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The purpose of this study is to describe the safety, tolerability and immunogenicity of the pentavalent rotavirus vaccine produced by Butantan Institute.
The Brazilian National Immunization Program (PNI) has introduced a oral monovalent vaccine against rotavirus for infants in its immunization schedule since 2006. Its introduction increased the Brazilian Ministry of Health budget because the vaccination in Brazil is free of charge. An agreement between Path Foundation and Butantan Institute has made possible the transfer of technology to Butantan Institute to produce, at a reduced cost, a pentavalent rotavirus vaccine including the the rotavirus serotypes more frequent in Brazil.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rotavirus vaccine | Experimental | 3 doses with 6 weeks interval |
|
| placebo | Placebo Comparator | 3 doses with 6 weeks interval |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rotavirus vaccine | Biological | 3 doses with 6 weeks interval |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events. | Safety and tolerability were evaluated by monitoring occurence of fever, diarrhea, vomiting, abdominal pain and increase of liver enzymes. | Within the first five days post-vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-rotavirus IgA Level. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander R Precioso, MD,PhD | Butantan Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto da Criança do Hospital das Clinicas da Faculade de Medicina da USP | São Paulo | São Paulo | 05403-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19551286 | Background | Higashi HG, Luna E, Precioso AR, Vilela M, Kubrusly FS, Dias WO, Raw I. Acellular and "low" pertussis vaccines: adverse events and the role of mutations. Rev Inst Med Trop Sao Paulo. 2009 May-Jun;51(3):131-4. doi: 10.1590/s0036-46652009000300002. |
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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
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rotavirus Vaccine | 3 doses with 6 weeks interval |
| FG001 | Placebo | 3 doses with 6 weeks interval |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
In the vaccine gorup one volunteer was not considered for the final analysis because He received the second dose of the vaccine in an anapropriate interval.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rotavirus Vaccine | 3 doses with 6 weeks interval |
| BG001 | Placebo | 3 doses with 6 weeks interval |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Anti-rotavirus IgA Level. | 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. | 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. | Posted | Median | Inter-Quartile Range | Arbitrary units | before each dose (total of doses:3) and after 6 weeks of the third dose |
|
Complaints and solicited symptoms were investigated following the first five days after vaccination.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rotavirus Vaccine | 3 doses with 6 weeks interval |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
The vaccine candidate needs to be evaluated further in larger trials, among the target population.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexander Roberto Precioso | Instituto Butantan | +5511-2627-9372 | 9372 | alexrp@butantan.gov.br |
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| ID | Term |
|---|---|
| D012400 | Rotavirus Infections |
| ID | Term |
|---|---|
| D012088 | Reoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D022243 | Rotavirus Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| placebo | Biological | 3 doses with 6 weeks interval |
|
|
| before each dose (total of doses:3) and after 6 weeks of the third dose |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Placebo |
3 doses with 6 weeks interval |
|
|
| Primary | Number of Participants With Adverse Events. | Safety and tolerability were evaluated by monitoring occurence of fever, diarrhea, vomiting, abdominal pain and increase of liver enzymes. | Posted | Number | participants | Within the first five days post-vaccination. |
|
|
|
| 0 |
| 39 |
| 10 |
| 39 |
| EG001 | Placebo | 3 doses with 6 weeks interval | 0 | 40 | 9 | 40 |
| Gastrointestinal Symptoms | Gastrointestinal disorders | Systematic Assessment |
|
| Loss of appetite | General disorders | Systematic Assessment |
|
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