An Open label Phase I Study to evaluate the Safety and Immunogenicity of Typhoid Bivalent Conjugate Vaccine of HBI when administered to Healthy Male Subjects of 18 to 50 years of age.
Overview
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Human Biologicals Institute
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Safety
Overview
Brief Summary
This
This is An Open label Phase I clinical trial to evaluate the Safety and Immunogenicity of Typhoid Bivalent Conjugate Vaccine of HBI administered in Healthy Male Subjects. 66 subjects will be enrolled in a single centre. The primary objectives are to evaluate the safety of Typhoid Bivalent Conjugate Vaccine of HBI in healthy male subjects of 18 to 50 years of age, proportion of the subjects experiencing local and/or systemic adverse events during follow up period and the occurrence of serious adverse events during follow up period. The Secondary objective is to determine the humoral immune response after administration of Typhoid Bivalent Conjugate Vaccine of HBI in healthy male subjects and the exploratory objectives are to determine the effect of pre-existing anti-tetanus antibodies on the immune responses to typhoid and paratyphoid A. Subjects meeting the inclusion/exclusion criteria will receive single dose (0.5 ml) of the vaccine by intramuscular injection. Subjects will be followed up for 180 days after the vaccination. Blood samples for the antibody titres estimation will be collected from all the enrolled subjects before vaccination on Day 0 (Visit 2), Day 28 (Visit 3), Day 90 (Visit 4) and Day 180 (Visit 5) for measuring anti-Vi IgG and IgA antibodies against S. Typhi and anti-O-polysaccharide IgG antibodies against S. Paratyphi A and functional antibodies using serum bactericidal assay (SBA) against S. Paratyphi A. Also, Anti-tetanus antibodies will be measured on Visit 2(Day 0) and Day 28 (Visit 3).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 50.00 Year(s) (—)
- Sex
- Male
Inclusion Criteria
- •1.Healthy male 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 is literate and has understood and provided written Informed Consent.
Exclusion Criteria
- •1.Participation in any other clinical trial in the four weeks preceding the trial vaccination.
- •2.Subjects who have previously received any vaccines against typhoid fever.
- •3.Subjects who have a previously ascertained or suspected disease caused by S.
- •Typhi or S.
- •Paratyphi A.
- •4.Any household member having or exposed to an individual with laboratory confirmed S.
- •5.Planned participation in any other clinical trial during the present trial period.
- •6.Subject who has a known history of allergy to any component of the vaccine.
- •7.Known or suspected primary or acquired disease of the immune system.
- •8.Receiving allergy immunotherapy or immunosuppressive therapy or systemic/oral corticosteroids.
Outcomes
Primary Outcomes
Safety
Time Frame: Solicited/unsolicited local and systemic adverse events up to the 28 days follow-up period. | Serious adverse events for entre study period.
1.Solicited/unsolicited local adverse events after a single dose vaccination and during the 28 days follow-up period.
Time Frame: Solicited/unsolicited local and systemic adverse events up to the 28 days follow-up period. | Serious adverse events for entre study period.
2.Solicited/unsolicited systemic adverse events after a single dose vaccination and during the 28 days follow-up period.
Time Frame: Solicited/unsolicited local and systemic adverse events up to the 28 days follow-up period. | Serious adverse events for entre study period.
3.Occurrence of serious adverse events during the study period.
Time Frame: Solicited/unsolicited local and systemic adverse events up to the 28 days follow-up period. | Serious adverse events for entre study period.
Secondary Outcomes
- 1.Seroconversion rates for anti-Vi IgG and anti-Vi IgA antibody titres against S. Typhi on Days 28, 90 and 180 after vaccination.(2.Seroconversion rates for anti-OPS and SBA antibody titres against S. Paratyphi A on Days 28, 90 and 180 after vaccination.)
Investigators
Dr Sai Krishna
Human Biologicals Institute