Safety and Immunogenicity of a New Inactivated Poliovirus Vaccine in Infants

This study has been completed.
Sponsor:
Collaborator:
World Health Organization
Information provided by (Responsible Party):
Pauline Verdijk, Institute of Public Health and the Environment
ClinicalTrials.gov Identifier:
NCT01709071
First received: October 16, 2012
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Poliomyelitis
Drug: IPV
Drug: Low dose Sabin-IPV
Drug: Low dose adjuvanted Sabin-IPV
Drug: Middle dose Sabin-IPV
Drug: Middle dose adjuvanted Sabin-IPV
Drug: High dose Sabin-IPV
Drug: High dose adjuvanted Sabin-IPV
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by National Institute for Public Health and the Environment (RIVM):

Primary Outcome Measures:
  • Number of adverse reactions following vaccination [ Time Frame: 5 days or until adverse reactions have resolved ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Level of virus neutralizing titers in serum [ Time Frame: 28 days after last vaccination ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: February 2012
Study Completion Date: May 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

Drug: Low dose Sabin-IPV
Experimental: 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.

Drug: Low dose adjuvanted Sabin-IPV
Experimental: 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.

Drug: Middle dose Sabin-IPV
Experimental: 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.

Drug: Middle dose adjuvanted Sabin-IPV
Experimental: 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.

Drug: High dose Sabin-IPV
Experimental: 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.

Drug: High dose adjuvanted Sabin-IPV
Active Comparator: 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.

Drug: IPV
Other Names:
  • IPV (NVI)
  • Inactivated poliomyelitis vaccine
  • Inactivated poliovirus vaccine
  • Inactivated polio vaccine

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

Ages Eligible for Study:   56 Days to 63 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709071

Locations
Poland
NZOZ Centrum Zdrowia "Błonie"
Bydgoszcz, Poland
Szpital im. Jana Pawła II
Krakow, Poland
Specjalistyczna Poradnia Medyczna "Przylądek Zdrowia"
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
Sponsors and Collaborators
Pauline Verdijk
World Health Organization
Investigators
Study Director: Pauline Verdijk, PhD National Institute for Public Health and the Environment (RIVM)
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pauline Verdijk, Clinical Research Scientist, Institute of Public Health and the Environment
ClinicalTrials.gov Identifier: NCT01709071     History of Changes
Other Study ID Numbers: NVI-256B, 2011-003792-11
Study First Received: October 16, 2012
Last Updated: February 20, 2014
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by National Institute for Public Health and the Environment (RIVM):
Vaccination
Inactivated poliomyelitis vaccine
poliomyelitis
Sabin strains

Additional relevant MeSH terms:
Poliomyelitis
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on October 19, 2014