Clinical trial NCT01709071: Safety and Immunogenicity of a New Inactivated Poliovirus Vaccine in Infants
Official title: Double Blind Dose - Escalation, Randomized, Controlled, Phase I-II Trial to Evaluate Safety and Immunogenicity of Three Doses of Sabin-IPV and Adjuvanted Sabin-IPV in Healthy Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Poliomyelitis
Keywords: Vaccination
Inactivated poliomyelitis vaccine
poliomyelitis
Sabin strains
Lead sponsor: National Institute for Public Health and the Environment (RIVM)
Sponsor class: OTHER_GOV
Collaborators: name: World Health Organization
First posted: 2012-10-17
Enrollment: 140
Sex: ALL
Minimum age (years): 56
Maximum age (years): 63
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A new inactivated polio vaccine based on attenuated poliovirus strains was developed to transfer the technology to manufacturers in low- and middle-income countries. This vaccine was produced in different dosages and in different formulations. In healthy adults the safety of the highest dose was comparable to that of the existing inactivated polio vaccine. The purpose of this trial is to determine the safety of the different dosages and formulations of the vaccine in infants. The second goal of this study is to analyse the immune response after three doses in infants.

Detailed description: The goal of this study is to assess the safety and immunogenicity of Sabin-IPV and adjuvanted Sabin-IPV produced with the production process set up for technology transfer by the National Institute for Public Health and the Environment (RIVM, formerly the Netherlands Vaccine Institute (NVI).

* The primary objective is to evaluate safety (local and systemic reactions) of intramuscular injection with Sabin-IPV and adjuvanted Sabin-IPV in healthy infants.
* The secondary objective is to evaluate immunogenicity of three doses Sabin-IPV and adjuvanted Sabin-IPV in infants.

Eligibility criteria: Inclusion Criteria:

* Age 8 weeks (56-63 days) at the time of first vaccination
* Infants in good general health, eligible to be vaccinated according to the Polish national vaccination program. The same health criteria apply as used in well-baby clinics when a child receives a vaccination, e.g. also children with a small increase in temperature (\< 38.5° C) or with a common cold (runny nose etc) are seen as children with normal health.
* The parent(s)/legally representative(s) have to be willing and able to allow their child to participate in the trial according to the described procedures
* Presence of a signed informed consent in which the parent(s)/legally representative(s) have given written informed consent after receiving oral and written information (signature from one parent in case of single-parent family).

Exclusion Criteria:

* Any IPV or OPV dose
* Known or suspected allergy against any of the vaccine components
* History of unusual or severe reactions to any previous vaccination administration of plasma (including immunoglobulins) or blood products prior and during the study
* Any vaccination less than 14 days before or after each vaccination with the IMP
* History of any neurological disorder including epilepsy or febrile seizures
* Any infectious disease at the time of screening and/or inclusion that might interfere with the results of the study
* Present evidence of serious disease(s) demanding immunosuppressive medical treatment, like cytostatics and prednisolones, that might interfere with the results of the study
* Any known or suspected primary or secondary immunodeficiency
* Communication problems interfering in the study realization according to the judgment of the investigator
* Bleeding disorders and use of anticoagulants
* Premature birth (\<37 weeks)
* Participation in another clinical trial

Primary outcomes:
measure: Number of adverse reactions following vaccination
timeFrame: 5 days or until adverse reactions have resolved
Secondary outcomes:
measure: Level of virus neutralizing titers in serum
timeFrame: 28 days after last vaccination
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: NZOZ Centrum Zdrowia "Błonie"
city: Krakow
country: Poland
facility: Specjalistyczna Poradnia Medyczna "Przylądek Zdrowia"
city: Krakow
country: Poland
facility: Szpital im. Jana Pawła II
city: Lubartów
country: Poland
facility: Samodzielny Publiczny ZOZ
city: Lublin
country: Poland
facility: NZOZ Praktyka Lekarza Rodzinnego "Eskulap"
city: Siemianowice Śląskie
country: Poland
facility: NZLA Michałkowice Jarosz i Partnerzy Spółka Lekarsk
city: Tarnów
country: Poland
facility: Alergo-Med Specjalistyczna Przychodnia Lekarska Sp z o.o.
Study officials:
affiliation: National Institute for Public Health and the Environment (RIVM)
name: Pauline Verdijk, PhD
role: STUDY_DIRECTOR
References:
citation: Bakker WA, Thomassen YE, van't Oever AG, Westdijk J, van Oijen MG, Sundermann LC, van't Veld P, Sleeman E, van Nimwegen FW, Hamidi A, Kersten GF, van den Heuvel N, Hendriks JT, van der Pol LA. Inactivated polio vaccine development for technology transfer using attenuated Sabin poliovirus strains to shift from Salk-IPV to Sabin-IPV. Vaccine. 2011 Sep 22;29(41):7188-96. doi: 10.1016/j.vaccine.2011.05.079. Epub 2011 Jun 7.
citation: Verdijk P, Rots NY, Bakker WA. Clinical development of a novel inactivated poliomyelitis vaccine based on attenuated Sabin poliovirus strains. Expert Rev Vaccines. 2011 May;10(5):635-44. doi: 10.1586/erv.11.51.
citation: Verdijk P, Rots NY, van Oijen MG, Oberste MS, Boog CJ, Okayasu H, Sutter RW, Bakker WA. Safety and immunogenicity of inactivated poliovirus vaccine based on Sabin strains with and without aluminum hydroxide: a phase I trial in healthy adults. Vaccine. 2013 Nov 12;31(47):5531-6. doi: 10.1016/j.vaccine.2013.09.021. Epub 2013 Sep 21.
citation: Verdijk P, Rots NY, van Oijen MG, Weldon WC, Oberste MS, Okayasu H, Sutter RW, Bakker WA. Safety and immunogenicity of a primary series of Sabin-IPV with and without aluminum hydroxide in infants. Vaccine. 2014 Sep 3;32(39):4938-44. doi: 10.1016/j.vaccine.2014.07.029. Epub 2014 Jul 18.