Safety and Immunogenicity of a New Inactivated Poliovirus Vaccine in Infants

Poliomyelitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01709071
• Other study ID #: NVI-256B
• Secondary ID: 2011-003792-11
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 16, 2012
• Last updated: February 20, 2014
• Start date: February 2012
• Est. completion date: May 2013

Study information

• Verified date: February 2014
• Source: National Institute for Public Health and the Environment (RIVM)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: May 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 56 Days to 63 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Poliomyelitis

Intervention

Drug:
• IPV

• Low dose Sabin-IPV

• Low dose adjuvanted Sabin-IPV

• Middle dose Sabin-IPV

• Middle dose adjuvanted Sabin-IPV

• High dose Sabin-IPV

• High dose adjuvanted Sabin-IPV

Locations

Country	Name	City	State
Poland	NZOZ Centrum Zdrowia "Blonie"	Bydgoszcz
Poland	Specjalistyczna Poradnia Medyczna "Przyladek Zdrowia"	Krakow
Poland	Szpital im. Jana Pawla II	Krakow
Poland	Samodzielny Publiczny ZOZ	Lubartów
Poland	NZOZ Praktyka Lekarza Rodzinnego "Eskulap"	Lublin
Poland	NZLA Michalkowice Jarosz i Partnerzy Spólka Lekarsk	Siemianowice Slaskie
Poland	Alergo-Med Specjalistyczna Przychodnia Lekarska Sp z o.o.	Tarnów

Sponsors (2)

Lead Sponsor	Collaborator
Pauline Verdijk	World Health Organization

Country where clinical trial is conducted

Poland, 

References & Publications (3)

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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse reactions following vaccination		5 days or until adverse reactions have resolved	Yes
Secondary	Level of virus neutralizing titers in serum		28 days after last vaccination	No