Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase II Dose-ranging Study of Oral RV3-BB Rotavirus Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03483116
Recruitment Status : Active, not recruiting
First Posted : March 30, 2018
Last Update Posted : February 28, 2020
Sponsor:
Information provided by (Responsible Party):
Murdoch Childrens Research Institute

Brief Summary:
The purpose of this study is to determine the serum IgA response of three dose levels of the oral RV3-BB vaccine when administered in a neonatal schedule or when administered as a high dose in an infant schedule.

Condition or disease Intervention/treatment Phase
Rotavirus Infections Biological: RV3-BB Biological: Placebo Phase 2

Detailed Description:

The primary objective of this study is to assess the cumulative anti-rotavirus serum IgA response (defined as a ≥3 fold increase from baseline) 4 weeks after 3 doses of RV3-BB administered in a neonatal schedule at a High, Mid or low vaccine titre. In addition the cumulative anti-rotavirus serum IgA response (defined as a ≥3 fold increase from baseline) 4 weeks after 3 doses of RV3-BB administered in an infant schedule at a high dose of vaccine will be assessed along with cumulative vaccine take and components of vaccine take after 3 doses of RV3-BB administered in a neonatal or infant schedule.

The safety and tolerability of RV3-BB when administered as an infant or as a neonatal schedule will be described.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 688 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a Phase II, randomised, double-blind, placebo-controlled, four-arm parallel group study of two different dosing schedules of oral RV3-BB
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase II Randomized, Double Blind, Parallel Group Dose-ranging Study of Oral RV3-BB Rotavirus Vaccine Administered at a High, Mid and Low Titre as a 3 Dose Neonate Schedule or Administered at a High Titre as a 3 Dose Infant Schedule.
Actual Study Start Date : June 15, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High dose RV3-BB neonatal schedule
High dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14)
Biological: RV3-BB
Oral administration

Biological: Placebo
Oral administration

Experimental: Mid dose RV3-BB neonatal schedule
Mid dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14)
Biological: RV3-BB
Oral administration

Biological: Placebo
Oral administration

Experimental: Low dose RV3-BB neonatal schedule
Low dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14)
Biological: RV3-BB
Oral administration

Biological: Placebo
Oral administration

Experimental: High dose RV3-BB infant schedule
High dose infant RV3-BB vaccine schedule. Placebo for Investigational product dose 1 (0-5 days) and RV3-BB Vaccine for Investigational product doses 2 (week 6) 3 (week 10) and dose 4 (week 14)
Biological: RV3-BB
Oral administration

Biological: Placebo
Oral administration




Primary Outcome Measures :
  1. Cumulative anti-rotavirus serum IgA response in neonatal vaccine schedule at high mid and low dose of RV3-BB [ Time Frame: At serum collection at approximately 14 weeks of age ]
    Defined as a ≥3 fold increase from baseline at each serum collection time point to 4 weeks after 3 doses of RV3-BB


Secondary Outcome Measures :
  1. Cumulative anti rotavirus serum IgA response after 3 doses in an infant RV3-BB schedule [ Time Frame: At serum collection visit approximately 18 weeks of age ]
    Defined as a ≥3 fold increase from baseline to 4 weeks after 3 doses of RV3-BB

  2. Serum anti rotavirus IgA titres in neonatal and infant schedule [ Time Frame: At serum collection time points at approximately 14 and 18 weeks of age ]
    Expressed as geometric mean titres (GMTs) from baseline to post dose 3

  3. Cumulative vaccine take and components of vaccine take (serum anti rotavirus IgA response or shedding of RV3-BB) after 3 doses of RV3-BB administered in a neonatal or infant schedule at a high dose of RV3-BB [ Time Frame: Sample collections at Week 0 through to approximately 14 and 18 weeks of age ]
    Vaccine take is defined as at least a threefold increase in serum anti-rotavirus immunoglobulin A (IgA) from baseline to post Investigational product dosing, or detectable RV3 shedding in stools (by ELISA or PCR) any day from day three to day five following administration of Investigational product. Cumulative vaccine take is defined as Vaccine take observed at the current assessment time point or following any previous dose

  4. Cumulative vaccine take and components of vaccine take after 3 doses of RV3-BB administered in a neonatal or infant schedule at a mid or low dose of RV3-BB [ Time Frame: Sample collections at Week 0 through to approximately 14 and 18 weeks of age ]
    Vaccine take is defined as at least a threefold increase in serum anti-rotavirus immunoglobulin A (IgA) from baseline to post Investigational Product dosing, or detectable RV3 shedding in stools (by ELISA or PCR) any day from day three to day five following administration of Investigational product. Cumulative vaccine take is defined as Vaccine take observed at the current assessment time point or following any previous dose

  5. Cumulative vaccine take and components of vaccine take after 2 doses of RV3-BB administered in a neonatal or infant schedule at a high, mid or low dose of RV3-BB [ Time Frame: Sample collections at Week 0 through to approximately 10 and 14 weeks of age ]
    Vaccine take is defined as at least a threefold increase in serum anti-rotavirus immunoglobulin A (IgA) from baseline to post Investigational product dosing, or detectable RV3 shedding in stools (by ELISA or PCR) any day from day three to day five following administration of Investigational product. Cumulative vaccine take is defined as Vaccine take observed at the current assessment time point or following any previous dose

  6. Cumulative vaccine take and components of vaccine take after 1 dose of RV3-BB administered in a neonatal or infant schedule at a high, mid or low dose of RV3-BB [ Time Frame: Sample collections at Week 0 through to approximately 6 and 10 weeks of age ]
    Vaccine take is defined as at least a threefold increase in serum anti-rotavirus immunoglobulin A (IgA) from baseline to post Investigational product dosing, or detectable RV3 shedding in stools (by ELISA or PCR) any day from day three to day five following administration of Investigational product. Cumulative vaccine take is defined as Vaccine take observed at the current assessment time point or following any previous dose

  7. Occurrence of Adverse Events (AE) [ Time Frame: First dose of investigational product to Study End at approximately 18 weeks of age ]
    Number of Subjects with Adverse Events

  8. Occurrence of Serious Adverse Events (SAEs) [ Time Frame: First dose of investigational product to Study End at approximately 18 weeks of age ]
    Number of Subjects with Serious Adverse Events (SAEs)

  9. Occurrence of Diarrhea [ Time Frame: First dose of Investigational product to Study End at approximately 18 weeks of age ]
    Diarrhea will be described according to severity and detection of wild type rotavirus in diarrhea samples collected



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 18 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Neonate is less than 6 days (≤144 hours) of age at the time of first dose.
  • Neonate is in good health as determined by clinical judgment, including a medical history and physical exam, which confirms the absence of a current or past disease state considered significant by the investigator.
  • Neonate birth weight 2500-4000g inclusive.
  • Neonate's parents/guardians expect to be available for the duration of the study, and agree to adhere to all protocol requirements.
  • Neonate's parents/guardians have provided written informed consent prior to study-related procedures being performed.

Exclusion Criteria:

  • Any medical, psychiatric, or social condition of a parent/guardian that in the opinion of the investigator would prevent the neonate's parents/guardians from giving proper informed consent or from complying with the study protocol.
  • Neonates with known or suspected major congenital malformations or genetically determined disease.
  • Neonates with intussusception.
  • Neonates with a known or suspected bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
  • Neonates who have ever received any blood products, including immunoglobulin, or for whom receipt of any blood product during the course of the study is anticipated.
  • Neonates in whom EPI vaccines or components are contraindicated.
  • Neonates who have received or who expect to receive during the study period, any rotavirus vaccine other than those which will be administered as part of this study.
  • Neonates who have ever received, or who are anticipated to receive during the study period, any investigational agent other than those which will be administered as part of this study.
  • Neonates with a previous anaphylactic reaction to any drug, vaccine or vaccine component.
  • Neonates with a significant evolving neurological disorder.
  • Neonates whose parents/guardians are site team employees with direct involvement with the investigators, or who are working on the study.
  • Neonates who have been exposed to immunosuppressive courses of glucocorticosteroids, cytotoxic drugs or blood products through prenatal exposure and/or breast milk in the four weeks prior to randomization.
  • Neonates with diarrhoea or vomiting in the 24 hours preceding randomisation.
  • Neonates with any moderate or severe illness, and/or who have a temperature of ≥37.5˚C axillary/oral or ≥38˚C rectal/tympanic within the 48 hours preceding randomization.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483116


Locations
Layout table for location information
Malawi
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
Blantyre, Malawi
Sponsors and Collaborators
Murdoch Childrens Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Desiree Witte, MD MTropPaed Malawi-Liverpool-Wellcome Trust Clinical Research Programme

Layout table for additonal information
Responsible Party: Murdoch Childrens Research Institute
ClinicalTrials.gov Identifier: NCT03483116    
Other Study ID Numbers: MCRI-RV3-BB-004
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Murdoch Childrens Research Institute:
Dose ranging
Neonatal vaccine
RV3-BB vaccine
Additional relevant MeSH terms:
Layout table for MeSH terms
Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs