About: Safety and immunogenicity of a virus-like particle pandemic influenza A (H1N1) 2009 vaccine in a blinded, randomized, placebo-controlled trial of adults in Mexico

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About: Safety and immunogenicity of a virus-like particle pandemic influenza A (H1N1) 2009 vaccine in a blinded, randomized, placebo-controlled trial of adults in Mexico Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : wasabi.inria.fr associated with source document(s)

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Safety and immunogenicity of a virus-like particle pandemic influenza A (H1N1) 2009 vaccine in a blinded, randomized, placebo-controlled trial of adults in Mexico
Creator	Allende, María Arriaga-Pizano, Lourdes Arteaga-Ruiz, Oscar Connolly, Kevin Ferat-Osorio, Eduardo Glenn, Gregory Isibasi, Armando Lenhard, Kathy López-Macías, Constantino Pincus, Steven Raghunandan, Ramadevi Smith, Gale Talavera, Juan Tenorio-Calvo, Alejandra Hickman, Somia
Source	Elsevier; Medline; PMC
abstract	Abstract Virus-like particles (VLPs) can be rapidly developed from influenza virus genetic sequences in order to supply vaccine after the onset of a pandemic. The safety and immunogenicity of one or two doses of a recombinant A (H1N1) 2009 influenza VLP vaccine was evaluated in a two-stage, Phase 2, randomized, double-blind, placebo-controlled study conducted in 4563 healthy adults, 18–64 years of age, during the H1N1 2009 pandemic in Mexico. In Part A, 1013 subjects were randomized into four treatment groups (5μg, 15μg, or 45μg hemagglutinin [HA] VLP vaccine or placebo) and vaccinated 21 days apart, with sera collected on Days 1, 14 and 36 for hemagglutination inhibition (HAI) testing. After review of safety and immunogenicity data from Part A, additional subjects were immunized with a single dose of 15μg VLP vaccine (N =2537) or placebo (N =1011) and assessed for safety in Part B. Results showed the H1N1 2009 VLP vaccine was safe and well-tolerated. Systemic solicited events were similar between placebo and VLP vaccinated groups with no vaccine-related serious adverse events. Dose response trends for solicited local adverse events were observed, with higher incidences of local pain, swelling, tenderness, and redness reported in the higher VLP dose groups (15μg and 45μg) compared to the placebo and 5μg VLP groups following both vaccinations. Although the majority of local AEs were mild in severity, a dose trend in events of moderate or greater severity was also noted for these solicited events. The VLP vaccine groups demonstrated robust HAI immune responses after a single vaccination, with high rates of seroprotection (≥40 HAI titer) in 82–92% of all subjects and in 64–85% of subjects who were seronegative at the time of immunization. HAI geometric mean titers (GMTs), geometric mean ratios (GMRs) and seroconversion rates were also all statistically higher in the VLP groups compared to placebo for both post-baseline time points. Based on these data, additional clinical trials are in development to evaluate influenza vaccine candidate antigens manufactured using Spodoptera frugiperda (Sf9)/baculovirus-based VLP technology.
has issue date	2011-10-13(xsd:dateTime)
bibo:doi	10.1016/j.vaccine.2011.07.099
bibo:pmid	21816199
has license	els-covid
sha1sum (hex)	b99136512970c5ad4257f21b5ac40218654de94b
schema:url	https://doi.org/10.1016/j.vaccine.2011.07.099
resource representing a document's title	Safety and immunogenicity of a virus-like particle pandemic influenza A (H1N1) 2009 vaccine in a blinded, randomized, placebo-controlled trial of adults in Mexico
has PubMed Central identifier	PMC7126971
has PubMed identifier	21816199
schema:publication	Vaccine
resource representing a document's body	covid:b99136512970c5ad4257f21b5ac40218654de94b#body_text
is schema:about of	named entity 'pain' named entity 'response' named entity 'vaccine' named entity 'influenza' named entity 'Systemic' named entity 'seroconversion' named entity 'Although' named entity 'immunization' named entity 'developed' named entity 'vaccine' named entity 'TENDERNESS' named entity 'MODERATE' named entity 'INCIDENCES' named entity 'TIME' named entity 'EVENTS' named entity 'SERONEGATIVE' named entity '4563' named entity 'RELATED' named entity 'HIGH' named entity 'INFLUENZA VIRUS' named entity 'ANTIGENS' named entity 'BASED' named entity 'GEOMETRIC MEAN' named entity '1011' named entity 'HEALTHY' named entity 'BLIND' named entity 'STAGE' named entity 'IMMUNE RESPONSES' named entity 'DAYS' named entity 'SIMILAR' named entity 'DEVELOPMENT' named entity 'ALL SUBJECTS' named entity 'THESE' named entity 'SERA' named entity 'HEMAGGLUTINATION INHIBITION' named entity 'HEMAGGLUTININ' named entity 'TO SUPPLY' named entity 'RAPIDLY' named entity 'EVALUATED' named entity 'VACCINATION' named entity 'TRENDS' named entity 'MAJORITY' named entity 'FOLLOWING' named entity 'VACCINE CANDIDATE' named entity 'USING' named entity 'REPORTED' named entity 'COLLECTED' named entity 'SEROCONVERSION' covid:arg/b99136512970c5ad4257f21b5ac40218654de94b named entity 'MEXICO' named entity 'ADULTS' named entity 'IMMUNOGENICITY' named entity 'ORDER' named entity 'VACCINATED' named entity 'GENETIC' named entity 'VIRUS-LIKE PARTICLES' named entity 'PAIN' named entity 'TREATMENT' named entity 'TREND' named entity 'DOUBLE' named entity 'RANDOMIZED' named entity 'VACCINATIONS' named entity 'SEQUENCES' named entity 'MILD' named entity 'REDNESS' named entity 'SYSTEMIC' named entity 'SAFE'

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