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Response to Rotavirus Vaccine in Infants in Ho Chi Minh City in Vietnam

Primary Purpose

Rotavirus, Diarrhea

Status

Completed

Phase

Phase 4

Locations

Vietnam

Study Type

Interventional

Intervention

Rotarix vaccine

About this trial

This is an interventional prevention trial for Rotavirus focused on measuring Rotavirus, Vaccine, Diarrhea, Host genetics

Eligibility Criteria

8 Weeks - 9 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Infants (both males and females) between 8 and 9 weeks (i.e. approximately 2 months) of age who are attending Hung Vuong Hospital to receive their standard EPI vaccinations.
Currently registered residents of Districts 5 (where Hung Vuong Hospital is located) or 1, 6, 8, 10, or 11 (districts that are neighbouring district 5) in Ho Chi Minh city, with no specific intention of relocating in the next 12 months.
Informed consent to be enrolled in the study and comply with study procedures, including host genetic studies.

Exclusion Criteria:

Refusal of consent.
Parent/ guardian under the age of 18.
Premature (i.e. gestation period <37 weeks).
Infants who have already been immunized with either a rotavirus vaccine or the standard 2-month EPI vaccinations.
History of hypersensitivity to any components of the vaccine or adverse vaccine event.
History of intussusception or congenital malformation of the gastrointestinal tract in the child that is likely to predispose child to intussusception.
History of severe combined immunodeficiency disease (SCID), acquired immune deficiency syndrome (AIDS) or Human immunodeficiency virus (HIV) positivity, or other known immunodeficiency syndromes that may place the child at risk during immunisation.

Sites / Locations

Hung Vuong Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rotavirus vaccine

Arm Description

The Rotarix vaccine package consist of 1.5 ml of oral suspension in a pre-filled oral applicator (type I glass) with a plunger stopper (rubber butyl) and a protective tip cap (rubber butyl) in pack sizes of 1. The vaccination course consists of two doses. The first dose may be administered from the age of 6 weeks. There should be an interval of at least 4 weeks between doses. The vaccination course should preferably be given before 16 weeks of age, but must be completed by the age of 24 weeks. Rotarix is for oral use only and should under no circumstancies be injected. All participating infants will receive two doses of Rotarix vaccine following the standard Rotarix immunization protocol.

Outcomes

Primary Outcome Measures

The rotavirus vaccine failure events during the time period from recruitment to 18 months of age.

The primary endpoint is to measure the proportion of rotavirus vaccine failure events during the time period from recruitment to 18 months of age after the first dose of vaccination.

Secondary Outcome Measures

Quantification of the antibody response following immunization

The temporal kinetics of rotavirus-specific antibody responses following immunization will be measured using virus-binding enzyme-linked immunosorbent assay (ELISA), which will be used to investigate the effect of host genetics, maternally transferred antibodies, and geospatial and epidemiological factors on the humoral response following vaccination.

Assessment of infecting rotavirus genotypes in vaccine failure cases

The rotavirus genotypes in vaccine failure cases will be assessed to investigate whether vaccine failure cases are a result of varying rotavirus genotypes.

Full Information

NCT ID

NCT03587389

First Posted

April 17, 2018

Last Updated

November 10, 2022

Sponsor

Oxford University Clinical Research Unit, Vietnam

Collaborators

Hung Vuong Hospital, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, Children's Hospital Number 1, Ho Chi Minh City, Vietnam, Wellcome Trust Sanger Institute, UK

1. Study Identification

Unique Protocol Identification Number

NCT03587389

Brief Title

Response to Rotavirus Vaccine in Infants in Ho Chi Minh City in Vietnam

Official Title

An Open Single-arm Interventional Study to Identify the Influence of Human Genetic Variation on Early Transcriptional Responses and Protective Immunity Following Immunization With Rotarix Rotavirus Vaccine in Infants in HCM City in Vietnam

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

March 19, 2019 (Actual)

Primary Completion Date

June 30, 2022 (Actual)

Study Completion Date

August 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Oxford University Clinical Research Unit, Vietnam

Collaborators

Hung Vuong Hospital, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, Children's Hospital Number 1, Ho Chi Minh City, Vietnam, Wellcome Trust Sanger Institute, UK

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary objective is to measure the effect of host human genetics on the resulting immunological responses and long-term protection following rotavirus immunization of a study population of infants in Ho Chi Minh City, Vietnam. The secondary objectives are to assess the temporal immunological responses following rotavirus vaccination, and to investigate the role of maternally derived antibodies, and other factors that could potentially affect immunological responses following rotavirus vaccination. Also to assess infecting rotavirus genotypes in the vaccine failure cases.

Detailed Description

This study will be an open single arm, single centre, interventional study conducted in Ho Chi Minh City, Vietnam. A sample size of 1,000 infants will be recruited to the study between 8 to 9 weeks (which is around 2 months) of age. These infants will receive two doses of the rotavirus vaccine, Rotarix with an interval of 28-37 days (or 4-5 weeks). The parents will be requested to bring the infants 2-3 days following each Rotarix vaccination to receive the standard EPI vaccinations. The infants will then be under passive and active surveillance for rotavirus-associated diarrhoea until 18 months of age. Blood samplings during pre and post vaccination and at 6, 12 and 18 month old visits will be collected.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rotavirus, Diarrhea

Keywords

Rotavirus, Vaccine, Diarrhea, Host genetics

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

818 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rotavirus vaccine

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Rotarix vaccine

Intervention Description

In this study, the 1st dose of Rotarix vaccine will be administered when infants are at ages between weeks 8-9 and the 2nd dose is 28-37 days after the 1st dose, which means that there is an interval of 28-37 days or 4-5 weeks between doses. A reminding call will be set at about 4 weeks after the 1st dose to remind parents to bring their children back to Hung Vuong Hospital for the 2nd dose of Rotarix to ensure the completion of the 2nd dose of Rotarix vaccine.

Primary Outcome Measure Information:

Title

The rotavirus vaccine failure events during the time period from recruitment to 18 months of age.

Description

The primary endpoint is to measure the proportion of rotavirus vaccine failure events during the time period from recruitment to 18 months of age after the first dose of vaccination.

Time Frame

from the recruitment to 18 months of age after the first dose of vaccination

Secondary Outcome Measure Information:

Title

Quantification of the antibody response following immunization

Description

Time Frame

data collected during 7 site visits (Visit 1: Rotarix Dose 1, Visit 2: 2-3 after Visit 1, Visit 3: 28-37 days after Visit 1, Visit 4: 2-3 days after Visit 3, Visit 5: 6 months old, Visit 6: 12 months old, Visit 7: 18 months old)

Title

Assessment of infecting rotavirus genotypes in vaccine failure cases

Description

The rotavirus genotypes in vaccine failure cases will be assessed to investigate whether vaccine failure cases are a result of varying rotavirus genotypes.

Time Frame

from the recruitment to 18 months of age after the first dose of vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Weeks

Maximum Age & Unit of Time

9 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Infants (both males and females) between 8 and 9 weeks (i.e. approximately 2 months) of age who are attending Hung Vuong Hospital to receive their standard EPI vaccinations. Currently registered residents of Districts 5 (where Hung Vuong Hospital is located) or 1, 6, 8, 10, or 11 (districts that are neighbouring district 5) in Ho Chi Minh city, with no specific intention of relocating in the next 12 months. Informed consent to be enrolled in the study and comply with study procedures, including host genetic studies. Exclusion Criteria: Refusal of consent. Parent/ guardian under the age of 18. Premature (i.e. gestation period <37 weeks). Infants who have already been immunized with either a rotavirus vaccine or the standard 2-month EPI vaccinations. History of hypersensitivity to any components of the vaccine or adverse vaccine event. History of intussusception or congenital malformation of the gastrointestinal tract in the child that is likely to predispose child to intussusception. History of severe combined immunodeficiency disease (SCID), acquired immune deficiency syndrome (AIDS) or Human immunodeficiency virus (HIV) positivity, or other known immunodeficiency syndromes that may place the child at risk during immunisation.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephen Baker, Professor

Organizational Affiliation

Oxford University Clinical Research Unit

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hung Vuong Hospital

City

Ho Chi Minh

ZIP/Postal Code

700000

Country

Vietnam

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Response to Rotavirus Vaccine in Infants in Ho Chi Minh City in Vietnam

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