A clinical trial to evaluate the Safety and Immunogenicity of Dengue Vaccine of HBI in Healthy Adults of 18 to 50 years of age
- Registration Number
- CTRI/2022/10/046728
- Lead Sponsor
- Human Biologicals Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Healthy Subjects of 18 to 50 years of age.
2.Judged to be in good health on the basis of reported medical history, physical examination, laboratory investigations and clinical judgement of the investigator.
3.Plans to remain in the study area for the entire length of the trial.
4.Subject who has understood and provided written Informed Consent.
5.Negative Urine Pregnancy test for female subjects prior to enrolment into the study.
1.Participation in any other clinical trial of an investigational agent in the four weeks preceding the trial vaccination.
2.Planned participation in any other clinical trial of an investigational agent during the present trial period.
3.Subject who has a known history of allergy to any component of the vaccine.
4.Pregnancy or planning to become pregnant during the trial period, Lactation or unreliable contraception in female subjects.
5.Known or suspected primary or acquired disease of the immune system.
6.Allergy immunotherapy or receiving immunosuppressive therapy except for using topical steroids.
7.Subjects on treatment with any hepatotoxic drug before receiving the vaccine during the last 90 days.
8.History of any significant underlying disease, including (but not limited to) malignancy, cardiopulmonary disease, renal, endocrinologic, hematologic or hepatic dysfunction and autoimmune disease.
9.Having an active or chronic history of arthritis.
10.History of suspected Yellow fever or Japanese encephalitis or history of previous receipt of a licensed or experimental Dengue vaccine, Yellow fever or JE vaccine.
11.History of recent contact with any confirmed case of COVID-19 or having tested positive for COVID-19 since less than a month.
12.Diabetes mellitus (type I or II), with the exception of a history of gestational diabetes.
13.Known or suspected acute respiratory illness at the time of vaccination with active symptoms and signs including one or more of the following: rhinorrhea, new cough, pharyngitis and respiratory problems (e.g. wheezing, shortness of breath).
14.Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that is expected to require the use of oral or intravenous corticosteroids.
15.Any fever with temperature >= 38.0°C (100.4oF) in last 3 days.
16.Known impairment of neurologic function or currently active seizure disorder or currently requiring medication for seizures or evidence of any other evolving neurological signs and symptoms.
17.Any known history or suspicion of thrombocytopenia or a bleeding disorder.
18.Known history or suspicion of HIV, HCV or Hepatitis B.
19.Any history of receipt of blood products in last 3 months.
20.Subjects who have received any live attenuated vaccine in past 30 days and any subunit or inactivated vaccine except for tetanus toxoid vaccine in past 14 days.
21.Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine or compliance with the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Solicited/unsolicited local adverse events till Day 28 in each arm of each group. <br/ ><br>Solicited/unsolicited systemic adverse events till Day 28 in each arm of each group. <br/ ><br>Number of serious adverse events in each arm of each group till Day 180. <br/ ><br>Proportion of subjects with clinically significant abnormal safety laboratory findings on Day 8 in each arm of each group. <br/ ><br>Timepoint: Solicited/unsolicited local adverse events till Day 28 in each arm of each group. <br/ ><br>Solicited/unsolicited systemic adverse events till Day 28 in each arm of each group. <br/ ><br>Number of serious adverse events in each arm of each group till Day 180. <br/ ><br>Proportion of subjects with clinically significant abnormal safety laboratory findings on Day 8 in each arm of each group. <br/ ><br>
- Secondary Outcome Measures
Name Time Method <br/ ><br>Seroconversion, seroprotection and GMT on days 28, 56, 90 and 180. <br/ ><br>Number and proportion of subjects having viremia and load of viremia on days 3, 8, 12 and 16.Timepoint: Days 28, 56, 90 and 180