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Trial record 57 of 277 for:    Panama

A Study to Evaluate the Safety and Immunogenicity of Novel Oral Polio Vaccine

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ClinicalTrials.gov Identifier: NCT03554798
Recruitment Status : Recruiting
First Posted : June 13, 2018
Last Update Posted : December 24, 2018
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Fidec Corporation

Brief Summary:

This will be a single center, age de-escalation, partly-blinded, randomized study.

The trial will be performed with the participation of 100 healthy children age 1-5 years who have been vaccinated with inactivated polio vaccine (IPV) and/or oral polio vaccine (OPV) in their first year of life and of 648 healthy 6 week-old infants, who will be pre-vaccinated with bOPV-IPV before being randomized to study groups. The allocation of 18-22 week-old infants to groups will be performed in a randomized manner. Following completion and Data Safety Monitoring Board (DSMB) review of follow-up for general safety data (Serioius Adverse Events -SAEs-, Important Medical Events -IMEs- and severe adverse events -AEs), a DSMB recommendation to proceed will result in randomization of the final cohort of infants. Allocation of 1 to 5 year-old children to groups will be performed in a randomized manner.

The DSMB will establish and continuously assess stopping rules for safety.


Condition or disease Intervention/treatment Phase
Poliomyelitis Biological: nOPV2 (monovalent oral polio vaccine) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 748 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Allocation of each subject to a given group will be described in a computer-generated randomization schedule. Based on this randomization code, the study vaccine will be packaged and labeled. Medication code numbers will be preprinted on the study vaccine labels and assigned as subjects qualify for the study and are randomly assigned to dosing schedule.
Primary Purpose: Prevention
Official Title: A Phase 2 Study to Evaluate the Safety and Immunogenicity of Two Novel Oral Polio Type 2 (nOPV2) Vaccine Candidates in Healthy Children Aged 1 to 5 Years and in Healthy Bivalent Oral Polio Vaccine-inactivated Polio Vaccine (bOPV-IPV) Vaccinated Infants
Actual Study Start Date : December 4, 2018
Estimated Primary Completion Date : February 10, 2020
Estimated Study Completion Date : February 10, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: nOPV2 Candidate 1 (monovalent oral poliovirus type1)

IPV and/or OPV vaccinated participants aged 1 to 5 years vaccinated with candidate 1.

6 weeks Infants vaccinated with 3 doses of bOPV and 1 dose of IPV, followed with 1 dose of candidate 1.

Biological: nOPV2 (monovalent oral polio vaccine)

50 IPV and/or OPV vaccinated participants aged 1 to 5 years vaccinated with candidate 1 or 2; two 10‸6 CCID50 (50% cell culture infective dose) doses separated by 28 days.

162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 10‸5 CCID50 dose of candidate 1 or 2.


Experimental: nOPV2 Candidate 2 (monovalent oral poliovirus type2)

IPV and/or OPV vaccinated participants aged 1 to 5 years vaccinated with candidate 2.

Infants vaccinated with 3 doses of bOPV and 1 dose of IPV, followed with 1 dose of candidate 2.

Biological: nOPV2 (monovalent oral polio vaccine)

50 IPV and/or OPV vaccinated participants aged 1 to 5 years vaccinated with candidate 1 or 2; two 10‸6 CCID50 (50% cell culture infective dose) doses separated by 28 days.

162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 10‸5 CCID50 dose of candidate 1 or 2.





Primary Outcome Measures :
  1. Serious Adverse Reactions (SARs), severe AEs and Important Medical Reactions (IMRs) incidence [ Time Frame: 6 months ]

    Incidence of serious adverse reactions [SARs] and severe adverse events [AEs; grade 3 according to CTCAE 4.03], and important medical reactions [IMR]) in all groups after one dose of each dose level of the two nOPV2 vaccine candidates considered consistent with a causal association to study vaccine.

    Separate tables and listings will be created for subjects who died, discontinued the study vaccine due to an AE, or experienced a severe or serious AE. Summaries, listings, and narratives may be provided, as appropriate.


  2. Single dose seroprotection rate [ Time Frame: 2 months ]
    Seroprotection rate against poliovirus type 2 of a single dose (at both 105 and 106 CCID50 dose levels) of each of the two nOPV2 vaccine candidates in infants at approximately 18-22 weeks of age after having been previously vaccinated with 3 doses of bOPV and 1 dose of IPV, relative to a control sample of infants receiving the same vaccination schedule followed by a single dose of Sabin mOPV2 in a prior study (M2) designed to serve as a historical control for the current study


Secondary Outcome Measures :
  1. SAEs, AEs and IMEs incidence [ Time Frame: 6 months ]
    Incidence, severity and causality of any other SAE, any solicited AE, any unsolicited AEs and any IME as well as any clinical laboratory deviation considered consistent with causal association to study vaccine (primary objective) following one or two doses of either nOPV2 candidates.

  2. Seroconversion rates comparison [ Time Frame: 2 months ]
    Seroconversion rates against type 2 of one or two 106 CCID50 doses of both nOPV2 vaccine candidates in healthy children aged 1 to 5 years and of two doses of both nOPV2 vaccine candidates at both 105 and 106 CCID50 dose levels at approximately 22 weeks of age in infants previously vaccinated with 3 doses of bOPV and 1 dose of IPV, and compare this immunogenicity with a control sample of participants receiving the same vaccination schedule followed by one or two doses of Sabin mOPV2 in a prior study (M2) designed and performed to serve as a control for the current study. Seroconversion is defined as a change from seronegative to seropositive, and in seropositive subjects, as an antibody titer increase of ≥ 4 fold over baseline (Day 0) titers corrected for maternal antibodies titers where applicable/age-appropriate.

  3. Seroprotection rates comparison [ Time Frame: 2 months ]
    Seroprotection rates against type 2 of one or two 106 CCID50 doses of both nOPV2 vaccine candidates in healthy children aged 1 to 5 years and of two doses of both nOPV2 vaccine candidates at both 105 and 106 CCID50 dose levels at approximately 22 weeks of age in infants previously vaccinated with 3 doses of bOPV and 1 dose of IPV, and compare this immunogenicity with a control sample of participants receiving the same vaccination schedule followed by one or two doses of Sabin mOPV2 in a prior study (M2) designed and performed to serve as a control for the current study.

  4. Viral shedding [ Time Frame: 2 months ]
    Level of viral shedding in stool at fixed time points following administration of one or two doses of both nOPV2 candidates at both 105 and 106 CCID50 dose levels in infants at approximately 18-22 weeks of age after having been previously vaccinated with 3 doses of bOPV and 1 dose of IPV, and compare this shedding to a control sample of participants receiving the same vaccination schedule followed by one or two doses of Sabin mOPV2 in a prior study designed to serve as a control for the current study.

  5. Neurovirulence [ Time Frame: 2 months ]
    Potential for neurovirulence of virus isolated from a subset of stool samples of infants at approximately 18-22 weeks of age after having been previously vaccinated with 3 doses of bOPV and 1 dose of IPV, and following a single dose of both nOPV2 candidates at the 106 CCID50 dose level, as measured in an animal model, and compare this with a control sample of participants receiving the same vaccination schedule followed by a single dose of Sabin mOPV2 in a prior study (M2) designed to serve as a control for the current study.



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Ages Eligible for Study:   6 Weeks to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. For Groups A1H and A2H, children enrolled at 1 to 5 years of age who have previously been vaccinated with three or four doses of OPV and/or IPV.
  2. For Groups B1L, B2L, C1L, C2L, B1H, B2H, C1H, and C2H to be eligible to continue into the experimental phase of the study, infants enrolled at 6 weeks of age must be vaccinated with 3 doses of bOPV and one dose of IPV prior to administration of the study vaccine, and the last polio vaccine must have been administered at least 4 weeks prior to the first dose of study vaccine.
  3. All participants must be healthy without obvious medical conditions that preclude the subject to be in the study as established by the medical history and physical examination.
  4. Written informed consent obtained from 1 or 2 parent(s) or legal guardian(s) as per country regulations.

Exclusion Criteria:

  1. For all participants the presence of a person in the subject's household (living in the same house or apartment unit) who does not have complete "age appropriate" vaccination status with respect to poliovirus vaccines.
  2. For all participants having a member of the subject's household (living in the same house or apartment unit) who has received OPV in the previous 3 months.
  3. For Groups A1H and A2H: receipt of polio vaccines within the 3 months prior to the administration of the study vaccine (number of previous polio vaccine doses to be documented). Any other vaccine 4 weeks before study entry.
  4. For Groups A1H and A2H: any children attending day care or pre-school.
  5. For Groups B1H, B2H, B1L, B2L, C1H, C2H, C1L, and C2L: any receipt of polio vaccines prior to administration of the study vaccine other than 3 doses of bOPV and 1 dose of IPV.
  6. Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus (HIV) infection.
  7. Family history of congenital or hereditary immunodeficiency.
  8. Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
  9. Known allergy to any component of the study vaccines or to any antibiotics.
  10. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections (of IPV).
  11. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  12. Acute severe febrile illness at day of vaccination deemed by the Investigator to be a contraindication for vaccination (the child can be included at a later time if within age window and all inclusion criteria are met.).
  13. Subject who, in the opinion of the Investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject.

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): NCT03554798


Contacts
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Contact: Ricardo Ruttimann, MD +5491161188536 rruttimann@fidec-online.org
Contact: Gabriela Aguirre, MSC +5491159647383 gaguirre@fidec-online.org

Locations
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Panama
Cevaxin Vaccination Center Recruiting
David, Chiriquí, Panama
Contact: Mayela Gaitán    (507) 6090 0112    mayela.gaitan@cevaxin.com   
Contact: María I, Caballero    (507) 317-1232    maria.caballero@cevaxin.com   
Principal Investigator: Tirza De León, MD         
Cevaxin Vaccination Center Recruiting
Panamá, Panama
Contact: María I. Caballero    (507) 317-1232    maria.caballero@cevaxin.com   
Contact: Rodrigo DeAntonio    (507) 317-1232    rodrigo.deantonio@cevaxin.com   
Principal Investigator: Xavier Sáez Llorens, MD         
Sponsors and Collaborators
Fidec Corporation
Bill and Melinda Gates Foundation

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Responsible Party: Fidec Corporation
ClinicalTrials.gov Identifier: NCT03554798     History of Changes
Other Study ID Numbers: M5 ABMG
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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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Poliomyelitis
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs