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

NCT ID: NCT03587389

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 818 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-19
• Study Completion Date: 2022-08-08

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.

Conditions

Rotavirus; Diarrhea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Rotavirus vaccine

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.

Group Type: EXPERIMENTAL

Rotarix vaccine

Intervention Type: BIOLOGICAL

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.

Interventions

Rotarix vaccine

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.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 8 Weeks
• Maximum Eligible Age: 9 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hung Vuong Hospital

OTHER

Sponsor Role: collaborator

Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

OTHER

Sponsor Role: collaborator

Children's Hospital Number 1, Ho Chi Minh City, Vietnam

OTHER

Sponsor Role: collaborator

Wellcome Sanger Institute

OTHER

Sponsor Role: collaborator

Oxford University Clinical Research Unit, Vietnam

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Baker, Professor

Role: PRINCIPAL_INVESTIGATOR

Oxford University Clinical Research Unit

Locations

Hung Vuong Hospital

Ho Chi Minh City, , Vietnam

Countries

Vietnam

Other Identifiers

21EN

Identifier Type: -

Identifier Source: org_study_id