Safety and Immunogenicity of a New Inactivated Poliovirus Vaccine in Infants

NCT ID: NCT01709071

Last Updated: 2014-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-05-31

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.

Conditions

Poliomyelitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Low dose Sabin-IPV

Intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 5, 8, 16 D-antigen units respectively of Sabin-1,-2 and -3 per dose.

Infants receive three vaccinations with an interval of 8 weeks between doses.

Group Type: EXPERIMENTAL

Low dose Sabin-IPV

Intervention Type: DRUG

Low dose adjuvanted Sabin-IPV

Intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 2.5, 4, 8 D-antigen units respectively of Sabin-1,-2 and -3 per dose adjuvanted with 0.5 mg aluminium hydroxide.

Infants receive three vaccinations with an interval of 8 weeks between doses.

Group Type: EXPERIMENTAL

Low dose adjuvanted Sabin-IPV

Intervention Type: DRUG

Middle dose Sabin-IPV

Intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 10, 16, 32 D-antigen units respectively of Sabin-1,-2 and -3 per dose.

Infants receive three vaccinations with an interval of 8 weeks between doses.

Group Type: EXPERIMENTAL

Middle dose Sabin-IPV

Intervention Type: DRUG

Middle dose adjuvanted Sabin-IPV

Intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 5, 8, 16 D-antigen units respectively of Sabin-1,-2 and -3 per dose adjuvanted with 0.5 mg aluminium hydroxide.

Infants receive three vaccinations with an interval of 8 weeks between doses.

Group Type: EXPERIMENTAL

Middle dose adjuvanted Sabin-IPV

Intervention Type: DRUG

High dose Sabin-IPV

Intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 20, 32, 64 D-antigen units respectively of Sabin-1,-2 and -3 per dose.

Infants receive three vaccinations with an interval of 8 weeks between doses.

Group Type: EXPERIMENTAL

High dose Sabin-IPV

Intervention Type: DRUG

High dose adjuvanted Sabin-IPV

Intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 10, 16, 32 D-antigen units respectively of Sabin-1,-2 and -3 per dose adjuvanted with 0.5 mg aluminium hydroxide.

Infants receive three vaccinations with an interval of 8 weeks between doses.

Group Type: EXPERIMENTAL

High dose adjuvanted Sabin-IPV

Intervention Type: DRUG

Conventional IPV

Intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 40, 8, and 32 D-antigen units respectively of Mahoney, MEF-1 and Saukett poliovirus per dose.

Infants receive three injections with an interval of 8 weeks between doses.

Group Type: ACTIVE_COMPARATOR

IPV

Intervention Type: DRUG

Interventions

IPV

Intervention Type: DRUG

Low dose Sabin-IPV

Intervention Type: DRUG

Low dose adjuvanted Sabin-IPV

Intervention Type: DRUG

Middle dose Sabin-IPV

Intervention Type: DRUG

Middle dose adjuvanted Sabin-IPV

Intervention Type: DRUG

High dose Sabin-IPV

Intervention Type: DRUG

High dose adjuvanted Sabin-IPV

Intervention Type: DRUG

Other Intervention Names

IPV (NVI); Inactivated poliomyelitis vaccine; Inactivated poliovirus vaccine; Inactivated polio vaccine

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

• Minimum Eligible Age: 56 Days
• Maximum Eligible Age: 63 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

World Health Organization

OTHER

Sponsor Role: collaborator

Pauline Verdijk

OTHER_GOV

Sponsor Role: lead

Responsible Party

Pauline Verdijk

Clinical Research Scientist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Pauline Verdijk, PhD

Role: STUDY_DIRECTOR

National Institute for Public Health and the Environment (RIVM)

Locations

NZOZ Centrum Zdrowia "Błonie"

Bydgoszcz, , Poland

Specjalistyczna Poradnia Medyczna "Przylądek Zdrowia"

Krakow, , Poland

Szpital im. Jana Pawła II

Krakow, , Poland

Samodzielny Publiczny ZOZ

Lubartów, , Poland

NZOZ Praktyka Lekarza Rodzinnego "Eskulap"

Lublin, , Poland

NZLA Michałkowice Jarosz i Partnerzy Spółka Lekarsk

Siemianowice Śląskie, , Poland

Alergo-Med Specjalistyczna Przychodnia Lekarska Sp z o.o.

Tarnów, , Poland

Countries

Poland

References

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.

Reference Type: BACKGROUND

PMID: 21651934 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21604984 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24063976 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25043278 (View on PubMed)

Other Identifiers

2011-003792-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NVI-256B

Identifier Type: -

Identifier Source: org_study_id