Safety review of the purified chick embryo cell rabies vaccine: Data from the Vaccine Adverse Event Reporting System (VAERS), 1997–2005

Dobardzic, Azra; Izurieta, Héctor S.; Woo, Emily Jane; Iskander, John K.; Shadomy, Sean V.; Rupprecht, Charles E.; Ball, Robert; Braun, M. Miles

doi:10.1016/j.vaccine.2007.02.075

Cited by 55 publications

(26 citation statements)

References 16 publications

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“…Twenty-four (7%) of the AEs were considered serious by the reporters and there were no reports of death. The authors concluded that the evaluation of Vaccine Adverse Event Reporting System reports did not suggest a high frequency or unusual pattern of serious or other medically important AEs, and most AEs were nonserious and consistent with pre-licensure safety data [84].…”

Section: Rabipur Post-marketing Surveillancementioning

confidence: 83%

30 years of rabies vaccination with Rabipur: a summary of clinical data and global experience

Giesen

Gniel

Malerczyk

2015

Expert Review of Vaccines

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Section: Rabipur Post-marketing Surveillancementioning

confidence: 83%

30 years of rabies vaccination with Rabipur: a summary of clinical data and global experience

Giesen

Gniel

Malerczyk

2015

Expert Review of Vaccines

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“…[8][9][10][11][12] The immunogenicity, efficacy and safety of PCECV have been well established for both PrEP and PEP in previous clinical trials conducted in children and adults. 6,[11][12][13][14][15] Moreover, PCECV may to elicit long-lasting immunity even after 14 years in subjects receiving a single booster dose 2 years following primary 3-dose immunization. 16 The intramuscular PEP recommended by the WHO includes 2 alternative immunization regimens: the 5-dose "Essen" (1-1-1-1-1), with doses administered on each of Days 0, 3, 7, 14, and 28; and the abbreviated 4-dose "Zagreb" regimen (2-1-1), with 2 injections administered on Day 0, followed by one further dose on each Days 7, and 21.…”

Section: Introductionmentioning

confidence: 99%

A randomized open-labeled study to demonstrate the non-inferiority of purified chick-embryo cell rabies vaccine administered in the Zagreb regimen (2-1-1) compared with the Essen regimen in Chinese adults

Wang

et al. 2014

Human Vaccines & Immunotherapeutics

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(2014) A randomized open-labeled study to demonstrate the non-inferiority of purified chick-embryo cell rabies vaccine administered in the Zagreb regimen (2-1-1) compared with the Essen regimen in Chinese adults, Human Vaccines & Immunotherapeutics, 10:10, 2805-2812, DOI: 10.4161/21645515.2014 Abbreviations: AE, adverse event; CCEEV, cell culture or embryonated egg-based rabies vaccines; CI, confidence interval; FDA, Food and Drug Administration; GMC, geometric mean concentration; HDCV, human diploid cell rabies vaccine; PCECV, purified chick embryo cell rabies vaccine; PDEV, purified duck embryo cell vaccine; PEP, post-exposure prophylaxis; PPS, per protocol set; PrEP, pre-exposure prophylaxis; PVRV, purified Vero cell rabies vaccine; RFFIT, rapid fluorescent focus inhibition test; RVNA, rabies virus neutralizing antibody; SAE, serious adverse event; WHO, World Health Organization.The Zagreb regimen has been used for 20 years in various countries. In China, until 2010, the Zagreb schedule was only approved for purified chick embryo cell vaccine (PCECV) and purified Vero cell rabies vaccines (PVRV). In this phase III clinical trial, we aimed to demonstrate the safety and immunogenic non-inferiority of the Zagreb regimen compared with the Essen regimen in healthy adult Chinese immunized with PCECV (Rabipur Ò ). The study enrolled 825 subjects aged 18 to 50 years; serum samples were collected on Days 0, 7, 14, 42, and at 13 months to assess rabies virus neutralizing antibody (RVNA) concentrations. Solicited and unsolicited local and systemic reactions were recorded for 6 days following the day of vaccination, and collected throughout the entire study period (Day 1 until Month 13). The Zagreb regimen was non-inferior to the Essen regimen with regard to RVNA concentrations after 7, 14, and 42 days, and 13 months of immunization. The non-inferiority of seroconversion was established at Days 14 and 42. The incidence of local and systemic reactions was similar between groups, and mostly of mild or moderate severity. Vaccine-related adverse events occurred more frequently in the Essen group than in the Zagreb group. Vaccination with PCECV under a 2-1-1 regimen is as safe and immunogenic as under the traditional 5-dose Essen regimen for rabies post-exposure prophylaxis, and is a more cost-effective option, has a more practical vaccination schedule, and can potentially increase compliance.

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“…Overall, this proportion of serious events reported to VAERS is in the same range as that after other vaccines in younger populations. 42,43 A small group of GBS cases after TIV were reported and confirmed. Among all the TIV reports to VAERS in children aged 2 to 17 years, no new clinically concerning AE clusters were identified beyond what has been noted on monitoring of the literature on the safety of influenza vaccine in children to date.…”

Section: Discussionmentioning

confidence: 85%

Adverse Events Following Trivalent Inactivated Influenza Vaccination in Children

Muhammad¹,

Haber²,

Broder³

et al. 2011

Pediatric Infectious Disease Journal

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Safety review of the purified chick embryo cell rabies vaccine: Data from the Vaccine Adverse Event Reporting System (VAERS), 1997–2005

Cited by 55 publications

References 16 publications

30 years of rabies vaccination with Rabipur: a summary of clinical data and global experience

30 years of rabies vaccination with Rabipur: a summary of clinical data and global experience

A randomized open-labeled study to demonstrate the non-inferiority of purified chick-embryo cell rabies vaccine administered in the Zagreb regimen (2-1-1) compared with the Essen regimen in Chinese adults

Adverse Events Following Trivalent Inactivated Influenza Vaccination in Children

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