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Onderzoek naar de bijwerkingen en immuunrespons na een boostervaccinatie tegen polio, toegediend met een naaldloze Jet Injector.


- candidate number7718
- NTR NumberNTR2196
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-feb-2010
- Secondary IDsNVI-250 / NL29671.000.09 CCMO / 2009-015175-27 EudraCT number
- Public TitleOnderzoek naar de bijwerkingen en immuunrespons na een boostervaccinatie tegen polio, toegediend met een naaldloze Jet Injector.
- Scientific TitleImmunogenicity and safety of intradermal injection of reduced dose Inactivated Poliovirus vaccine (IPV) with a jet injector in healthy adults.
- ACRONYM
- hypothesisChanging the route of administration from intramuscular to intradermal may improve the immunogenicity of IPV and allow dose reduction. By using a jet injector instead of a needle and syringe, more antigen can be spared by reducing loss of vaccine due to dead space volume and removal of air and superfluous fluid. In addition, administration will be both needle-free and needs little training, making it especially suitable for developing countries.
- Healt Condition(s) or Problem(s) studiedVaccination, Poliomyelitis, Intradermal, Needle-free, Jet injector
- Inclusion criteria1. Age 18 years;
2. Good health according to the investigator;
3. Must have received in total 6 combined DTP-IPV vaccinations according to the NIP as a child (before 11 years of age) and must not have received any polio vaccination since then.
- Exclusion criteria1. IPV booster dose after 10 years of age;
2. OPV dose;
3. Known or suspected allergy against any of the vaccine components;
4. History of unusual or severe reactions to any previous vaccination;
5. Known or suspected disease or use of medication that may influence the immune system;
6. History of any neurological disorder including epilepsy or febrile seizures;
7. Pregnancy.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2010
- planned closingdate31-okt-2010
- Target number of participants120
- InterventionsVaccination with inactivated poliomyelitis vaccine (IPV):
1. Reference: 0.5 ml of IPV intramuscular injection with needle and syringe;
2. Group A: 0.5 ml of IPV intramuscular injection with jet injector;
3. Group B: 0.1 ml of IPV intramuscular injection with needle and syringe;
4. Group C: 0.1 ml of IPV intradermal with jet injector.
- Primary outcome1. Safety of injection of IPV with jet injector and of intradermal injection of IPV (local and system reactions);
2. Immunogenicity of intradermal injection of reduced dose IPV versus intramuscular injection of full dose IPV (neutralizing antibody titers in serum).
- Secondary outcomeImmunogenicity (Neutralizing IgA titers) in saliva and the number of poliospecific IgA-producing B cells in peripheral blood.
- Timepoints1. Vaccination on day 0;
2. Safety: the participants are asked to keep a diary for 4 day starting on day 0;
3. Blood samples: day 0, 7, 28 and 365;
4. Saliva samples: day 0, 7, 28.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDrs. D. Soonawala
- CONTACT for SCIENTIFIC QUERIESDr. P. Verdijk
- Sponsor/Initiator Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
- Funding
(Source(s) of Monetary or Material Support)
Rijksinstituut voor Volksgezondheid en Milieu (RIVM), Leiden University Medical Center (LUMC), PharmaJet
- PublicationsN/A
- Brief summaryRationale:
For global eradication of poliomyelitis Inactivated Poliovirus Vaccine (IPV) needs to become available for developing countries. This requires a lower price and increased availability of vaccine doses. Antigen sparing by reducing the dose to one-fifth of the standard dose will have a positive effect on both. Changing the route of administration from intramuscular to intradermal may improve the immunogenicity of IPV and thereby allow this degree of dose reduction. By using a jet injector instead of a needle and syringe, more antigen can be spared by reducing loss of vaccine due to dead space volume and removal of air and superfluous fluid. In addition, administration will be both needle-free and needs little training, making it especially suitable for developing countries.
Primary objective is to compare the immunogenicity and safety (local and systemic reactions) of a reduced dose intradermal IPV (NVI) booster vaccination administered with a jet injector to a standard full dose intramuscular IPV (NVI) booster vaccination administered with a needle and syringe.
- Main changes (audit trail)
- RECORD2-feb-2010 - 18-okt-2012


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