Changing 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…
ID
Bron
Aandoening
poliomyelitis, polio, vaccination, vaccinatie, intradermal, intradermaal, jet injector, needle-free, naaldloos
Ondersteuning
RIVM, formerly Nederland Vaccine, Institute (NVI)
RIVM, formerly Nederland Vaccine, Institute (NVI), LUMC , Pharmajet
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Safety of injection of IPV with jet injector and of intradermal injection of IPV (local and system reactions);<br>
2. Immunogenicity of intradermal injection of reduced dose IPV versus intramuscular injection of full dose IPV (neutralizing antibody titers in serum).
Achtergrond van het onderzoek
Rationale:
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.
Doel van het onderzoek
Changing 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.
Onderzoeksopzet
1. 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.
Onderzoeksproduct en/of interventie
Vaccination 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.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Age ¡Ý 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2079 |
| NTR-old | NTR2196 |
| Ander register | NL29671.000.09 CCMO / 2009-015175-27 EudraCT number : NVI-250 / |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |