- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02145000
Efficacy and Safety of a Pentavalent Rotavirus Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis in Niger (ROSE)
Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Assess the Efficacy and Safety of a Pentavalent Rotavirus Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis Among Infants in Niger
The study is a double-blinded, randomized, placebo-controlled, trial with two groups of infants receiving vaccine or placebo to assess the efficacy and safety of BRV-PV. Three doses of BRV-PV containing ≥ Log10 5.6 FFU/Dose of each serotype G1, G2, G3, G4 and G9 will be administered at 4 week intervals between doses. The first administration will occur at 6-8 weeks of age.
We hypothesize a difference in vaccine efficacy of three doses of BRV-PV vaccine vs. placebo against severe rotavirus gastroenteritis in healthy infants in Niger.
Active surveillance for gastroenteritis episodes will be conducted throughout the trial. Surveillance for adverse events will be carried out among all children from the time of first vaccination and 28 days post-Dose 3. Surveillance for all serious adverse events, including intussusception and death, will be conducted on all participants until they each reach two years of age.
To assess the effect of prenatal nutrition supplementation on infant immune response to the BRV-PV vaccine, study villages in the immunogenicity sub-cohort will be randomized in a 1:1:1 ratio to provide pregnant women with daily iron-folate, multiple micronutrients or a lipid-based nutrition supplement. Infants of participating women, if eligible at 6-8 weeks of age, will be randomized in a 1:1 ratio to receive three doses of vaccine or placebo and enter the main trial as part of the immunogenicity sub-cohort.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Maradi
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Madarounfa, Maradi, Niger
- Madarounfa Health District
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- aged 6-8 weeks at the time of inclusion
- able to swallow and no history of vomiting within 24 hours
- resident in Madarounfa Health District and within the catchment area of the central health facility
- intending to remain in the study area for 2 years
- parent/guardian providing written informed consent
Exclusion Criteria:
Any of the following will exclude an infant from randomization in the study:
- known history of congenital abdominal disorders, intussusception, or abdominal surgery
- receipt of intramuscular, oral, or intravenous corticosteroid treatment within 2 wks
- receipt or planned administration of a blood transfusion or blood products, including immunoglobulins
- any known immunodeficiency condition
- any serious medical condition
- any other condition in which, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or the parent/guardian's ability to give informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Rotavirus vaccine (BRV-PV)
Live attenuated bovine-human [UK] reassortant rotavirus vaccine manufactured by the Serum Institute of India, Limited (SIIL).
The pentavalent vaccine (BRV-PV) contains rotavirus serotypes G1, G2, G3, G4, and G9 (≥5.6 log10 FFU/serotype/dose).
The vaccine is in lyophilized form and supplied with 2.5 ml of citrate bicarbonate buffer that is added for reconstitution just before oral administration.
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Three doses of BRV-PV containing ≥ Log10 5.6 FFU/Dose of each serotype G1, G2, G3, G4 and G9, or placebo, will be administered at 4 week intervals between doses (with a window of -1 to +4 weeks).
The first administration will occur at 6-8 weeks of age.
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Placebo Comparator: Placebo
Same constituents as the active vaccine but without the viral antigens; manufactured by SIIL.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Laboratory-confirmed episode of severe rotavirus gastroenteritis
Time Frame: From 28 days post-Dose 3 until 117 cases are accrued or when all participating infants reach 2 years of age if 117 cases are not attained
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From 28 days post-Dose 3 until 117 cases are accrued or when all participating infants reach 2 years of age if 117 cases are not attained
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Laboratory-confirmed episode of rotavirus gastroenteritis of any severity
Time Frame: From 28 days post-Dose 3 to 1 year of age, from 1 to 2 years of age, and from 28 days post-Dose 3 to 2 years of age
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From 28 days post-Dose 3 to 1 year of age, from 1 to 2 years of age, and from 28 days post-Dose 3 to 2 years of age
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Laboratory-confirmed episode of rotavirus gastroenteritis with a Vesikari score of ≥ 17
Time Frame: From 28 days post-Dose 3 to 1 year of age, from 1 to 2 years of age, and from 28 days post-Dose 3 to 2 years of age
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From 28 days post-Dose 3 to 1 year of age, from 1 to 2 years of age, and from 28 days post-Dose 3 to 2 years of age
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Laboratory-confirmed episode of severe rotavirus gastroenteritis due to rotavirus serotypes G1, G2, G3, G4 and G9
Time Frame: From 28 days post-Dose 3 to 1 year of age, from 1 to 2 years of age, and from 28 days post-Dose 3 to 2 years of age
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From 28 days post-Dose 3 to 1 year of age, from 1 to 2 years of age, and from 28 days post-Dose 3 to 2 years of age
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Episode of gastroenteritis of any cause
Time Frame: From 28 days post-Dose 3 to 1 year of age, from 1 to 2 years of age, and from 28 days post-Dose 3 to 2 years of age
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From 28 days post-Dose 3 to 1 year of age, from 1 to 2 years of age, and from 28 days post-Dose 3 to 2 years of age
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Hospitalization due to laboratory-confirmed cases of rotavirus gastroenteritis of any cause
Time Frame: From 28 days post-Dose 3 to 1 year of age, from 1 to 2 years of age, and from 28 days post-Dose 3 to 2 years of age
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From 28 days post-Dose 3 to 1 year of age, from 1 to 2 years of age, and from 28 days post-Dose 3 to 2 years of age
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Hospitalization of any cause
Time Frame: From 28 days post-Dose 3 to 1 year of age, from 1 to 2 years of age, and from 28 days post-Dose 3 to 2 years of age
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From 28 days post-Dose 3 to 1 year of age, from 1 to 2 years of age, and from 28 days post-Dose 3 to 2 years of age
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Any adverse health event
Time Frame: From the time of Dose 1 to 28 days post-Dose 3
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From the time of Dose 1 to 28 days post-Dose 3
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Serious adverse events
Time Frame: From the time of Dose 1 until 2 years of age
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From the time of Dose 1 until 2 years of age
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Anti-rotavirus IgA sero-response rate
Time Frame: 28 days post-Dose 3
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28 days post-Dose 3
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Anti-rotavirus IgA geometric mean titres
Time Frame: 28 days post-Dose 3
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28 days post-Dose 3
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Rebecca Grais, PhD, Epicentre
- Principal Investigator: Sheila Isanaka, ScD, Epicentre
Publications and helpful links
General Publications
- Sudfeld CR, Bliznashka L, Salifou A, Guindo O, Soumana I, Adehossi I, Langendorf C, Grais RF, Isanaka S. Evaluation of multiple micronutrient supplementation and medium-quantity lipid-based nutrient supplementation in pregnancy on child development in rural Niger: A secondary analysis of a cluster randomized controlled trial. PLoS Med. 2022 May 2;19(5):e1003984. doi: 10.1371/journal.pmed.1003984. eCollection 2022 May.
- Kohlmann K, Sudfeld CR, Garba S, Guindo O, Grais RF, Isanaka S. Exploring the relationships between wasting and stunting among a cohort of children under two years of age in Niger. BMC Public Health. 2021 Sep 21;21(1):1713. doi: 10.1186/s12889-021-11689-6.
- Isanaka S, Garba S, Plikaytis B, Malone McNeal M, Guindo O, Langendorf C, Adehossi E, Ciglenecki I, Grais RF. Immunogenicity of an oral rotavirus vaccine administered with prenatal nutritional support in Niger: A cluster randomized clinical trial. PLoS Med. 2021 Aug 10;18(8):e1003720. doi: 10.1371/journal.pmed.1003720. eCollection 2021 Aug. Erratum In: PLoS Med. 2021 Oct 15;18(10):e1003776.
- Isanaka S, Langendorf C, McNeal MM, Meyer N, Plikaytis B, Garba S, Sayinzoga-Makombe N, Soumana I, Guindo O, Makarimi R, Scherrer MF, Adehossi E, Ciglenecki I, Grais RF. Rotavirus vaccine efficacy up to 2 years of age and against diverse circulating rotavirus strains in Niger: Extended follow-up of a randomized controlled trial. PLoS Med. 2021 Jul 2;18(7):e1003655. doi: 10.1371/journal.pmed.1003655. eCollection 2021 Jul.
- Isanaka S, Kodish SR, Mamaty AA, Guindo O, Zeilani M, Grais RF. Acceptability and utilization of a lipid-based nutrient supplement formulated for pregnant women in rural Niger: a multi-methods study. BMC Nutr. 2019 Jul 1;5:34. doi: 10.1186/s40795-019-0298-3. eCollection 2019.
- Coldiron ME, Guindo O, Makarimi R, Soumana I, Matar Seck A, Garba S, Macher E, Isanaka S, Grais RF. Safety of a heat-stable rotavirus vaccine among children in Niger: Data from a phase 3, randomized, double-blind, placebo-controlled trial. Vaccine. 2018 Jun 14;36(25):3674-3680. doi: 10.1016/j.vaccine.2018.05.023. Epub 2018 May 8.
- Isanaka S, Guindo O, Langendorf C, Matar Seck A, Plikaytis BD, Sayinzoga-Makombe N, McNeal MM, Meyer N, Adehossi E, Djibo A, Jochum B, Grais RF. Efficacy of a Low-Cost, Heat-Stable Oral Rotavirus Vaccine in Niger. N Engl J Med. 2017 Mar 23;376(12):1121-1130. doi: 10.1056/NEJMoa1609462.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R822388
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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