Evaluation of the Human Rotavirus Vaccine at Varying Schedules and Doses in Rural Ghana

PATH456 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

456

Conditions

Rotavirus Gastroenteritis

Interventions

Human Rotavirus VaccineBIOLOGICAL

Rotavirus vaccine will be administered concomitantly with other routine Expanded Programme on Immunization (EPI) vaccinations at 6 \& 10 weeks of age, 10 \& 14 weeks of age, or 6, 10, \& 14 weeks of age, depending on study arm assignment.

Eligibility

Sex: ALLMin age: 42 DaysMax age: 55 DaysHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Navrongo Health Research Center

Navrongo, Upper East Region, Ghana

Outcomes

Primary Outcomes

Immunoglobulin A (IgA) Seroconversion: 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules

Anti-rotavirus IgA seroconversion will be defined as the detection of anti-rotavirus IgA antibodies at a concentration ≥20 U/mL post-vaccination in infants seronegative for anti-rotavirus IgA pre-vaccination as measured by Enzyme Immunoassay (EIA).

Time frame: 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)

Secondary Outcomes

IgA Seroconversion: 6 & 10 Week vs. 10 & 14 Week Vaccination Schedules

Time frame: 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)

IgA Geometric Mean Titers (GMTs): 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules

IgA GMTs measured by EIA will be compared post-vaccination between participants receiving Rotarix at 6 and 10 weeks of age and those receiving Rotarix at 6, 10, and 14 weeks of age. For participants in Group 1, where post-vaccination response was measured at both 14 and 18 weeks of age, the highest response between these two visits was used as the final response for comparison.

Time frame: 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)

IgA GMTs: 6 & 10 Week vs. 10 & 14 Week Vaccination Schedule

IgA GMTs measured by EIA will be compared post-vaccination between participants receiving Rotarix at 6 and 10 weeks of age and those receiving Rotarix at 10 and 14 weeks of age. For participants in Group 1, where post-vaccination response was measured at both 14 and 18 weeks of age, the highest response between these two visits was used as the final response for comparison.

Time frame: 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)

Data from ClinicalTrials.gov

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