Trial Outcomes & Findings for Open-label Safety and Tolerability Study of CoVaccine HT™ in Healthy Volunteers (NCT NCT01015703)

Last Updated: 2014-09-15

Results Overview

Safety/tolerability study design of 5 doses of test article administered to healthy volunteers. Each dose was injected 21 days apart. Participants were withdrawn upon experiencing any adverse event.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

50 participants

Primary outcome timeframe

Duration of study

Results posted on

2014-09-15

Participant Flow

Participant milestones

Participant milestones
Measure	1 mg Dose 1 mg CoVaccine HT	2 mg Dose 2 mg CoVaccine HT	5 mg Dose 5 mg CoVaccine HT	7 mg Dose 7 mg CoVaccine HT	10 mg Dose 10 mg CoVaccine HT
Overall Study STARTED	10	10	10	10	10
Overall Study COMPLETED	8	9	10	10	10
Overall Study NOT COMPLETED	2	1	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	1 mg Dose 1 mg CoVaccine HT	2 mg Dose 2 mg CoVaccine HT
Overall Study Withdrawal by Subject	0	1
Overall Study Adverse Event	1	0
Overall Study Protocol Violation	1	0

Baseline Characteristics

Open-label Safety and Tolerability Study of CoVaccine HT™ in Healthy Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1 mg Dose n=10 Participants 1 mg CoVaccine HT	2 mg Dose n=10 Participants 2 mg CoVaccine HT	5 mg Dose n=10 Participants 5 mg CoVaccine HT	7 mg Dose n=10 Participants 7 mg CoVaccine HT	10 mg Dose n=10 Participants 10 mg CoVaccine HT	Total n=50 Participants Total of all reporting groups
Age, Continuous	41 years STANDARD_DEVIATION 11 • n=99 Participants	46 years STANDARD_DEVIATION 11 • n=107 Participants	49 years STANDARD_DEVIATION 9 • n=206 Participants	44 years STANDARD_DEVIATION 15 • n=157 Participants	36 years STANDARD_DEVIATION 9 • n=390 Participants	42 years STANDARD_DEVIATION 10 • n=16 Participants
Sex: Female, Male Female	1 Participants n=99 Participants	2 Participants n=107 Participants	1 Participants n=206 Participants	3 Participants n=157 Participants	1 Participants n=390 Participants	8 Participants n=16 Participants
Sex: Female, Male Male	9 Participants n=99 Participants	8 Participants n=107 Participants	9 Participants n=206 Participants	7 Participants n=157 Participants	9 Participants n=390 Participants	42 Participants n=16 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	0 Participants n=390 Participants	0 Participants n=16 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	0 Participants n=390 Participants	1 Participants n=16 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	0 Participants n=390 Participants	0 Participants n=16 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	2 Participants n=390 Participants	4 Participants n=16 Participants
Race (NIH/OMB) White	8 Participants n=99 Participants	9 Participants n=107 Participants	10 Participants n=206 Participants	10 Participants n=157 Participants	8 Participants n=390 Participants	45 Participants n=16 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	0 Participants n=390 Participants	0 Participants n=16 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	0 Participants n=390 Participants	0 Participants n=16 Participants

PRIMARY outcome

Timeframe: Duration of study

Safety/tolerability study design of 5 doses of test article administered to healthy volunteers. Each dose was injected 21 days apart. Participants were withdrawn upon experiencing any adverse event.