Clinical trial NCT01603875: Immune Response in Adults to PrEP and Simulated Booster PEP With a New CPRV
Official title: Immune Response in Adults to Pre-exposure Rabies Vaccination and Simulated Post-exposure Rabies Booster Vaccination With a New Chromatographically Purified Vero-cell Rabies Vaccine(SPEEDA®) : a Randomized Controlled Trial With Purified Vero-cell Rabies Vaccine (PVRV)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Efficacy of the New CPRV
Keywords: CPRV
SPEEDA
intradermal
pre-exposure
booster
Lead sponsor: Queen Saovabha Memorial Institute
Sponsor class: OTHER
First posted: 2012-05-23
Enrollment: 105
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pre exposure rabies vaccination with a new Chromatographically Purified Vero-cell Rabies Vaccine(SPEEDA) is as effective as Purified Vero-cell Rabies vaccine.

After the pre exposure rabies vaccination with a new Chromatographically Purified Vero-cell Rabies Vaccine(SPEEDA), the Rabies neutralizing antibodies in all patients on day 42 are 0.5 IU/ml or more.

And Simulated post-exposure rabies booster vaccination with a new Chromatographically Purified Vero-cell Rabies Vaccine(SPEEDA) is as effective as Purified Vero-cell Rabies vaccine.

After the simulated post-exposure rabies booster vaccination with a new Chromatographically Purified Vero-cell Rabies Vaccine(SPEEDA), the Rabies neutralizing antibodies in all patients on day 14 after the booster are 0.5 IU/ml or more.

Detailed description: Pre-exposure vaccination will be done according to standard protocol. Participants will be injected with one dose on day 0, 7 and 28. Blood samples will be taken on day 0, 28 and 42 after the first vaccination dose.

360 days later, participants will receive simulated post-exposure rabies booster vaccination one dose on day 0 and 3. Blood samples will be taken again on day 0(360 days) and 14(374 days) after the booster vaccination.

Rabies neutralizing antibody levels will be measured by Rapid Fluorescent Focus Inhibition Test(RFFIT). And the levels of 0.5 IU/ml or more is considered acceptable protective level.

For statistical analysis, percentage of subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time. The average of the titer used in this study is Geometric mean titer(GMT). 95 percent confidence interval(95% CI) of the GMT will be calculated for each study group from individual measurements of serum rabies antibody levels at each sampling time. One-way ANOVA would be used to calculated the significance of the difference between the GMT of three groups, SPEEDA® intradermal injection, SPEEDA® intramuscular injection and PVRV intramuscular injection. The primary criterion for this comparison are the rabies antibody value on day 42 (2 weeks after the third vaccine dose of pre-exposure vaccination) and on day 374(2 weeks after the first vaccine dose of booster vaccination). Results will be deemed statistically significant at p \< 0.05. Safety data (immediate, local and systemic reactions) were summarized as numbers and percentages.

Eligibility criteria: Inclusion Criteria:

* Healthy
* Can visit according to the protocol

Exclusion Criteria:

* Fever
* Acute illness
* History of rabies vaccination
* Allergic to the vaccines' component
* Immunosuppressive conditions such as HIV infection, transplantation, chronic renal failure, received steroid or immunosuppressive drugs and anti-malarial drugs within previous two months or any blood products within previous three months
* Female participant must not be pregnant
* All female participant must have urine pregnancy test negative prior to participate the study

Primary outcomes:
measure: Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)
timeFrame: on day 0
measure: Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)
timeFrame: on day 28
measure: Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)
timeFrame: on day 42
measure: Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)
timeFrame: on day 360
measure: Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)
timeFrame: on day 374
Secondary outcomes:
measure: Side Effects of the Vaccines. These Include Pain, Swelling, Redness, Myalgia, Rash, Fever. Serious Adverse Events Will Also be Recorded.
timeFrame: up to 7 days after each injection
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Queen Saovabha Memorial Institute
Study officials:
affiliation: Queen Saovabha Memorial Institute
name: Terapong Tantawichien, M.D.
role: PRINCIPAL_INVESTIGATOR
References: