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

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.

Conditions

• Severe Rotavirus Gastroenteritis

Interventions

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.

BIOLOGICAL

Placebo

Sponsors & Collaborators

• Medecins Sans Frontieres, Netherlands

  collaborator OTHER

• Serum Institute of India Pvt. Ltd.

  collaborator INDUSTRY

• FORSANI (Forum Santé Niger)

  collaborator UNKNOWN

• Ministère de la Santé Publique, Niger

  collaborator UNKNOWN

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• Epicentre

  lead OTHER

Principal Investigators

• Sheila Isanaka, ScD · Epicentre

• Rebecca Grais, PhD · Epicentre

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

6 Weeks

Max Age

2 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-06-30

Primary Completion

2015-12-31

Completion

2020-12-31

Countries

• Niger

Study Locations