Sperimentazione fase 2a vaccino GeoVax

Notizie scientifiche e mediche riguardanti il virus, l'infezione e la malattia da HIV. Farmaci, vaccini e cure in sperimentazione.
skydrake
Messaggi: 9917
Iscritto il: sabato 19 marzo 2011, 1:18

Sperimentazione fase 2a vaccino GeoVax

Messaggio da skydrake » lunedì 3 ottobre 2011, 15:05

L'americana GeoVax Labs ha comunicato di aver concluso la formazione della coorte per la sperimentazione in fase 2a del HVTN 205, il suo vaccino PREVENTIVO.
I risultati della precedente fase erano incoraggianti. Dei 46 soggetti a cui è stato inoculato il vaccino, il 50% hanno reagito con attività "neutralizzante" per la variante tier 2 clade b e il 26% con anticorpi neutralizzanti per la variante tier 2 clade B isolate SC22.3C2

http://www.sacbee.com/2011/10/03/395582 ... trial.html
http://biomedreports.com/2011100480109/ ... -test.html

Di tale vaccino se ne era già parlato in passato su questo forum:
http://lilanew.forumup.it/about1183-0.html
http://lilanew.forumup.it/ntopic2018-lilanew.html
______

Sempre oggi, la Biotron ha annunciato che inizierà la sperimentazione fase 1b/2a del suo farmaco BIT225 anti HIV. Poichè interesserà solo un gruppo di 18 pazienti che riceveranno tale farmaco per un periodo di 10 giorni, i risultati sono previsti già nel primo trimestre del 2012.:
http://clinicaltrials.pharmaceutical-bu ... ial-031011
Ultima modifica di skydrake il martedì 4 ottobre 2011, 16:14, modificato 2 volte in totale.



paoloto40
Messaggi: 16
Iscritto il: sabato 28 aprile 2007, 21:35

Re: Conclusa sperimentazione fase 2a vaccino GeoVax

Messaggio da paoloto40 » martedì 4 ottobre 2011, 12:41

si se ne era già parlato sul vecchio forum....questo vaccino è da un po che lo studiano... ma mi sembra che ci fosse anche un trial in corso sempre 2 testato come terapeutico....e sembrava che aveva dato dei risultati decenti e avevano preso parechi soldi per andare avanti ...
ma non trovo l articolo...



skydrake
Messaggi: 9917
Iscritto il: sabato 19 marzo 2011, 1:18

Re: Conclusa sperimentazione fase 2a vaccino GeoVax

Messaggio da skydrake » martedì 4 ottobre 2011, 14:04

paoloto40 ha scritto:si se ne era già parlato sul vecchio forum....questo vaccino è da un po che lo studiano... ma mi sembra che ci fosse anche un trial in corso sempre 2 testato come terapeutico....e sembrava che aveva dato dei risultati decenti e avevano preso parechi soldi per andare avanti ...
ma non trovo l articolo...
intendi la discussione all'ultimo link che ho postato?

In ogni caso adesso si parla di vaccino preventivo:
The vaccine is being developed for use in uninfected people to prevent infection should they be exposed to the virus
e anche nella precedente discussione di parlava di vaccino preventivo. In ogni caso la Geovax ha sperimentato più candidati vaccini, preventivi o funzionali



paoloto40
Messaggi: 16
Iscritto il: sabato 28 aprile 2007, 21:35

Re: Conclusa sperimentazione fase 2a vaccino GeoVax

Messaggio da paoloto40 » martedì 4 ottobre 2011, 15:44

si lo so però so anche che stanno facendo o faranno un trial come terapeutico...i tempi non li conosco

http://www.cisionwire.com/the-investor- ... e,c9138918



Dora
Messaggi: 7488
Iscritto il: martedì 7 luglio 2009, 10:48

Re: Sperimentazione fase 2a vaccino GeoVax

Messaggio da Dora » lunedì 31 ottobre 2011, 9:42

Un aggiornamento sugli aspiranti vaccini GeoVax, dal 13th Annual International Meeting of the INSTITUTE OF HUMAN VIROLOGY.

Harriet Robinson ha presentato GeoVax HIV/AIDS Vaccine Program, Preclinical and Clinical Studies

GeoVax is developing a recombinant modified vaccinia Ankara (MVA) vaccine that can be used in the presence or absence of a DNA prime. Both vaccines express non-infectious virus-like-particles displaying trimeric membrane bound envelope (Env). In both rhesus and humans, two DNA primes followed by two MVA boosts given at 8 weeks intervals (DDMM regimen) elicit the highest T cell responses; whereas three MVA immunizations given at weeks 0, 8 and 24 elicit the highest Env-specific Ab responses. The DNA prime is being tested in both the presence and absence of a granulocyte macrophage-colony stimulating factor (GM-CSF) adjuvant, which is co-expressed in the prime. In rhesus, by far the best prevention of infection (70% for 12 repeated SIVsmE660 challenges) is found for the GM-CSF-adjuvanted SIVmac239 vaccine. A strong correlate for this protection is the avidity of Env-specific Ab for the Env of the challenge virus. The protection elicited by the GM-CSF-adjuvanted regimen is long lasting: 80% of animals receiving an MVA boost at one year after the 1st 12 challenge have been protected against an ongoing 2nd series initiated 6 months after the boost.

Geopfert P.A., et al., Phase 1 Safety and Immunogenicity Testing of DNA and Recombinant Modified Vaccinia Ankara Vaccines Expressing HIV-1 Virus-like Particles. Journal of Infectious Diseases. 203; 610-619, 2011.
Lai L., et al., Prevention of Infection by a GM-CSF Co-Expressing DNA/MVA Simian Immunodeficiency Virus Vaccine. Journal of Infectious Diseases. 204; 164-172, 2011.



paoloto40
Messaggi: 16
Iscritto il: sabato 28 aprile 2007, 21:35

Re: Sperimentazione fase 2a vaccino GeoVax

Messaggio da paoloto40 » lunedì 31 ottobre 2011, 13:15

la fase 2 conclusa era quella preventiva.
so che hanno investito molti soldi e anche ricevuto soldi dal governo.

penso che sia partita da poco anche la fase I per il vaccino terapeutico che è stato un po modificato

http://www.prnewswire.com/news-releases ... 13133.html

forse il prossimo anno si saprà di più.....



skydrake
Messaggi: 9917
Iscritto il: sabato 19 marzo 2011, 1:18

Re: Sperimentazione fase 2a vaccino GeoVax

Messaggio da skydrake » giovedì 8 marzo 2012, 15:03

Si riparla nuovamente del Vaccino GeoVax. Harriet L. Robinson ha presentato ieri al CROI i risultati delle sperimentazioni in corso, in realtà già anticipati qualche mese fa. Tuttavia, questa volta, è andato più in dettaglio, in particolare sulla modalità di somministrazione.

http://zeenews.india.com/news/health/di ... 15942.html

http://www.sciencecodex.com/hivaids_vac ... ates-87462

_______________________________________________________________________________--

An Atlanta research collaboration may be one step closer to finding a vaccine that will provide long-lasting protection against repeated exposures to human immunodeficiency virus (HIV). Scientists at Emory University and GeoVax Labs, Inc. developed a vaccine that has protected nonhuman primates against multiple exposures to simian immunodeficiency virus (SIV) given in three clusters over more than three years. SIV is the nonhuman primate version of HIV.

Harriet L. Robinson, PhD, chief scientific officer at GeoVax Labs, Inc., and former director of the division of microbiology and immunology at Yerkes National Primate Research Center, has been leading the research team with Rama Rao Amara, PhD, associate professor of microbiology and immunology, Yerkes National Primate Research Center and the Emory Vaccine Center.

The research was presented Wednesday at the Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle, Wash.

The vaccine regimen included a DNA prime vaccine that co-expressed HIV proteins and granulocyte-macrophage colony-stimulating factor (GM-CSF). GM-CSF is a normal protein that promotes the initiation of immune responses and thus enhances the ability of the vaccine to elicit blocking antibodies for the SIV virus before it enters cells.

Vaccination consisted of two DNA inoculations at months 0 and 2 to prime the vaccine response and then two booster inoculations at months 4 and 6. The booster vaccine was MVA, an attenuated poxvirus expressing HIV proteins. Six months after the last vaccination, both vaccinated and unvaccinated animals were exposed to SIV through 12 weekly exposures, resulting in an 87 percent per exposure efficacy and 70 percent overall protection. Over the next two years uninfected animals were exposed multiple times in two more series, resulting in an 82 percent per exposure efficacy during the second series and an 84 percent per exposure efficacy during the third series.

"Repeated challenges in animals are used to mimic sexual transmission," says Robinson. "The hope is that the results in the nonhuman primate models will translate into vaccine-induced prevention in humans."

"It is impressive to note that protection could be observed against both neutralization sensitive and neutralization resistant viruses," says Amara.

Neutralization is the process by which some antibodies can block virus infection.

A first generation GeoVax DNA/MVA vaccine that does not co-express GM-CSF has shown excellent safety and reproducible vaccine responses in Phase 1 and 2a clinical trials in more than 400 uninfected people. These trials, supported and conducted by the National Institutes of Health HIV Vaccine Trials Network, have set the stage for the second-generation GM-CSF co-expressing vaccine to move from its initial Phase 1 safety testing slated to start in March of this year to a Phase 2b efficacy trial in participants who are at high risk of exposure to HIV. The vaccine is designed for a version of the virus prevalent in the Americas.



Dora
Messaggi: 7488
Iscritto il: martedì 7 luglio 2009, 10:48

Re: Sperimentazione fase 2a vaccino GeoVax

Messaggio da Dora » domenica 23 ottobre 2016, 7:40

skydrake ha scritto:A first generation GeoVax DNA/MVA vaccine that does not co-express GM-CSF has shown excellent safety and reproducible vaccine responses in Phase 1 and 2a clinical trials in more than 400 uninfected people. These trials, supported and conducted by the National Institutes of Health HIV Vaccine Trials Network, have set the stage for the second-generation GM-CSF co-expressing vaccine to move from its initial Phase 1 safety testing slated to start in March of this year to a Phase 2b efficacy trial in participants who are at high risk of exposure to HIV. The vaccine is designed for a version of the virus prevalent in the Americas.
TRIAL HVTN 094

GeoVax ha presentato all'HIVR4P di Chicago i risultati della fase I del suo vaccino preventivo DNA/MVA [chiamato MVA/HIV62B (MVA62B)] (trial HVTN 094).

Dal comunicato stampa:

GeoVax HIV Vaccine Clinical Data Presented At HIVR4P Conference
  • Vaccine Shown to Induce Durable Functional Antibodies Against HIV

    ATLANTA, GA--(Marketwired - Oct 20, 2016) - GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company specializing in developing human vaccines, announced today the presentation of clinical data from a phase 1 human clinical trial of its investigational HIV vaccine (trial designation HVTN 094) at the HIV Research for Prevention, Partnering for Prevention (HIVR4P) conference in Chicago, Illinois.

    The presentation, entitled "DNA/MVA HIV Vaccine Producing Virus-like Particles (VLPs) is Well-tolerated and Induces Durable Functional Antibodies (Abs) in HVTN 094", was delivered by Susan P. Buchbinder, MD, Director of Bridge HIV at the San Francisco Department of Public Health.

    HVTN 094 evaluated the safety and immunogenicity of GeoVax's adjuvanted DNA/MVA vaccine that co-expresses GM-CSF in the priming DNA vaccine. Four U.S. clinical sites randomized a total of 48 participants to receive one of three vaccine dosing regimens.

    All vaccination regimens were well-tolerated and safe. Conclusions drawn from the study were that the DNA/MVA prime-boost regimen induced functional humoral responses that included antibody dependent cellular cytotoxicity (ADCC), antibody avidity, and Env IgG1 and IgG3 binding responses with specificities in the gp41 subunit of Env known to mediate virus capture and phagocytosis (an immune system process that removes pathogens). A third MVA boost was shown to enhance both the titers and function of the antibody responses. Because the levels of antibody primed by the DNA vaccine, with or without the co-expression of GM-CSF, were similar, the DNA product without co-expressed GM-CSF will be used in further clinical trials. Also, based on the third MVA boost enhancing immune responses, further trials will include a third MVA boost. HVTN 094 was conducted by the HIV Vaccine Trials Network (HVTN) with funding support from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

    Harriet L. Robinson, PhD, GeoVax's Chief Scientific Officer, commented, "We are pleased with the outcome of the HVTN 094 trial, which added to the prior clinical data demonstrating the excellent safety profile of our vaccine. Also, in HVTN 094, the regimen using two full dose DNA primes followed by three MVA boosts elicited remarkably durable IgG1 and IgG3 responses to gp41. At six months post-vaccination, essentially all participants had detectable IgG1 responses and approximately 40% of the participants had detectable IgG3 responses. Response rates and magnitudes dropped only slightly from six to twelve months post-vaccination. We wish to thank the extensive team at HVTN involved with the conduct and evaluation of this study. We also want to thank NIAID for their support of HVTN 094, and for their continued support of our HIV vaccine program."

    Dr. Robinson continued, "We now look forward to the commencement of the HVTN 114 trial, which will begin the evaluation of our vaccine in combination with a protein boost. HVTN 114 is scheduled to start in December of this year." [...]



skydrake
Messaggi: 9917
Iscritto il: sabato 19 marzo 2011, 1:18

Re: Sperimentazione fase 2a vaccino GeoVax

Messaggio da skydrake » domenica 23 ottobre 2016, 8:17

Dora ha scritto:At six months post-vaccination, essentially all participants had detectable IgG1 responses and approximately 40% of the participants had detectable IgG3 responses. Response rates and magnitudes dropped only slightly from six to twelve months post-vaccination.
Questo a me pare più un'ammissione di fallimento.



uffa2
Amministratore
Messaggi: 6752
Iscritto il: lunedì 26 novembre 2007, 0:07

Re: Sperimentazione fase 2a vaccino GeoVax

Messaggio da uffa2 » domenica 23 ottobre 2016, 15:18

inizio a sospettare che, come in maniera poco scientifica ho già sostenuto, l'unica vera vaccinazione di massa che mai vedremo sarà la diffusione della terapia antiretrovirale come tale o come PrEP... finora l'unica cosa che funzioni...


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