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

  • STATUS
    Recruiting
  • End date
    Dec 21, 2022
  • participants needed
    1000
  • sponsor
    Oxford University Clinical Research Unit, Vietnam
Updated on 21 July 2021
vaccination
rotavirus
rotarix
rotavirus vaccine

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.

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.

Details
Condition Rotavirus, Diarrhea, Recurrent Diarrhea, Clostridium Difficile-Associated Diarrhea, diarrhoea, loose stools
Treatment Rotarix vaccine
Clinical Study IdentifierNCT03587389
SponsorOxford University Clinical Research Unit, Vietnam
Last Modified on21 July 2021

Eligibility

Yes No Not Sure

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
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