Trial Outcomes & Findings for Dose-Escalation Study to Evaluate the Safety and Immunogenicity of MTBVAC Vaccine in Comparison With BCG Vaccine. (NCT NCT02013245)

NCT ID: NCT02013245

Last Updated: 2017-03-24

Results Overview

Safety and reactogenicity for all subjects as determined by: * Occurrence of solicited symptoms during the 7-day follow-up period following vaccination and occurrence of unsolicited symptoms during the 210-day follow-up period following vaccination. * Occurrence of grade 3 vaccine related local and general symptoms during the 210-day follow-up period following vaccination and occurrence of serious adverse events throughout the entire study period. * Haematological and biochemical safety test levels prior and after vaccination

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 36 participants
• Primary outcome timeframe: 7 months follow up
• Results posted on: 2017-03-24

Participant Flow

Participant milestones

Measure	MTBVAC Group 1 Intervention: MTBVAC live vaccine (low dose 5 x 10\^3 CFU)	MTBVAC Group 2 Intervention: MTBVAC live vaccine (middle dose 5 x 10\^4 CFU)	MTBVAC Group 3 Intervention: MTBVAC live vaccine (high dose 5 x 10\^5 CFU)	BCG Control Group Intervention: Commercially available BCG live vaccine (dose 5 x 10\^5 CFU)
Overall Study STARTED	9	9	9	9
Overall Study COMPLETED	9	8	9	9
Overall Study NOT COMPLETED	0	1	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dose-Escalation Study to Evaluate the Safety and Immunogenicity of MTBVAC Vaccine in Comparison With BCG Vaccine.

Baseline characteristics by cohort

Measure	Group 1 n=9 Participants MTBVAC low dose group (5 x 10\^3 CFU MTBVAC)	Group 2 n=9 Participants MTBVAC intermediate dose group (5 x 10\^4 CFU MTBVAC)	Group 3 n=9 Participants MTBVAC high dose group (5 x 10\^5 CFU MTBVAC)	BCG Control Group n=9 Participants BCG standard dose group (5 x 10\^5 CFU BCG)	Total n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	9 Participants n=4 Participants	36 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	28 years STANDARD_DEVIATION 9.6 • n=5 Participants	28.2 years STANDARD_DEVIATION 3.2 • n=7 Participants	27.1 years STANDARD_DEVIATION 6.1 • n=5 Participants	25.6 years STANDARD_DEVIATION 3.4 • n=4 Participants	27.2 years STANDARD_DEVIATION 6.0 • n=21 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	6 Participants n=4 Participants	22 Participants n=21 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	14 Participants n=21 Participants
Region of Enrollment Switzerland	9 participants n=5 Participants	9 participants n=7 Participants	9 participants n=5 Participants	9 participants n=4 Participants	36 participants n=21 Participants

PRIMARY outcome

Timeframe: 7 months follow up

Safety and reactogenicity for all subjects as determined by:

• Occurrence of solicited symptoms during the 7-day follow-up period following vaccination and occurrence of unsolicited symptoms during the 210-day follow-up period following vaccination.
• Occurrence of grade 3 vaccine related local and general symptoms during the 210-day follow-up period following vaccination and occurrence of serious adverse events throughout the entire study period.
• Haematological and biochemical safety test levels prior and after vaccination

Outcome measures

Measure	MTBVAC Group 1 n=9 Participants Intervention: MTBVAC live vaccine (low dose 5 x 10\^3 CFU)	MTBVAC Group 2 n=9 Participants Intervention: MTBVAC live vaccine (middle dose 5 x 10\^4 CFU)	MTBVAC Group 3 n=9 Participants Intervention: MTBVAC live vaccine (high dose 5 x 10\^5 CFU)	BCG Control Group n=9 Participants Intervention: Commercially available BCg live vaccine (standard dose 5 x 10\^5 CFU)
Number of Participants With Adverse Events up to 210 Days After Vaccination	9 participants	9 participants	9 participants	9 participants

SECONDARY outcome

Timeframe: Day 28

Population: Number of Participants with Three-cytokine-positive CD4+ T-cell Response (per protocol analysis)

Measure of the kinetics of CD4+ T-cell responses to MTBVAC or BCG vaccination by tracking the expression of IFNγ, TNFα and IL-2 upon stimulation with live MTBVAC or BCG

Outcome measures

Measure	MTBVAC Group 1 n=9 Participants Intervention: MTBVAC live vaccine (low dose 5 x 10\^3 CFU)	MTBVAC Group 2 n=8 Participants Intervention: MTBVAC live vaccine (middle dose 5 x 10\^4 CFU)	MTBVAC Group 3 n=9 Participants Intervention: MTBVAC live vaccine (high dose 5 x 10\^5 CFU)	BCG Control Group n=9 Participants Intervention: Commercially available BCg live vaccine (standard dose 5 x 10\^5 CFU)
Number of Participants With Three-cytokine-positive CD4+ T-cell Response	0 participants	0 participants	4 participants	1 participants

Adverse Events

MTBVAC Group 1

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

MTBVAC Group 2

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

MTBVAC Group 3

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

BCG Control Group

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	MTBVAC Group 1 n=9 participants at risk Intervention: MTBVAC live vaccine (low dose 5 x 10\^3 CFU)	MTBVAC Group 2 n=9 participants at risk Intervention: MTBVAC live vaccine (middle dose 5 x 10\^4 CFU)	MTBVAC Group 3 n=9 participants at risk Intervention: MTBVAC live vaccine (high dose 5 x 10\^5 CFU)	BCG Control Group n=9 participants at risk Intervention: Commercially available BCG live vaccine (standard dose 5 x 10\^5 CFU)
Skin and subcutaneous tissue disorders Pain at injection site	33.3% 3/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.	55.6% 5/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.	55.6% 5/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.	88.9% 8/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.
Skin and subcutaneous tissue disorders Erythema	55.6% 5/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.	88.9% 8/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.	88.9% 8/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.	77.8% 7/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.
Skin and subcutaneous tissue disorders Induration	55.6% 5/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.	77.8% 7/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.	88.9% 8/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.	100.0% 9/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.
Skin and subcutaneous tissue disorders Pruritis	33.3% 3/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.	33.3% 3/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.	11.1% 1/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.	22.2% 2/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.
Skin and subcutaneous tissue disorders Discharge	0.00% 0/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.	0.00% 0/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.	22.2% 2/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.	44.4% 4/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.
General disorders Headache	55.6% 5/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.	44.4% 4/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.	33.3% 3/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.	33.3% 3/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.
Musculoskeletal and connective tissue disorders Musculoskeletal	55.6% 5/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.	22.2% 2/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.	55.6% 5/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.	22.2% 2/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.
General disorders Fatigue	77.8% 7/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.	44.4% 4/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.	33.3% 3/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.	44.4% 4/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.
Gastrointestinal disorders Digestive	11.1% 1/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.	33.3% 3/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.	22.2% 2/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.	33.3% 3/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.
General disorders Fever	11.1% 1/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.	44.4% 4/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.	33.3% 3/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.	11.1% 1/9 • Solicited local and systemic adverse events: within 7 days of vaccination (diary card). Unsolicited local and systemic adverse events at days 0, 7, 28, 56, 90, 150 and 210 Safety was assessed based on a collection of solicited local (injection site pain, erythema, induration, pruritus and discharges) and systemic (fever, headache, fatigue, musculoskeletal pains, gastrointestinal symptoms) adverse events (AEs) within 7 days of vaccination (diary card). Unsolicited local and systemic AEs as well as serious AEs (SAEs) were collected during the entire study period.

Additional Information

Dr. François Spertini, Associate Professor, Division Immunology & Allergy

Centre Hospitalier Universitaire Vaudois (CHUV)

Phone: +41 21 31 40 799

Email: Francois.Spertini@chuv.ch

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60