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Completed

NCT Number: NCT03587389

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

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.

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Key information

Conditions

Rotavirus Diarrhea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

8 week–9 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hung Vuong Hospital

Ho Chi Minh City, 700000, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rotarix vaccine

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.

Primary outcomes

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

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

    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 outcomes

  1. Quantification of the antibody response following immunization

    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)

    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.

  2. Assessment of infecting rotavirus genotypes in vaccine failure cases

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

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

Sponsors and collaborators

Lead sponsor

Oxford University Clinical Research Unit, Vietnam

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 16, 2018
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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