Double-blind study comparing the immunogenicity of a licensed DTwPHib-CRM197 conjugate vaccine (Quattvaxem™) with three investigational, liquid formulations using lower doses of Hib-CRM197 conjugate

Tamm, Eda; Veronese, Alessandra; Contorni, Mario; Meriste, Sirli; Nacci, Pantaleo; Viviani, Simonetta

doi:10.1016/j.vaccine.2004.09.028

Cited by 17 publications

(8 citation statements)

References 10 publications

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“…While the incidence of local adverse events was slightly higher for the combination vaccine, the overall burden of local reactions is obviously lower with the combination vaccine, which eliminates the need for two separate injections. In addition, although direct comparisons are not possible due to differences in data collection and analysis methods, adverse event rates either similar to or higher than the ranges found in the present study have been reported elsewhere for the DTPw-Hib vaccine (Quattvaxem ® ), 27 which is a component of the pentavalent vaccine, and also for another liquid pentavalent vaccine formulation. 25 This is the first study assessing the safety and immunogenicity of this new DTPw-HepB-Hib combination vaccine.…”

Section: Discussionsupporting

confidence: 73%

“…High maternal anti-PRP titers are also common, as observed in countries with low coverage for Hib vaccination. 18,27 Our results indicate that the immunoresponse to the investigational DTPw-HepBHib combination vaccine is not negatively influenced by the presence of high maternal antibody titers.…”

Section: Discussionmentioning

confidence: 60%

“…This variability has been observed for the same Hib-CRM 197 conjugate vaccine used as either monovalent vaccine or in combination with the same DTPw vaccine incorporated into the DTPw-HepB-Hib formulation. 18,27 Despite this variability, anti-PRP seroprotection rates were consistently close to 100% with antibody titers well above protective levels.…”

Section: Discussionmentioning

confidence: 99%

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Safety and Immunogenicity of a New Fully Liquid DTPw-HepB-Hib Combination Vaccine in Infants

Kara¹,

Demiralp²,

Contorni³

et al. 2006

Human Vaccines

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We assessed the safety and immunogenicity of a fully liquid, DTPw-HepB-Hib combination vaccine (Quinvaxem TM ) in comparison with separately administered DTPw-Hib and hepatitis B vaccines. Infants participating in this open-label, randomized, phase II study received a primary vaccination course using a 2-3-4 month schedule. Blood samples were taken immediately prior to the first and one month after the third vaccination. Adverse events were assessed over a 7-day post-vaccination period using subject diaries. After completion of the primary vaccination course, 94.7% [95% CI: 89.8-97.7%] of infants receiving the combination vaccine achieved protective anti-HBs antibody titers (≥10 mIU/mL) with a mean 39-fold increase in GMTs in comparison with 99.3% [95% CI: 96.3-100%] seroprotection and a mean 29-fold GMT increase in the comparator group. Diphtheria, tetanus and Haemophilus influenzae type b (Hib) seroprotection rates and pertussis seroconversion rates were also similar between the two groups. There was no statistically significant difference in GMTs for diphtheria between the two groups, but significant differences were shown for tetanus, Hib, and pertussis with higher GMTs for each antigen observed in the comparator group. The combination vaccine was well tolerated, with fever (body temperature ≥38˚C) being the most frequently reported adverse event in both the DTPw-HepB-Hib (12.5% [95% CI: 7.7-18.8%]) and comparator (12.6% [95% CI: 7.7-19.0%]) groups. This study demonstrated that the fully liquid DTPw-HepB-Hib combination vaccine has safety and immunogenicity profiles similar to the DTPw-Hib and hepatitis B vaccines when administered separately.

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Section: Discussionsupporting

confidence: 73%

Section: Discussionmentioning

confidence: 60%

Section: Discussionmentioning

confidence: 99%

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Safety and Immunogenicity of a New Fully Liquid DTPw-HepB-Hib Combination Vaccine in Infants

Kara¹,

Demiralp²,

Contorni³

et al. 2006

Human Vaccines

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“…High maternal anti-PRP concentrations were previously reported from countries with low coverage for Hib vaccination. [6][7][8] There was an appreciable increase in Hib antibody titers observed after vaccination, indicating a good immune response to the Hib component of the DTwP-HepB-Hib vaccine.…”

Section: Resultsmentioning

confidence: 97%

A phase III single arm, multicenter, open-label study to assess the immunogenicity and tolerability of a pentavalent DTwP–HepB–Hib vaccine in indian infants

Eregowda

Lalwani

Chatterjee

et al. 2013

Human Vaccines & Immunotherapeutics

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“…This 58.4 kDa protein is a licensed carrier for childhood vaccines and has been shown to be safe and effective in numerous clinical trials [22][23][24][25]. We also evaluated antibody responses of …”

Section: Introductionmentioning

confidence: 99%

Characterization of Citrobacter sp. line 328 as a source of Vi for a Vi-CRM197 glycoconjugate vaccine against Salmonella Typhi

Rondini

Micoli

Lanzilao

et al. 2012

J Infect Dev Ctries

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Introduction: Salmonella enterica serovar Typhi is the causative agent of typhoid fever with over 22 million cases and over 200,000 deaths reported annually. A vaccine is much needed for use in young children and the Novartis Vaccines Institute for Global Health (NVGH) is developing a conjugate vaccine which targets S. Typhi Vi capsular polysaccharide. Methodology: Here we describe a method suitable for industrial scale production of the Vi antigen based on expression by a Citrobacter line. We optimized the production of Vi by selecting a suitable Citrobacter strain (Citrobacter 328) that yields high and stable expression of Vi in chemically defined medium under industrial-scale fermentation conditions. Results: Vi-CRM 197 made using Vi from Citrobacter 328 elicited high anti-Vi antibody levels in mice and rabbits. Conclusions: Citrobacter 328 is a suitable strain for production of Vi for conjugate anti-Typhi vaccines. Being a BSL-1 organism, which grows in defined medium and stably produces high yields of Vi, it offers excellent potential for the safe production of inexpensive vaccines for populations at risk of typhoid fever.

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Double-blind study comparing the immunogenicity of a licensed DTwPHib-CRM197 conjugate vaccine (Quattvaxem™) with three investigational, liquid formulations using lower doses of Hib-CRM197 conjugate

Cited by 17 publications

References 10 publications

Safety and Immunogenicity of a New Fully Liquid DTPw-HepB-Hib Combination Vaccine in Infants

Safety and Immunogenicity of a New Fully Liquid DTPw-HepB-Hib Combination Vaccine in Infants

A phase III single arm, multicenter, open-label study to assess the immunogenicity and tolerability of a pentavalent DTwP–HepB–Hib vaccine in indian infants

Characterization of Citrobacter sp. line 328 as a source of Vi for a Vi-CRM197 glycoconjugate vaccine against Salmonella Typhi

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