides from Gag, Nef and Pol proteins | Aventis Pasteur/ANRS | Phase II |
| VRC-HIVDNA009-00-VP | DNA vaccine encoding gag, pol, nef, and multisubtype (A, B, and C) env genes together with an adjuvant gene encoding an IL-2 fusion protein | VRC/NIAID | Phase I/II |
| VRC-HIVADV014-00-VP | Adenovirus serotype 5 vector containing gag, pol and multisubtype (A, B, and C) env genes | VRC/NIAID | Phase I/II |
| LC002, a DermaVir Vaccine | DNA expressing all HIV proteins except integrase formulated to a mannosilated particle to target antigen-presenting cells | Research Institute for Genetic & Human Therapy (RIGHT), NIAID/ACTG | Phase I/II |
| MVA-BN-nef | MVA vector encoding subtype B HIV nef gene | Bavarian Nordic | Phase I |
| MVA-mBN32 | MVA vector encoding multiple CTL epitopes | Bavarian Nordic/Epimmune | Phase I |
| MRKAd5 | Adenovirus serotype 5 vector containing gag, pol and nef genes | Merck | Phase II |
| Autologous dendritic cells pulsed w/ALVAC (vCP1452) | Canarypox vector encoding env, gag, the protease-encoding portion of the pol gene and CTL epitopes from the nef and pol gene products | ACTG/Aventis | Phase I |
| Autologous dendritic cell HIV vaccination w/conserved HIV-derived peptides | University of Pittsburgh | Phase I | |
| Multi-epitope DNA | 21 CTL epitopes and proprietary, non-HIV derived "universal" CD4 T cell epitope | Epimmune | Phase I |
| DNA/MVA | DNA vaccine and an MVA vector encoding gag and multiple CTL epitopes | Cobra Pharmaceuticals, Impfstoffwerk Dessau-Tornau GmbH (IDT), Oxford University/MRC | Phase I/II |
| Remune +/- AmpliVax | Whole-killed subtype A/G recombinant HIV isolate depleted of gp120 | Immune Response Corporation | Failed phase III; remains under investigation in context of STIs |
| Tat vaccine | Recombinant protein | Aventis Pasteur | Phase I |
| GTU-nef DNA vaccine | DNA encoding the subtype B nef gene | FIT-Biotech | Phase I |
| TBC-M358 (MVA) TBC-M335 (MVA) TBC-F357 (FPV) TBC-F349 (FPV) | MVA and fowlpox vectors encoding env, gag, tat, rev, nef, and reverse transcriptase genes from HIV-1 subtype B | NIAID, Therion | Phase I |
| GSK Protein HIV Vaccine | Recombinant Tat, Nef, and gp120 proteins in ASO2A adjuvant | GlaxoSmithKline, Marcus Altfeld, M.D., Ph.D | Phase I |
| VRC-HIVDNA016-00-VP | Six separate DNA plasmids containing gag, pol, and nef genes from HIV-1 subtype B, and env genes from subtypes A, B, and C | NIH Vaccine Research Center | Phase I |
| HIV-1gag DNA vaccine IL-15 DNA IL-12 DNA | DNA vaccines encoding HIV-1 subtype B gag, IL-12 and IL-15 (all formulated with bupivacaine) | Wyeth | Phase I |
| HIV CTL MEP + RC529-SE and GM-CSF adjuvants | DNA vaccine containing CTL epitopes from env or gag | Wyeth | Phase I |
| GW825780 | DNA vaccine encoding a fusion protein incorporating epitopes from RT, Gag and Nef (delivered coated onto gold particles via gene gun) | GlaxoSmithKline | Phase I |
Table 5. Cytokine & Immunomodulators
| Product | Type | Manufacturer | Status |
| Interleukin-2 (IL-2) | Cytokine | Chiron | Phase III |
| Pegasys (peginterferon alfa-2a) | Cytokine | Roche Pharmaceuticals | Phase Ib/II |
| BAY 50-4798 | Modified IL-2 | Bayer | Phase I/II |
| HRG214 Ppassive Iimmunotherapy | HIV-specific goat antibodies | Virionyx Corporation Ltd | Phase I/II |
| Iinterleukin-7 (IL-7) | Cytokine | Cytheris | Phase I |
| IL-4/IL-13 trap | Anti-cytokines | Regeneron Pharmaceuticals | Phase I |
| Serostim | Human growth hormone | Serono | Phase II |
| Tucaresol | Schiff base forming drug | GlaxoSmithKline | Phase I |
| MDX-010 anti-CTLA4 antibody | Monoclonal antibody | Medarex | Phase I |
| Cyclosporine A | Immunosuppressant | Novartis | AIEDRP AIN501/ACTG A5216 |
| Zenapax (daclizumab) | Anti-CD25 monoclonal antibody | National Institutes of Health Clinical Center, Roche Pharmaceuticals | Phase I |
| Palifermin (recombinant human keratinocyte growth factor) | Fibroblast growth factor | Amgen | Phase I/II (ACTG 5212) |
| Leukotriene B4 (LTB4) | Neutrophil agonist | Virocell Inc | Phase II |
| Leflunomide | Pyrimidine synthesis inhibitor | National Institutes of Health Clinical Center | Phase I |
| VGV-1 | Thymus Nuclear Protein extracted from mammalian thymus tissue (TNP-1) | Viral Genetics | Phase II |
Table 6. Gene Therapies
| Product | Type | Manufacturer | Status |
| CD4zeta modified CD4 and CD8 T cells | Ex vivo T cell Modifier | Cell Genesys | Phase II |
| OZ1 ribozyme gene therapy | Antiviral ribozyme targeted against the tat gene, introduced into CD4 T cells via stem cells | Johnson & Johnson | Phase II |
| VRX496 | Lentiviral vector encoding antiretroviral antisense, introduced into CD4 T cells ex vivo | VIRxSYS | Phase I |
| HGTV43 | Vector encoding antiretroviral antisense, introduced into CD4 T cells ex vivo | Enzo Biochem | Phase II |
| M87o | Entry inhibitor gene encoded by a lentiviral vector, introduced into CD4 T cells ex vivo | EUFETS AG | Phase I |
Antiretrovirals in the Pipeline
Basic Science IndexTAG index