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Immune Response in Adults to PrEP and Simulated Booster PEP With a New CPRV

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jaruboot Angsanakul, MD, Queen Saovabha Memorial Institute
ClinicalTrials.gov Identifier:
NCT01603875
First received: May 16, 2012
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Efficacy of the New CPRV
Biological: New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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)

Resource links provided by NLM:


Further study details as provided by Queen Saovabha Memorial Institute:

Primary Outcome Measures:
  • Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT) [ Time Frame: on day 0 ] [ Designated as safety issue: No ]
    Blood samples will be drawn on day 0(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time.

  • Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT) [ Time Frame: on day 28 ] [ Designated as safety issue: No ]
    Blood samples will be drawn on day 28(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time.

  • Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT) [ Time Frame: on day 42 ] [ Designated as safety issue: No ]
    Blood samples will be drawn on day 42(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time.

  • Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT) [ Time Frame: on day 360 ] [ Designated as safety issue: No ]
    Blood samples will be drawn on day 360(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time.

  • Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT) [ Time Frame: on day 374 ] [ Designated as safety issue: No ]
    Blood samples will be drawn on day 374(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time.


Secondary Outcome Measures:
  • Side Effects of the Vaccines. These Include Pain, Swelling, Redness, Myalgia, Rash, Fever. Serious Adverse Events Will Also be Recorded. [ Time Frame: up to 7 days after each injection ] [ Designated as safety issue: Yes ]

    There are five injections, on day 0, 7, 28, 360 and 363.

    The side effects will be record in number and percentage.



Enrollment: 105
Study Start Date: July 2012
Study Completion Date: October 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PrEP and Simulated PEP with PVRV by intramuscular route Biological: New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).
new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
Experimental: PrEP and Simulated PEP with new CPRV by intramuscular route Biological: New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).
new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
Experimental: PrEP and Simulated PEP with new CPRV by intradermal route Biological: New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).
new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention

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

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01603875

Locations
Thailand
Queen Saovabha Memorial Institute
Bangkok, Thailand, 10330
Sponsors and Collaborators
Queen Saovabha Memorial Institute
Investigators
Principal Investigator: Terapong Tantawichien, M.D. Queen Saovabha Memorial Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Jaruboot Angsanakul, MD, Jaruboot Angsanakul, Medical Officer 4, Queen Saovabha Memorial Institute
ClinicalTrials.gov Identifier: NCT01603875     History of Changes
Other Study ID Numbers: RC5506
Study First Received: May 16, 2012
Results First Received: January 3, 2014
Last Updated: January 3, 2014
Health Authority: Thailand: Food and Drug Administration

Keywords provided by Queen Saovabha Memorial Institute:
CPRV
SPEEDA
intradermal
pre-exposure
booster

ClinicalTrials.gov processed this record on November 25, 2014