Intradermal Sample Clauses

Intradermal administration of one fifth of the amount of yellow fever vaccine administered subcutaneously results in protective seroimmunity in all volunteers. Albeit this vaccination route should enable vaccination of five-times as many individuals at risk for disease, these results should now be confirmed in field studies in areas with potential yellow fever virus transmission to change vaccination policy. Introduction Yellow fever is a re-emerging viral hemorrhagic febrile illness in tropical and sub-tropical areas of Africa and remains a major health threat in South-America. It is estimated to affect 200.000 individuals annually of whom approximately 30.000 die worldwide [1]. The virus is transmitted by infected Aedes mosquitoes, and may cause a wide spectrum of disease, from mild symptoms to severe illness accompanied by fever, hepatic and myocardial injury, renal failure, hemorrhage, and even death. There is no curative treatment for yellow fever, making vector control and vaccination essential ingredients in the prevention of yellow fever morbidity and mortality. Although this flavivirus has never emerged in Asia, the Asian continent is considered vulnerable to future introduction of the virus, because of the presence of a large susceptible human population, the presence of the urban vector and increasing international travel [2]. Also Western countries may be at risk: for instance, in the Netherlands, the Aedes albopictus mosquito was introduced via imported bamboo from China, and its capability of transmission of flaviviruses is currently under investigation. Thus, there is a potential risk for large epidemics of urban yellow fever now that migration of people from rural areas may introduce the virus into areas of high human population density, such as large African and South-American cities. During yellow fever epidemics in non-immune populations, case-fatality rates may be as high as 50% [3]. In case of simultaneous outbreaks in megacities the current emergency stockpile of yellow fever vaccine of 6 million doses will not be sufficient to protect the large populations from the disease [4]. Yellow fever vaccination is the single most important and effective means to prevent the occurrence of yellow fever, and carries a low risk of serious adverse events. The live-attenuated 17D vaccine provides protective immunity within one to two weeks in 95% of those vaccinated [5]. The World Health Organization (WHO) therefore strongly recommends to include yellow fever ...
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Intradermal influenza vaccine is a medically-necessary preventive service for members eighteen (18) to sixty-four (64) years of age when influenza immunization is recommended by the member’s doctor.
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Intradermal. ID injection (unclear) CAF01b Mice Similar (type 1 and 3) or superior VN titers after ID vaccination plus adjuvant and superior IgG titers compared to IM injection. No mucosal IgA (feces) [39] ID injection 1-10; 1-10; 1-10 dmLT Mice Similar VN titers and superior polio- specific IgG titers compared to IM vaccination. Prolonged systemic immunity (VN) Mucosal type 1 and 2-specfic IgA titers (feces and PP) [40] Microneedles (hollow) 5/15;NA;NA NA Rats Polio-specific IgG and VN titers similar to IM and ID vaccination using needle/ syringe [77] Microneedles (hollow; Micronjet600) 2-40; 0,4-8; 1,6-32 (5-100% of shd) NA Rats Superior VN titers for 40% ID with 40% IM and when comparing 40% ID with 100% IM (49 days) [35] Microneedles (coated) 47;9;38 NA Monkeys VN titers similar to IM injection for type 1 and 2, but inferior VN titers for type 3 [38] Microneedles (coated) 45;NA;NA TMC Rats Inferior polio-specific systemic IgG titers compared to IM or ID injection [34] Mucosal (sublingual) Thermoresponsive gels 1.34;0.3;1.1 6.5;1.5;5.5 dmLT Mice No immune responses detected without adjuvant. Inferior VN titers or systemic Ig titers compared to IM injection. Superior mucosal IgA titers (feces, saliva) for SL vaccination (+adjuvant) compared to IM injection [60] Abbreviations used:
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Intradermal adjuvants The necessity of adjuvants to stimulate systemic as well as mucosal immunity has been reported in the preclinical dermal immunization studies for Hepatitis B, HIV, Diphtheria, Cholera and ETEC diarrheal antigens. Two adjuvants have been studied in combination with ID administration of IPV; CAF01 and dmLT (Table 2). CAF01 is a liposomal formulation composed of the cationic lipid DDA (dimethyldioctadecylammonium) and TDB (trehalose-6,6-dibehenate). Xxxxxxxx et al. reported that IPV mixed with CAF01 and administered to mice via ID injection, was able to induce superior polio-specific serum IgG levels and virus-neutralizing titers compared to the non-adjuvated vaccine [39]. No mucosal immunity (XxX in feces) was detected after ID administration alone. However, simultaneous priming of CAF01 adjuvated IPV at an ID and IM site followed by IM boosting induced significant levels of fecal IgA, without compromising serum virus-neutralizing titers [39]. Another study investigated the use of genetically detoxified E. coli heat-labile toxin (dmLT) as adjuvant for IPV administered via IM or ID injection in mice [40]. Intradermal vaccination with a fractional IPV-dose combined with dmLT as adjuvant, elicited serum virus-neutralizing antibody titers similar to those obtained by non-adjuvated IPV given via IM injection leading to a five-fold dose sparing. The duration of the systemic antibody responses was prolonged for the mice vaccinated with IPV adjuvated with dmLT either via IM or ID delivery. Moreover, dmLT enhanced mucosal immunity as defined by fecal and intestinal polio-specific IgA secretion, when mixed with IPV and given IM or ID [39]. CHAPTER 2 Table 3 Clinical trials investigating the intradermal (ID) route for vaccination with inactivated poliovirus vaccine (IPV). Volume IPV dose Seroconversion (%) Study (year) Vaccine Age N Route Administration (mL) (DU) Schedule Type 1 Type 2 Type 3 Ref T1;T2;T3 India (1998) Imovax Polio 6, 14 w or 6, 10, 14 w 69 ID Mantoux injection 0.1 8;1.6;6.4 2 doses 3 doses 90 90 70 80 97 98 [22] Oman (2010) Poliorix 2, 4, 6 mo 186 IM Needle & syringe 0.5 40;8;32 1 dose 22 32 45 [27] 2 doses 88 86 92 3 doses 100 100 100 187 ID Jet injector (Biojector 0.1 8;1.6;6.4 1 dose 10 17 9 2000) 2 doses 70 72 72 3 doses 97 96 98 Cuba (2010) SSI, Denmark 6, 10, 14 w 177 IM Needle & syringe 0.5 40;8;32 1 dose 19 36 42 [26] 2 doses 63 76 93 3 doses 89 96 99 187 ID Jet injector (Biojector 0.1 8;1.6;6.4 1 dose 5 19 8 2000) 2 doses 21 55 43 3 ...
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Intradermal injections
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Intradermal vaccination The mean diameter of the arisen cutaneous wheal measured after vaccination was 8 mm (range 7-10 mm), indicating that all i.d. vaccinations (N=85) were performed correctly according to our standard. Immunogenicity after primary and booster vaccination Primary i.d. vaccination with PCECV in a three-dose 0.1 mL regimen induced antibody titres ≥0.5 EU/mL in 25/25 participants. Booster vaccination with one dose 0.1 mL PCECV induced protective titres in 10/10 participants (table 1). The geometric mean titre (GMT) after booster vaccination was significantly higher when compared to the GMT following primary vaccination (p = 0.02), indicating a good anamnestic response. Half of the boostered participants showed an antibody titre above 30 EU/mL (table 1), which is considered predictive for a longer duration of seroconversion after i.m. vaccination [17]. Correlation between immunogenicity after primary and booster vaccination The divergent antibody responses to primary and even more to booster vaccination (ranges 2.9 – 52.4 EU/mL and 3.9 – 94.0 EU/mL, respectively), allowed to investigate if a high immunologic response after primary vaccination could predict a high Table 1 Immunogenicity after (3-dose) i.d. primary and (1-dose) i.d. booster vaccination with PCECV (0.1mL/dose) EU/mL EU/mL Primary Day 0 0.0 - - - 0/25 - Day 42 10.7 2.9 52.4 8.3 – 13.1 25/25 4/25 Booster Day 550 0.9 0.2 2.5 0.0 – 3.4 8/10 0/10 Day 7 PB 4.8 0.9 19.0 2.1 – 7.5 10/10 0/10 Day 14 PB 23.9 3.9 94.0 21.2 – 26.6 10/10 5/10 Vaccination Time after vaccination GMT Minimum Maximum 95% CI of n/N n/N (EU/mL) (EU/mL) the GMT titre>0.5 titre>30 Booster vaccination was performed approximately 1.5 years after primary vaccination (day 550, or day 0 PB). PB = post booster vaccination response after booster vaccination. However, no correlation was observed (coefficient = 0.2, p = 0.6) (data not shown) when logarithmically transformed antibody titres after primary vaccination were plotted against the titres after booster vaccination. This lack of intra-individual consistency as far as the height of the antibody response after vaccination is concerned, is demonstrated by the multiple crossing lines (figure 1). Safety of primary and booster vaccination Local erythema and swelling at the site of injection occurred in 96% of participants after primary vaccination and in all subjects after booster vaccination. A trend towards more severe local adverse events was documented after booster vaccination, e...
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