panflu Stats Forum Indexpanflu Stats
Influenza Pandemic Science, Statistics and News
 
 FAQFAQ   SearchSearch   MemberlistMemberlist   UsergroupsUsergroups   RegisterRegister 
 ProfileProfile   Log in to check your private messagesLog in to check your private messages   Log inLog in            Calendar

NEWS:
Phase II results for an adjuvanted H5N1 pandemic vax

 
Post new topic   Reply to topic    panflu Stats Forum Index -> Vaccine Development
View previous topic :: View next topic  
Author Message
Mixin



Joined: 15 Dec 2007
Posts: 1419
:


Items

PostPosted: Sun Mar 22, 2009 10:53 pm    Post subject: Phase II results for an adjuvanted H5N1 pandemic vax Reply with quote

Clinical Infectious Diseases April 2009;48:1087-1095

Generally, higher immune responses were elicited in participants vaccinated 28 days apart than those vaccinated 14 days apart.

Conclusions
The inactivated, aluminum-adjuvanted, whole-virion H5N1 vaccine not only showed good immunogenicity and safety but also elicited significant cross-reactivity against heterologous H5N1 strains in clade 2.

Background
Avian influenza A virus H5N1 has the potential to cause a pandemic. Adjuvants and whole-virion vaccines are regarded as antigen sparing for pandemic vaccines.

Methods
A double-blind, randomized trial was performed from 28 August to 22 December 2007 in 402 adults; 301 adults were randomly assigned to receive 2 doses of an inactivated, aluminum-adjuvanted, whole-virion H5N1 vaccine containing 5, 10, or 15 ug of hemagglutinin per dose 28 days apart, and 101 of them received 2 doses of 10 ug of vaccine 14 days apart. The vaccine was manufactured from the recombinant A/Vietman/1194/2004 (NIBRG14) strain. Blood samples were collected for hemagglutination inhibition and microneutralization assays.

Results
All formulations were well tolerated, with no serious adverse events. Most local and systemic reactions were mild or moderate. Immune responses were induced after 1 dose in all vaccination groups. The highest immune response was seen after 2 doses of 15 ug of vaccine, with 90% and 100% seroconversion rates and 90% and 100% of participants having a titer of 1:40 for hemagglutination inhibition and microneutralization assays, respectively. Both the 10 and 15 ug doses met or exceeded European Union licensure criteria.

Cross-reaction assays showed that after 2 doses of 10 ug of vaccine, 98% and 87% of participants had a microneutralization titer of 1:40 against heterologous Indonesia and Anhui strains, respectively.

Trial registration.ClinicalTrials.gov identifier: NCT00535665.
http://www.journals.uchicago.edu/doi/abs/10.1086/597401
_________________
https://twitter.com/mixin1771
Back to top
View user's profile Send private message
Display posts from previous:   
Post new topic   Reply to topic    panflu Stats Forum Index -> Vaccine Development All times are GMT
Page 1 of 1

 
Jump to:  
You cannot post new topics in this forum
You cannot reply to topics in this forum
You cannot edit your posts in this forum
You cannot delete your posts in this forum
You cannot vote in polls in this forum
panflu Stats topic RSS feed 


Powered by phpBB © 2001, 2005 phpBB Group
FREE FORUM HOSTING by AtFreeForum. Terms of Service - Privacy Policy
FASHION ACCESSORIES - BLING BLING - LADIES WATCHES - KOREAN CHILDREN CLOTHING - ONLINE BARGAIN STORE - FASHION JEWELLERIES