Parameters potentially affecting interpretation of immunogenicity and efficacy data in vaccine trials: are they adequately reported?

Poirier, Maria K.; Jacobson, Robert M.

doi:10.1016/0264-410x(95)00170-6

Cited by 30 publications

(15 citation statements)

References 16 publications

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“…Manufacturers of vaccines and medications specify the route and injection site based on route and site used in clinical trials, but they rarely state patient weight or gender of the studied population and instrument data such as needle length. [27,28] Another manufacturing problem is the "one size fits all" auto injectors used with medications such as epinephrine. The typical needles used in these injectors are often too short to reach muscle in heavier populations, including women and children.…”

Section: Injection Depthmentioning

confidence: 99%

Evidence calls for practice change in intramuscular injection techniques

Strohfus

Paugh²,

Tindell³

et al. 2017

JNEP

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Background and Objective: Intramuscular (IM) injections are administered to patients in all health care settings. Even though this procedure is invasive and the evidence supporting the process of administration is extensive, techniques and procedures vary throughout the literature and in practice. The purpose of this descriptive correlational study was to 1) investigate the literature on current evidence-based IM injection procedures pertaining to gender, patient weight, injection site, needle length, and technique, 2) compare surveyed healthcare personnel self-reported IM injection practices, and 3) query respondents on informational resources they access, continuing education they receive, and their years of healthcare experience and higher education. Methods: The Intramuscular Injection Questionnaire (IIQ) was sent via email to various professional healthcare facilities and their respective social media sites. Two hundred and six (206) healthcare personnel of various healthcare backgrounds and educational levels accessed the IIQ via a link to Qualtrics software. SPSS Version 24 was used for data analysis. Results: Most respondents were registered nurses with 4 -15+ years of experience. Seventy-eight percent of respondents considered their IM injection knowledge at above average or expert levels. Gender was not considered an important factor when selecting an injection needle among 75% of participants. Of all respondents, 61% use z-track technique, 59% use the ventrogluteal site and 34% always bunch or stretch the skin during injection. IM injection education was not provided in 75% of healthcare facilities. Conclusions: IM injection practices vary among respondents and in the literature; some reported practices are contrary to current evidence-based practice. While the evidence provides some sound recommendations, some procedures are not well-documented or supported including in nursing texts. Nurses and other healthcare personnel must critically analyze the site, depth, needle, volume, medication, vaccine, and whether to bunch or stretch, according to evidence-based practice. Healthcare facilities should provide IM injection education routinely to ensure safe practices. Future studies (Level 1 and 2) are needed to further demonstrate the best evidence leading to safe and effective IM injections.

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Section: Injection Depthmentioning

confidence: 99%

Evidence calls for practice change in intramuscular injection techniques

Strohfus

Paugh²,

Tindell³

et al. 2017

JNEP

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“…Evidence based route of administration of vaccines Route of administration is a poorly developed area of vaccinology with Poirier et al 60 observing in a review of 83 vaccine trials that 59% described the anatomic injection site, 24% utilizing intramuscularly administered vaccines recorded needle length and only 10% described the injection technique used.…”

Section: © 2 0 0 8 L a N D E S B I O S C I E N C E D O N O T D I S mentioning

confidence: 99%

Evidence based route of administration of vaccines

Cook¹

2008

Human Vaccines

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“…13 Numerous factors are known to influence the immunogenicity of a yellow fever vaccine, including handling conditions, particularly a poor cold chain, dose (possibility of a prozone effect in which too high a dose of yellow fever attenuated virus may lead to reduced immunogenicity), injection site, route of administration, and subject characteristics. 14 It would thus seem worthwhile to verify the immunogenicity of these vaccines on a regular basis using rigorous clinical trial methodology.…”

mentioning

confidence: 99%

Comparison of the immunogenicity and safety of two 17D yellow fever vaccines.

Lang

Zuckerman²,

Clarke³

et al. 1999

The American Journal of Tropical Medicine and Hygiene

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Abstract. As part of the clinical validation process of a new working seed of a licensed yellow fever vaccine (new working seed PV26, Stamaril; Pasteur Mérieux Connaught, Lyon, France), the immunogenicity and safety of two batches of this vaccine (PM-YF) were compared with those of another commercially available vaccine (Arilvax; Evans Medical-Wellcome, Liverpool, United Kingdom) in 211 healthy adults. While the geometric mean titer values at days 10-14 and day 28 after vaccination were higher in the PM-YF group, the vaccines provided equivalent seroprotection (titers Ն1/10) one month after a single vaccine dose (100% PM-YF versus 99% W-YF; P ϭ 0.001, by one-sided equivalence test). Both vaccines were safe. There were no serious local or systemic reactions reported, nor any clinically significant hepatic function abnormalities associated with the use of either vaccine. These two 17D yellow fever vaccines from different European vaccine manufacturers were highly immunogenic and safe, and provided equivalent seroprotection.Yellow fever is a viral tropical disease, occurring endemically, with periodic epidemics, in the Americas and Africa. The yellow fever virus, a member of the Flavivirus family, is mosquito borne, and in humans produces a clinical disease characterized by sudden onset of fever, followed by hepatorenal dysfunction and hemorrhage. Epidemics can be associated with attack rates of 33% and mortality rates of more than 75%.

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Parameters potentially affecting interpretation of immunogenicity and efficacy data in vaccine trials: are they adequately reported?

Cited by 30 publications

References 16 publications

Evidence calls for practice change in intramuscular injection techniques

Evidence calls for practice change in intramuscular injection techniques

Evidence based route of administration of vaccines

Comparison of the immunogenicity and safety of two 17D yellow fever vaccines.

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