Clinical trial NCT01365494: Immunogenicity and Safety of Rabies Vaccine, Administered With Two Different Simulated Post Exposure Schedules
Official title: A Phase IV, Multi-center, Randomized, Open-label Study of PCECV (Rabipur®) Comparing the Immunogenicity and Safety of Two Different Simulated Post Exposure Schedules (Zagreb 2-1-1 Versus Essen Regimen 1-1-1-1-1) in Healthy Indian Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rabies
Keywords: Rabies
rabies vaccines
post-exposure prophylaxis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-06-03
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was planned to establish the non-inferiority of Rabipur administered as simulated post exposure Zagreb schedule as compared to Essen schedule, in healthy Indian adult subjects.


Eligibility criteria: Inclusion Criteria:

1. Males and females of age ≥ 18 years.
2. Individuals who had given written consent.
3. Individuals in good health and available for all the visits scheduled in the study.

Exclusion Criteria:

1. Pregnancy or unwillingness to practice acceptable contraception.
2. A history of Rabies vaccination.
3. History of allergy to egg protein.
4. Known hypersensitivity to neomycin, tetracycline, amphotericin-B or any other vaccine component.
5. A significant acute or chronic infectious disease or use of antibiotics that may impact the subject's safety and /or immunogenicity in the Investigators opinion at the time of enrolment.
6. Body temperature ≥38.0°C (≥ 100.4°F) within 3 days of study vaccination.
7. Treatment with an anti-malarial drug, up to two months prior to the study.
8. Individuals who received any other vaccines within 28 days prior to enrollment.
9. Subjects who have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks.
10. Any planned surgery during the study period.
11. Subjects who have cancer disorders excluding nonmelanotic skin cancer.

Primary outcomes:
measure: Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Each of the Zagreb and Essen Groups on Study Day 14
timeFrame: On Day 0 and Day 14
Secondary outcomes:
measure: Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Zagreb and Essen Groups at Days 7, 14 and 42
timeFrame: Study day 7, 14 and 42
measure: Ratio of GMCs in Study Groups (Zagreb/Essen Schedules) on Days 7 and 42 as Measured by RVNA Geometric Mean Concentrations
timeFrame: Day 0, Day 7, Day 14 and Day 42
measure: Percentages of Subjects Reporting Adverse Events (AEs)
timeFrame: All reported SAEs and medically attended AEs or AEs that resulted in the premature withdrawal of subjects were collected up to 42 days after first vaccination. Adverse events were collected throughout the study period
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Kempegowda Institute of Medical Sciences Hospital (KIMS)
state: KA
city: Mandya
country: India
facility: Mandya Institute of Medical Sciences
state: KA
city: Pune
country: India
facility: Padmashree Dr. D.Y Patil Hospital
state: MS
Study officials:
affiliation: Novartis
name: Novartis Vaccines and Diagnostics
role: STUDY_DIRECTOR
References:
citation: Mahendra BJ, Narayana DA, Agarkhedkar S, Ravish HS, Harish BR, Agarkhedkar S, Madhusudana SN, Belludi A, Ahmed K, Jonnalagedda R, Vakil H, Bhusal C, Arora AK. Comparative study on the immunogenicity and safety of a purified chick embryo cell rabies vaccine (PCECV) administered according to two different simulated post exposure intramuscular regimens (Zagreb versus Essen). Hum Vaccin Immunother. 2015;11(2):428-34. doi: 10.4161/21645515.2014.995059.