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Completed

NCT Number: NCT01575197

Evaluation of the Human Rotavirus Vaccine at Varying Schedules and Doses 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.

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Key information

Conditions

Rotavirus Gastroenteritis

Age range

42 day–55 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Navrongo Health Research Center

Navrongo, Upper East Region, Ghana

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Human Rotavirus Vaccine

Biological

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.

Other names: Rotarix

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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)

    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.

  2. 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 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.

  3. 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)

    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.

  4. 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)

    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.

  5. Vaccine-type Rotavirus Shedding in Stool

    Time frame: Days 4 and 7 post each study vaccination

    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.

  6. 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

    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.

Sponsors and collaborators

Lead sponsor

PATH

Other

Collaborators

  • Centers for Disease Control and Prevention
  • Navrongo Health Research Centre, Ghana
  • Noguchi Memorial Institute for Medical Research

Registry information

Official study title

Immunogenicity of the Human Rotavirus Vaccine (Rotarix™) at Varying Schedules, Doses, and Ages in Rural Ghana

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 11, 2012
Registry last updated
Jun 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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