Role of oral and inactivated poliovitus vaccines in inducing mucosal immunity - a trial in small children in Cuba

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616000169448
• Date of registration: 10/02/2016
• Prospective Registration: Yes
• Primary sponsor: WHO
• Public title: Role of oral and inactivated poliovitus vaccines in inducing mucosal immunity - a trial in small children in Cuba
• Scientific title: Comparison of mucosal immunity against polioviruses induced by inactivated poliovirus vaccine alone or in combination with bivalent oral poliovirus vaccine - a trial in small children in Cuba
• Date of first enrolment: 15/02/2016
• Target sample size: 300
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12616000169448.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Non-randomised trial;

Countries of recruitment

Cuba

Contacts

• Name: Dr ondrej mach

• Name: Dr Ondrej Mach

Key inclusion & exclusion criteria

Inclusion criteria: Healthy infants born between June 1 and August 31, 2015 (>3rd percentile for height and weight) at enrollment living within the catchment’s area of the participating health centers will be eligible for enrollment to Arms 1 and 2.
Healthy infants born between November 1 and December 31, 2015 (>3rd percentile for height and weight) at enrollment living within the catchment’s area of the participating health centers will be eligible for enrollment to Arm 3.

Exclusion criteria: Infants <3 percentile for height and weight, residence outside the catchment’s area, or families expecting to move away during the study period, will be excluded. A diagnosis, suspicion or treatment of immunodeficiency disorder (either in the participant or in a member of the immediate family) will render the child ineligible for the study. Infants of mother age below legal age (<18 years) or with mentally incapacity will not be eligible to participate.

Age minimum: 3 Months
Age maximum: 7 Months
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Public Health - Epidemiology

Infection - Other infectious diseases

poliomyelitis;
poliomyelitis

Intervention(s)

IPV: one dose (0.5 ml) of Inactivated poliovirus vaccine administered intramuscularly; tOPV: one dose (2 drops) of trivalent oral poliovirus vaccine administered orally; bOPV: one dose (2 drops) of bivalent poliovirus vaccine administered orally; all vaccines administered on-site by study staff

All Arms: blood collection at enrollment, 30 and 60 days post enrollment; stool collection 30, 37, 44 and 51 days post enrollment

Arm 1: IPV at enrollment; tOPV 30 days post enrollment
Arm 2: IPV+bOPV at enrollment, tOPV 30 days post enrollment
Arm 3: no vaccine at enrollment, tOPV 30 days post enrollment

Primary Outcome(s)

difference in poliovirus shedding in stool [7 days after tOPV dose]

Secondary Outcome(s)

difference in dynamic of poliovirus shedding after tOPV dose assessed by virus isolation in stool on days 14, 21 and 42 after tOPV dose[14, 21 and 42 days after tOPV challenge]

Secondary ID(s)

nil

Source(s) of Monetary Support

WHO

Ethics review

Status: Approved
Approval date:
Contact:

ERC Ministry of Health, Cuba