Trial Outcomes & Findings for Rotavirus Vaccine Produced by Butantan Institute (NCT NCT00981669)

Results Overview

Safety and tolerability were evaluated by monitoring occurence of fever, diarrhea, vomiting, abdominal pain and increase of liver enzymes.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

80 participants

Primary outcome timeframe

Within the first five days post-vaccination.

Results posted on

2013-04-25

Participant Flow

Recruitment period: From February to August 2009.79 healthy adult volunteers from 18 to 40 years of age were selected. Participants were screened for eligibility and enrolled by the investigators following the signing of an informed consent. Due to a recommendation from ANVISA, female volunteers were not allowed to be recruited.

98 potential volunteers were interviewed, 80 of them were enrolled: 40 volunteers were allocated to receive the investigational product (rotavirus vaccine) and 40 were allocated to receive placebo; 79 completed the follow-up. Before randomization 18 volunteers were excluded, 3 refused to participate and 15 had screening failure

Participant milestones

Participant milestones
Measure	Rotavirus Vaccine 3 doses with 6 weeks interval	Placebo 3 doses with 6 weeks interval
Overall Study STARTED	40	40
Overall Study COMPLETED	39	40
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rotavirus Vaccine Produced by Butantan Institute

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rotavirus Vaccine n=40 Participants 3 doses with 6 weeks interval	Placebo n=40 Participants 3 doses with 6 weeks interval	Total n=80 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
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	29.2 years STANDARD_DEVIATION 6.6 • n=5 Participants	28.2 years STANDARD_DEVIATION 6.2 • n=7 Participants	28.7 years STANDARD_DEVIATION 6.2 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Region of Enrollment Brazil	40 participants n=5 Participants	40 participants n=7 Participants	80 participants n=5 Participants

PRIMARY outcome

Timeframe: Within the first five days post-vaccination.

Safety and tolerability were evaluated by monitoring occurence of fever, diarrhea, vomiting, abdominal pain and increase of liver enzymes.

Outcome measures

Outcome measures
Measure	Rotavirus Vaccine n=39 Participants 3 doses with 6 weeks interval	Placebo n=40 Participants 3 doses with 6 weeks interval
Number of Participants With Adverse Events.	14 participants	12 participants

SECONDARY outcome

Timeframe: before each dose (total of doses:3) and after 6 weeks of the third dose

Population: As in most phase I trials, sample size was not calculated to provide statistically significant differences between groups. Rather, a descriptive analysis on the frequency of AE and immunogenicity data was undertaken.

It was evaluated by anti-rotavirus IgA levels in terms of optical density. Pre-vaccination levels of anti-rotavirus antibodies were not considered as an exclusion criterion. Seroconversion was considered as a fourfold increase in IgA titers. The proportion of seroconverters in both groups was compared. IgA levels in optical density were not converted to any unit of measure.

Outcome measures

Outcome measures
Measure	Rotavirus Vaccine n=39 Participants 3 doses with 6 weeks interval	Placebo n=40 Participants 3 doses with 6 weeks interval
Anti-rotavirus IgA Level.	0.51 Arbitrary units Interval 0.41 to 0.71	0.35 Arbitrary units Interval 0.3 to 0.46

Adverse Events

Rotavirus Vaccine

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Rotavirus Vaccine n=39 participants at risk 3 doses with 6 weeks interval	Placebo n=40 participants at risk 3 doses with 6 weeks interval
Nervous system disorders Headache	7.7% 3/39 • Number of events 3 • Complaints and solicited symptoms were investigated following the first five days after vaccination.	5.0% 2/40 • Number of events 2 • Complaints and solicited symptoms were investigated following the first five days after vaccination.
Gastrointestinal disorders Gastrointestinal Symptoms	12.8% 5/39 • Number of events 5 • Complaints and solicited symptoms were investigated following the first five days after vaccination.	17.5% 7/40 • Number of events 7 • Complaints and solicited symptoms were investigated following the first five days after vaccination.
General disorders Loss of appetite	5.1% 2/39 • Number of events 2 • Complaints and solicited symptoms were investigated following the first five days after vaccination.	0.00% 0/40 • Complaints and solicited symptoms were investigated following the first five days after vaccination.

Additional Information

Alexander Roberto Precioso

Instituto Butantan

Phone: +5511-2627-9372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place