| Title |
A randomized, controlled clinical trial to evaluate the immunogenicity of a PreS/S hepatitis B vaccine Sci-B-Vac™, as compared to Engerix B®, among vaccine naïve and vaccine non-responder dialysis patients
|
|---|---|
| Published in |
Clinical and Experimental Nephrology, April 2017
|
| DOI | 10.1007/s10157-017-1416-7 |
| Pubmed ID | |
| Authors |
E. Elhanan, M. Boaz, I. Schwartz, D. Schwartz, G. Chernin, H. Soetendorp, A Gal Oz, A. Agbaria, T. Weinstein |
| Abstract |
Dialysis patients have a suboptimal response to hepatitis B (HBV) vaccination. This study aimed to compare the immunogenicity of two vaccines: the third-generation Sci-B-Vac™ vs. the second-generation Engerix B(®). The cohort included two groups of dialysis patients: naïve and previously vaccinated non-responders. Primary endpoints were antibody titers ≥10 IU/L at 3 and 7 month post-vaccination. Secondary objectives were seroprotection rates in vaccine-naïve patients and in previously vaccinated non-responders. Eighty-six patients were assigned to vaccine (Sci-B-Vac™ or Engerix B(®)) using computer-generated randomization, stratified by age, gender, diabetes, and previous HBV vaccination. Sci-B-Vac™ was administered in three doses, 10 μg, at 0, 1, and 6 months in naïve patients; or 20 μg in previously vaccinated non-responders. Engerix B(®) included four doses, 40 μg at 0, 1, 2, and 6 months. Each group had 43 patients. Seroconversion was 69.8% with Engerix B(®) vs. 73.2% with Sci-B-Vac™. Antibody titers at 7 months were higher with Sci-B-Vac™ (266.4 ± 383.9, median 53.4) than with Engerix(®) (193.2 ± 328.9, median 19). However, these differences were not significant, perhaps due to a suboptimal sample size. This study suggests comparable immunogenicity for both vaccines. Thus, we cannot reject the null hypothesis that there is no difference in seroconversion by vaccine type. It is noteworthy that naïve patients were vaccinated with a standard dose of Sci-B-Vac™, while Engerix B(®) was administered at a double dose. Similarly, although mean antibody titer levels in the Sci-B-Vac™ group were higher than in the Engerix(®) group, this difference did not reach significance. Consequently, a future clinical trial should recruit a larger cohort of patients, using a standard double-dose protocol in both groups. |
X Demographics
The data shown below were collected from the profiles of 3 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Bosnia and Herzegovina | 1 | 33% |
| Japan | 1 | 33% |
| Unknown | 1 | 33% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 3 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 55 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 55 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Researcher | 10 | 18% |
| Student > Bachelor | 8 | 15% |
| Student > Ph. D. Student | 7 | 13% |
| Student > Master | 6 | 11% |
| Student > Postgraduate | 4 | 7% |
| Other | 4 | 7% |
| Unknown | 16 | 29% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 18 | 33% |
| Biochemistry, Genetics and Molecular Biology | 6 | 11% |
| Nursing and Health Professions | 4 | 7% |
| Immunology and Microbiology | 2 | 4% |
| Earth and Planetary Sciences | 2 | 4% |
| Other | 4 | 7% |
| Unknown | 19 | 35% |
Attention Score in Context
This research output has an Altmetric Attention Score of 3. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 20 May 2020.
All research outputs
#13,547,035
of 23,849,058 outputs
Outputs from Clinical and Experimental Nephrology
#306
of 769 outputs
Outputs of similar age
#151,636
of 312,800 outputs
Outputs of similar age from Clinical and Experimental Nephrology
#4
of 12 outputs
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