Rotavirus InfectionsPhase 1NCT00981669
Rotavirus Vaccine Produced by Butantan Institute
A Phase 1 study testing rotavirus vaccine in people with Rotavirus Infections, run by Butantan Institute at 1 site in Brazil.
Trial summary
The purpose of this study is to describe the safety, tolerability and immunogenicity of the pentavalent rotavirus vaccine produced by Butantan Institute. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Rotavirus Infections
- What is being tested?
- rotavirus vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2009to Jun 2010
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male healthy
- Age ≥18-40 years
- Not taking immunosuppressive drugs
- No clinical history of gastrointestinal diseases or surgeries
- No history of cardiac, neurologic, immunologic or endocrine diseases
- Normal eligibility laboratory tests
- To be willing to participate and sign the informed consent form
- No participation in another clinical trial in the past 6 months
Who cannot join
- Had received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto da Criança do Hospital das Clinicas da Faculade de Medicina da USP
São Paulo, São Paulo, 05403-000
About this study
Official title: Evaluation of Rotavirus Vaccine Produced by Butantan Institute. Phase I - Safety, Tolerability and Immunogenicity Evaluation
The purpose of this study is to describe the safety, tolerability and immunogenicity of the pentavalent rotavirus vaccine produced by Butantan Institute.
Read the detailed description
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.
- Conditions
- Rotavirus Infections
- Being tested
- rotavirus vaccine, placebo
- Keywords
- brazilian pentavalent rotavirus vaccine, safety, tolerability, immunogenicity
- Medical subject headings
- Rotavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rotavirus vaccineBiological
Also called brazilian rotavirus vaccine
3 doses with 6 weeks interval
placeboBiological
Also called butantan placebo
3 doses with 6 weeks interval
| Study group | Role | What they receive |
|---|---|---|
| rotavirus vaccine | Experimental | 3 doses with 6 weeks interval Receives: Biological: rotavirus vaccine |
| placebo | Placebo comparator | 3 doses with 6 weeks interval Receives: Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within the first five days post-vaccination.
Secondary outcomes (1)
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.
Measured: before each dose (total of doses:3) and after 6 weeks of the third dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotavirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butantan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Alexander R Precioso, MD,PhD, Study director, Butantan Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981669
- Sponsor's protocol ID
- 1242/06
- Status last verified
- Mar 2013
- First submitted
- 17 Sep 2009
- Last updated
- 25 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 19551286
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Rotavirus Vaccine Produced by Butantan Institute. Phase I - Safety, Tolerability and Immunogenicity Evaluation
- ClinicalTrials.gov ID
- NCT00981669
- Acronym / sponsor ID
- 1242/06
- Conditions
- Rotavirus Infections
- Keywords
- brazilian pentavalent rotavirus vaccine, safety, tolerability, immunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Butantan InstituteOther government
- Study start
- Mar 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 22 Sep 2009 (estimated)
- Results
- Posted 25 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to describe the safety, tolerability and immunogenicity of the pentavalent rotavirus vaccine produced by Butantan Institute.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rotavirus vaccine | Experimental | Biological: rotavirus vaccine3 doses with 6 weeks interval |
| placebo | Placebo comparator | Biological: placebo3 doses with 6 weeks interval |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male healthy
- Age ≥18-40 years
- Not taking immunosuppressive drugs
- No clinical history of gastrointestinal diseases or surgeries
- No history of cardiac, neurologic, immunologic or endocrine diseases
Key exclusion criteria (1 listed)
- Had received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rotavirus vaccineAlso: brazilian rotavirus vaccine3 doses with 6 weeks interval | Biological | rotavirus vaccine |
| placeboAlso: butantan placebo3 doses with 6 weeks interval | Biological | placebo |
Primary outcome
Number of Participants With Adverse Events.
Time frame: 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.
1 secondary outcome
Anti-rotavirus IgA Level.
Time frame: before each dose (total of doses:3) and after 6 weeks of the third dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19551286Higashi 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander R Precioso, MD,PhD study director
Butantan Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rotavirus vaccine in people with Rotavirus Infections, run by Butantan Institute at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events. (time frame: Within the first five days post-vaccination.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00981669, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2013.