NCT04344054

Brief Summary

The study will evaluate safety and immunogenicity of LORV (Rotarix and RV3-BB) when TV P2-VP8, a parentally administered rotavirus vaccine is administered either concomitantly or as a prime/boost model. Participants would be newborn babies or infants approximately at 6 weeks of age ta the time of enrollment. The vaccines will be administered at birth (only for one cohort) and at 6, 10 and 14 weeks. Immune response will be assessed prior to first vaccination, 14 weeks and at 18 weeks of age. The study will also evaluate the shedding of Rotarix virus after a challenge dose administered 28 days after last investigational product administration. Safety assessments will be conducted throughout the study duration.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
850

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 14, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

February 22, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2022

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2022

Completed
Last Updated

November 29, 2022

Status Verified

November 1, 2022

Enrollment Period

1.5 years

First QC Date

April 6, 2020

Last Update Submit

November 28, 2022

Conditions

Rotavirus Vaccine

Keywords

Parental Rotavirus VaccineRotarixRV3-BBTV P2-VP8Mixed scheduleRotavirus Booster

Outcome Measures

Primary Outcomes (7)

  • Immunogenicity 1

    Immunogenicity: Between-arm comparisons (all comparisons except for LORV alone vs TV P2-VP8-boosted LORV) will be performed by computing Geometric Mean Concentration (GMC) ratios for LORV-specific serum anti-rotavirus IgA antibody and corresponding confidence intervals.

    4 weeks after the last vaccination within each regimen being compared.

  • Immunogenicity 2

    Immunogenicity: Within-arm evaluation of boosting will be performed using the geometric mean fold rise (GMFR) of LORV-specific serum anti-rotavirus IgA antibody and its corresponding confidence interval.

    4 weeks after completion of LORV (Week 14)

  • Immunogenicity 3

    Immunogenicity: Within-arm evaluation of boosting will be performed using the geometric mean fold rise (GMFR) of LORV-specific serum antirotavirus IgA antibody and its corresponding confidence interval.

    4 weeks post-boost (Week 18)

  • Safety 1: Percentage of participants reporting immediate adverse events after each vaccination

    Immediate Adverse Events: Percentage of participants reporting immediate adverse events after each vaccination

    within 30 minutes' post-vaccination

  • Safety 2: Percentage of participants reporting solicited post-vaccination reactogenicity

    Solicited Adverse Events: Percentage of participants reporting solicited post-vaccination reactogenicity

    7 day period after each vaccination

  • Safety 3: Percentage of participants reporting unsolicited AEs

    Unsolicited Adverse Events: Percentage of participants reporting unsolicited AEs

    from first vaccination through 4 weeks after the last vaccination

  • Safety 4: Percentage of participants reporting SAEs

    Serious Adverse Events: Percentage of participants reporting SAEs

    from first vaccination through 4 weeks after the last vaccination of each study participant

Secondary Outcomes (8)

  • Immunogenicity 1

    4 weeks after the last vaccination within each regimen being compared

  • Immunogenicity 2

    4 weeks after the last vaccination

  • Immunogenicity 3

    4 weeks after the last vaccination

  • Immunogenicity 4

    4 weeks after the last vaccination

  • Immunogenicity 5

    4 weeks after the last vaccination

  • +3 more secondary outcomes

Study Arms (6)

Arm 1

EXPERIMENTAL

RV3-BB/TV P2-VP8 boost

Biological: RV3-BBBiological: Trivalent P2-VP8 Booster dose

Arm 2

EXPERIMENTAL

RV3-BB/TV P2-VP8 co-administered

Biological: RV3-BBBiological: Trivalent P2-VP8

Arm 3

EXPERIMENTAL

RV3-BB primed TV P2-VP8

Biological: Trivalent P2-VP8Biological: RV3-BB birth dose

Arm 4

EXPERIMENTAL

Rotarix®/TV P2-VP8 Boost

Biological: RotarixBiological: Trivalent P2-VP8 Booster dose

Arm 5

EXPERIMENTAL

Rotarix®/TV P2-VP8 co-administered

Biological: Trivalent P2-VP8Biological: Rotarix

Arm 6

EXPERIMENTAL

TV P2-VP8 alone

Biological: Trivalent P2-VP8

Interventions

RV3-BBBIOLOGICAL

1.0 mL of the thawed rotavirus vaccine to be administered orally at birth, 6 weeks and 10 weeks of age

Arm 1Arm 2
Trivalent P2-VP8BIOLOGICAL

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 2Arm 3Arm 5Arm 6
RotarixBIOLOGICAL

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 4Arm 5
RV3-BB birth doseBIOLOGICAL

1.0 mL of the thawed rotavirus vaccine to be administered orally at birth.

Arm 3
Trivalent P2-VP8 Booster doseBIOLOGICAL

0.5 mL of vaccine containing 90 μg of the TV P2-VP8 antigen; IM; at 14 weeks of age

Arm 1Arm 4

Eligibility Criteria

AgeUp to 56 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy male and female infants as established by medical history and clinical examination at enrollment.
  • Age: ≤ 6 days old (Cohort A) or between the age of 6-8 weeks (42-56 days; inclusive) (Cohort B)
  • Birth weight of ≥ 2500 grams.
  • Parent's/legally acceptable representative's (LAR) ability and willingness to provide informed consent.
  • Parent/LAR confirms intention to stay in the area and bring their infant for the required study visits.

You may not qualify if:

  • Concurrent participation in another clinical trial throughout the entire timeframe of this study.
  • 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.
  • History of premature birth (\<37 weeks gestation) as per the investigator's assessment.
  • History of congenital abdominal disorders, intussusception, abdominal surgery.
  • Known or suspected impairment of immunological function based on medical history and physical examination.
  • Prior receipt of or intent to receive age specified EPI vaccines including rotavirus vaccine, outside of the study center and during study participation.
  • A known sensitivity or allergy to any components of the study medication.
  • Clinically detectable congenital anomaly or genetic defect.
  • History of persistent diarrhea (defined as diarrhea more than 14 days). Not applicable for selection of Cohort A.
  • Participant's parent/LAR not able, available or willing to accept active follow-up by the study staff.
  • Receipt of 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 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Wits RHI Shandukani Research Centre

Johannesburg, Gauteng, 2003, South Africa

Location

Vaccine and Infectious Diseases Analytics (VIDA) - formerly known as Respiratory and Meningococcal Pathogens Research Unit (RMPRU)

Johannesburg, Gauteng, 2013, South Africa

Location

MeSH Terms

Interventions

RIX4414 vaccine

Study Officials

  • Stanley Cryz, PhD

    PATH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The participants will receive vaccine as per the assigned treatment to the arm to which he/she has been randomized.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study will enroll infants in six arms divided into two cohorts enrolling infants at birth (0-6 days) or at approximately 6 weeks of age. Within each cohort, the enrolled infants will be randomized to the three arms in a ratio of 6:6:5.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2020

First Posted

April 14, 2020

Study Start

February 22, 2021

Primary Completion

September 6, 2022

Study Completion

September 9, 2022

Last Updated

November 29, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

Summary results for primary and secondary objectives to be posted at CT.gov.

Shared Documents
STUDY PROTOCOL
Time Frame
Within 12 months of completion of study
Access Criteria
Researchers who provide a methodologically sound proposal may be provided access after sponsor permission.

Locations

ZA(2)