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: pactr.samrc.ac.za
Trial no.: PACTR202404654347323 Date of Approval: 10/04/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of the Immunogenicity of Concomitant Administration of Novel Oral Polio Type 2 Vaccine (nOPV2) with Sabin OPV in Children aged 6 - 59 months in Mozambique
Official scientific title Evaluation of the Immunogenicity of Concomitant Administration of Novel Oral Polio Type 2 Vaccine (nOPV2) with Sabin OPV in Children aged 6 - 59 months in Mozambique
Brief summary describing the background and objectives of the trial Concurrent circulation of cVDPV2 and other poliovirus types is a major concern in some areas with low vaccination coverage. Most common is the co-circulation of cVDPV2 and type 1 poliovirus (cVDPV1 or WPV1), which was observed in Mozambique in the northern provinces of Cabo Delgado, Nampula and Manica. The study is intended to assess the immunogenicity of nOPV2 concomitantly administered with mOPV1 or bOPV in SIA-eligible children 6 to 24 months, to inform outbreak response options for areas experiencing poliovirus serotype co-circulation. This will be an open label, randomized, immunogenicity study of nOPV2 concomitantly administered with Sabin OPV among infants between 6 to 24 months of age in Mozambique. Participants will be selected from two sites of Maputo city, namely Hospital Geral José Macamo and Centro de Saúde 1 de Junho, all will be randomized to one of three arms: nOPV2 alone, nOPV2 + bOPV and nOPV2 + mOPV1. The arm assignment of vaccine recipients will be known to study staff and the vaccine recipient’s parents after randomization. CDC laboratory staff testing for poliovirus antibody titers will remain blinded throughout the study.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) nOPV2 PLUS
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Poliovirus
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 06/05/2024
Actual trial start date 03/06/2024
Anticipated date of last follow up 31/07/2024
Actual Last follow-up date 30/08/2024
Anticipated target sample size (number of participants) 888
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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 randomization using a randomization 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
Experimental Group nOPV2 and mOPV1 Each dose (2 drops = 0.1 mL), each enrolled children will receive two drops of each polio vaccines. Each participants will be enrolled and followd for 12 weeks, according to the schedule bellow: Visit 1: Baseline (1st Vaccine Administration Blood draw) Visit 2: Four weeks (2nd Vaccine Administration Blood draw) Visit 3: Eight weeks (3rd Vaccine Administration Blood draw) Visit 4: 12 weeks (Blood draw) Children assigned for this intervention arm will receive concomitantlly nOPV2 and mOPV1 vaccines. 296
Experimental Group nOPV2 and bOPV vaccines Each dose (2 drops = 0.1 mL), during three visits (baseline, 4 weeks and 8 weeks) 12 weeks divided by: Baseline (1st Vaccine Administration and Blood draw), 4 weeks (2nd Vaccine Administration Blood draw), 8 weeks (3rd Vaccine Administration and Blood draw), 12 weeks (Blood draw). nOPV2 + bOPV vaccines co-administration 296
Control Group nOPV2 vaccine only Each dose (2 drops = 0.1 mL) 12 weeks divided by: Baseline (1st Vaccine Administration and Blood draw), 4 weeks (2nd Vaccine Administration Blood draw), 8 weeks (3rd Vaccine Administration and Blood draw), 12 weeks (Blood draw). Children will receive nOPV2 vaccine only 296 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
 Healthy child aged 6-59 months old  Resident in study area for the duration of the study period  Parent/guardian consent for participation in the study  Child included in nOPV2 study or their brothers, cousins, neighbour children  Health issue contraindication for venepuncture  Acutely sick child or child requiring hospitalization.  Diagnosis or suspicion of congenital immunodeficiency disorder in the subject or an immediate family member Infant: 0 Month-23 Month,Infant: 1 Month-23 Month,Preschool Child: 2 Year-5 Year 6 Month(s) 59 Month(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
No 20/03/2024 National Committee for Bioethics in Health of Mozambique
Ethics Committee Address
Street address City Postal code Country
112 Maputo City 264 Mozambique
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 13/03/2024 Ethics Review Committee WHO
Ethics Committee Address
Street address City Postal code Country
20 GENEVA 27 Maputo 1211 Switzerland
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To compare type 2 immunogenicity of two doses of nOPV2 administered alone to two doses of nOPV2 co-administered with mOPV1 and two doses of nOPV2 co-administered with bOPV. The outcome will be measured after 12 weeks when the children complete all the vaccine doses intervention and visits.
Secondary Outcome To compare type 1 and type 3 immunogenicity of two doses of nOPV2 administered alone to two doses of nOPV2 co-administered with mOPV1 and two doses of nOPV2 co-administered with bOPV. The outcome will be measured after 12 weeks when the children complete all the vaccine doses intervention and visits.
Secondary Outcome To compare type 1, type 2 and 3 immunogenicity of three doses of nOPV2 administered alone to three doses of nOPV2 co-administered with mOPV1 and three doses of nOPV2 co-administered with bOPV. The outcome will be measured after 12 weeks when the children complete all the vaccine doses intervention and visits.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centro de Saude Jose Macamo 1095 R/C Maputo City Mozambique
Centro de Saude 1 de Junho 4.276 Maputo City Mozambique
FUNDING SOURCES
Name of source Street address City Postal code Country
Worls Health Organization 20 Geneve Switzerland CH-1211 Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor World Health Organization 20, Geneva 27 Geneva 1211 Switzerland Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Nilsa de Deus EN1 3943 Maputo Province Mozambique
Adilson Bauhofer EN1 3943 Maputo Mozambique
Olga Maquessene EN1 3943 Maputo Mozambique
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nilsa de Deus nilsa.dedeus@ins.gov.mz +258843697690 EN1, 3943
City Postal code Country Position/Affiliation
Maputo Province Mozambique National Institute of Health
Role Name Email Phone Street address
Public Enquiries Rocio Lopes lopezro@who.int +34664664432 20 Avenue Appia, Geneva
City Postal code Country Position/Affiliation
Geneva 1202 Switzerland World Health Organization
Role Name Email Phone Street address
Scientific Enquiries Adilson Bauhofer adilson.bauhofer@ins.gov.mz +258847684160 EN1, Parcela 3943
City Postal code Country Position/Affiliation
Maputo City Mozambique Instituto Nacional de Saude
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participants data that underline the results reported in this article, will be shared after the deidentification. Informed Consent Form,Statistical Analysis Plan,Study Protocol Begins 3 months and end 5 year after the publication Proporsals should be directed to Adilson Bauhofer through his e-amail adilson.bauhofer@ins.gov.mz. To gain access, the requestor will need to sign a data aceess agreement
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information