ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of a Pentavalent Rotavirus Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis in Niger (ROSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02145000
Recruitment Status : Active, not recruiting
First Posted : May 22, 2014
Last Update Posted : November 29, 2017
Sponsor:
Collaborators:
Medecins Sans Frontieres, Netherlands
Serum Institute of India Pvt. Ltd.
FORSANI (Forum Santé Niger)
Ministry of Public Health Niger
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Epicentre

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Severe Rotavirus Gastroenteritis Biological: Rotavirus vaccine (BRV-PV) Biological: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6586 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : June 2014
Actual Primary Completion Date : December 2015
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gastroenteritis
U.S. FDA Resources

Arm Intervention/treatment
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.
Biological: Rotavirus vaccine (BRV-PV)
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.
Placebo Comparator: Placebo
Same constituents as the active vaccine but without the viral antigens; manufactured by SIIL.
Biological: Placebo



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. Any adverse health event [ Time Frame: From the time of Dose 1 to 28 days post-Dose 3 ]
  8. Serious adverse events [ Time Frame: From the time of Dose 1 until 2 years of age ]
  9. Anti-rotavirus IgA sero-response rate [ Time Frame: 28 days post-Dose 3 ]
  10. Anti-rotavirus IgA geometric mean titres [ Time Frame: 28 days post-Dose 3 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Weeks to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. aged 6-8 weeks at the time of inclusion
  2. able to swallow and no history of vomiting within 24 hours
  3. resident in Madarounfa Health District and within the catchment area of the central health facility
  4. intending to remain in the study area for 2 years
  5. parent/guardian providing written informed consent

Exclusion Criteria:

Any of the following will exclude an infant from randomization in the study:

  1. known history of congenital abdominal disorders, intussusception, or abdominal surgery
  2. receipt of intramuscular, oral, or intravenous corticosteroid treatment within 2 wks
  3. receipt or planned administration of a blood transfusion or blood products, including immunoglobulins
  4. any known immunodeficiency condition
  5. any serious medical condition
  6. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02145000


Locations
Niger
Madarounfa Health District
Madarounfa, Maradi, Niger
Sponsors and Collaborators
Epicentre
Medecins Sans Frontieres, Netherlands
Serum Institute of India Pvt. Ltd.
FORSANI (Forum Santé Niger)
Ministry of Public Health Niger
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Sheila Isanaka, ScD Epicentre
Study Director: Rebecca Grais, PhD Epicentre

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Epicentre
ClinicalTrials.gov Identifier: NCT02145000     History of Changes
Other Study ID Numbers: R822388
First Posted: May 22, 2014    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017

Keywords provided by Epicentre:
Rotavirus
Gastroenteritis
Diarrhea
Vaccine
Niger

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs