Trial Outcomes & Findings for Clinical Trial to Study 4 Different Doses of the Vaccine RUTI in Healthy Volunteers (NCT NCT00546273)

NCT ID: NCT00546273

Last Updated: 2009-05-27

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 24 participants
• Primary outcome timeframe: at protocol defined timepoints: days 0, 1, 3, 7, 21, 28, 29, 31, 35, 56
• Results posted on: 2009-05-27

Participant Flow

Four RUTI doses were tested, in a sequencial way (n=6 each). 14 days before starting each level of treatment, subjects, after signing the informed consent, were screened in the Phase 1 Unit (Hospital Germans Trias i Pujol) in order to decide if they were elegible to be part of the study.

24 volunteers were enrolled and distributed in 4 groups, one group for every period (each period: 6 new volunteers). There was one period per dose tested, and doses were tested increasingly, not beginning to test one dose until clinically ensured the safety of the previous dose. The double blind was opened at the end of the study.

Participant milestones

Measure	RUTI 5 Micrograms of FCMtb RUTI dose: 5 micrograms of FCMtb	RUTI 25 Micrograms of FCMtb RUTI dose: 25 micrograms of FCMtb	RUTI 100 Micrograms of FCMtb RUTI dose: 100 micrograms of FCMtb	RUTI 200 Micrograms of FCMtb RUTI dose: 200 micrograms of FCMtb	Placebo placebo of the vaccine RUTI, given subcutaneously twice, on days 0 and 28
I STARTED	4	0	0	0	2
I COMPLETED	4	0	0	0	2
I NOT COMPLETED	0	0	0	0	0
II STARTED	0	4	0	0	2
II COMPLETED	0	4	0	0	2
II NOT COMPLETED	0	0	0	0	0
III STARTED	0	0	4	0	2
III COMPLETED	0	0	4	0	2
III NOT COMPLETED	0	0	0	0	0
IV STARTED	0	0	0	4	2
IV COMPLETED	0	0	0	4	2
IV NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Trial to Study 4 Different Doses of the Vaccine RUTI in Healthy Volunteers

Baseline characteristics by cohort

Measure	RUTI 5 Micrograms of FCMtb n=4 Participants RUTI dose: 5 micrograms of FCMtb	RUTI 25 Micrograms of FCMtb n=4 Participants RUTI dose: 25 micrograms of FCMtb	RUTI 100 Micrograms of FCMtb n=4 Participants RUTI dose: 100 micrograms of FCMtb	RUTI 200 Micrograms of FCMtb n=4 Participants RUTI dose: 200 micrograms of FCMtb	Placebo n=8 Participants placebo of the vaccine RUTI, given subcutaneously twice, on days 0 and 28	Total n=24 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	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	8 Participants n=21 Participants	24 Participants n=10 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	0 Participants n=10 Participants
Age Continuous	25.25 years STANDARD_DEVIATION 2.87 • n=5 Participants	26 years STANDARD_DEVIATION 2.94 • n=7 Participants	23 years STANDARD_DEVIATION 2.16 • n=5 Participants	22.25 years STANDARD_DEVIATION 2.22 • n=4 Participants	24 years STANDARD_DEVIATION 4.75 • n=21 Participants	24.08 years STANDARD_DEVIATION 3.46 • n=10 Participants
Sex: Female, Male Female	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	0 Participants n=10 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	8 Participants n=21 Participants	24 Participants n=10 Participants
Region of Enrollment Spain	4 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants	4 participants n=4 Participants	8 participants n=21 Participants	24 participants n=10 Participants

PRIMARY outcome

Timeframe: at protocol defined timepoints: days 0, 1, 3, 7, 21, 28, 29, 31, 35, 56

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: during the whole study

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: at protocol defined timepoints: days 0, 7, 21, 28, 35, 56, 112 & 156

Population: All the participants of the study were analyzed for this specific outcome measure.

haematological and biochemical laboratory tests

Outcome measures

Measure	RUTI 5 Micrograms of FCMtb n=4 Participants RUTI dose: 5 micrograms of FCMtb	RUTI 25 Micrograms of FCMtb n=4 Participants RUTI dose: 25 micrograms of FCMtb	RUTI 100 Micrograms of FCMtb n=4 Participants RUTI dose: 100 micrograms of FCMtb	RUTI 200 Micrograms of FCMtb n=4 Participants RUTI dose: 200 micrograms of FCMtb	Placebo n=8 Participants placebo of the vaccine RUTI, given subcutaneously twice, on days 0 and 28
Number of Clinically Relevant Abnormalities in the Laboratory Tests According to the Doctors' Impression	0 number of abnormalities	0 number of abnormalities	0 number of abnormalities	0 number of abnormalities	0 number of abnormalities

SECONDARY outcome

Timeframe: at protocol defined timepoints: days 0, 7, 21, 28, 35, 56, 112 & 156

Immunological assays are performed at all timepoints to determine vaccine immunogenicity

Outcome measures

Outcome data not reported

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Cristina Vilaplana, MD

UTE. Fund. Inst. Germans Trias i Pujol

Phone: +34 93 497 86 81

Email: cvilaplana@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee The disclosure of the results has to be previously arranged if mutually agreeable to both investigators and the company manufacturer of the vaccine RUTI: Archivel Farma S.L.
• Publication restrictions are in place

Restriction type: OTHER