Human Challenge With Live-attenuated Rotavirus to Assess Next-generation Rotavirus Vaccines in Africa
Diarrhea, Diarrhea Rotavirus
About this trial
This is an interventional prevention trial for Diarrhea focused on measuring Human Infection Challenge
Eligibility Criteria
Inclusion Criteria:
- Healthy infants as established by medical history and physical examination.
- Infants will be 6-10 weeks old at time of enrollment
- parents plan to remain in the area for the duration of the study.
- Parent/guardian understands the study procedures and willing to provide informed consent to participate in the study
Exclusion Criteria:
- Acutely unwell
- Infant or infant's mother has syndromic or documented evidence of being immunocompromised (independent of HIV status)
- Known allergy to any vaccine component
- Previously received rotavirus vaccine
- Received immunosuppressive medication
- Major congenital or genetic abnormality
- 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.
- Participant's parents not available or willing to accept active follow-up by the study staff
Sites / Locations
- Chawama first level hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
No Intervention
Experimental
Experimental
Experimental
rotarix only
P2 VP8 only
Rotarix + 1 dose P2-VP8
Rotarix + 3 doses P2-VP8
Rotarix will be administered at 6 and 10 weeks of age following the national Expanded Program for Immunization (EPI) schedule. A challenge dose of Rotarix will be administered at 18 weeks of age and stool samples collected just before challenge and 5, 7 & 9 days later.
Parenteral P2-VP8 subunit vaccine will be administered at 6, 10 and 14 weeks of age. A challenge dose of Rotarix will be administered at 18 weeks of age and stool samples collected just before challenge and 5, 7 & 9 days later.
Rotarix will be administered at 6 and 10 weeks of age, followed by parenteral P2-VP8 subunit vaccine at 14 weeks of age. A challenge dose of Rotarix will be administered at 18 weeks of age and stool samples collected just before challenge and 5, 7 & 9 days later.
Rotarix and parenteral P2-VP8 subunit vaccine will be coadministered at 6 and 10 weeks of age, with an additional dose of P2-VP8 subunit vaccine administered at 14 weeks of age. A challenge dose of Rotarix will be administered at 18 weeks of age and stool samples collected just before challenge and 5, 7 & 9 days later.