Serum-free purified Vero rabies vaccine is safe and immunogenic in children: Results of a randomized phaseII pre-exposure prophylaxis regimen study.
Vaccine
; 40(35): 5170-5178, 2022 08 19.
Article
em En
| MEDLINE
| ID: mdl-35906106
ABSTRACT
BACKGROUND:
A serum-free, highly purified Vero rabies vaccine (PVRV-NG) has been developed with no animal or human components and low residual DNA content. A phaseII randomized clinical study aimed to demonstrate the non-inferiority of the immune response and assess the safety profile of PVRV-NG versus a licensed human diploid cell culture rabies vaccine (HDCV) in a pre-exposure regimen in healthy children and adolescents in the Philippines.METHODOLOGY:
Children aged 2-11 years and adolescents aged 12-17 years were randomized (21) to receive three injections of either PVRV-NG or HDCV (on day [D] 0, D7 and D28). Rabies virus-neutralizing antibodies (RVNA) were measured at D0, D42 and 6 months after the first injection (month [M] 6). Safety was assessed during the vaccination period and up to 28 days after the last vaccination. Serious adverse events were followed until 6 months after last vaccination. PRINCIPALFINDINGS:
342 healthy participants (171 children and 171 adolescents) were randomized and followed for 6 months after the last dose. All participants in both groups had an RVNA titer ≥ 0.5 IU/ml at D42, demonstrating non-inferiority in seroconversion rate for PVRV-NG versus HDCV. Over 90% of participants had RVNA titer ≥ 0.5 IU/ml at M6. PVRV-NG was well tolerated after each vaccination and up to 6 months following the last dose. There were no major safety concerns during the study, and the type and severity of solicited adverse events was similar for both treatment groups.CONCLUSIONS:
This study demonstrated the non-inferior immune profile of PVRV-NG compared with HDCV in a pre-exposure setting within a pediatric population. PVRV-NG was well tolerated with no safety concerns. This study is registered at ClinicalTrials.gov (NCT01930357) and EU Clinical Trials Register (2015-003203-30).Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Raiva
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Vírus da Raiva
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Vacina Antirrábica
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Profilaxia Pré-Exposição
Tipo de estudo:
Clinical_trials
Limite:
Adolescent
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Animals
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Child
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Humans
Idioma:
En
Ano de publicação:
2022
Tipo de documento:
Article