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

NCT01575197 | Completed Phase 4 Results

• 2 other identifiers: GHANA-HRV-01OPP1017334
• Study Type: interventional
• Target: 456
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotavirus Gastroenteritis

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  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

  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

  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

  Baseline, 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)

• Vaccine-type Rotavirus Shedding in Stool

  Days 4 and 7 post each study vaccination

Study Arms (3)

Rotavirus Vaccine at age 6 & 10 weeks

ACTIVE COMPARATOR

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

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.

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.

Biological: Human Rotavirus Vaccine

Interventions

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.

Also known as: Rotarix

Rotavirus Vaccine at age 6 & 10 weeks; Rotavirus vaccine at age 10 & 14 weeks; Rotavirus vaccine at age 6,10,&14 weeks

Eligibility Criteria

• Age: 42 Days - 55 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PATH: lead
• Noguchi Memorial Institute for Medical Research: collaborator
• Navrongo Health Research Center: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Navrongo Health Research Center

Navrongo, Upper East Region, Ghana

Location

Related Publications (1)

• 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.

  PMID: 26823335 DERIVED

MeSH Terms

Interventions

RIX4414 vaccine

Results Point of Contact

• Title: Senior Clinical Research Scientist
• Organization: PATH

klewis@path.org

206-285-3500

Study Officials

• George Armah, PhD

  Noguchi Memorial Institute for Medical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2012
• First Posted: April 11, 2012
• Study Start: September 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: June 1, 2015
• Results First Posted: June 1, 2015

Record last verified: 2015-04

Locations

GH (1)