Non Inferiority Trial of Locally Manufactured Rabies Vaccine 'Rabix-VC' in Bangladesh
Non Inferiority Trial of Locally Manufactured Rabies Vaccine 'Rabix-VC' in Bangladesh
Rabies is a viral infectious disease of mammals including humans. Early symptoms of rabies
 include fever and tingling at the site of exposure, followed by one or more symptoms such as
 fear of water, violent movements, confusion, uncontrolled excitement, inability to move parts
 of the body, and loss of consciousness. Once symptoms of the disease develop, rabies is
 invariably fatal. It is one of the oldest human diseases. It continues to be a major public
 health problem in developing countries. Rabies is the 10th biggest cause of death due to
 infectious diseases worldwide. Rabies is endemic in Bangladesh with high public health
 significance and ranked third highest among rabies-endemic countries for human rabies deaths.
 In Bangladesh, an estimated 200 000 animal bite cases with more than 2000 human rabies deaths
 are reported annually. Most importantly, most of the victims are children below 15 years old
 coming from poor rural communities.

 Rabies is a vaccine-preventable viral disease and is highly effective when given pre- or
 post-exposure to a bite from a potentially rabid animal. Currently there is no locally
 manufactured Rabies vaccine available in Bangladesh. The results of this study will provide
 information regarding the immunogenicity and safety of the locally manufactured Rabies
 vaccine 'Rabix VC' as a test vaccine using 'Rabipur' as a comparator vaccine in a non
 inferiority study design.
This will be a randomized, controlled, double-blind, parallel design, comparative,
 non-inferiority study on a total of 440 healthy adult participants (18-75 years of age).
 Participants who will be eligible for the study, will be invited to participate in the study.
 The study will be conducted in four groups. In One Comparator group, 110 participants will
 receive Rabipur through Intramuscular Route, in Test group, 110 participants will receive
 Rabix VC through Intramuscular Route. In another Comparator group, 110 participants will
 receive Rabipur through Intradermal Route and Test group, 110 participants will receive Rabix
 VC through Intradermal Route. Total 220 participants will receive Rabix VC (Test Group) and
 220 participants will receive Rabipur (Comparator Group), 1.0 ml through Intramuscular Route
 and 0.2 ml through Intradermal Route, (0.1 ml each arm) respectively.

 Informed consent will be obtained from the participants. Only participants who give voluntary
 consent will be enrolled in the study. The potential risk and the procedures to be carried
 out are mentioned in the consent form. Compensation will include transportation costs for the
 participants. Participants only can decide whether they will participate in the study. They
 will also be able to withdraw their name from the study at any time, without giving any
 explanation, and will be able to refuse collection of any or all laboratory samples for the
 study.

 Participants may not directly benefit from participating in the study; however, results
 obtained from this study will be useful in understanding of potential antigenic components
 for designing an effective Shigella vaccine and may thus benefit the society. The whole study
 period for each individual will be 90 days. Specimen collection and interview will be carried
 out 9-10 (maximum) times including enrollment and it will take around 30 minutes per visit.

 After taking consent from participants, they will be asked to do the following: Blood (10-12
 ml for adults) specimens will be collected at screening (day -7 to -2), day 14 and day 30 or
 day 44. For Intramuscular group vaccination schedule will be on day 0, day 7, day 21 and day
 0, day 3, day 7, day 28 for intradermal group. Also, there will be additional follow up on
 day 60 and final visit on day 90.
Inclusion Criteria:

 -  1. Males and females of age 18 years to 75 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. Known hypersensitivity to neomycin, tetracycline,
 amphotericin-B or any other vaccine component.

 4. 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.

 5. Body temperature ≥38.0°C (≥ 100.4°F) within 3 days of study vaccination. 6.
 Individuals who received any other vaccines within 28 days prior to enrolment.

 7. Clinically Significant abnormalities in screening hematology and serum
 bio-chemistry, as determined by the study physician.

 8. Subjects who have received blood, blood products and/or plasma derivatives or any
 parenteral immunoglobulin preparation in the past 12 weeks.

 9. Any planned surgery during the study period. 10. Subjects who have cancer disorders
 excluding non-melatonin skin cancer.