None listed
Conditions
Interventions
Intervention1: Dengue Tetravalent Vaccine, Live
Attenuated (Recombinant, Lyophilized) â?? DengiAll of Panacea Biotec Limited, India: A 0.5 ml of single dose of DengiAll will be administered subcutaneo
Sponsors
Panacea Biotec Limited
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy adults between 18 to 60 years of age, in good health, based on medical history, clinical laboratory tests (protocol specified) and physical examination. 2.Participants willing to participate throughout the study period of 2 years (after signing written informed consent) Inclusion Criteria for Women: ï?§ Female with non-child bearing potential (Females having documented history of surgical sterilization or are postmenopausal - 12 months of amenorrhea after the last menstrual period) ï?§ Female with child bearing potential is eligible if she: has used an effective method of contraception or abstinence from at least 4 weeks prior to vaccination AND is willing to avoid pregnancies up to 90 days post vaccination by use of an effective method of contraception or abstinence AND has negative serum pregnancy test on the screening day and negative urine pregnancy test on the day of vaccination
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or breastfeeding. 2. Acute or chronic, clinically significant pulmonary, cardiovascular, endocrine, metabolic, gastrointestinal, neurological, hepatic, renal functional abnormality or any other systemic disorder, that are assessed by the investigator (based on medical history or physical examination) as being clinically unstable within the prior 4 weeks as evidenced by: â?ª Hospitalization for the condition, including surgical interventions. â?ª New significant organ function deterioration. â?ª Needing addition of new treatments or major dose adjustments of current treatments (mild or moderate well-controlled comorbidities are allowed) 3. Any confirmed or suspected condition with impaired/altered function of immune system (e.g., immunodeficient or autoimmune conditions) 4. Known case of HIV, Hepatitis B, and Hepatitis C reported by the participant 5. History of any bleeding disorder 6. History of severe allergic reactions or anaphylaxis. History of allergy to any of the component of Investigational Medicinal product 7. Any evidence of clinically significant acute illness or infection or fever within the past 3 days of study screening for study participation 8. Any evidence of clinically significant acute illness or infection or fever within the past 3 days of vaccination 9. Oral Temperature should not be >= 37.8°C (100°F) on the day of vaccination (temporary exclusion). 10. Any major surgery within the past 90 days prior to vaccination 11. Any abnormal laboratory value which is considered clinically significant by the Investigator or is grade III or higher. 12. Receipt of immunosuppressive therapy 13. History of intake of anti-cancer chemotherapy or radiation therapy at any time in the past 14. Chronic ( > 14 days continuously) systemic corticosteroid therapy / within the past 90 days prior to vaccination or planned use through the study period (prednisone, or equivalent, >= 0.5 mg/kg per day). 15. Received any other immunosuppressive therapy prior to study entry within the past 90 days prior to vaccination or planned treatment during the trial duration. (Inhaled, intranasal, and topical steroids are allowed) 16. Have received blood products in the past 90 days prior to vaccination, including transfusions or immunoglobulin 17. Use of anticoagulant medication in the past 90 days prior to vaccination 18. Receipt of any vaccine in the past 4 weeks prior to study vaccination (vaccination can be planned 4 weeks after trial vaccination has been given) 19. Previous receipt of any Dengue vaccine (licensed or Experimental) 20. Current alcohol use or drug addiction that may interfere with the participantsâ?? ability to comply with the trial procedures. 21. Concurrent/planned participation in any other clinical trial 22. Individuals who are part of study team or close family members of individuals conducting this study 23. Inability of participants to remain in follow-up for 2 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of â??DengiAll ? among adults in preventing symptomatic laboratory confirmed dengue infection over a period of 2 years after vaccinationTimepoint: Febrile illness with laboratory confirmation of dengue determined by NS1-ELISA and/or rRT-PCR, occurring one month to 2 years post vaccination (vaccine or placebo). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To determine the safety of â??DengiAll ? in adults as assessed by the frequency of adverse events, graded by seriousness, causality and severity.Timepoint: 1a. All solicited AEs and Unsolicited AEs occurring within 28 days post vaccination, with respect to causality, seriousness, severity and frequency in reactogenicity cohort. 1b. SAEs throughout the study duration post vaccination, with respect to causality, severity and frequency among all participants. 1c. Related grade 3 and above unsolicited AEs through 28 days post-vaccination with respect to severity and frequency in all participants.;2. To assess the immunogenicity of â??DengiAll ? in comparison to the placebo using serum plaque reduction neutralization titer 50% (PRNT50) against dengue virus serotypes.Timepoint: 2a.The Geometric Mean Antibody serum plaque reduction neutralization titer 50 percent (PRNT50) to dengue virus serotypes in vaccinated and placebo arms on Days 0, 28, 56, 84 ,180, 1 year and 2 years post vaccination. 2b. Seroconversion and seropositivity rates by PRNT50 test to dengue virus serotypes on study days 28, 56, 84, 180, 1 year and 2 years post vaccination. 2c. Monovalent, bivalent, trivalent, and tetravalent seropositivity post vaccination.;3. To determine viremia in a subset of dengue naïve and exposed trial participants on Days 9 and Day 12 post vaccination.Timepoint: 3. Presence of Viremia for each serotype in a sub set of Dengue trial participants on Day 9 and Day 12 post vaccination.;4.To evaluate the efficacy of DengiAll among adults in preventing symptomatic laboratory confirmed dengue infection by dengue virus serotypes over a period of 2 years after vaccinationTimepoint: 4. Febrile illness with laboratory confirmed dengue occurring one month to 2 years post vaccination.;5. To compare the incidence of laboratory confirmed severe dengue and dengue related deaths between DengiAll and placebo groupsTimepoint: 5a. Incidence of Severe Dengue cases. 5b. Deaths among part | — |
Countries
India
Contacts
Public ContactDr Khalid Ali Syed
INDIAN COUNCIL OF MEDICAL RESEARCH
Outcome results
None listed