A randomized controlled trial of two versus three doses of Rotarix¿ vaccine for boosting and longevity of vaccine immune responses in Zambia

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201804003096919
• Date of registration: 16/02/2018
• Prospective Registration: Yes
• Primary sponsor: Centre for Infectious Disease Research in Zambia
• Public title: A randomized controlled trial of two versus three doses of Rotarix¿ vaccine for boosting and longevity of vaccine immune responses in Zambia
• Scientific title: A randomized controlled trial of two versus three doses of Rotarix¿ vaccine for boosting and longevity of vaccine immune responses in Zambia
• Date of first enrolment: 01/03/2018
• Target sample size: 212
• Recruitment status: Other
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3096
• Study type: Interventional
• Study design: Parallel: different groups receive different interventions at same time during study,Randomised,Simple randomisation using a radomisation table created by a computer software program,Sealed opaque envelopes
• Phase: Not Applicable

Countries of recruitment

Zambia

Contacts

• Name: Natasha Laban
• Affiliation: Research Fellow- Centre for Infectious Disease Research in Zambia

• Name: Joyce Chilekwa
• Affiliation: Project Manager - Centre for Infectious Disease Research in Zambia

Key inclusion & exclusion criteria

Inclusion criteria: 1. Mother willing to participate voluntarily and able to provide signed informed consent (with witness in the case of illiterate participant)

2. infant is eligible for rotavirus vaccine immunisation as per national policy (male or female, between 6 to 12 weeks old)

3. Mother willing to be physically examined, provide socio-demographic and medical data, blood at enrolment and breastmilk at scheduled visits.

4. Mother willing for infant to receive 2 or 3-dose Rotarix, saliva and stool sampling at enrolment , phlebotomy and enrolment, 14 weeks, 12 and 24 months and pre and 4 days post dose 1, 2 and 3

5. Mother willing to bring child to the clinic on scheduled dates, when infant has diarrhoea for collection of stool samples and plans to remain resident in the area
Exclusion criteria: 1. Contraindication to rotavirus vaccination

2. Previous administration of rotavirus vaccine to the infant

3. recent immunosuppressive therapy in child (including high-dose systemic corticosteroids)

4. History of ever receiving a blood transfusion or blood products, including immunoglobulins within the last 6 months for mother and child

5. Any condition deemed by the study investigator to pose potential harm to the participants or jeopardise the validity of study results

6. any existing congenital anomalies

Age minimum: 6 Week(s)
Age maximum: 12 Week(s)
Gender: Both

Health Condition(s) or Problem(s) studied

Digestive System
Diarrhoea, Rotavirus

Diarrhoea, Rotavirus

Digestive System

Intervention(s)

Two-dose Rotarix vaccination

Three-dose Rotarix vaccination

Primary Outcome(s)

Boosting of rotavirus-specific immunoglobulin A antibody responses between infants receiving two versus three doses of Rotarix vaccine post dose 3 until 12 months of infant's age

Secondary Outcome(s)

Longevity of rotavirus-specific immunoglobulin A antibody responses by the second year of life

Profile of maternal breastmilk rotavirus specific immunoglobulins and innate anti-viral glycoproteins

Profile of infant histo-blood group antigen phenotypes and genotypes

Profile of infant pre-vaccination and vaccine induced innate and adaptive immune responses

Safety of the 3-dose Rotarix vaccine regimen

Secondary ID(s)

TMA2016SF-1511

Source(s) of Monetary Support

The European and Developing Countries Clinical Trials Partnership (EDCTP)

Ethics review

Status: Approved
Approval date: 19/04/2018
Contact:

[e-mail]

The University of Zambia Biomedical Research Ethics Committee

[phone]

[e-mail]