Evaluation of the Human Rotavirus Vaccine at Varying Schedules and Doses in Rural Ghana - Full Text View

Purpose

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.

Condition	Intervention	Phase
Rotavirus Gastroenteritis	Biological: Human Rotavirus Vaccine	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Immunogenicity of the Human Rotavirus Vaccine (Rotarix™) at Varying Schedules, Doses, and Ages in Rural Ghana

Resource links provided by NLM:

MedlinePlus related topics: Gastroenteritis

Drug Information available for: Rotarix

U.S. FDA Resources

Further study details as provided by Program for Appropriate Technology in Health:

Primary Outcome Measures:

IgA seroconversion: 6 & 10 week vs. 6, 10, & 14 week vaccination schedules [ Time Frame: 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group) ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

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) ] [ Designated as safety issue: No ]
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 GMTs: 6 & 10 week vs. 6, 10, & 14 week vaccination schedules [ Time Frame: 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group) ] [ Designated as safety issue: No ]
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.
IgA GMTs: 6 & 10 week vs. 10 & 14 week vaccination schedule [ Time Frame: 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group) ] [ Designated as safety issue: No ]
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.
Baseline IgG levels: Impact on IgA seroconversion post-vaccination [ Time Frame: Baseline, 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group) ] [ Designated as safety issue: No ]
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 ELISA. Low and high IgG categories will be determined based on the IgG antibody level distribution.
Vaccine-type rotavirus shedding in stool [ Time Frame: Days 4 and 7 post each study vaccination ] [ Designated as safety issue: No ]
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 [ 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 ] [ Designated as safety issue: Yes ]
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.

Enrollment:	456
Study Start Date:	September 2012
Study Completion Date:	February 2013
Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Rotavirus Vaccine at age 6 & 10 weeks Participants are provided with the Human Rotavirus Vaccine at 6 & 10 weeks of age.	Biological: Human Rotavirus Vaccine Rotavirus vaccine will be administered concomitantly with other routine 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. Other Name: Rotarix
Experimental: Rotavirus vaccine at age 10 & 14 weeks Participants are provided with the Human Rotavirus Vaccine at 10 & 14 weeks of age.	Biological: Human Rotavirus Vaccine Rotavirus vaccine will be administered concomitantly with other routine 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. Other Name: Rotarix
Experimental: Rotavirus vaccine at age 6,10,&14 weeks Participants are provided with the Human Rotavirus Vaccine at 6, 10, & 14 weeks of age.	Biological: Human Rotavirus Vaccine Rotavirus vaccine will be administered concomitantly with other routine 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. Other Name: Rotarix

Eligibility

Ages Eligible for Study:	42 Days to 55 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01575197

Locations

Ghana
Navrongo Health Research Center
Navrongo, Upper East Region, Ghana

Sponsors and Collaborators

Program for Appropriate Technology in Health

Noguchi Memorial Institute for Medical Research, University of Ghana

Navrongo Health Research Center

Centers for Disease Control and Prevention

Investigators

Principal Investigator:

George Armah, PhD

Noguchi Memorial Institute for Medical Research, University of Ghana

More Information

No publications provided

Responsible Party:	Program for Appropriate Technology in Health
ClinicalTrials.gov Identifier:	NCT01575197 History of Changes
Other Study ID Numbers:	GHANA-HRV-01, OPP1017334
Study First Received:	April 6, 2012
Last Updated:	March 7, 2013
Health Authority:	Ghana : Food and Drugs Board Ghana: Ministry of Health through review by the Ghana Health Service Ethical Review Committee Ghana: Navrongo Health Research Center Institutional Review Board Ghana: Noguchi Memorial Institute for Medical Research Institutional Review Board United States: Western Institutional Review Board United States: Centers for Disease Control and Prevention Institutional Review Board

Additional relevant MeSH terms:

Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013