None listed
Conditions
Interventions
Intervention1: Inactivated Kyasanur Forest Disease (KFD) Vaccine: Subjects will be administered two doses of 0.5 mL on Days 1 and 29 by intramuscular route on deltoid.
Control Intervention1: Placebo:
Sponsors
Human Biologicals Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female volunteer aged 18-49 years, inclusive, at the time of signing the informed consent. 2.Participants with Body Mass Index (BMI) within the range 18.5 to 29 kg/m2 (both inclusive). 3.Healthy volunteers as determined by medical history, physical examination (including vital signs) as well as safety laboratory parameters during screening and as per the clinical judgment of the investigator. 4.The participant is willing and able to read, sign, and date the written informed consent after the nature of the trial has been explained according to local regulatory requirements and willing to follow the requirements of the study. 5.If the participant is a woman of childbearing potential, a negative Urine Pregnancy Test (UPT) at screening and prior to eligibility assessment before each dose. 6.Both male (if he has a partner of childbearing potential) and female participants (of childbearing potential) willing to use an acceptable and effective contraceptive method up to 6 months from start of trial (Day 1).
Exclusion criteria
Exclusion criteria: 1.Febrile illness (oral temperature greater than or equal to 100 F) or moderate or severe acute illness or infection within 7 days of screening, at randomization, or administration of the inactivated KFD vaccine or placebo. 2.History or any illness that, in the opinion of the investigator, can interfere with the results of the trial or pose an additional risk to the participant due to participation in the trial, including but not limited to: a.Participants with known hypersensitivity or allergy to any of the vaccine components. b.Female participants who are pregnant or breastfeeding or are planning to conceive during the conduct of this clinical trial (up to 6 months from start of trial). c.Women of childbearing potential who are sexually active (and has not used any of the acceptable and effective contraceptive methods for at least two months prior to study entry), and who refuse to use acceptable contraceptive methods. Acceptable methods of birth control are defined as one or more of the following: i.Hormonal contraceptives (such as oral, injection, transdermal patch, implant, cervical ring). ii. Barrier (condom or diaphragm) each and every time during intercourse. iii. Intrauterine device (IUD). iv.Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to participants study entry. d. Participants with any serious chronic or progressive disease according to judgment of the investigator (e.g. Any malignancy, leukaemia, lymphoma, or therapy with alkylating agents, antimetabolites, and radiation, any clinically significant pulmonary, cardiovascular, renal, neurological (including seizure disorder), psychiatric illness, or blood dyscrasia, or metabolic (including diabetes mellitus), gastrointestinal, hepato-biliary, or auto-immune disorders, Guillain-Barre syndrome, or known infection with hepatitis C virus, or hepatitis B virus). e.History of recent contact with any confirmed case of COVID-19 or having tested positive for COVID-19 since less than a month. f.Known or suspected acute respiratory illness at the time of vaccination with active symptoms and signs including one or more of the following: rhinorrhoea, new cough, pharyngitis and respiratory problems (e.g. wheezing, shortness of breath). g.Asthma that is unstable, requiring 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. h.Participants on treatment with any hepatotoxic drug for treatment of any chronic illness before receiving the vaccine during the last 90 days. 3. Participants with known or suspected impairment or alteration of immune function, including the following: a. Has received systemic immunosuppressants or immune-modifying drugs for more than 14 days in total within 6 months prior to IMP dose administration (for corticosteroids, a dose equivalent to 2 mg per kg of body weight or a total of 20 mg per day of prednisone) or planning to receive during the conduct of the trial. b. Is on other immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy. c. Is on treatment with any anti-cytokine therapies. d. Participants who have received immune modulators within 60 days prior to Day 1. e. Has been administered immunoglobulins and/or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Reactogenicity Assessment will be measured by Severity Seriousness Frequency and Percentage of participants with solicited local and systemic adverse events 2.Safety Assessment will be measured by Severity Seriousness Frequency Percentage of participants with: Immediate adverse events (AE) Solicited adverse events (local and systemic) Unsolicited adverse events Adverse Events of Special Interest (AESI) Serious Adverse Events (SAEs) 3.Immediate Adverse Events will be measured within 2 hours post each vaccine/placebo injection by Severity Seriousness Frequency and Percentage of participants affected 4.Safety laboratory parameters will be evaluated based on the absolute values as well as change from baseline (screening) of safety laboratory values (serum chemistry and haematology) Timepoint: till day 57 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To compare the proportion of participants achieving seropositivity between each arm by PRNT50 2.Fold increase from baseline in neutralizing anti KFDV antibody titre will be determined amongst those who achieve seropositivity. 3.To compare the geometric mean titres of neutralizing antibodies by PRNT50 against the KFDV between each arm. 4.To compare the reverse cumulative distribution of serum anti-KFD NAb titre between each arm. Timepoint: Till day 57;Exploratory: 1.Safety will be assessed by measuring the severity, seriousness, and the frequency and percentage of participants with unsolicited adverse events, Adverse Events of Special Interest (AESI), and Serious Adverse Events (SAEs). 2.To compare safety in subgroups identified at baseline based on flavivirus serostatus. 3.To compare the proportion of participants achieving seropositivity between each arm by PRNT50 4.Fold increase from baseline in neutralizing anti KFDV antibody titre will be determined amongst those who achieved seropositivity. 5.To compare geometric mean titres of neutralizing antibodies by PRNT50 against the KFDV between each arm. 6. To compare reverse cumulative distribution of serum anti-KFD NAb titre. 7. To compare immunogenicity in subgroups identified at baseline based on flavivirus serostatus. Timepoint: Till day 366 | — |
Countries
India
Contacts
Public ContactDr Sai Krishna
Human Biologicals Institute
Outcome results
None listed