Safety and effectiveness of boosting healthy adults with new cell-culture-derived JE vaccine (JESPECT), where mouse-brain-derived vaccine (JEVAX) has previously been administered.

Safety and immunogenicity of inactivated vero-cell-derived Japanese encephalitis vaccine in military personnel previously vaccinated with inactivated mouse-brain-derived JE vaccine.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12611001090909

Enrollment

150

Registered

2011-10-20

Start date

2009-09-16

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

With the cessation of manufacture of MBDV in 2005, alternative JE vaccines were developed, including the VCDV approved by the TGA in Jan 2009. This vaccine was selected by the Australian Defence Force to continue its program of JE vaccination of members on 'short-notice-to-move'. Prior to this study there were no published reports of tolerability and immunogenicity of VCDV in previous MBDV vaccinees. Military volunteers who had previously received MBDV and were due for boosting were invited to take part in the study (the alternative was to have a single booster dose of MBDV from remaining stocks). The full primary course of two doses of VCDV 28 days apart was provided to each participant (shown by the manufacturer to be effective at inducing immunogenicity), and blood was drawn prior to each dose for PRNT50 assays of immunogenicity. This was done in order to determine whether a single dose of VCDV was effective as a 'booster' dose, as measured at 28 days. The aim of the study was to determine tolerability of the vaccine in this population, and to determine whether a single dose of VCDV would be adequate to boost immunogenicity in this population.

Interventions

Administration of TGA-approved vero-cell-derived JE vaccine (VCDV) in standard primary schedule of two 0.5 mL intramuscular doses 28 days apart, as recommended by the manufacturer. All participants had previously been vaccinated with mouse-brain-derived JE vaccine (MBDV), and were due for boosting.

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

1) Previous MBDV vaccinee, due for boosting (3-5 years post last dose). 2) Volunteer in 'short-notice-to-move' military unit which requires currency with JE vaccination.

Exclusion criteria

1) Pregnancy 2) Lactation 3) Administration of any vaccine 30 days prior to VCDV administration 4) Serious ADR to a previous vaccine 5) Acute febrile illness 6) Known or suspected immune deficiency

Outcome results