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

Primary Purpose

Rotavirus Gastroenteritis

Status
Completed
Phase
Phase 4
Locations
Ghana
Study Type
Interventional
Intervention
Human Rotavirus Vaccine
Sponsored by
PATH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rotavirus Gastroenteritis

Eligibility Criteria

42 Days - 55 Days (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Navrongo Health Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Rotavirus Vaccine at age 6 & 10 weeks

Rotavirus vaccine at age 10 & 14 weeks

Rotavirus vaccine at age 6,10,&14 weeks

Arm Description

Participants are provided with the Human Rotavirus Vaccine (HRV) at 6 & 10 weeks of age.

Participants are provided with the Human Rotavirus Vaccine (HRV) at 10 & 14 weeks of age.

Participants are provided with the Human Rotavirus Vaccine (HRV) at 6, 10, & 14 weeks of age.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

IgA Seroconversion: 6 & 10 Week vs. 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 EIA.
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.
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.
Baseline Immunoglobulin G (IgG) Levels: Impact on IgA Seroconversion Post-vaccination
The number and percentage of participants demonstrating IgA seroconversion post-vaccination as defined above in infants seronegative for anti-rotavirus IgA pre- vaccination using the EIA assay) by EIA pre- and post-vaccination will be compared between participants in each group who had low as compared to high rotavirus immunoglobulin G (IgG) antibody levels pre-vaccination (i.e., at 6 weeks in Groups 1 and 3 and at 10 weeks in Group 2) as measured by Enzyme linked immunosorbent assay (ELISA). Low and high IgG categories will be determined based on the IgG antibody level distribution.
Vaccine-type Rotavirus Shedding in Stool
Vaccine-type rotavirus shedding in the stool at 4 (±1 day) and 7 days (±1 day) following each Rotarix vaccination will be identified using EIA for rotavirus antigens and compared to baseline levels obtained just prior to each study vaccination. If shedding in stool is detected at either time point (per manufacturer's specifications) following each Rotarix vaccination, this will be considered evidence of vaccine take.
SAE Assessment
Serious adverse events (SAEs) occurring at anytime during the study will be measured as observed by study staff and/or reported by parent at any time. SAEs will be subcategorized according to treatment group as those deemed related to vaccination or not by an independent study monitor.

Full Information

First Posted
April 6, 2012
Last Updated
May 13, 2015
Sponsor
PATH
Collaborators
Noguchi Memorial Institute for Medical Research, Navrongo Health Research Center, Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT01575197
Brief Title
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

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PATH
Collaborators
Noguchi Memorial Institute for Medical Research, Navrongo Health Research Center, Centers for Disease Control and Prevention

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotavirus Gastroenteritis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
456 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rotavirus Vaccine at age 6 & 10 weeks
Arm Type
Active Comparator
Arm Description
Participants are provided with the Human Rotavirus Vaccine (HRV) at 6 & 10 weeks of age.
Arm Title
Rotavirus vaccine at age 10 & 14 weeks
Arm Type
Experimental
Arm Description
Participants are provided with the Human Rotavirus Vaccine (HRV) at 10 & 14 weeks of age.
Arm Title
Rotavirus vaccine at age 6,10,&14 weeks
Arm Type
Experimental
Arm Description
Participants are provided with the Human Rotavirus Vaccine (HRV) at 6, 10, & 14 weeks of age.
Intervention Type
Biological
Intervention Name(s)
Human Rotavirus Vaccine
Other Intervention Name(s)
Rotarix
Intervention Description
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.
Primary Outcome Measure Information:
Title
Immunoglobulin A (IgA) Seroconversion: 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules
Description
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 Outcome Measure Information:
Title
IgA Seroconversion: 6 & 10 Week vs. 10 & 14 Week Vaccination Schedules
Description
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 EIA.
Time Frame
4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)
Title
IgA Geometric Mean Titers (GMTs): 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules
Description
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)
Title
IgA GMTs: 6 & 10 Week vs. 10 & 14 Week Vaccination Schedule
Description
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)
Title
Baseline Immunoglobulin G (IgG) Levels: Impact on IgA Seroconversion Post-vaccination
Description
The number and percentage of participants demonstrating IgA seroconversion post-vaccination as defined above in infants seronegative for anti-rotavirus IgA pre- vaccination using the EIA assay) by EIA pre- and post-vaccination will be compared between participants in each group who had low as compared to high rotavirus immunoglobulin G (IgG) antibody levels pre-vaccination (i.e., at 6 weeks in Groups 1 and 3 and at 10 weeks in Group 2) as measured by Enzyme linked immunosorbent assay (ELISA). Low and high IgG categories will be determined based on the IgG antibody level distribution.
Time Frame
Baseline, 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)
Title
Vaccine-type Rotavirus Shedding in Stool
Description
Vaccine-type rotavirus shedding in the stool at 4 (±1 day) and 7 days (±1 day) following each Rotarix vaccination will be identified using EIA for rotavirus antigens and compared to baseline levels obtained just prior to each study vaccination. If shedding in stool is detected at either time point (per manufacturer's specifications) following each Rotarix vaccination, this will be considered evidence of vaccine take.
Time Frame
Days 4 and 7 post each study vaccination
Title
SAE Assessment
Description
Serious adverse events (SAEs) occurring at anytime during the study will be measured as observed by study staff and/or reported by parent at any time. SAEs will be subcategorized according to treatment group as those deemed related to vaccination or not by an independent study monitor.
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
42 Days
Maximum Age & Unit of Time
55 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Armah, PhD
Organizational Affiliation
Noguchi Memorial Institute for Medical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Navrongo Health Research Center
City
Navrongo
State/Province
Upper East Region
Country
Ghana

12. IPD Sharing Statement

Citations:
PubMed Identifier
26823335
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. Erratum In: J Infect Dis. 2016 Oct 1;214(7):1127.
Results Reference
derived

Learn more about this trial

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

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