Effect of reduced dose schedules and intramuscular injection of anthrax vaccine adsorbed on immunological response and safety profile: A randomized trial

Wright, Jean Ann; Plikaytis, Brian D.; Rose, Charles E.; Parker, Scott; Babcock, Janiine; Keitel, Wendy A.; Sahly, Hana M. El; Jacobson, Robert M.; Keyserling, Harry L.; Semenova, Vera; Li, Han; Schiffer, Jarad; Dababneh, Hanan; Martin, Sandra; Martin, Stacey W.; Marano, Nina; Messonnier, Nancy E.; Quinn, Conrad P.

doi:10.1016/j.vaccine.2013.10.039

Cited by 32 publications

(66 citation statements)

References 34 publications

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“…Serological noninferiority analyses for peak anti-PA IgG and lethal toxin neutralization activity (TNA) in response to the 3-IM priming schedule and alternative booster schedules were reported previously, and the safety profile of AVA administered IM in humans was confirmed to be similar to that for other alum-containing vaccines (4)(5)(6). Less frequent AVA injection doses resulted in a reduction in some injection site adverse events (AEs), and IM administration resulted in reduced frequency, duration, and severity of AEs (5)(6)(7)(8)(9)(10)(11). The potential for increasing the intervals between booster doses requires an assessment of sustained antibody functional activity, CMI, and the ability to develop rapid protective anamnestic responses (5,6,12).…”

mentioning

confidence: 63%

“…The study design for the CDC AVRP human clinical trial has been reported in detail previously (6). Laboratory methods and statistical analyses of humoral and CMI responses in humans were by design similar or equivalent to those reported previously for the analogous responses in rhesus macaques (13).…”

Section: Methodsmentioning

confidence: 99%

“…Less frequent AVA injection doses resulted in a reduction in some injection site adverse events (AEs), and IM administration resulted in reduced frequency, duration, and severity of AEs (5)(6)(7)(8)(9)(10)(11). The potential for increasing the intervals between booster doses requires an assessment of sustained antibody functional activity, CMI, and the ability to develop rapid protective anamnestic responses (5,6,12).…”

mentioning

confidence: 99%

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Humoral and Cell-Mediated Immune Responses to Alternate Booster Schedules of Anthrax Vaccine Adsorbed in Humans

Quinn

Sabourin

Schiffer

et al. 2016

Clin Vaccine Immunol

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A nthrax vaccine adsorbed (AVA; BioThrax; Emergent Bio Solutions Inc., Lansing, MI) is the only Food and Drug Administration (FDA)-approved vaccine in the United States for prevention of anthrax in humans. The primary immunogen in AVA is anthrax toxin protective antigen (PA). Serum anti-PA antibody levels are accurate immune correlates of protection in nonhuman primate (NHP) models of inhalation anthrax and for predicted probability of survival in humans (1-3). There is a significant lack of data in humans regarding the onset, duration, quantitative analysis, and functional activity of humoral antibody and cell-mediated immunity (CMI) responses following priming and boosting with AVA.In 2012, the preexposure schedule for AVA was approved as a priming series of three 0.5-ml intramuscular (IM) injections at 0, 1, and 6 months (3-IM) with subsequent boosters at 12 and 18 months and annually thereafter for those at continued risk of infection (http://www.fda.gov/BiologicsBloodVaccines/Vaccines /ApprovedProducts/ucm304758.htm; http://www.fda.gov /downloads/BiologicsBloodVaccines/BloodBloodProducts /ApprovedProducts/LicensedProductsBLAs/UCM074923 .pdf). In 2013, AVA received market approval in the European Union (EU) using a 3-IM priming series and 3-yearly booster schedule (http://emergentbiosolutions.com/sites/default/files /BioThrax_Germany.pdf).These recent changes in the FDA-approved priming schedule and route of administration for AVA and EU approval of an alternate schedule warranted detailed characterization of their immunological impact. Serological noninferiority analyses for peak anti-PA IgG and lethal toxin neutralization activity (TNA) in response to the 3-IM priming schedule and alternative booster schedules were reported previously, and the safety profile of AVA administered IM in humans was confirmed to be similar to that for other alum-containing vaccines (4-6). Less frequent AVA injection doses resulted in a reduction in some injection site adverse events (AEs), and IM administration resulted in reduced frequency, duration, and severity of AEs (5-11). The potential for increasing the intervals between booster doses requires an assessment of sustained antibody functional activity, CMI, and the ability to develop rapid protective anamnestic responses (5,6,12).In a rhesus macaque model of inhalation anthrax, the AVA

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confidence: 63%

Section: Methodsmentioning

confidence: 99%

mentioning

confidence: 99%

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Humoral and Cell-Mediated Immune Responses to Alternate Booster Schedules of Anthrax Vaccine Adsorbed in Humans

Quinn

Sabourin

Schiffer

et al. 2016

Clin Vaccine Immunol

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“…Wright et al 35 In a study with type F botulinum toxoid, Edelman et al 37 reported that subcutaneous nodules were more frequent after primary and booster injection given subcutaneously 64/264 (24%) compared with intramuscularly administered vaccine 4/97 (4.0%).…”

Section: Subcutaneous Nodulesmentioning

confidence: 99%

Best vaccination practice and medically attended injection site events following deltoid intramuscular injection

Cook¹

2015

Human Vaccines & Immunotherapeutics

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Analysis of medically attended injection site events data provides a vehicle to appreciate the inadequacies of vaccination practice for deltoid intramuscular injection and to develop best practice procedures. These data can be divided into 3 groups; nerve palsies, musculoskeletal injuries and cutaneous reactions and reflect inappropriate site of injection, needle over or under penetration, local sepsis and vascular complications. The aim of this review is to formulate best vaccination practice procedures for deltoid intramuscular injection of vaccines through the collation and analysis of medically attended injection site events.

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“…In AVA vaccination specifically, intramuscular rather than subcutaneous administration may reduce the rate of local AEs but does not seem to influence the rate of systemic AEs (20). Additionally, certain types of reactions may be associated with sex, ethnicity, and body mass index (14,16,17).…”

mentioning

confidence: 99%

Unique Inflammatory Mediators and Specific IgE Levels Distinguish Local from Systemic Reactions after Anthrax Vaccine Adsorbed Vaccination

Garman

Smith

Muns

et al. 2016

Clin Vaccine Immunol

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Effect of reduced dose schedules and intramuscular injection of anthrax vaccine adsorbed on immunological response and safety profile: A randomized trial

Cited by 32 publications

References 34 publications

Humoral and Cell-Mediated Immune Responses to Alternate Booster Schedules of Anthrax Vaccine Adsorbed in Humans

Humoral and Cell-Mediated Immune Responses to Alternate Booster Schedules of Anthrax Vaccine Adsorbed in Humans

Best vaccination practice and medically attended injection site events following deltoid intramuscular injection

Unique Inflammatory Mediators and Specific IgE Levels Distinguish Local from Systemic Reactions after Anthrax Vaccine Adsorbed Vaccination

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