Clinical trial NCT00260312: Study of Inactivated Poliovirus Vaccine Given at an Earlier Schedule With Shorter Intervals
Official title: Randomized Placebo-Controlled Trial of Inactivated Poliovirus Vaccine in Cuba
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Level of Immunity Against Poliovirus Infection
Keywords: inactived
polio
vaccine
cuba
trial
randomized
eradication
Lead sponsor: Pan American Health Organization
Sponsor class: OTHER
Collaborators: name: World Health Organization
name: Institute Pedro Kouri, Ministry of Public Health (Cuba)
name: Centers for Disease Control and Prevention
First posted: 2005-12-01
Enrollment: 300
Sex: MALE
Minimum age (years): 6
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to evaluated the effectiveness of inactivated poliovirus vaccine at a vaccine schedule that is commonly used in developing countries. The effectiveness of inactivated poliovaccine given at this schedule is important to national policy makers as they consider vaccination policies after the use of oral polio vaccine is discontinued.

Detailed description: After polio eradication, access to live polioviruses will be highly restricted, and oral poliovirus vaccine (OPV) use must be discontinued. OPV-using countries must decide whether to switch to inactivated poliovirus vaccine (IPV) or stop polio vaccination. Because only limited data are available on IPV immunogenicity in tropical developing countries, we conducted a randomized controlled trial of IPV in Cuba. The objectives of this study were to assess the humoral and mucosal immunogenicity conferred by IPV administered at the WHO-EPI schedule (6,10,14 wks of age) vs. placebo. A third arm was added to evaluate the immunogenicity of IPV administered at 2 and 4 months of age. Antibody titers were measured prior to the first dose as well as 1 month after the last dose in each study arm. Target sample size was 100 children in each arm. Mucosal (intestinal immunity) was measured indirectly through assessing poliovirus excretion in each group after a "natural challenge" of trivalent oral polio vaccine (OPV)recieved by study participants through their participation in the annual OPV mass campaigns approximately 1 month after their last dose of vaccine.

Eligibility criteria: Inclusion Criteria:

Infants born 18 - 20 weeks prior to the first round of the 2002 National Immunization Days in cuba (in March 2002).

Born healthy at one of the 4 designated maternity hospitals in Cuba

Exclusion Criteria:

Serious congenital defect/disease at birth

-

Primary outcomes:
measure: Seroconversion by measuring level of poliovirus antibodies in serum. Also, measure of virus titer in stools to indirectly assess the level of intestinal mucosal immunity
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ministry of Public Health, Cuba
name: Miguel Galindo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cuba IPV Study Collaborative Group. Randomized, placebo-controlled trial of inactivated poliovirus vaccine in Cuba. N Engl J Med. 2007 Apr 12;356(15):1536-44. doi: 10.1056/NEJMoa054960.