Severe Rotavirus GastroenteritisPhase 3ROSENCT02145000
Efficacy and Safety of a Pentavalent Rotavirus Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis in Niger
A Phase 3 study testing Rotavirus vaccine (BRV-PV) in people with Severe Rotavirus Gastroenteritis, run by Epicentre at 1 site in Niger.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 weeks to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Severe Rotavirus Gastroenteritis
- What is being tested?
- Rotavirus vaccine (BRV-PV)
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6,586 participants
- Where
- 1 siteNiger
- Study dates
- Jun 2014to 31 Dec 2020
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 weeks to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Severe Rotavirus Gastroenteritis
- Being tested
- Rotavirus vaccine (BRV-PV), Placebo
- Keywords
- Rotavirus, Gastroenteritis, Diarrhea, Vaccine, Niger
- Medical subject headings
- Gastroenteritis, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotavirus vaccine (BRV-PV)Biological
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.
PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| Rotavirus vaccine (BRV-PV) | Experimental | 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. Receives: Biological: Rotavirus vaccine (BRV-PV) |
| Placebo | Placebo comparator | Same constituents as the active vaccine but without the viral antigens; manufactured by SIIL. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory-confirmed episode of severe rotavirus gastroenteritis
Measured: 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
Secondary outcomes (10)
Laboratory-confirmed episode of rotavirus gastroenteritis of any severity
Measured: 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
Laboratory-confirmed episode of rotavirus gastroenteritis with a Vesikari score of ≥ 17
Measured: 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
Laboratory-confirmed episode of severe rotavirus gastroenteritis due to rotavirus serotypes G1, G2, G3, G4 and G9
Measured: 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
Episode of gastroenteritis of any cause
Measured: 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
Hospitalization due to laboratory-confirmed cases of rotavirus gastroenteritis of any cause
Measured: 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
Hospitalization of any cause
Measured: 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
Any adverse health event
Measured: From the time of Dose 1 to 28 days post-Dose 3
Serious adverse events
Measured: From the time of Dose 1 until 2 years of age
Anti-rotavirus IgA sero-response rate
Measured: 28 days post-Dose 3
Anti-rotavirus IgA geometric mean titres
Measured: 28 days post-Dose 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2015
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Severe Rotavirus GastroenteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6,586 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epicentre
- Sponsor type
- University, hospital or other
- Collaborators
- Medecins Sans Frontieres, Netherlands, Serum Institute of India Pvt. Ltd., FORSANI (Forum Santé Niger), Ministère de la Santé Publique, Niger, Children's Hospital Medical Center, Cincinnati
- Responsible party
- Sponsor
- Investigators
- Sheila Isanaka, ScD, Principal investigator, EpicentreRebecca Grais, PhD, Study director, Epicentre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145000
- Sponsor's protocol ID
- R822388
- Acronym
- ROSE
- Status last verified
- Sep 2023
- First submitted
- 20 May 2014
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 35500028Kohlmann 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.
PubMed 34548050Isanaka 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.
PubMed 34375336Isanaka 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.
PubMed 34214095Isanaka 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.
PubMed 32153947Coldiron 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.
PubMed 29752026Isanaka 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.
PubMed 28328346