Reduced-Dose Intradermal Vaccination against Hepatitis A with an Aluminum-Free Vaccine Is Immunogenic and Can Lower Costs

Pancharoen, Chitsanu; Mekmullica, Jutarat; Thisyakorn, Usa; Kasempimolporn, Songsri; Wilde, Henry; Herzog, Christian

doi:10.1086/497266

Cited by 33 publications

(16 citation statements)

References 6 publications

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“…Additional studies using rPA doses within the 10-g-to 0.2-g range will be required to further elucidate the potential dose-sparing benefits of the i.d. route, as have been observed for other vaccines (1,2,10,12,20,22).…”

Section: Discussionsupporting

confidence: 67%

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Microneedle-Based Intradermal Delivery of the Anthrax Recombinant Protective Antigen Vaccine

et al. 2006

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The recombinant protective antigen (rPA) of Bacillus anthracis is a promising anthrax vaccine. We compared serum immunoglobulin G levels and toxin-neutralizing antibody titers in rabbits following delivery of various doses of vaccine by microneedle-based intradermal (i.d.) delivery or intramuscular (i.m.) injection using conventional needles. Intradermal delivery required less antigen to induce levels of antibody similar to those produced via i.m. injection during the first 2 weeks following primary and booster inoculation. This dosesparing effect was less evident at the later stages of the immune response. Rabbits immunized i.d. with 10 g of rPA displayed 100% protection from aerosol spore challenge, while i.m. injection of the same dose provided slightly lower protection (71%). Groups immunized with lower antigen doses were partially protected (13 to 29%) regardless of the mode of administration. Overall, our results suggest rPA formulated with aluminum adjuvant and administered to the skin by a microneedle-based device is as efficacious as i.m. vaccination.In the autumn of 2001, anthrax spores were intentionally released through the U.S. mail. This bioterror attack resulted in 11 cases of cutaneous anthrax and 11 cases of inhalational anthrax, 5 of which were fatal (7, 9). There has been an unprecedented level of public and private support for the development of new means of preventing and treating anthrax during the years following these attacks. Although antibiotics are nearly 100% effective in treating the cutaneous form of the disease, the case fatality rate for inhalational anthrax was estimated to be 75% or higher, even in the presence of supportive care and postexposure antibiotic treatment (information found at the CDC website [http://www.bt.cdc.gov/agent/anthrax /faq/signs.asp]). A recombinant form of the Bacillus anthracis protective antigen (rPA) is a candidate for replacement of Anthrax Vaccine Adsorbed (BioThrax), the currently licensed anthrax vaccine. Proposed applications of the rPA vaccine include prophylactic vaccination as well as therapeutic postexposure use in combination with antibiotics (5). Numerous preclinical studies have demonstrated that the rPA vaccine can provide complete protection against lethal inhalational anthrax (4, 8,11,13,14,18,23). Results of phase I clinical trials suggest that the vaccine is safe and immunogenic following intramuscular (i.m.) injection in humans (6).Most licensed and new vaccines under clinical development, including rPA, are administered by i.m. or subcutaneous injection using conventional needles and syringes. However, recent studies demonstrate that vaccine delivery to the skin can increase the magnitude of the immune response and, in some cases, do so using less vaccine than required with i.m. injection (1,2,10,12,(18)(19)(20)22). For example, clinical studies evaluating intradermal (i.d.) delivery of influenza vaccine have suggested that dose sparing relative to i.m. administration can be achieved (1, 10). Although conventional needles can be used...

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Section: Discussionsupporting

confidence: 67%

“…However, recent studies demonstrate that vaccine delivery to the skin can increase the magnitude of the immune response and, in some cases, do so using less vaccine than required with i.m. injection (1,2,10,12,(18)(19)(20)22). For example, clinical studies evaluating intradermal (i.d.)…”

mentioning

confidence: 99%

Microneedle-Based Intradermal Delivery of the Anthrax Recombinant Protective Antigen Vaccine

et al. 2006

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“…The intradermal and intramuscular routes have been extensively compared for licensed vaccines against hepatitis A, hepatitis B, influenza and rabies [36], [37], [38], [39]. Both routes are safe and immunogenic in clinical trials however the generalisability of these findings to other vaccines is limited.…”

Section: Discussionmentioning

confidence: 99%

Comparing the safety and immunogenicity of a candidate TB vaccine MVA85A administered by intramuscular and intradermal delivery

Meyer

Harris

Satti

et al. 2013

Vaccine

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“…41,46,60,61,66,69 For poliovirus vaccine, ID vaccination elicited similar 46 or lower 49 antibody titers as a booster. As a primary series, all but one 46 showed negative data for ID vaccination; antibody titers were lower, 41, 51 and furthermore less seroconversion rates in 2 studies.…”

Section: Potential Drawbacks Of Id Vaccinationmentioning

confidence: 99%

Intradermal vaccination for infants and children

Saitoh

Aizawa

2016

Human Vaccines & Immunotherapeutics

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Intradermal (ID) vaccination induces a more potent immune response and requires lower vaccine doses as compared with standard vaccination routes. To deliver ID vaccines effectively and consistently, an ID delivery device has been developed and is commercially available for adults. The clinical application of ID vaccines for infants and children is much anticipated because children receive several vaccines, on multiple occasions, during infancy and childhood. However, experience with ID vaccines is limited and present evidence is sparse and inconsistent. ID delivery devices are not currently available for infants and children, but recent studies have examined skin thickness in this population and reported that it did not differ in proportion to body size in infants, children, and adults. These results are helpful in developing new ID devices and for preparing new vaccines in infants and children.

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Reduced-Dose Intradermal Vaccination against Hepatitis A with an Aluminum-Free Vaccine Is Immunogenic and Can Lower Costs

Cited by 33 publications

References 6 publications

Microneedle-Based Intradermal Delivery of the Anthrax Recombinant Protective Antigen Vaccine

Microneedle-Based Intradermal Delivery of the Anthrax Recombinant Protective Antigen Vaccine

Comparing the safety and immunogenicity of a candidate TB vaccine MVA85A administered by intramuscular and intradermal delivery

Intradermal vaccination for infants and children

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