The primary objective of this trial 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 (…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The level of neutralizing antibodies in serum and the number and intensity of
local and systemic adverse reactions.
Secondary outcome
The number of B-lymphocytes producing IPV-specific IgA in blood and the level
of poliovirus specific IgA antibodies in saliva.
Background summary
Inactivated poliovirus vaccine (IPV) was first introduced into the market in
1957. It is very effective and safe but due to its high costs it is only used
in high-income countries and some middle-income countries. Other countries
therefore use an oral poliovirus vaccine based on attenuated polioviruses.
Drawback of this vaccine is that in rare cases it can cause poliomyelitis and
it can revert to a neurovirulent polio virus. This has caused outbreaks of
vaccine-derived polio. For global eradication of poliomyelitis Inactivated
Poliovirus Vaccine (IPV) vaccine 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, administration will be both needle-free and need little
training, making it especially suitable for developing counties.
Study objective
The primary objective of this trial 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.
Secondary objectives are:
1) to evaluate the immunogenicity and safety (local and systemic reactions) of
a full dose intramuscular IPV (NVI) booster vaccination administered with a jet
injector compared with a standard full dose intramuscular IPV (NVI) booster
vaccination administered with a needle and syringe.
2) to compare the immunogenicity of intradermal and intramuscular vaccination
with reduced dose IPV.
Study design
Randomized, controlled clinical trial with 4 arms:
Reference group: Intramuscular injection of 0.5 ml IPV with needle and syringe
Group A: Intramuscular injection of 0.5 ml IPV with jet injector
Group B: Intramuscular injection of 0.1 ml IPV with needle and syringe
Group C: Intradermal injection of 0.1 ml IPV with jet injector
The subjects will receive a single vaccination with IPV. Blood samples will be
taken before vaccination and on day 7, 28 and 365 after vaccination. Saliva
samples will be taken before vaccination and on day 7 and 28.
Study burden and risks
Four blood samples and three saliva samples will be taken and one vaccination
with a well-known vaccine will be given, which requires in total four visits.
The participants are asked to fill in a diary during the study. No risks are
associated with participation, other than general discomfort that can be
experienced after vaccination with IPV and/or after blood sampling.
Antonie van Leeuwenhoeklaan 11
3720 AL Bilthoven
NL
Antonie van Leeuwenhoeklaan 11
3720 AL Bilthoven
NL
Listed location countries
Age
Inclusion criteria
Subjects have to fulfill all of the following criteria:
• Age >= 18 years
• Good health according to the investigator
• Must have received in total 6 combined DTP-IPV vaccinations according to the National Immunization Programme as a child (before 11 years of age) and must not have received any polio vaccination since then.
• Willingness and ability to adhere to the study regimen
• Having a signed informed consent form
Exclusion criteria
Any of the following criteria will exclude a volunteer from participation, at start of this study:
•IPV booster dose after 10 years of age
•OPV dose
•Known or suspected allergy against any of the vaccine components
•History of unusual or severe reactions to any previous vaccination
•Known or suspected disease or use of medication that may influence the immune system
•Administration of plasma or blood products three months prior to the study
•Any vaccination within one month prior to the study
•History of any neurological disorder including epilepsy or febrile seizures
•Evidence of excessive alcohol use or drug use
•Pregnancy
•Females not willing to use contraceptives during the first 28 days following vaccination, or if breastfeeding
•Bleeding disorders or the usage of anticoagulants
Delay criteria
•If body temperature >= 38.0°C this will lead to postponement of participation. Screening may continue when the temperature has normalized.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-015175-27-NL |
| CCMO | NL29671.000.09 |