Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: www.pactr.org
Trial no.: PACTR201804003096919 Date registered: 16/02/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A randomized controlled trial of two versus three doses of Rotarix¿ vaccine for boosting and longevity of vaccine immune responses in Zambia
Official scientific title A randomized controlled trial of two versus three doses of Rotarix¿ vaccine for boosting and longevity of vaccine immune responses in Zambia
Brief summary describing the background and objectives of the trial Rotavirus vaccines exhibit lower immunogenicity, efficacy and duration of protection in low-middle income countries and it is not clear why. We propose a randomised controlled trial to test the hypothesis that a third dose of Rotarix vaccine administered at 9 months¿ infant age will boost rotavirus specific immunoglobulin A by 1-year of infant age and potentially confer stronger and enduring immunity in the second year of life. We will also profile infant innate and adaptive immune responses to vaccination and assess effects of maternal breastmilk and infant genetic factors on vaccine immunogenicity.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ROVAS 2
Disease(s) or condition(s) being studied Diarrhoea, Rotavirus,Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 01/03/2018
Actual trial start date 13/09/2018
Anticipated date of last follow up 01/09/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 212
Actual target sample size (number of participants) 214
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
TMA2016SF-1511 The European and Developing Countries Clinical Trial Partnership
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Two-dose Rotarix vaccination single dose Rotarix vaccine administered at 6 and 10 weeks infant's age 106 Active-Treatment of Control Group
Experimental Group Three-dose Rotarix vaccination single dose Rotarix vaccine administered at 6 weeks, 10 weeks and 9 months infant's age 106
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 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 6 Week(s) 12 Week(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/04/2018 The University of Zambia Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ridgeway Campus Lusaka 00000 Zambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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 Three months after administration of Rotarix dose 3 at 12 months infant's age
Secondary Outcome Safety of the 3-dose Rotarix vaccine regimen Throughout the entire study period
Secondary Outcome Longevity of rotavirus-specific immunoglobulin A antibody responses by the second year of life At 24 months infant's age
Secondary Outcome Profile of infant pre-vaccination and vaccine induced innate and adaptive immune responses (1) At baseline before infant receives the first dose of Rotarix vaccine (2) At 4 and 21 days after the infant receives the first dose of Rotarix vaccine (3) At 4 days and one month after the infant receives the second dose of Rotarix vaccine (4) Before and 4 days after the infant receives the third dose of Rotarix vaccine or not
Secondary Outcome Profile of infant histo-blood group antigen phenotypes and genotypes At baseline before the infant receives the first dose of Rotarix vaccine
Secondary Outcome Profile of maternal breastmilk rotavirus specific immunoglobulins and innate anti-viral glycoproteins (1) Before the child receives the first, second and third dose of Rotarix vaccine (2) At all scheduled monthly visits throughout the entire study period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
George Clinical Study Site Lusaka District Health Management Team, George Clinic Lusaka P.O Box 50827 Zambia
FUNDING SOURCES
Name of source Street address City Postal code Country
The European and Developing Countries Clinical Trials Partnership (EDCTP) Anna van Saksenlaan 51, 2593 HW The Hague P.O Box 93015 Netherlands
The European and Developing Countries Clinical Trials Partnership (EDCTP) Anna van Saksenlaan 51, 2593 HW The Hague P.O Box 93015 Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Centre for Infectious Disease Research in Zambia Plot 34620 Off Alick Nkhata Road, Mass Media Lusaka P.O Box 34681 Zambia Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
London School of Hygiene and Tropical Medicine Keppel Street, Bloomsbury London WC1E 7HT United Kingdom
Christian Medical College Ida Scudder Road Vellore, Tamil Nadu 632004 India
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Roma Chilengi roma.chilengi@cidrz.org 00260973724935 Plot 34620 Off Alick Nkhata Rd between ERB and FAZ, Mass Media
City Postal code Country Position/Affiliation
Lusaka 10101 Zambia Chief Scientific Officer- Centre for Infectious Disease Research in Zambia
Role Name Email Phone Street address
Public Enquiries Joyce Chilekwa Joyce.Chilekwa@cidrz.org +260977197469 Plot 34620 Off Alick Nkhata Road, Mass Media
City Postal code Country Position/Affiliation
Lusaka P.O Box 34681 Zambia Project Manager - Centre for Infectious Disease Research in Zambia
Role Name Email Phone Street address
Scientific Enquiries Natasha Laban natasha.laban@cidrz.org 00260979349417 Plot 34620 Off Alick Nkhata Rd between ERB and FAZ, Mass Media
City Postal code Country Position/Affiliation
Lusaka 10101 Zambia Research Fellow- Centre for Infectious Disease Research in Zambia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result URL Hyperlinks Baseline Characters Participant Flow Adverse Events Outcome Measures Description
Link To Protocol
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 05/07/2018 pactr update Not Applicable
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Acronym 05/07/2018 pactr update ROVAS-2 RV1
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Purpose of the trial 05/07/2018 pactr update Prevention Prevention: Vaccines
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Disease(s) 05/07/2018 pactr update Other Digestive System, Other
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 26/10/2018 First patient enrolled 13 Sep 2018
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 26/10/2018 Study has started recruiting Not yet recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Acronym 12/11/2019 when the PACTR website went through an upgrade, the acronym was erroneously changed. This is to correct it RV1 ROVAS 2
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 12/11/2019 – trial has finished recruitment as in now in follow up phase Recruiting Closed to recruitment,follow-up continuing
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 12/11/2019 this is the total infants recruited into the study 214
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 12/11/2019 updated information TRUE, The University of Zambia Biomedical Research Ethics Committee, Ridgeway Campus, Lusaka, P.O Box 50110, Zambia, , 19 Apr 2018, , , TRUE, The University of Zambia Biomedical Research Ethics Committee, Ridgeway Campus, Lusaka, 00000, Zambia, , 19 Apr 2018, +2601256067, unzarec@unza.zm, 3096_2673_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 12/11/2019 new entry No
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results Available 12/11/2019 Not published yet No No