Status:
COMPLETED
Development of a Live Attenuated Rotavirus Vaccine as a Human Infection Challenge Model
Lead Sponsor:
Centre for Infectious Disease Research in Zambia
Collaborating Sponsors:
Imperial College London
Christian Medical College, Vellore, India
Conditions:
Diarrhoeal Disease
Eligibility:
All Genders
6-8 years
Phase:
NA
Brief Summary
The impact of licensed rotavirus vaccines in LMICs is limited by their lower immunogenicity and efficacy in these settings. Improved vaccines and vaccination schedules would result in substantially gr...
Detailed Description
Diarrhoeal disease is a leading cause of morbidity and mortality in young children, particularly those living in the developing countries of South Asia and sub-Saharan Africa1. Rotavirus is the most c...
Eligibility Criteria
Inclusion
- healthy infants as established by medical history and clinical examination before entering study
- age: \> 6 and \<8 weeks at the time of enrollment
- parental ability and willingness to provide informed consent
- parental intention to remain in the area with the child during the study period.
Exclusion
- Presence of fever on the day of enrollment
- Acute disease at the time of enrollment
- Concurrent participation in another clinical trial throughout the entire timeframe for this study
- Presence of malnutrition or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination that would compromise the participant's health or is likely to result in nonconformance to the protocol
- History of premature birth (\<37 weeks gestation)
- History of congenital abdominal disorders, intussusception, or abdominal surgery
- Known or suspected impairment of immunological function based on medical history and physical examination
- Prior receipt of rotavirus vaccine
- A known sensitivity or allergy to any components of the study vaccine
- History of anaphylactic reaction
- Major congenital or genetic defect
- Participant's parents not able, available or willing to accept active follow-up by the study staff
- Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period
- History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids.
- Any condition in the parents/infant that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parents' ability to give informed consent.
Key Trial Info
Start Date :
January 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2019
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04123119
Start Date
January 22 2019
End Date
May 10 2019
Last Update
October 14 2019
Active Locations (1)
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1
George Clinical Research Site
Lusaka, Zambia, 10101