HIV Vaccine Development

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Presentation transcript:

HIV Vaccine Development Issues related to Goals: Prevention vs. Treatment Neutralizing antibodies vs. cell-based (CD4/CD8) Mucosal vs. Intravenous immunity Issues related to Means: Protein(s) - which one(s) and how presented Whole virus - attenuated* / killed *trials appear to have led to HIV infection Vectors - viral, DNA Prime and Boost

Vaccines in Clinical Trials Treatment Trials REMUNE: gp120-depleted killed whole HIV-1 virus Phase III in US - was disappointing, Focused on HAART patients with low/undetectable HIV-1 RNA Increased CD4+ counts, some decreased HIV-1 RNA, but not as promising as hoped Sponsor company Immune Response underwent Restructuring. Now focusing on: REMUNE for treatment naive pateints (potential to delay need for HAART) IR103 = REMUNE + adjuvant, is in Phase I

Vaccines in Clinical Trials AIDSVAX - gp120-based vaccine for prevention originally co-sponsored by NIH, since pulled support due to lack cell-based response. Phase III clinical trial showed no effect in patient population as a whole; however, certain minority groups showed a modest effect - not statistically/biologically relevant Sponsor Company VaxGen is being sued by investors for not being up-front with preliminary clinical trial data

Vaccines in Clinical Trials Aventis: ALVAC vCP-1452 canarypox vector expressing HIV-1 env-gag-pol Currently undergoing a controversial Phase III trial in combination with AIDSVAX B/C in Thailand Merck: Ad5 adenovirus vector expressing gag Problems with patients already exposed to Ad5

Vaccines in Clinical Trials Epimmune: EP HIV-1090 DNA-based vaccine includes 21 key elements HIV-1 epitopes plus a Universal Helper T-cell epitope (to enhance magnitude and duration of response) Phase I trials ongoing - so far the vaccine is well tolerated, but immune responses are low - modified dosing route and schedule are in the works.

Opportunistic Viral Infections Cytomegalovirus (CMV) - widespread virus, up to 85% of total US population infected with no symptoms. In AIDS patients, can cause liver/lung damage and is a leading cause of blindness Recently Approved: - Vistide (cidofovir) - Vitravene (fomivirsen)* - Foscavir (foscarnet) - Cytovene (gangcylovir) Herpes Simplex Virus (HSV) -Valacyclovir (Valtrex)

How Antisense Drugs work protein mRNA DNA antisense drug mRNA destroyed

Opportunistic Infections Pneumocystis carinii pneumonia (PCP) 65% of AIDS patients develop pulmonary infection mortality rate is 10-50% per episode Recently Approved: - Bactrim - Septra - NebuPant (pentamidine) - Pentam (pentamidine) - Neutrexin (trimetrexate) - Mepron (atovaquinone) In Trials: - dapsone

Opportunistic Mycobacterial Infections Tuberculosis- Recently Approved: -Rifapentine Mycobacterium avium- intracellulare complex (MAC) - Zithromax (azithromycin) - Mycobutin (rifabutin) - Biaxin (clarithromycin)

Kaposi Sarcoma (KS) Recently Approved: - DaunoXome - Doxil - Intron A (interferon alpha-2b) - Roferon (interferon alpha 2a) - Taxol - Panretin (alitretinoin) In Trials: - Thalidomide - Virulizin