Matthew E Coldiron1, Ousmane Guindo2, Rockyath Makarimi3, Issaka Soumana4, Amadou Matar Seck5, Souna Garba6, Emilie Macher7, Sheila Isanaka8, Rebecca F Grais9. 1. Epicentre, 8 rue Saint-Sabin, Paris, France. Electronic address: matthew.coldiron@epicentre.msf.org. 2. Epicentre, Maradi, Niger. Electronic address: ousmane.guindo@epicentre.msf.org. 3. Epicentre, Maradi, Niger. Electronic address: rockyiath.makarimi@epicentre.msf.org. 4. Epicentre, Maradi, Niger. Electronic address: issaka.soumana@epicentre.msf.org. 5. Epicentre, Maradi, Niger. Electronic address: amadou.matar@epicentre.msf.org. 6. Epicentre, Maradi, Niger. Electronic address: souna.garba@epicentre.msf.org. 7. Médecins Sans Frontières, 78 rue de Lausanne, Geneva, Switzerland. Electronic address: emilie.macher@geneva.msf.org. 8. Epicentre, 8 rue Saint-Sabin, Paris, France. Electronic address: sheila.isanaka@epicentre.msf.org. 9. Epicentre, 8 rue Saint-Sabin, Paris, France. Electronic address: rebecca.grais@epicentre.msf.org.
Abstract
BACKGROUND: Rotavirus remains a major cause of diarrhea among children under 5 years of age. The efficacy of RotaSIIL, a pentavalent rotavirus vaccine, was shown in an event-driven trial in Niger. We describe the two-year safety follow-up of this trial. METHODS: Follow-up of safety outcomes began upon administration of the first dose of RotaSIIL or placebo. Adverse events were followed until 28 days after the third dose, and serious adverse events were followed until 2 years of age. Suspected cases of intussusception were evaluated at first point of contact and then referred to hospital for surgical evaluation. Causes of death were obtained by chart review and verbal autopsy. Passive surveillance was carried out in health centers. Community health workers carried out active surveillance in villages. Between-group differences were evaluated using the chi-squared test and Fisher's exact test. RESULTS: A total of 4092 children were randomized, and 4086 received at least one dose of RotaSIIL or placebo, constituting the intention-to-treat population, who accrued a total of 7385 child-years of follow-up time. At two years of follow-up, 58 (2.8%) participants who received RotaSIIL and 49 (2.4%) participants who received placebo had died (p = 0.38). Most deaths were due to infectious causes common to the study area. One participant had confirmed intussusception, 542 days after receiving the third dose of RotaSIIL. A total of 395 (19.3%) participants receiving RotaSIIL and 419 (20.5%) participants receiving placebo experienced any serious adverse event (p = 0.36). Most serious adverse events were hospitalizations due to infection (malaria, lower respiratory tract infection and gastroenteritis) or marasmus. Overall, 1474 (72.1%) participants receiving RotaSIIL and 1456 (71.1%) participants receiving placebo had at least one adverse event (p = 0.49) in the follow-up period. CONCLUSIONS: At two years of follow-up, RotaSIIL was found to be safe. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02145000.
RCT Entities:
BACKGROUND: Rotavirus remains a major cause of diarrhea among children under 5 years of age. The efficacy of RotaSIIL, a pentavalent rotavirus vaccine, was shown in an event-driven trial in Niger. We describe the two-year safety follow-up of this trial. METHODS: Follow-up of safety outcomes began upon administration of the first dose of RotaSIIL or placebo. Adverse events were followed until 28 days after the third dose, and serious adverse events were followed until 2 years of age. Suspected cases of intussusception were evaluated at first point of contact and then referred to hospital for surgical evaluation. Causes of death were obtained by chart review and verbal autopsy. Passive surveillance was carried out in health centers. Community health workers carried out active surveillance in villages. Between-group differences were evaluated using the chi-squared test and Fisher's exact test. RESULTS: A total of 4092 children were randomized, and 4086 received at least one dose of RotaSIIL or placebo, constituting the intention-to-treat population, who accrued a total of 7385 child-years of follow-up time. At two years of follow-up, 58 (2.8%) participants who received RotaSIIL and 49 (2.4%) participants who received placebo had died (p = 0.38). Most deaths were due to infectious causes common to the study area. One participant had confirmed intussusception, 542 days after receiving the third dose of RotaSIIL. A total of 395 (19.3%) participants receiving RotaSIIL and 419 (20.5%) participants receiving placebo experienced any serious adverse event (p = 0.36). Most serious adverse events were hospitalizations due to infection (malaria, lower respiratory tract infection and gastroenteritis) or marasmus. Overall, 1474 (72.1%) participants receiving RotaSIIL and 1456 (71.1%) participants receiving placebo had at least one adverse event (p = 0.49) in the follow-up period. CONCLUSIONS: At two years of follow-up, RotaSIIL was found to be safe. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02145000.
Authors: Rachel M Burke; Jacqueline E Tate; Carl D Kirkwood; A Duncan Steele; Umesh D Parashar Journal: Curr Opin Infect Dis Date: 2019-10 Impact factor: 4.915
Authors: James Atampiiga Avoka; Elvis J Dun-Dery; Issah Seidu; Armel N E Abou; Paul Twene; Isaac Obeng Tandoh; Frederick Dun-Dery Journal: BMC Pediatr Date: 2021-02-19 Impact factor: 2.125
Authors: Slavica Mijatovic-Rustempasic; Jose Jaimes; Charity Perkins; M Leanne Ward; Mathew D Esona; Rashi Gautam; Jamie Lewis; Michele Sturgeon; Junaid Panjwani; Gail A Bloom; Steve Miller; Erik Reisdorf; Ann Marie Riley; Morgan A Pence; James Dunn; Rangaraj Selvarangan; Robert C Jerris; Dona DeGroat; Umesh D Parashar; Margaret M Cortese; Michael D Bowen Journal: Viruses Date: 2022-08-15 Impact factor: 5.818