Rotavirus GastroenteritisPhase 4NCT01575197
Evaluation of the Human Rotavirus Vaccine at Varying Schedules and Doses in Rural Ghana
A Phase 4 study testing Human Rotavirus Vaccine in people with Rotavirus Gastroenteritis, run by PATH at 1 site in Ghana.
Trial 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. Read more about this study
- Who is it for?
- Ages 42 to 55 daysHealthy volunteers can take part
- Conditions the study is for
- Rotavirus Gastroenteritis
- What is being tested?
- Human Rotavirus Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 456 participants
- Where
- 1 siteGhana
- Study dates
- Sep 2012to Feb 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 to 55 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity of the Human Rotavirus Vaccine (Rotarix™) at Varying Schedules, Doses, and Ages in Rural Ghana
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.
- Conditions
- Rotavirus Gastroenteritis
- Being tested
- Human Rotavirus Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Rotavirus VaccineBiological
Also called Rotarix
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.
| Study group | Role | What they receive |
|---|---|---|
| Rotavirus Vaccine at age 6 & 10 weeks | Active comparator | Participants are provided with the Human Rotavirus Vaccine (HRV) at 6 \& 10 weeks of age. Receives: Biological: Human Rotavirus Vaccine |
| Rotavirus vaccine at age 10 & 14 weeks | Experimental | Participants are provided with the Human Rotavirus Vaccine (HRV) at 10 \& 14 weeks of age. Receives: Biological: Human Rotavirus Vaccine |
| Rotavirus vaccine at age 6,10,&14 weeks | Experimental | Participants are provided with the Human Rotavirus Vaccine (HRV) at 6, 10, \& 14 weeks of age. Receives: Biological: Human Rotavirus Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2012 (estimated)
- Study startSep 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotavirus GastroenteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 456 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Noguchi Memorial Institute for Medical Research, Navrongo Health Research Centre, Ghana, Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- George Armah, PhD, Principal investigator, Noguchi Memorial Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575197
- Sponsor's protocol ID
- GHANA-HRV-01
- Other IDs
- OPP1017334
- Status last verified
- Apr 2015
- First submitted
- 6 Apr 2012
- Last updated
- 1 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 26823335
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity of the Human Rotavirus Vaccine (Rotarix™) at Varying Schedules, Doses, and Ages in Rural Ghana
- ClinicalTrials.gov ID
- NCT01575197
- Acronym / sponsor ID
- GHANA-HRV-01
- Conditions
- Rotavirus Gastroenteritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 456 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Noguchi Memorial Institute for Medical Research, Navrongo Health Research Centre, Ghana, Centers for Disease Control and Prevention
- Study start
- Sep 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 11 Apr 2012 (estimated)
- Results
- Posted 1 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rotavirus Vaccine at age 6 & 10 weeks | Active comparator | Biological: Human Rotavirus VaccineParticipants are provided with the Human Rotavirus Vaccine (HRV) at 6 \& 10 weeks of age. |
| Rotavirus vaccine at age 10 & 14 weeks | Experimental | Biological: Human Rotavirus VaccineParticipants are provided with the Human Rotavirus Vaccine (HRV) at 10 \& 14 weeks of age. |
| Rotavirus vaccine at age 6,10,&14 weeks | Experimental | Biological: Human Rotavirus VaccineParticipants are provided with the Human Rotavirus Vaccine (HRV) at 6, 10, \& 14 weeks of age. |
Who may qualify
- Ages
- 42 to 55 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Rotavirus VaccineAlso: RotarixRotavirus 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. | Biological | Rotavirus Vaccine at age 6 & 10 weeks, Rotavirus vaccine at age 10 & 14 weeks, Rotavirus vaccine at age 6,10,&14 weeks |
Primary outcome
Immunoglobulin A (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)
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).
6 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
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
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
Time frame: Baseline, 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)
Vaccine-type Rotavirus Shedding in Stool
Time frame: Days 4 and 7 post each study vaccination
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26823335Armah 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Armah, PhD principal investigator
Noguchi Memorial Institute for Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Human Rotavirus Vaccine in people with Rotavirus Gastroenteritis, run by PATH at 1 site in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunoglobulin A (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01575197, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2015.