A Phase 4 interventional study of Human Rotavirus Vaccine in Rotavirus Gastroenteritis, sponsored by PATH. Completed at 1 site in Ghana. Open to participants aged 42 Days to 55 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-01.
Sponsored by PATH · Phase 4, Interventional, and Prevention
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.
243 studies on the registry are indexed under Gastroenteritis; 15 are open to participants now.
This study's enrollment of 456 is above the median of 126 across 160 interventional studies indexed under Gastroenteritis.
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Exclusion Criteria:
Participants are provided with the Human Rotavirus Vaccine (HRV) at 6 \& 10 weeks of age.
Biological: Human Rotavirus Vaccine
Participants are provided with the Human Rotavirus Vaccine (HRV) at 10 \& 14 weeks of age.
Biological: Human Rotavirus Vaccine
Participants are provided with the Human Rotavirus Vaccine (HRV) at 6, 10, \& 14 weeks of age.
Biological: Human Rotavirus Vaccine
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.
Also known as: Rotarix
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)
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.
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)
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.
Time frame: Baseline, 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)
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.
Time frame: Days 4 and 7 post each study vaccination
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.
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
| Milestone | Rotavirus Vaccine at Age 6 & 10 Weeks | Rotavirus Vaccine at Age 10 & 14 Weeks | Rotavirus Vaccine at Age 6,10,&14 Weeks |
|---|---|---|---|
| Started | 152 | 152 | 152 |
| Completed | 149 | 143 | 146 |
| Not completed | 3 | 9 | 6 |
| Withdrew: Migration out of study area | 1 | 5 | 4 |
| Withdrew: Sae | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 1 |
| Withdrew: Protocol violation | 2 | 1 | 1 |
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).
| percentage of participants | Rotavirus Vaccine at Age 6 & 10 Weeks | Rotavirus Vaccine at Age 6,10,&14 Weeks |
|---|---|---|
| Immunoglobulin A (IgA) Seroconversion: 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules | 28.9 (22.1 to 36.8) | 43.4 (35.5 to 51.6) |
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.
| percentage of participants | Rotavirus Vaccine at Age 6 & 10 Weeks | Rotavirus Vaccine at Age 10 & 14 Weeks |
|---|---|---|
| IgA Seroconversion: 6 & 10 Week vs. 10 & 14 Week Vaccination Schedules | 28.9 (22.1 to 36.8) | 37.4 (29.8 to 45.7) |
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.
| titers | Rotavirus Vaccine at Age 6 & 10 Weeks | Rotavirus Vaccine at Age 6,10,&14 Weeks |
|---|---|---|
| IgA Geometric Mean Titers (GMTs): 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules | 22.5 (17.4 to 28.2) | 32.6 (24.7 to 43.2) |
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.
| titers | Rotavirus Vaccine at Age 6 & 10 Weeks | Rotavirus Vaccine at Age 10 & 14 Weeks |
|---|---|---|
| IgA GMTs: 6 & 10 Week vs. 10 & 14 Week Vaccination Schedule | 22.1 (17.4 to 28.2) | 26.5 (20.7 to 34.0) |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Collected over Adverse events: 1 month following each study vaccination; serious adverse events: throughout study period, up to 5 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rotavirus Vaccine at Age 6 & 10 Weeks | — | 1/152 (0.7%) | 78/152 (51.3%) |
| Rotavirus Vaccine at Age 10 & 14 Weeks | — | 4/152 (2.6%) | 76/152 (50%) |
| Rotavirus Vaccine at Age 6,10,&14 Weeks | — | 3/151 (2%) | 71/151 (47%) |
| Event | Rotavirus Vaccine at Age 6 & 10 Weeks | Rotavirus Vaccine at Age 10 & 14 Weeks | Rotavirus Vaccine at Age 6,10,&14 Weeks |
|---|---|---|---|
| Acute Respiratory InfectionInfections and infestations | 0/152 | 0/152 | 2/151 |
| Gluteal Abscess/ SepsisInfections and infestations | 0/152 | 2/152 | 0/151 |
| GastroenteritisGastrointestinal disorders | 1/152 | 0/152 | 1/151 |
| Abscess of the Left JawInfections and infestations | 0/152 | 1/152 | 0/151 |
| Congenital HydrocephalusCongenital, familial and genetic disorders | 0/152 | 1/152 | 0/151 |
| Event | Rotavirus Vaccine at Age 6 & 10 Weeks | Rotavirus Vaccine at Age 10 & 14 Weeks | Rotavirus Vaccine at Age 6,10,&14 Weeks |
|---|---|---|---|
| Respiratory infectionRespiratory, thoracic and mediastinal disorders | 44/152 | 45/152 | 43/151 |
| Abdominal Pain/DiarrheaGastrointestinal disorders | 27/152 | 37/152 | 27/151 |
| Infection/Abscess/Boil/SepsisInfections and infestations | 29/152 | 25/152 | 26/151 |
| MalariaInfections and infestations | 14/152 | 15/152 | 12/151 |
| FeverInfections and infestations | 10/152 | 7/152 | 0/151 |
| Irritable/refusing to feedInfections and infestations | 1/152 | 2/152 | 0/151 |
| Otitis MediaEar and labyrinth disorders | 1/152 | 0/152 | 1/151 |
All enrolled subjects who received at least one rotavirus vaccine dose and are IgA seronegative (\< 20 U/mL) at 6 (Groups 1 and 3) or 10 (Group 2) weeks of age at baseline.
| Age, Continuous(weeks) | Rotavirus Vaccine at Age 6 & 10 Weeks | Rotavirus Vaccine at Age 10 & 14 Weeks | Rotavirus Vaccine at Age 6,10,&14 Weeks | Total |
|---|---|---|---|---|
| Mean | 6.2 ± 0.2 | 6.2 ± 0.2 | 6.2 ± 0.2 | 6.2 ± 0.2 |
| Sex: Female, Male(Participants) | Rotavirus Vaccine at Age 6 & 10 Weeks | Rotavirus Vaccine at Age 10 & 14 Weeks | Rotavirus Vaccine at Age 6,10,&14 Weeks | Total |
|---|---|---|---|---|
| Female | 68 | 79 | 72 | 219 |
| Male | 82 | 70 | 79 | 231 |
| Region of Enrollment(participants) | Rotavirus Vaccine at Age 6 & 10 Weeks | Rotavirus Vaccine at Age 10 & 14 Weeks | Rotavirus Vaccine at Age 6,10,&14 Weeks | Total |
|---|---|---|---|---|
| Ghana | 150 | 149 | 151 | 450 |
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