A local reaction at or near injection site: Case definition and guidelines for collection, analysis, and presentation of immunization safety data

Gidudu, Jane; Kohl, Katrin; Halperin, Scott A.; Hammer, Sandra Jo; Heath, Paul T; Hennig, Renald; Hoet, Bernard; Rothstein, Edward; Schuind, Anne; Varricchio, Frederick; Walop, Wikke

doi:10.1016/j.vaccine.2008.10.006

Cited by 65 publications

(21 citation statements)

References 35 publications

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“…The local skin reactions (induration, erythema and ulceration) are not surprising for a local immune reaction following intradermal administration [15]. In fact, these local reactions indicate the development of immune responses.…”

Section: Clinical Safetymentioning

confidence: 97%

First clinical results of a personalized immunotherapeutic vaccine against recurrent, incompletely resected, treatment-resistant glioblastoma multiforme (GBM) tumors, based on combined allo- and auto-immune tumor reactivity

Schijns

Pretto²,

Devillers³

et al. 2015

Vaccine

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Glioblastoma multiforme (GBM) patients have a poor prognosis. After tumor recurrence statistics suggest an imminent death within 1-4.5 months. Supportive preclinical data, from a rat model, provided the rational for a prototype clinical vaccine preparation, named Gliovac (or ERC 1671) composed of autologous antigens, derived from the patient's surgically removed tumor tissue, which is administered together with allogeneic antigens from glioma tissue resected from other GBM patients. We now report the first results of the Gliovac treatment for treatment-resistant GBM patients. Nine (9) recurrent GBM patients, after standard of care treatment, including surgery radio- and chemotherapy temozolomide, and for US patients, also bevacizumab (Avastin™), were treated under a compassionate use/hospital exemption protocol. Gliovac was given intradermally, together with human GM-CSF (Leukine(®)), and preceded by a regimen of regulatory T cell-depleting, low-dose cyclophosphamide. Gliovac administration in patients that have failed standard of care therapies showed minimal toxicity and enhanced overall survival (OS). Six-month (26 weeks) survival for the nine Gliovac patients was 100% versus 33% in control group. At week 40, the published overall survival was 10% if recurrent, reoperated patients were not treated. In the Gliovac treated group, the survival at 40 weeks was 77%. Our data suggest that Gliovac has low toxicity and a promising efficacy. A phase II trial has recently been initiated in recurrent, bevacizumab naïve GBM patients (NCT01903330).

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Section: Clinical Safetymentioning

confidence: 97%

First clinical results of a personalized immunotherapeutic vaccine against recurrent, incompletely resected, treatment-resistant glioblastoma multiforme (GBM) tumors, based on combined allo- and auto-immune tumor reactivity

Schijns

Pretto²,

Devillers³

et al. 2015

Vaccine

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“…These local reactions are of minor importance in the general population and typically do not interfere relevantly with business requirements [22–25]. However, this is not necessarily true in athletes.…”

Section: Principles Of Vaccination In Elite Athletesmentioning

confidence: 99%

Vaccination in Elite Athletes

Гартнер

Meyer

2014

Sports Med

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Public health vaccination guidelines cannot be easily transferred to elite athletes. An enhanced benefit from preventing even mild diseases is obvious but stronger interference from otherwise minor side effects has to be considered as well. Thus, special vaccination guidelines for adult elite athletes are required. In most of them, protection should be strived for against tetanus, diphtheria, pertussis, influenza, hepatitis A, hepatitis B, measles, mumps and varicella. When living or traveling to endemic areas, the athletes should be immune against tick-borne encephalitis, yellow fever, Japanese encephalitis, poliomyelitis, typhoid fever, and meningococcal disease. Vaccination against pneumococci and Haemophilus influenzae type b is only relevant in athletes with certain underlying disorders. Rubella and papillomavirus vaccination might be considered after an individual risk–benefit analysis. Other vaccinations such as cholera, rabies, herpes zoster, and Bacille Calmette–Guérin (BCG) cannot be universally recommended for athletes at present. Only for a very few diseases, a determination of antibody titers is reasonable to avoid unnecessary vaccinations or to control efficacy of an individual’s vaccination (especially for measles, mumps, rubella, varicella, hepatitis B and, partly, hepatitis A). Vaccinations should be scheduled in a way that possible side effects are least likely to occur in periods of competition. Typically, vaccinations are well tolerated by elite athletes, and resulting antibody titers are not different from the general population. Side effects might be reduced by an optimal selection of vaccines and an appropriate technique of administration. Very few discipline-specific considerations apply to an athlete’s vaccination schedule mainly from the competition and training pattern as well as from the typical geographical distribution of competitive sites.

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“…Case definition and time limit for onset of each AEFIc were determined. Brighton collaboration case definitions, WHO documents on vaccine pharmacovigilance, and published articles were perused in this process (Table 1) [38][39][40][41][42][43][44][45][46][47][48][49][50]. Using the case definition and onset time limit criteria, two investigators independently went through the data and identified the cases which were within the selected six AEFIc under review.…”

Section: Methodsmentioning

confidence: 99%

Active safety monitoring of measles-mumps-rubella vaccine in the National Immunisation Programme of Sri Lanka

et al. 2017

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Objectives This study was designed to report incidence and characteristics of selected adverse events following immunisation which have consistent causal association (AEFIc) with Measles-Mumps-Rubella (MMR) vaccination given at the age of one year in the National Immunisation Programme of Sri Lanka.Methods The data presented here were obtained from a cohort event monitoring study. It was carried out in the Jaffna Regional Directorate of Health Services area from November 2012 to December 2014. A representative sample of 3002 infants who received MMR immunisation were actively followed up for adverse events (AE) using over the phone interviews, self-reporting, and home or hospital visits up to 45 days. All AEs were reviewed by two investigators independently in two step-wise processes to detect the AEFIc. Seven AEFIc were detected using standard case definitions and onset time limit criteria. They were subjected to further analysis to describe the incidence rates and characteristics.Results Of the 2398 (80%) infants who completed follow up of 45 days, 1321 infants experienced 2621 AEFI. Of them 209 were classified as AEFIc. Incidence of AEFIc was 87/ 1000 immunisation. They were mainly nonserious and resolved completely. There were no fatal or life threatening AEFIs. Incidence per 1000 immunisations; allergic reactions 0.83, injection site reactions 4.58, fever100.4° F or lasting more than  3 days 9.59, macular papular rash 2.92, parotitis 2.92 and generalised convulsions 1.25. ConclusionThe MMR vaccine used in NIP of Sri Lanka had low incidence of AEFIc and were mainly non-serious in nature.

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A local reaction at or near injection site: Case definition and guidelines for collection, analysis, and presentation of immunization safety data

Cited by 65 publications

References 35 publications

First clinical results of a personalized immunotherapeutic vaccine against recurrent, incompletely resected, treatment-resistant glioblastoma multiforme (GBM) tumors, based on combined allo- and auto-immune tumor reactivity

First clinical results of a personalized immunotherapeutic vaccine against recurrent, incompletely resected, treatment-resistant glioblastoma multiforme (GBM) tumors, based on combined allo- and auto-immune tumor reactivity

Vaccination in Elite Athletes

Active safety monitoring of measles-mumps-rubella vaccine in the National Immunisation Programme of Sri Lanka

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