Mixed Schedule Study of Live Oral Rotavirus Vaccines and Trivalent P2-VP8 Subunit Rotavirus Vaccine
NCT ID: NCT04344054
Last Updated: 2022-11-29
Study Results
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Basic Information
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COMPLETED
PHASE2
850 participants
INTERVENTIONAL
2021-02-22
2022-09-09
Brief Summary
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Detailed Description
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A blood sample will be obtained from all the participating infants pre-vaccination and post-vaccination at week 14 and week 18 in both cohorts. All serum samples will be tested for serum IgA binding antibody by ELISA using virus lysates prepared from RV3-BB and 89-12 strains. Additionally, anti-P2-VP8 IgG binding and serum neutralizing antibody levels to each of the 3 strains of rotavirus from which TV P2-VP8 is derived will be determined.
Vaccine safety will be evaluated by 1) recording the immediate adverse events for 30 minutes after immunization, 2) solicited adverse events for 7 days after each study vaccination, 3) unsolicited events for 28 days after each dose, and 4) serious adverse events 28 days after last dose of study vaccination.
All participants in all the study arms will receive a challenge dose of Rotarix® at visit 5following completion of primary series of vaccinations. Stool sample will be collected to evaluate vaccine viral shedding.
The primary objective of the study is to compare the immunogenicity in participants receiving LORV co-administration with TV P2- VP8 or those receiving the TV P2-VP8 booster after receiving a standalone LORV primary series with the standalone LORV. A comparison of immune responses to birth dose of RV3-BB boosted with TV P2-VP8 to TV P2-VP8 administered alone will also be conducted. All primary immunogenicity analysis will be based on LORV specific serum anti-rotavirus IgA antibody concentration. Placebo administration (oral and parenteral) were appropriately placed to facilitate blinding.
The secondary objective were to compare the different treatment regimens within a cohort using serum anti-P2-VP8 IgG antibodies and neutralizing antibodies to each of the 3 strains of rotavirus from which TV P2-VP8 is derived.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1
RV3-BB/TV P2-VP8 boost
RV3-BB
1.0 mL of the thawed rotavirus vaccine to be administered orally at birth, 6 weeks and 10 weeks of age
Trivalent P2-VP8 Booster dose
0.5 mL of vaccine containing 90 μg of the TV P2-VP8 antigen; IM; at 14 weeks of age
Arm 2
RV3-BB/TV P2-VP8 co-administered
RV3-BB
1.0 mL of the thawed rotavirus vaccine to be administered orally at birth, 6 weeks and 10 weeks of age
Trivalent P2-VP8
0.5 mL of vaccine containing 90 μg of the TV P2-VP8 antigen; IM; at approximately 6, 10 and 14 weeks of age
Arm 3
RV3-BB primed TV P2-VP8
Trivalent P2-VP8
0.5 mL of vaccine containing 90 μg of the TV P2-VP8 antigen; IM; at approximately 6, 10 and 14 weeks of age
RV3-BB birth dose
1.0 mL of the thawed rotavirus vaccine to be administered orally at birth.
Arm 4
Rotarix®/TV P2-VP8 Boost
Rotarix
1.5 mL of the liquid vaccine containing the RIX4414 strain of human rotavirus vaccine to be administered orally at 6 weeks and 10 weeks of age.
Trivalent P2-VP8 Booster dose
0.5 mL of vaccine containing 90 μg of the TV P2-VP8 antigen; IM; at 14 weeks of age
Arm 5
Rotarix®/TV P2-VP8 co-administered
Trivalent P2-VP8
0.5 mL of vaccine containing 90 μg of the TV P2-VP8 antigen; IM; at approximately 6, 10 and 14 weeks of age
Rotarix
1.5 mL of the liquid vaccine containing the RIX4414 strain of human rotavirus vaccine to be administered orally at 6 weeks and 10 weeks of age.
Arm 6
TV P2-VP8 alone
Trivalent P2-VP8
0.5 mL of vaccine containing 90 μg of the TV P2-VP8 antigen; IM; at approximately 6, 10 and 14 weeks of age
Interventions
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RV3-BB
1.0 mL of the thawed rotavirus vaccine to be administered orally at birth, 6 weeks and 10 weeks of age
Trivalent P2-VP8
0.5 mL of vaccine containing 90 μg of the TV P2-VP8 antigen; IM; at approximately 6, 10 and 14 weeks of age
Rotarix
1.5 mL of the liquid vaccine containing the RIX4414 strain of human rotavirus vaccine to be administered orally at 6 weeks and 10 weeks of age.
RV3-BB birth dose
1.0 mL of the thawed rotavirus vaccine to be administered orally at birth.
Trivalent P2-VP8 Booster dose
0.5 mL of vaccine containing 90 μg of the TV P2-VP8 antigen; IM; at 14 weeks of age
Eligibility Criteria
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Inclusion Criteria
2. Age: ≤ 6 days old (Cohort A) or between the age of 6-8 weeks (42-56 days; inclusive) (Cohort B)
3. Birth weight of ≥ 2500 grams.
4. Parent's/legally acceptable representative's (LAR) ability and willingness to provide informed consent.
5. Parent/LAR confirms intention to stay in the area and bring their infant for the required study visits.
Exclusion Criteria
2. Presence of acute disease at the time of enrollment; temporary exclusion.
3. Presence of fever on the day of enrollment (axillary temperature ≥37.5 °C); temporary exclusion.
4. Concurrent participation in another clinical trial throughout the entire timeframe of this study.
5. Presence of 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 which would compromise the child's health or is likely to result in non-conformance to the protocol.
6. History of premature birth (\<37 weeks gestation) as per the investigator's assessment.
7. History of congenital abdominal disorders, intussusception, abdominal surgery.
8. Known or suspected impairment of immunological function based on medical history and physical examination.
9. Prior receipt of or intent to receive age specified EPI vaccines including rotavirus vaccine, outside of the study center and during study participation.
10. A known sensitivity or allergy to any components of the study medication.
11. Clinically detectable congenital anomaly or genetic defect.
12. History of persistent diarrhea (defined as diarrhea more than 14 days). Not applicable for selection of Cohort A.
13. Participant's parent/LAR not able, available or willing to accept active follow-up by the study staff.
14. Receipt of any immunoglobulin therapy and/or blood products since birth or planned administration during the study period.
15. History of chronic administration (defined as more than 14 days) of high doses of immunosuppressant including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study. Not applicable for selection of Cohort A.
16. Any medical condition in the parents/infants that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parent's/LAR's ability to give informed consent.
56 Days
ALL
Yes
Sponsors
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SK Bioscience Co., Ltd.
INDUSTRY
Murdoch Childrens Research Institute
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
Bill and Melinda Gates Foundation
OTHER
PATH
OTHER
Responsible Party
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Principal Investigators
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Stanley Cryz, PhD
Role: STUDY_DIRECTOR
PATH
Locations
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Wits RHI Shandukani Research Centre
Johannesburg, Gauteng, South Africa
Vaccine and Infectious Diseases Analytics (VIDA) - formerly known as Respiratory and Meningococcal Pathogens Research Unit (RMPRU)
Johannesburg, Gauteng, South Africa
Countries
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Other Identifiers
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CVIA 082
Identifier Type: -
Identifier Source: org_study_id
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