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An Age-stratified, Randomized Immunogenicity Trial of Killed Oral Cholera Vaccine with Delayed Second Dose in Cameroon.
Ateudjieu, Jérôme; Sack, David A; Nafack, Sonia Sonkeng; Xiao, Shaoming; Tchio-Nighie, Ketina Hirma; Tchokomeni, Herve; Bita'a, Landry Beyala; Nyibio, Paul Ntsekendio; Guenou, Etienne; Mondung, Kedia Mayah; Dieumo, Frank Forex Kiadjieu; Ngome, Rosanne Minone; Murt, Kelsey N; Ram, Malathi; Ali, Mohammad; Debes, Amanda K.
Afiliación
  • Ateudjieu J; MA Sante, Yaoundé, Cameroon.
  • Sack DA; Department of Public Health, Faculty of Medicine and Pharmaceutical Sciences, University of Dschang, Cameroon.
  • Nafack SS; Clinical Research Unit, Division of Health Operations Research, Ministry of Public Health, Cameroon.
  • Xiao S; Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
  • Tchio-Nighie KH; MA Sante, Yaoundé, Cameroon.
  • Tchokomeni H; Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
  • Bita'a LB; MA Sante, Yaoundé, Cameroon.
  • Nyibio PN; MA Sante, Yaoundé, Cameroon.
  • Guenou E; MA Sante, Yaoundé, Cameroon.
  • Mondung KM; MA Sante, Yaoundé, Cameroon.
  • Dieumo FFK; MA Sante, Yaoundé, Cameroon.
  • Ngome RM; MA Sante, Yaoundé, Cameroon.
  • Murt KN; MA Sante, Yaoundé, Cameroon.
  • Ram M; Department of Bacteriology-Parasitology-Mycology Laboratory, Centre Pasteur of Cameroon (CPC), Yaoundé, Cameroon.
  • Ali M; Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
  • Debes AK; Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
Am J Trop Med Hyg ; 107(5): 974-983, 2022 11 14.
Article en En | MEDLINE | ID: mdl-36395746
The recommended schedule for killed oral cholera vaccine (OCV) is two doses, 2 weeks apart. However, during vaccine campaigns, the second round is often delayed by several months. Because more information is needed to document antibody responses when the second dose is delayed, we conducted an open-label, phase 2, noninferiority clinical trial of OCV. One hundred eighty-six participants were randomized into three dose-interval groups (DIGs) to receive the second dose 2 weeks, 6 months, or 11.5 months after the first dose. The DIGs were stratified into three age strata: 1 to 4, 5 to 14, and > 14 years. Inaba and Ogawa vibriocidal titers were assessed before and after vaccination. The primary analysis was geometric mean titer (GMT) 2 weeks after the second dose. Data for primary analysis was available from 147 participants (54, 44, and 49 participants from the three DIGs respectively). Relative to the 2-week interval, groups receiving a delayed second dose had significantly higher GMTs after the second dose. Two weeks after the second dose, Inaba GMTs were 55.1 190.3, and 289.8 and Ogawa GMTs were 70.4, 134.5, and 302.4 for the three DIGs respectively. The elevated titers were brief, returning to lower levels within 3 months. We conclude that when the second dose of killed oral cholera vaccine was given after 6 or 11.5 months, vibriocidal titers were higher than when given after the standard period of 2 weeks. This provides reassurance that a delayed second dose does not compromise, but rather enhances, the serological response to the vaccine.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Vacunas contra el Cólera / Cólera Tipo de estudio: Clinical_trials Límite: Adolescent / Humans País/Región como asunto: Africa Idioma: En Revista: Am J Trop Med Hyg Año: 2022 Tipo del documento: Article País de afiliación: Camerún Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Vacunas contra el Cólera / Cólera Tipo de estudio: Clinical_trials Límite: Adolescent / Humans País/Región como asunto: Africa Idioma: En Revista: Am J Trop Med Hyg Año: 2022 Tipo del documento: Article País de afiliación: Camerún Pais de publicación: Estados Unidos