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Submitted by: John Michael Dominic Go 2019-06-21 09:44:39 Last Updated by: Principe, Jeverly Ann S 2019-06-25 17:54:06


Long Term Follow-up of Immunogenicity of Healthy Filipino Adults and Children who participated in Phase I study

PHRR190625-002159

IVI T005

2019-CT0504

Long Term Follow-up of Immunogenicity of Healthy Filipino Adults and Children who participated in Phase I study

Phase I study showed the Vi-DT test vaccine was safe, well tolerated, and elicited good immune response in a limited number of participant aged 2-45 years. It is confirmed through the phase II study that  the results in younger participants aged 6 months to 23 months, and the similar  will need to be established in larger statistically powered phase III studies.

The phase I study (IVI- T001) was designed to follow the participants for 1 month after Vi-DT administration. Since we don’t know the long term persistence of the anti-Vi antibodies, IVI decided to collect blood samples from the Vi-DT vaccine recipients in the phase I study  at 3rd, 4th and 5th year time points. This data will throw light on the antibody persistence as well as the potential need for boosting those responses, if at all. This will generate the data required by WHO to understand the antibody kinetics for TCV.

Start Date Duration in Months Target Completion Date Actual Completion Date
2019-08-31 36 2022-08-31 2019-06-21

Pending

pending EC approval

Institution Classification Region LTO #
International Vaccine Institute Private Business South Korea NA
Institution Classification Region LTO #
INC Research Philippines, Inc. Private Business Region IV-A 3000001893279
Institution Region
International Vaccine Institute South Korea
Name E-Mail Institution and Institution Address
John Go john.go@syneoshealth.com Syneos Health, Units 2903/4, 29th Floor, Discovery Centre, 25 ADB Avenue, Ortigas Center, Pasig City 1605, Philippines
Name E-Mail Institution and Institution Address
Dr. Arijit Sil Arijit.Sil@ivi.int International Vaccine Institute, SNU Research Park, 1 Gwanak-ro, Gwanak-gu, Seoul, #08826 Republic of Korea
Name Expertise Affiliation
Maria Rosario Z. Capeding, MD Pediatrician Tropical Disease Foundation, Inc.
Project Location Institutional Ethics Review Board
Tropical Disease Foundation, Inc. Tropical Disease Foundation Institutional Review Board

Typhoid Fever

To assess the long-term immunogenicity (Geometric Mean Titers (GMT) and Seroconversion) using anti-Vi IgG at different time points (i.e., at 3 years, 4 years, and 5 years) of those who had received  at least one dose of 25 µg of Vi-DT typhoid conjugate vaccine or Vi-polysaccharide during the phase I study

To assess the long-term immunogenicity using serum bactericidal antibody (SBA) at different time points (i.e., at 3 years, 4 years, and 5 years) of those who had received  at least one dose of 25 µg of Vi-DT typhoid conjugate vaccine or Vi-polysaccharide during the phase I study

Pending

  • Philippines

Clinical Trial

IVI T005

20190503103703

2019-05-31

0000-00-00

144

Unspecified

Unspecified

31 Aug 2019

Inclusion:

  1. Individuals who had participated in the Phase I (IVI-T001) study and had received at least one dose of Vi-DT typhoid conjugate or Vi-polysaccharide vaccine.
  1. Participants/Parents who have voluntarily given informed consent or assent
  2. Participants willing to provide at least one blood sample in this study

Exclusion:

1.            Individuals immunized with any typhoid vaccines after completion of the Phase I study (Last subject Last visit) in February 2017.

Observational

Unspecified

Unspecified

None

Non-Randomized

N/A

Unspecified

Not Applicable

To assess the long-term immunogenicity (Geometric Mean Titers (GMT) and Seroconversion) using anti-Vi IgG at different time points (i.e., at 3 years, 4 years, and 5 years) of those who had received  at least one dose of 25 µg of Vi-DT typhoid conjugate vaccine or Vi-polysaccharide during the phase I study

Phase I

Utilization Utilization Info
Publication
Oral Presentation
Drug Literature
Posters
Others
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