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A Trial to Assess the Safety, Immunogenicity and Efficacy of a Trivalent Rotavirus P2-VP8 Subunit Vaccine in Prevention of Severe Rotavirus Gastroenteritis in Healthy Infants in Africa and India

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ClinicalTrials.gov Identifier: NCT04010448
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : October 28, 2019
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
SK Bioscience Co., Ltd.
Information provided by (Responsible Party):
PATH

Brief Summary:
The trial will be a multinational, randomized, double-blind, double-dummy, endpoint driven, group-sequential, active comparator-controlled study, in which participating infants will be randomized 1:1 to receive either: 1) 90 µg of the TV P2-VP8 vaccine IM plus oral placebo, or 2) Rotarix® per os (PO) plus IM placebo. Participants will receive three doses of TV P2-VP8/placebo IM and two doses of Rotarix®/placebo PO at monthly intervals starting at ≥6 to <8 weeks of age, administered concomitantly with EPI/UIP vaccines. To maintain the blind, infants allocated to the TV P2-VP8 vaccine arm will receive both TV P2-VP8 IM as well as oral placebo vaccine, and infants allocated to receive Rotarix® will receive both Rotarix® PO and placebo IM. Active surveillance for episodes of gastroenteritis (GE) will be conducted throughout the study, through weekly contact with participants' parents. Unsolicited AEs grade ≥ 2 through 28 days after the last study vaccination will be recorded in the study database, as will data for SAEs (including intussusception) throughout the study.

Condition or disease Intervention/treatment Phase
Rotavirus Infection of Children Biological: TV P2-VP8 Biological: Rotarix Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participating infants will be randomized 1:1 to receive either: 1) 90 µg of the TV P2-VP8 vaccine IM plus oral placebo, or 2) Rotarix® PO plus IM placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: To maintain the blind, infants allocated to the TV P2-VP8 vaccine arm will receive both TV P2-VP8 IM as well as oral placebo vaccine, and infants allocated to receive Rotarix® will receive both Rotarix® PO and placebo IM.
Primary Purpose: Prevention
Official Title: A Phase 3 Double-blind, Randomized, Active Comparator-controlled, Group-sequential, Multinational Trial to Assess the Safety, Immunogenicity and Efficacy of a Trivalent Rotavirus P2-VP8 Subunit Vaccine in Prevention of Severe Rotavirus Gastroenteritis in Healthy Infants
Actual Study Start Date : October 10, 2019
Estimated Primary Completion Date : August 15, 2024
Estimated Study Completion Date : December 15, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TV P2-VP8 Biological: TV P2-VP8
90 µg of the TV P2-VP8 vaccine IM plus oral placebo administered on study days 1, 29 and 57

Active Comparator: Rotarix® Biological: Rotarix
Rotarix® PO plus IM placebo administered on study days 1, 29 and 57




Primary Outcome Measures :
  1. Number of laboratory confirmed cases of severe rotavirus gastroenteritis (SRVGE; any strain) [ Time Frame: For cases with onset at least 2 weeks after 3rd study vaccination and onset at any time after first vaccination; for all events within the first 2 years of life ]
    SRVGE is defined by a Vesikari score of >11 (primary analysis to be performed once >99 cases are identified with onset at least 2 weeks after receipt of third study vaccination)

  2. Number of serious adverse events (SAEs), including intussusception [ Time Frame: Through 28 days after the last dose of study vaccine ]
  3. Number of Adverse Events (AEs) > or = to grade 2 [ Time Frame: Through 28 days after the last dose of study vaccine ]

Secondary Outcome Measures :
  1. Number of laboratory confirmed cases of very severe rotavirus gastroenteritis (VSRVGE; any strain) [ Time Frame: For cases with onset at least 2 weeks after 3rd study vaccination and onset at any time after first vaccination; for all events within the first 2 years of life ]
    VSRVGE is defined by a Vesikari score of >15

  2. Number of P-type specific (P[4], P[6] and P[8]) laboratory confirmed cases of SRVGE and VSRGE [ Time Frame: For cases with onset at least 2 weeks after 3rd study vaccination and onset at any time after first vaccination; for all events within the first 2 years of life ]
  3. Number of laboratory confirmed cases of rotavirus gastroenteritis (any strain) of any severity [ Time Frame: For cases with onset at least 2 weeks after 3rd study vaccination and onset at any time after first vaccination; for all events within the first 2 years of life ]
  4. Number of laboratory confirmed cases hospitalized for RVGE (any severity) [ Time Frame: For cases with onset at least 2 weeks after 3rd study vaccination and onset at any time after first vaccination; for all events within the first 2 years of life ]
  5. Incidence of SRVGE and VSRVGE per 100 children-years [ Time Frame: For cases with onset at least 2 weeks after 3rd study vaccination and onset at any time after first vaccination; for all events within the first 2 years of life ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 8 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy infants as established by medical history and clinical examination before entering the study
  • Age: ≥6 and <8 weeks at the time of first study vaccination (42 days through 55 days old, inclusive, with the day after birth considered 1-day old)
  • Parental/legal guardian's ability and willingness to provide written informed consent
  • Intention of the participants' parents to remain in the area with the child during the study period

Exclusion Criteria:

  • Acute disease at the time of first study vaccination - temporary exclusion
  • Presence of fever on the day of first study vaccination (axillary temperature >37.6oC) - temporary exclusion
  • Concurrent participation in another clinical trial throughout the entire timeframe for this study (participation in non-interventional observational study is allowed if there is no blood draw)
  • Presence of severe malnutrition (weight-for-height z-score ≤-3SD median, per WHO published child growth standards) 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) and/or birth weight of <2.5 kg
  • History of congenital abdominal disorders, intussusception, or abdominal surgery
  • Prior receipt of rotavirus vaccine
  • Known sensitivity or allergy to any components of the study vaccine
  • Contraindication to any EPI/UIP vaccine
  • History of anaphylactic reaction
  • Major congenital or genetic defect
  • Parents not able, available or willing to accept active weekly follow-up by the study staff
  • Receipt of any immunoglobulin therapy and/or blood products
  • Nursing infants whose mother are receiving immunosuppressive biologicals
  • History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids (those on inhaled or topical steroids may be permitted to participate in the study)
  • Any medical condition in the participant or parents that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a parents' ability to give informed consent

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): NCT04010448


Contacts
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Contact: Joanne Csedrik, RN, MPH +1-202-540-4496 jcsedrik@path.org
Contact: Tushar Tewari, MD +91-11-40640005 ttewari@path.org

Locations
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Zambia
Centre for Infectious Disease Research in Zambia (CIDRZ) Recruiting
Lusaka, Zambia
Contact: Roma Chilengi, MD         
Contact: Caroline Chisenga, PhD         
Sponsors and Collaborators
PATH
Bill and Melinda Gates Foundation
SK Bioscience Co., Ltd.
Investigators
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Principal Investigator: George Armah, PhD Noguchi Memorial Institute for Medical Research, University of Ghana, Legon
Principal Investigator: Desiree Witte, MD Malawi-Liverpool-Wellcome Trust (MLW) Clinical Research Programme
Principal Investigator: Roma Chilengi, MD Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka

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Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT04010448    
Other Study ID Numbers: CVIA 061
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Summary results for primary and secondary objectives
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rotavirus Infections
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Reoviridae Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs