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Chronologisch overzicht van Crucells Malaria trial - zoek de verschillen!
Bonus: Gedachte over Crucell's laatste cryptische mededeling betreffende deze trial.
December 19, 2006:
[quote=Crucell]
Crucell today announced that it has obtained regulatory and ethical approval to test the safety, tolerability and immunogenicity of its AdVac®-based malaria vaccine it is currently developing in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH). This opens the way for the imminent commencement of a Phase I clinical trial, with recruitment of volunteers underway.
The clinical trial will be a randomized, double-blind, placebo-controlled study that will test the vaccine in a dose-escalation trial involving 96 healthy volunteers. The Phase I trial will be funded by NIAID and conducted by researchers at Vanderbilt University, one of NIAID's Vaccine and Treatment Evaluation Units.
[/quote]
Q4 2006 (february 13, 2007):
[quote=Crucell]
Crucell obtained regulatory approval to start Phase I clinical trials to test safety, tolerability and immunogenicity of its malaria vaccine, developed in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH).
[/quote]
Q1 2007:
[quote=Crucell]
Crucell received a €2.4 million European Union-funded grant in January aimed at advancing the development of a malaria vaccine.
[/quote]
Q2 2007:
[quote=Crucell]
Crucell and its partner, the National Institute of Health (NIH), have decided to add clinical sites in the US to speed up recruitment for their Phase I trial. Phase I results are not expected to be available by year-end 2007.
[/quote]
Q3 2007:
[quote=Crucell]
Crucell and its partner, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), have added an additional clinical site in the US to speed up recruitment for their Phase I trial. Since opening the additional site, the pace of recruitment has increased allowing so far enrolment of 18 and 15 volunteers in the first and second cohort, respectively. Initial findings of Phase I results are expected to be available in 2008. No serious adverse side-effects have been reported to date.
[/quote]
Q4 2007 (12-02-2008):
[quote=Crucell]
AdVac®/PER.C6® Technology-Based Malaria Vaccine: Crucell and its partner, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), are conducting a Phase I trial in the U.S. The study is being carried out on two sites, VanderBilt and Stanford University. The first and second cohorts, comprising 18 and 17 volunteers respectively, have been successfully enrolled. No serious adverse side-effects have been reported to date. Current plans call for subsequent enrollment of two additional cohorts at higher vaccine doses, provided the vaccine has an appropriate safety profile. Following review of the safety data by a Safety Monitoring Committee, a decision has been made to begin recruitment of the third cohort. Initial findings of this Phase I trial are expected to be available in 2008.
[/quote]
Q1 2008:
[quote=Crucell]
The first and second cohorts, comprising of 18 and 17 volunteers respectively, have been enrolled. Enrollment of a third group of 18 volunteers is progressing and is near completion. Enrollment for the fourth and final group of volunteers is expected to start in the summer. Initial findings of this Phase I trial are expected to be available in 2008.
[/quote]
Q2 2008:
[quote=Crucell]
The first three cohorts, comprising of 18, 17 and 18 volunteers respectively, have been enrolled. Enrollment for the fourth and final group of volunteers is expected to start soon. Initial findings of this Phase I trial are expected to be available in 2008.
[/quote]
Q3 2008:
[quote=Crucell]
The first three cohorts have been enrolled and ongoing safety monitoring has revealed no significant safety concerns to date, but formal analysis awaits unblinding of the data. Enrollment for the fourth and final group of volunteers is still ongoing and initial findings of this Phase I trial are expected in the first quarter of 2009.
[/quote]
Q4 2008 (februari 2009):
[quote=Crucell]
The first three cohorts have been enrolled and ongoing safety monitoring has revealed no significant safety concerns to date, but formal analysis awaits unblinding of the data. Enrollment for the fourth and final group of volunteers is ongoing. Preliminary results of the first three cohorts are expected before the end of the first quarter of 2009. Further updates on this program will be communicated in our first quarter 2009 results.
[/quote]
Dus we zijn al meer dan twee jaartjes bezig, en het wordt wel minstens drie jaar voordat het is afgerond. ALS ie wordt afgerond, want wat betekent "further updates on this program will be communicated in Q109 results?"
Klinkt onheilspellend. Zou dat kunnen betekenen iets als:
"Ondanks dat we deze Ad5 malaria Phase I trial al meer dan twee jaar hebben laten voortkabbelen, hebben we met (langzaam) voortschrijdend inzicht, besloten om geheel van Ad5 vectoren af te stappen, en na onze HIV, Tuberculosis en Ebola/marburg vaccins, ook ons Malaria vaccin met andere, minder voorkomende Ad-vectoren te gaan maken, teneinde de problemen met bestaande immuniteit tegen Ad5 te voorkomen. We achtten het beter om NU nog te veranderen van vector, in plaats van afronding van de phase II trial in 2017. Praktisch betekent dit dat we een geheel nieuwe phase I trial op basis van rAdxx opstarten, die hopenlijk sneller zal gaan verlopen." Op lange termijn zien wij nog steeds een trivalent HIV/Tuberculosis/Malaria vaccin, en daarom zal de rAdxx vector qua immuniteit niet interfereren met de Ad35 vector voor ons Tuberculosis vaccin en de rAd26 vector voor ons HIV vaccin, en zelfs niet met de toekomstige rAdyy vector voor ons nieuwe Ebola/Marburg vaccin."
??
We zullen zien bij de Q1 2009 cijfers.