None listed
Conditions
Interventions
Intervention1: Purified Vero Cell Rabies Vaccine (PVRV) (Human): RLS Rabies Vaccine will be administered either by intradermal or by intramuscular route. Intramuscular Route- 1.0 ml Intradermal Route-
Sponsors
Reliance Life Sciences Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female healthy human adult participants 18-60 years (both age cut-offs inclusive). 2. The participants voluntarily agreed to participate in the study, and signed an informed consent form, and can provide legal identification; understand and abide by the requirements of the trial protocol; can participate in required follow up. 3. Healthy status as determined by the investigator based on history, clinical laboratory results, vital sign measurements, and on medical physical examination at screening. 4. Participants must refrain from blood or plasma donation from the time of vaccination until 3 months thereafter. 5. Agrees to remain in the study and follow the protocol timelines and guidelines during the study. 6. Female and male participants of childbearing potential must be using adequate birth control measures, as discussed with the study doctor and should agree to continue such precautions for 6 months after receiving the last dose of study vaccine. Menopausal females should have experienced their last period more than 12 months prior to study entry to be classified as not of childbearing potential. Note-Female participants of child bearing potential must agree to use adequate contraception during the study and continue at least six months after the last dose of study vaccine. For this study, acceptable and effective methods of contraception for females include: Intrauterine device placed at least 3 months prior to the start of the study and remaining in place during the study period. Two barrier methods used together (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide plus a male or female condom) or. Absolute sexual abstinence (no sexual intercourse or genital contact with a male partner). For males, adequate birth control methods suggested and defined as double barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam. It is absolutely essential that participants are adequately counselled at the time of ICF and also, reminded at each visit that the use of birth control measures is mandatory.
Exclusion criteria
Exclusion criteria: 1. Known history of rabies vaccination / receipt of rabies immunoglobulin 2. Participants at high risk of rabies exposure during the trial period. 3. Concomitant antimalarial drugs. 4. Thrombocytopenia. 5. Current participation in another clinical trial or plan to participate in the clinical trial before completion of present trial. 6. Have a history of severe allergies to any component of the research vaccine, including aluminum preparations, such as: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis (Arthus reaction); or any previous History of serious side effects of vaccines or drugs, such as allergies, urticaria, skin eczema, dyspnea, angioedema etc. 7. Have taken antipyretics or painkillers within 24 hours before the first dose of vaccine. 8. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness; 9. Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week for at least one year; 10. Chronic administration (defined as more than 14 days in total) of immunosuppressant (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.) or other immune-modifying drugs (e.g. interferons) during the period starting six months prior to the first vaccine dose including use of any blood products. For corticosteroids, this will mean prednisone 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed; 11. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination 12. Any medical condition that in the judgment of the investigator would make study participation unsafe. 13. Individuals who are part of the study team or close family members of individuals conducting the study. 14. Lactating women or pregnant women (including blood or urine pregnancy test positive). 15. Participants under immune suppression post-transplant 16. Any research or unregistered product (medicine, vaccine, biological product or device) other than the research product was used within past 3 months 17. The investigator believes that the presence of any disease or condition in the participant may put the participant at an unacceptable risk; the participant cannot meet the protocol requirements; and interfere with the assessment of vaccine response.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of Acute Local Adverse Events (i.e. up to day 7) after administration of Rabies Vaccine. (i.e. Following signs /symptoms at Injection site: Pain, tenderness, erythema/redness and swelling). 2.Incidence of Acute Systemic Adverse Events (i.e. up to day 7) after administration of Rabies Vaccine. (fever, fatigue, headache, chills, vomiting, nausea/vomiting, abdominal pain)Timepoint: up to day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Solicited Systemic Adverse Events (fever, fatigue, headache, chills, nausea/vomiting, abdominal pain) up to 30 days following single dose of Rabies vaccine. 2. All unsolicited local and systemic adverse events from first dose till day 30. 3. Safety laboratory values (serum chemistry, hematology) (absolute and change from baseline where identified) at baseline and at day 30. 4.Serious AEs (SAEs) from first dose to day 30. Timepoint: up to 30 days | — |
Countries
India
Contacts
Public ContactMr Ganesh Bagul
Reliance Life Sciences Pvt Ltd
Outcome results
None listed