Merck staph vaccine enters phase II
From Forbes:
VIENNA, Aug 28 (Reuters) – Austrian biotech firm Intercell <ICEL.VI> said on Thursday its partner Merck & Co <MRK.N> has started a Phase II clinical trial to evaluate a vaccine candidate against Staphylococcus aureus infections.
Merck is responsible for clinical development, manufacturing and marketing of the vaccine. Intercell is eligible to receive milestone payments and royalties on future net sales
This is the second trial start following a separate Phase II trial launch in December 2007.
And according to Vaczine :
A wider challenge beyond the technical aspects of Staph vaccine development will be choosing the appropriate future vaccination strategy. Presently it does seem logical to protect defined groups at high risk from Staph bacteremias; however, many experts believe that in terms of overall societal burden, preventing Staph SSTIs and reducing carriage should also be high priorities. Lessening these would involve some form of population-based vaccination with one US expert venturing that a Staph vaccine should be on the pediatric schedule. Opponents to this ambitious concept are likely to raise the issue of cost and the fear of “over vaccination” but at least in immunological terms potential vaccinees could be protected for life having sufficient time to develop protective immunity. The present evolving strategy of vaccinating patients to be hospitalized needs a rapid acting vaccine. Based on this research VacZine Analytics believes it should be considered the starting point of something bigger.
Regular InsideVaccines readers are probably already familiar with the topic of staph and how it relates to vaccines already on the pediatric schedule from our Sisyphus series.
Most probably knew a vaccine for staph was on its way soon, but it’s still interesting to see it happening so quickly.
Also, it’s informative to learn from history about how universal recommendations for infants come about. This is about the rotavirus vaccine for infants, but the principal of the politics probably applies to most or all vaccines:
Public confidence and the support of vaccine providers for vaccination recommendations, although difficult to quantify, are important factors in the decision-making process. Ethical distinctions between causing significant morbidity in some children while averting disease among others are a consideration, given that oral rehydration therapy for rotavirus infection has no associated risks.
Although B. Murphy et al. [6] suggest that the ACIP could have made a permissive recommendation for RRV-TV, the manufacturer stated that it would not market RRV-TV without a universal recommendation for RRV-TV [11].
Comments
4 Comments on Merck staph vaccine enters phase II
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wallacesmum on
Mon, 29th Sep 2008 5:17 pm
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Richard G Jaeckle MD on
Wed, 9th Mar 2011 11:09 am
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admin on
Sat, 12th Mar 2011 3:00 pm
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toni bark on
Mon, 25th Apr 2011 9:55 am
So what’s next? Prevnar and Hib cause babies to get staph, staphvax causes babies to get….
I love that the pharmas get to “threaten” not to market their own products, in order to scare te CDC into toeing the line.
Update, please, on status of development and anticipated availability.
I’d reply saying that apart from a trial in immunosuppressed not much has happened:
http://www.intercell.com/main/forbeg…stigational-s/
November 18, 2010
Intercell announces initial results of Phase II clinical trial evaluating V710, an investigational Staphylococcus aureus vaccine, in patients with end-stage renal disease
•Primary Immunogenicity and Safety objectives met
•All formulations of V710 were immunogenic following a single or two dose application
Vienna (Austria), November 18, 2010 – Intercell AG (VSE: ICLL) today announced top-line results from a Phase II clinical trial of V710, an investigational vaccine for the prevention of Staphylococcus aureus (S. aureus) infections. The study, conducted by Intercell’s collaborator, a subsidiary of Merck & Co., Inc, (known outside the U.S. and Canada as MSD) (“Merck”) was designed to evaluate the safety and immunogenicity of V710 in patients with end-stage renal disease (ESRD) undergoing hemodialysis treatment.
In the randomized double blind, placebo controlled study 201 patients received vaccine or placebo at 12 centers in the U.S. The study was designed to assess whether administration of V710 to ESRD patients receiving hemodialysis at high risk of developing serious S. aureus infections could increase the level of antibodies to the V710 antigen. The primary endpoints of the study were the change of antibody levels compared to baseline at 28 days after a 2-dose regimen provided 28 days apart and all adverse experiences for 14 days after each vaccination. Overall the immunogenicity data suggest that V710 can elicit a sustained immune response in a relatively immunocompromised patient population who are at chronic risk for developing serious S. aureus infections.
Overall, the results of the safety evaluations demonstrated that V710 was generally well tolerated when administered as a single- or multiple-dose regimen at any dosage group studied. There were no vaccine-related serious adverse experiences reported throughout the study duration (Days 1 to 360), and no patients discontinued the study or subsequent vaccinations due to a vaccine-related adverse experience.
Merck plans to present the data at an upcoming medical meeting.
“It is very encouraging to see that the S. aureus vaccine has proven immunogenic and was generally well tolerated in ESRD patients receiving hemodialysis. We are looking forward to the continued progress of the S. aureus program at our strategic partner Merck”, commented Gerd Zettlmeissl, CEO of Intercell.
The S. aureus vaccine candidate is based on a conserved protein antigen discovered by Intercell and licensed to Merck 2004 on an exclusive world wide basis. Merck is responsible for clinical development, manufacturing and marketing. Intercell is eligible to receive milestone payments and royalties on future net sales. In previous studies the S. aureus candidate vaccine was shown to be immunogenic and generally well tolerated.
http://www.intercell.com/main/forvac…ureus-vaccine/
The first critical interim analysis (surpassing futility) are expected for 2011.
it is conceivable that there will be mandates for vaccines against normal skin flora such as staph and strep for school entry soon.
this is so frightening and will lead to many other issues like even more superbugs and eczema as well as disease states we don’t even know of at the moment.
but once a vaccine is approved, it is a matter of time before it is added to the lst of mandates.
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