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PREVAIL I Cluster Vaccination Study With rVSVΔG-ZEBOV-GP as Part of a Public Health Response in Liberia.
Bolay, Fatorma K; Grandits, Greg; Lane, H Clifford; Kennedy, Stephen B; Johnson, Melvin P; Fallah, Mosoka P; Wilson, Barthalomew; Njoh, Wissedi S; McNay, Laura A; Hensley, Lisa E; Higgs, Elizabeth S.
Afiliación
  • Bolay FK; National Public Health Institute of Liberia, Monrovia, Liberia.
  • Grandits G; Division of Biostatistics, University of Minnesota, Minneapolis.
  • Lane HC; Division of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda.
  • Kennedy SB; Liberia College of Physicians and Surgeons, Liberia.
  • Johnson MP; PREVAIL, Monrovia, Liberia.
  • Fallah MP; National Public Health Institute of Liberia, Monrovia, Liberia.
  • Wilson B; PREVAIL, Monrovia, Liberia.
  • Njoh WS; Leidos Biomedical Research Inc., Fredrick, Maryland.
  • McNay LA; Division of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda.
  • Hensley LE; Division of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda.
  • Higgs ES; Division of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda.
J Infect Dis ; 219(10): 1634-1641, 2019 04 19.
Article en En | MEDLINE | ID: mdl-30561672
OBJECTIVE: In November 2015, a 15-year-old boy received a diagnosis of Ebola virus disease (EVD) at the John F. Kennedy Medical Center in Monrovia, Liberia. Two additional family members received a diagnosis of EVD. The protocol for a phase 2 placebo-controlled trial of 2 Ebola vaccines was amended and approved; in 4 days, a single-arm cluster vaccination trial using the Merck rVSVΔG-ZEBOV-GP vaccine was initiated. Here, we evaluate the safety and immunogenicity of the vaccine and discuss challenges for its implementation in a small Ebola outbreak. METHOD: We conducted a ring vaccination study among contacts and contacts of close contacts of EVD cases a in Monrovia. Participants were evaluated 1 and 6 months after vaccination. RESULTS: Among 650 close contacts and contacts of close contacts of EVD cases, 210 (32%) consented and were vaccinated with rVSVΔG-ZEBOV-GP. Of those vaccinated, 189 (90%) attended the month 1 follow-up visit; 166 (79%) attended the month 6 visit. No serious adverse events were reported. Among 88 participants without an elevated antibody level at baseline, 77.3% (95% confidence interval, 68.5-86.1) had an antibody response at 1 month. CONCLUSIONS: The Merck rVSVΔG-ZEBOV-GP vaccine appeared to be safe and immunogenic among the vaccinated individuals. However, fewer than one third of eligible individuals consented to vaccination. These data may help guide implementation decisions for of cluster vaccination programs in an Ebola cluster outbreak response situation.
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Vacunación / Fiebre Hemorrágica Ebola / Vacunas contra el Virus del Ébola Tipo de estudio: Clinical_trials / Guideline / Prognostic_studies Límite: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged País/Región como asunto: Africa Idioma: En Revista: J Infect Dis Año: 2019 Tipo del documento: Article País de afiliación: Liberia

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Vacunación / Fiebre Hemorrágica Ebola / Vacunas contra el Virus del Ébola Tipo de estudio: Clinical_trials / Guideline / Prognostic_studies Límite: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged País/Región como asunto: Africa Idioma: En Revista: J Infect Dis Año: 2019 Tipo del documento: Article País de afiliación: Liberia