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

• ClinicalTrials.gov Identifier: NCT01603875
• Recruitment Status: Completed
• First Posted: May 23, 2012
• Results First Posted: February 25, 2014
• Last Update Posted: February 25, 2014
• Sponsor: Queen Saovabha Memorial Institute
• Information provided by (Responsible Party): Jaruboot Angsanakul, MD, Queen Saovabha Memorial Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Efficacy of the New CPRV	Biological: New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 105 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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)
• Study Start Date: July 2012
• Actual Primary Completion Date: July 2013
• Actual Study Completion Date: October 2013

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT) [ Time Frame: on day 0 ]
   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.
2. Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT) [ Time Frame: on day 28 ]
   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.
3. Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT) [ Time Frame: on day 42 ]
   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.
4. Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT) [ Time Frame: on day 360 ]
   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.
5. Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT) [ Time Frame: on day 374 ]
   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 :

1. 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 ]

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

   The side effects will be record in number and percentage.

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 60 Years (Child, Adult)
• Sexes Eligible for Study: All
• 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

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:

Contact information 

• Responsible Party: Jaruboot Angsanakul, MD, Jaruboot Angsanakul, Medical Officer 4, Queen Saovabha Memorial Institute
• ClinicalTrials.gov Identifier: NCT01603875
• Other Study ID Numbers: RC5506
• First Posted: May 23, 2012
• Results First Posted: February 25, 2014
• Last Update Posted: February 25, 2014
• Last Verified: January 2014

Keywords provided by Jaruboot Angsanakul, MD, Queen Saovabha Memorial Institute:

CPRV; SPEEDA; intradermal; pre-exposure; booster