Clinical trial NCT01575197: Evaluation of the Human Rotavirus Vaccine at Varying Schedules and Doses in Rural Ghana
Official title: Immunogenicity of the Human Rotavirus Vaccine (Rotarix™) at Varying Schedules, Doses, and Ages in Rural Ghana
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rotavirus Gastroenteritis
Lead sponsor: PATH
Sponsor class: OTHER
Collaborators: name: Noguchi Memorial Institute for Medical Research
name: Navrongo Health Research Center
name: Centers for Disease Control and Prevention
First posted: 2012-04-11
Enrollment: 456
Sex: ALL
Minimum age (years): 42
Maximum age (years): 55
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether giving the Human Rotavirus Vaccine on alternate dosing schedules will enhance the immune response to the vaccine in a low-resource, high-burden country in Africa. Alternate dosing schedules studied include giving the 2-dose vaccine schedule at a slightly older age and giving an additional dose of the vaccine.


Eligibility criteria: Inclusion Criteria:

* Between 42 and 55 days of age at the time of enrollment.
* Healthy infant free of chronic or serious medical condition as determined by history and physical examination at the time of study enrollment.
* Parents/guardians of each subject are able to understand and follow study procedures and agree to participate in the study by providing parental/guardian permission.

Exclusion Criteria:

* If child has previously had intussusception or abdominal surgery.
* Use of any immunosuppressive drugs or immunoglobulin and/or blood product use since birth or anticipated during study period.
* Current enrollment in any other intervention trial or use of any investigational drug or vaccine throughout the study period.
* Birthweight less than 2000 grams or gestation \< 36 weeks, if this information is available.
* Any subject who reports plan to leave the study area before the completion of the study (i.e., relocation, migration, etc.).
* Another child living in the same compound is already enrolled in the trial (i.e., only one participant can be enrolled per compound).
* After the rotavirus vaccine is introduced into the routine EPI system in Navrongo: Another child in the compound is less than 16 weeks of age.
* The child has received rotavirus vaccine outside of this study.

Primary outcomes:
measure: Immunoglobulin A (IgA) Seroconversion: 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules
timeFrame: 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)
Secondary outcomes:
measure: IgA Seroconversion: 6 & 10 Week vs. 10 & 14 Week Vaccination Schedules
timeFrame: 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)
measure: IgA Geometric Mean Titers (GMTs): 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules
timeFrame: 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)
measure: IgA GMTs: 6 & 10 Week vs. 10 & 14 Week Vaccination Schedule
timeFrame: 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)
measure: Baseline Immunoglobulin G (IgG) Levels: Impact on IgA Seroconversion Post-vaccination
timeFrame: Baseline, 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)
measure: Vaccine-type Rotavirus Shedding in Stool
timeFrame: Days 4 and 7 post each study vaccination
measure: SAE Assessment
timeFrame: Throughout study period; Group 1: from enrollment through approximately 8 weeks of study participation, Groups 2 & 3: from enrollment through approximately 12 weeks of study participation
Other outcomes:
Locations:
city: Navrongo
country: Ghana
facility: Navrongo Health Research Center
state: Upper East Region
Study officials:
affiliation: Noguchi Memorial Institute for Medical Research
name: George Armah, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Armah G, Lewis KD, Cortese MM, Parashar UD, Ansah A, Gazley L, Victor JC, McNeal MM, Binka F, Steele AD. A Randomized, Controlled Trial of the Impact of Alternative Dosing Schedules on the Immune Response to Human Rotavirus Vaccine in Rural Ghanaian Infants. J Infect Dis. 2016 Jun 1;213(11):1678-85. doi: 10.1093/infdis/jiw023. Epub 2016 Jan 27.