Effects of a Reduced Dose Schedule and Intramuscular Administration of Anthrax Vaccine Adsorbed on Immunogenicity and Safety at 7 Months&lt;subtitle&gt;A Randomized Trial&lt;/subtitle&gt;

Marano, Nina; Plikaytis, Brian D.; Martin, Stacey W.; Rose, Charles E.; Semenova, Vera; Martin, Sandra; Freeman, Alison; Li, Han; Mulligan, Mark J.; Parker, Scott; Babcock, Janiine; Keitel, Wendy A.; Sahly, Hana M. El; Poland, Gregory A.; Jacobson, Robert M.; Keyserling, Harry L.; Soroka, Stephen; Fox, Sarah P.; Stamper, John L.; McNeil, Michael M.; Perkins, Bradley A.; Messonnier, Nancy E.; Quinn, Conrad P.

doi:10.1001/jama.300.13.1532

Cited by 93 publications

(103 citation statements)

References 34 publications

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“…F > M Marano et al 66 n = 1005; 505 M, 500 F. Warmth, tenderness, itching, pain, arm motion, Age 30-61 years, mean age 38.4 yrs erythema, induration, oedema, nodules.…”

Section: Anthrax Vaccinementioning

confidence: 99%

Sex differences in injection site reactions with human vaccines

Cook¹

2009

Human Vaccines

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“…F > M Marano et al 66 n = 1005; 505 M, 500 F. Warmth, tenderness, itching, pain, arm motion, Age 30-61 years, mean age 38.4 yrs erythema, induration, oedema, nodules.…”

Section: Anthrax Vaccinementioning

confidence: 99%

Sex differences in injection site reactions with human vaccines

Cook¹

2009

Human Vaccines

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“…This is an especially important issue because complex immunization regimens comprising many immunizations (for instance, 7 in the AIDSVAX trials and 6 in the RV144 trial) are unlikely to be brought to market. Yet simple modifications in the number, timing, or sequence of heterologous vectors can have a major impact on immunogenicity (23,24). Such modifications offer a lot of potential, as they can be tested quite easily without again performing safety analyses if the individual components have already been assessed.…”

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confidence: 99%

Potential To Streamline Heterologous DNA Prime and NYVAC/Protein Boost HIV Vaccine Regimens in Rhesus Macaques by Employing Improved Antigens

Asbach

Kliche

Köstler

et al. 2016

J Virol

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In a follow-up to the modest efficacy observed in the RV144 trial, researchers in the HIV vaccine field seek to substantiate and extend the results by evaluating other poxvirus vectors and combinations with DNA and protein vaccines. Earlier clinical trials (EuroVacc trials 01 to 03) evaluated the immunogenicity of HIV-1 clade C GagPolNef and gp120 antigens delivered via the poxviral vector NYVAC. These showed that a vaccination regimen including DNA-C priming prior to a NYVAC-C boost considerably enhanced vaccine-elicited immune responses compared to those with NYVAC-C alone. Moreover, responses were improved by using three as opposed to two DNA-C primes. In the present study, we assessed in nonhuman primates whether such vaccination regimens can be streamlined further by using fewer and accelerated immunizations and employing a novel generation of improved DNA-C and NYVAC-C vaccine candidates designed for higher expression levels and more balanced immune responses. Three different DNA-C prime/NYVAC-C؉ protein boost vaccination regimens were tested in rhesus macaques. All regimens elicited vigorous and well-balanced CD8 ؉ and CD4 ؉ T cell responses that were broad and polyfunctional. Very high IgG binding titers, substantial antibody-dependent cellular cytotoxicity (ADCC), and modest antibody-dependent cell-mediated virus inhibition (ADCVI), but very low neutralization activity, were measured after the final immunizations. Overall, immune responses elicited in all three groups were very similar and of greater magnitude, breadth, and quality than those of earlier EuroVacc vaccines. In conclusion, these findings indicate that vaccination schemes can be simplified by using improved antigens and regimens. This may offer a more practical and affordable means to elicit potentially protective immune responses upon vaccination, especially in resource-constrained settings. IMPORTANCEWithin the EuroVacc clinical trials, we previously assessed the immunogenicity of HIV clade C antigens delivered in a DNA prime/NYVAC boost regimen. The trials showed that the DNA prime crucially improved the responses, and three DNA primes with a NYVAC boost appeared to be optimal. Nevertheless, T cell responses were primarily directed toward Env, and humoral responses were modest. The aim of this study was to assess improved antigens for the capacity to elicit more potent and balanced responses in rhesus macaques, even with various simpler immunization regimens. Our results showed that the novel antigens in fact elicited larger numbers of T cells with a polyfunctional profile and a good Env-GagPolNef balance, as well as high-titer and Fc-functional antibody responses. Finally, comparison of the different schedules indicates that a simpler regimen of only two DNA primes and one NYVAC boost in combination with protein may be very efficient, thus showing that the novel antigens allow for easier immunization protocols.

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“…A nthrax vaccine adsorbed (AVA; BioThrax) was licensed in the United States in 1970 for prevention of anthrax in humans (30,37,56,58). AVA is prepared from sterile culture filtrates of the toxigenic, nonencapsulated Bacillus anthracis strain V770-NP1-R grown under microaerophilic conditions in a chemically defined protein-free medium.…”

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confidence: 99%

“…injections, at 0, 1, and 6 months, with subsequent boosters at 12 and 18 months and annually thereafter for those at continued risk of infection (http://www.fda.gov/BiologicsBlood Vaccines/Vaccines/ApprovedProducts/ucm304758.htm). These and other recent changes in the use of AVA subsequent to the 1970 schedule were based on data from the Centers for Disease Control and Prevention (CDC) Anthrax Vaccine Research Program (AVRP) (30). The AVRP comprised a phase 4 human clinical trial to assess the safety and serological noninferiority of reduced schedules and parenteral AVA injection.…”

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confidence: 99%

A Three-Dose Intramuscular Injection Schedule of Anthrax Vaccine Adsorbed Generates Sustained Humoral and Cellular Immune Responses to Protective Antigen and Provides Long-Term Protection against Inhalation Anthrax in Rhesus Macaques

Quinn¹,

Sabourin²,

Niemuth³

et al. 2012

Clin. Vaccine Immunol.

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05). PA-specific gamma interferon (IFN-␥) and interleukin-4 (IL-4) CD4؉ cell frequencies and T cell stimulation indices were sustained through 50.5 months (the last time point measured). PA-specific memory B cell frequencies were highly variable but, in general, were detectable in peripheral blood mononuclear cells (PBMC) by 2 months, were significantly above control levels by 7 months, and remained detectable in the HuAVA and 1:5 and 1:20 AVA groups through 42 months (the last time point measured). HuAVA and diluted AVA elicited a combined Th1/Th2 response and robust immunological priming, with sustained production of high-avidity PA-specific functional antibody, long-term immune cell competence, and immunological memory (30 months for 1:20 AVA and 52 months for 1:10 AVA). Vaccinated animals surviving inhalation anthrax developed high-magnitude anamnestic anti-PA IgG and TNA responses.

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Effects of a Reduced Dose Schedule and Intramuscular Administration of Anthrax Vaccine Adsorbed on Immunogenicity and Safety at 7 Months<subtitle>A Randomized Trial</subtitle>

Cited by 93 publications

References 34 publications

Sex differences in injection site reactions with human vaccines

Sex differences in injection site reactions with human vaccines

Potential To Streamline Heterologous DNA Prime and NYVAC/Protein Boost HIV Vaccine Regimens in Rhesus Macaques by Employing Improved Antigens

A Three-Dose Intramuscular Injection Schedule of Anthrax Vaccine Adsorbed Generates Sustained Humoral and Cellular Immune Responses to Protective Antigen and Provides Long-Term Protection against Inhalation Anthrax in Rhesus Macaques

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