Submitted by: Pearly Anne Cheng 2019-04-10 10:03:50 Last Updated by: Pearly Anne Cheng 2019-04-29 08:58:47 Export to PDF

An Open-Label, comparative, single dose, clinical phase 1 study to assess the safety and tolerability of Typhiod Conjugate Vaccine (EuTCV) in Healthy adults

PHRR190415-002098

UTCV_101

2018-CT0470

An Open-Label, comparative, single dose, clinical phase 1 study to assess the safety and tolerability of Typhiod Conjugate Vaccine (EuTCV) in Healthy adults

An open-label randomized, comparative, single dose, clinical phase 1 studyEuBiologics Co., Ltd. 18 / 39

 

Vital signs including body temperature, sitting blood pressure and pulse rate will be measured and recorded at Visit 2, prior to the administration of dose, 0.5 and 1.0 hour after administration of dose. Local and systemic adverse reactions will be assessed and recorded up to one hour on the day of the vaccination. Clinical examination of the subjects will be done at four time points (Visit 1, 2, 3, and 4). During the study, subjects will be monitored specifically for local adverse events (AEs) (pain, tenderness, erythema, redness, swelling, induration and pruritis associated with injection) and systemic AEs (fever [ >38oC], headache, fatigue, myalgia, nausea, vomiting, arthralgia, chills and acute allergic reaction). Subjects will be questioned for well-being at the time of clinical examinations and vital signs will be recorded.

Laboratory assessments of hematology, biochemistry and urinalysis tests will be done at the time of screening. Laboratory tests will also be done on Day 7 and Day 42 post vaccination. Any abnormality in laboratory finding results will be evaluated for clinical relevance, and clinically relevant abnormal value will be treated as an AE.

Regime Classification Priority
2017 - 2022 Research to enhance and extend healthy lives Non-communicable diseases
Start Date Duration in Months Target Completion Date Actual Completion Date
2019-04-08 8 2019-12-08 0000-00-00

Ongoing

Institution Classification Region LTO #
Eubiologics Co. Ltd Private Business South Korea 3000002140826
Institution Classification Region LTO #
Novotech (Australia) Pty. Ltd. - Philippine Branch Private Business NCR 3000002140826
Institution Amount Region
Eubiologics Co. Ltd N/A South Korea
Name E-Mail Phone Number Postal Address
Jennifer Arellano jenny.arellano@novotech-cro.com +639175243981 1605
Name E-Mail Phone Number Postal Address
Jennifer Arellano jenny.arellano@novotech-cro.com +639175243981 1605
Name Expertise Affiliation
Loreta Baldovino Zoleta-de Jesus, MD Infectious Disease De La Salle Angelo King Medical Research Center
Project Location Institutional Ethics Review Board
De La Salle Angelo King Medical Research Center N/A

Typhoid Fever

To evaluate safety and tolerability of a single dose EuTCV in healthy subjects 18 – 45 years of age compared to comparator vaccines

To evaluate immunogenicity of a single dose EuTCV in healthy subjects 18 – 45 years of age compared to comparator vaccines

Ÿ Proportion of subjects with seroconversion (defined as a 4- fold or more rise in anti-Vi antibody titers at Day 42 compared to baseline,

as measured by anti-Vi Immunoglobulin G (IgG) enzyme linked immunosorbent assay [ELISA])

Ÿ Geometric Mean Titer (GMT) as measured by anti-Vi IgG antibody titer at Day 42

Ÿ Geometric Mean Fold rise (GMFrise) for anti-Vi IgG antibody titers from baseline to Day 42

 

Pending

Clinical Trial

2018-CT0470

2019-03-26

None

Inclusion

  1. Subjects aged between and including 18 and 45 years at time of Visit 1
  2. Willing to give written informed consent to participate in the trial
  3. Subjects who are healthy as determined by medical history, with no clinically significant abnormalities in clinical examination and laboratory tests

 

Exclusion Criteria

The following volunteers will be excluded from the study-

  1. Subject unwilling to give his/her consent to participate in the trial
  2. Subjects who have received the last dose of Typhoid containing vaccines less than 10 years back
  3. Subjects who have past history of Typhoid as judged per investigator
  4. Subject already immunized with any licensed vaccine within 4 weeks prior to enrolment/vaccination (Day 1) and expected to receive other licensed vaccines during the study period
  5. Subjects with known hypersensitivity to any component of the study vaccine or a life-threatening reaction after previous administration of the vaccine or a vaccine containing the same substances
  6. Pregnant, lactating women or women of childbearing age not using a reliable method of contraception
  7. Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the subject and interfere with the assessment of the trial objectives
  8. Evidence of acute illness within past 7 days requiring systemic antibiotic or antiviral therapy
  9. Subjects who have experienced transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or Typhoid
  10. Known history of immune function disorders including immunodeficiency disease, or chronic use of systemic steroids (>20 mg/day prednisone equivalent for periods exceeding 10 days), cytotoxic or other immunosuppressive drugs
  11. Known history of administration of blood or blood-derived products in the past 90 days
  12. History of alcohol or substance abuse
  13. Subjects who in the opinion of the investigator will not be able to comply with any of the protocol required procedure
  14. Subjects who have participated in other trials 90 days prior to enrollment
  15. Subjects planning to leave the area of study site before completion of the study

Observational

Unspecified

Unspecified

Non-Randomized

Open Label

Unspecified

Single

 

The purpose of this study is to evaluate the safety and tolerability of a single-dose regimen of a Vi-CRM197 EuTCV, in comparison to the WHO prequalified typhoid conjugate vaccine (Typbar-TCV™, Bharat Biotech) and Vi-Polysaccharide (Typhim Vi®, Sanofi Pasteur) typhoid vaccine, in healthy adult volunteers aged 18-45 years. This study will be conducted with three arms where healthy adult volunteers (18 to 45 years) will be randomized in a 1:1:1 ratio to receive single dose of test or the comparator vaccines. Safety, tolerability and immunogenicity data from the adult cohort will be submitted to the National Regulatory Authority (PFDA).  

 

 

Phase I

75

Unspecified

Unspecified

08 Apr 2019

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