دورية أكاديمية
أعرض في EDS

Immunogenicity, safety and reactogenicity of ROTAVAC® in healthy infants aged 6-8 weeks in Vietnam.

التفاصيل البيبلوغرافية
العنوان: Immunogenicity, safety and reactogenicity of ROTAVAC® in healthy infants aged 6-8 weeks in Vietnam.
المؤلفون: Hai NM; Department of Assessment and Accreditation, Vietnam Military Medical University (VMMU), Viet Nam., Dung ND; Department of Immunology, Vietnam Military Medical University (VMMU), Viet Nam., Pho DC; Department of Infection Control, Military Hospital 103, Vietnam Military Medical University, Viet Nam., Son VT; Department of Epidemiology, Vietnam Military Medical University, Viet Nam., Hoan VN; Department of Epidemiology, Vietnam Military Medical University, Viet Nam., Dan PT; Department of Preventive Medicine, Vietnam Military Medical Department, Viet Nam., The Anh BD; Department of Epidemiology, Vietnam Military Medical University, Viet Nam., Giang H; Department of Epidemiology, Vietnam Military Medical University, Viet Nam., Hung PN; Department of Epidemiology, Vietnam Military Medical University, Viet Nam; Department of Training, Vietnam Military Medical University, Viet Nam. Electronic address: pnhungqy@vmmu.edu.vn.
المصدر: Vaccine [Vaccine] 2021 Feb 12; Vol. 39 (7), pp. 1140-1147. Date of Electronic Publication: 2021 Jan 16.
نوع المنشور: Clinical Trial, Phase IV; Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Elsevier Science Country of Publication: Netherlands NLM ID: 8406899 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-2518 (Electronic) Linking ISSN: 0264410X NLM ISO Abbreviation: Vaccine Subsets: MEDLINE
أسماء مطبوعة: Publication: Amsterdam, The Netherlands : Elsevier Science
Original Publication: [Guildford, Surrey, UK] : Butterworths, [c1983-
مواضيع طبية MeSH: Rotavirus* , Rotavirus Infections*/prevention & control , Rotavirus Vaccines*/adverse effects, Antibodies, Viral ; Humans ; Immunogenicity, Vaccine ; Infant ; Infant, Newborn ; Vaccines, Attenuated ; Vietnam
مستخلص: Background: ROTAVAC® is derived from human 116E rotavirus (RV) neonatal strain. In this study, we evaluated the immunogenicity, safety and reactogenicity of ROTAVAC® in Vietnam.
Method: We conducted a phase IV clinical trial in healthy infants aged 6-8 weeks using the complete regimen of ROTAVAC® with three doses. Serum anti-RV IgA was measured by enzyme-linked immunosorbent assay to assess the geometric mean concentration in infants who received the complete regimen of the vaccine.
Results: A total of 360 participants were enrolled in this clinical trial. The mean age ± standard deviation at enrollment was 6.9 ± 0.6 weeks. The anti-RV IgA titer was 4.01 ± 3.74 mg/ml pre-vaccination and substantially increased to 29.27 ± 80.64 mg/ml post-vaccination. The value of logIgA significantly increased (p = 0.003) from 0.28 ± 0.79 to 1.03 ± 0.54. The proportion of participants with equal to and greater than 3-fold and 4-fold shifts in pre- to post-vaccination antibody titer (IgA) were 55.4% and 48.3%, respectively. No adverse events or serious adverse events were recorded immediately within 30 min after the administration of each dose. The most common adverse events within 14 days after each visit were fever, unusual crying and irritability. Other adverse events occurred at a low rate, and no case of intussusception was noted.
Conclusions: The complete regimen of ROTAVAC® demonstrated an immunological response with clinically acceptable safety profile. Post-completion of this study, ROTAVAC® is now a WHO-prequalified vaccine and available in Vietnam.
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Declaration of Competing Interest statement The authors do not have commercial or other association that might pose a conflict of interest (e.g., pharmaceutical stock ownership, consultancy, pharmaceutical board membership, relevant patents, or research funding).
(Copyright © 2021 Elsevier Ltd. All rights reserved.)
فهرسة مساهمة: Keywords: ROTAVAC; Rotavirus; Vaccine; Vietnam
المشرفين على المادة: 0 (Antibodies, Viral)
0 (Rotavirus Vaccines)
0 (Vaccines, Attenuated)
تواريخ الأحداث: Date Created: 20210119 Date Completed: 20210521 Latest Revision: 20220531
رمز التحديث: 20221213
DOI: 10.1016/j.vaccine.2020.12.086
PMID: 33461837
قاعدة البيانات: MEDLINE
الوصف
تدمد:1873-2518
DOI:10.1016/j.vaccine.2020.12.086