PoliomyelitisPhase 1NCT01571505
Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in INDIA (PROVIDE)
A Phase 1 study testing IPV vaccination in people with Poliomyelitis and Tropical Enteropathy, run by International Vaccine Institute at 1 site in India.
Trial summary
Oral polio and rotavirus vaccines are significantly less effective in children living in the developing world. Tropical enteropathy, which is associated with intestinal inflammation, decreased absorption and increased permeability, may contribute substantially to oral vaccine failure in developing country settings. Read more about this study
- Who is it for?
- Ages 42 to 49 daysHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis, Tropical Enteropathy
- What is being tested?
- IPV vaccination
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 372 participants
- Where
- 1 siteIndia
- Study dates
- 1 Mar 2012to 30 Nov 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 42 to 49 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Mother willing to sign informed consent form.
- Infant aged 0 to 49 days old.
- No obvious congenital abnormalities or birth defects.
Who cannot join
- Parents are not willing to have child's blood drawn.
- Parents are planning to enroll child into another clinical study during the time period of this trial.
- Mother not willing to have blood drawn and breast milk extracted.
- Parents not willing to have field research assistant in home.
- History of seizures or other apparent neurologic disorders.
- Infant does not have proof of BCG and OPV since birth by immunization card.
- History of acute illness and/or immunocompromised state of the child.
- Immunocompromised or chronically ill mother
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in INDIA
Oral polio and rotavirus vaccines are significantly less effective in children living in the developing world. Tropical enteropathy, which is associated with intestinal inflammation, decreased absorption and increased permeability, may contribute substantially to oral vaccine failure in developing country settings. Other possible causes of oral vaccine underperformance include malnutrition, interference with maternal or breast milk antibodies, changes in gut microbiota, and genetic susceptibility.The primary Objective of this study is to determine whether decreased vaccine responsiveness to oral poliovirus or rotavirus vaccines is associated with the presence of tropical enteropathy.
Read the detailed description
Intervention of this study is to vaccinate oral poliovirus vaccine and oral rotavirus vaccine to the child with two group; with inactivated poliovirus vaccine and without inactivated poliovirus vaccine. Rotavirus vaccines give to the child at 10 weeks of age and 17 weeks of age.
- Conditions
- Poliomyelitis, Tropical Enteropathy
- Being tested
- IPV vaccination
- Keywords
- Oral vaccines, Vaccine Responsiveness, Tropical Enteropathy
- Medical subject headings
- Poliomyelitis, Sprue, Tropical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPV vaccinationBiological
Also called Rotavirus vaccination to children at 10 and 17 weeks of age.
Randomized IPV or OPV to children aged at 39weeks.
| Study group | Role | What they receive |
|---|---|---|
| IPV vaccination | Experimental | Randomized IPV vaccination to children at the age of 39 weeks. Receives: Biological: IPV vaccination |
| OPV vaccination | Placebo comparator | Randomized OPV vaccination to children at the age of 39 weeks. Receives: Biological: IPV vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine immunogenicity of oral vaccines (Oral Polio Vaccine and Rotavirus Vaccine) with the presence of tropical enteropathy using Lactose/Mannitol ratio in urine.
Responsiveness of oral vaccines compare with Tropical Enteropathy and without Tropical Enteropathy; using lactose/mannitol ratio.
Measured: Birth to one year
Secondary outcomes (2)
Systemic immune responses (neutralizing antibodies) of impact of an inactivated polio vaccine (IPV) and polio vaccine boost following vaccination with oral polio vaccine (OPV).
Measured: Birth to one year
Mucosal immune responses (shedding OPV vaccine virus) of impact of an inactivated polio vaccine (IPV) and polio vaccine boost following vaccination with oral polio vaccine (OPV).
Measured: Birth to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study start1 Mar 2012
- Primary completion30 Nov 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PoliomyelitisStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 372 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Vaccine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, National Institute of Cholera and Enteric Diseases, India, University of Virginia, University of Vermont
- Responsible party
- Sponsor
- Investigators
- Ayan Dey, Ph.D, Principal investigator, International Vaccine InstituteWilliam Petri, M.D, Principal investigator, University of VirginiaBeth Kirkpatrick, M.D., Principal investigator, University of VermontSuman Kanungo, M.D., Principal investigator, National Institute of Cholera and Enteric Diseases, IndiaRanjan K Nandy, M.D., Principal investigator, National Institute of Cholera and Enteric Diseases, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571505
- Sponsor's protocol ID
- POLIO ROTA-02
- Status last verified
- Aug 2017
- First submitted
- 28 Mar 2012
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Kanungo S, Kim DR, Haldar B, Snider C, Nalavade U, Kim SA, Park JY, Sinha A, Mallick AH, Manna B, Sur D, Nandy RK, Deshpande JM, Czerkinsky C, Wierzba TF, Petri WA Jr, Ali M, Dey A. Comparison of IPV to tOPV week 39 boost of primary OPV vaccination in Indian infants: an open labelled randomized controlled trial. Heliyon. 2017 Jan 9;3(1):e00223. doi: 10.1016/j.heliyon.2016.e00223. eCollection 2017 Jan.
PubMed 28194449
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in INDIA
- ClinicalTrials.gov ID
- NCT01571505
- Acronym / sponsor ID
- POLIO ROTA-02
- Conditions
- Poliomyelitis, Tropical Enteropathy
- Keywords
- Oral vaccines, Vaccine Responsiveness, Tropical Enteropathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 372 participants (actual)
- Lead sponsor
- International Vaccine InstituteUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, National Institute of Cholera and Enteric Diseases, India, University of Virginia, University of Vermont
- Study start
- 1 Mar 2012 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 5 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oral polio and rotavirus vaccines are significantly less effective in children living in the developing world. Tropical enteropathy, which is associated with intestinal inflammation, decreased absorption and increased permeability, may contribute substantially to oral vaccine failure in developing country settings. Other possible causes of oral vaccine underperformance include malnutrition, interference with maternal or breast milk antibodies, changes in gut microbiota, and genetic susceptibility.The primary Objective of this study is to determine whether decreased vaccine responsiveness to oral poliovirus or rotavirus vaccines is associated with the presence of tropical enteropathy.
Detailed description
Intervention of this study is to vaccinate oral poliovirus vaccine and oral rotavirus vaccine to the child with two group; with inactivated poliovirus vaccine and without inactivated poliovirus vaccine. Rotavirus vaccines give to the child at 10 weeks of age and 17 weeks of age.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPV vaccination | Experimental | Biological: IPV vaccinationRandomized IPV vaccination to children at the age of 39 weeks. |
| OPV vaccination | Placebo comparator | Biological: IPV vaccinationRandomized OPV vaccination to children at the age of 39 weeks. |
Who may qualify
- Ages
- 42 to 49 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Mother willing to sign informed consent form.
- Infant aged 0 to 49 days old.
- No obvious congenital abnormalities or birth defects.
Key exclusion criteria (8 listed)
- Parents are not willing to have child's blood drawn.
- Parents are planning to enroll child into another clinical study during the time period of this trial.
- Mother not willing to have blood drawn and breast milk extracted.
- Parents not willing to have field research assistant in home.
- History of seizures or other apparent neurologic disorders.
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 |
|---|---|---|
| IPV vaccinationAlso: Rotavirus vaccination to children at 10 and 17 weeks of age.Randomized IPV or OPV to children aged at 39weeks. | Biological | IPV vaccination, OPV vaccination |
Primary outcome
Vaccine immunogenicity of oral vaccines (Oral Polio Vaccine and Rotavirus Vaccine) with the presence of tropical enteropathy using Lactose/Mannitol ratio in urine.
Time frame: Birth to one year
Responsiveness of oral vaccines compare with Tropical Enteropathy and without Tropical Enteropathy; using lactose/mannitol ratio.
2 secondary outcomes
Systemic immune responses (neutralizing antibodies) of impact of an inactivated polio vaccine (IPV) and polio vaccine boost following vaccination with oral polio vaccine (OPV).
Time frame: Birth to one year
Mucosal immune responses (shedding OPV vaccine virus) of impact of an inactivated polio vaccine (IPV) and polio vaccine boost following vaccination with oral polio vaccine (OPV).
Time frame: Birth to one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2017.
- Results publication: PubMed 28194449Kanungo S, Kim DR, Haldar B, Snider C, Nalavade U, Kim SA, Park JY, Sinha A, Mallick AH, Manna B, Sur D, Nandy RK, Deshpande JM, Czerkinsky C, Wierzba TF, Petri WA Jr, Ali M, Dey A. Comparison of IPV to tOPV week 39 boost of primary OPV vaccination in Indian infants: an open labelled randomized controlled trial. Heliyon. 2017 Jan 9;3(1):e00223. doi: 10.1016/j.heliyon.2016.e00223. eCollection 2017 Jan.
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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.
Ayan Dey, Ph.D principal investigator
International Vaccine Institute
William Petri, M.D principal investigator
University of Virginia
Beth Kirkpatrick, M.D. principal investigator
University of Vermont
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 IPV vaccination in people with Poliomyelitis and Tropical Enteropathy, run by International Vaccine Institute at 1 site in India.
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 3 inclusion and 8 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 31 Aug 2017. 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 India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Vaccine immunogenicity of oral vaccines (Oral Polio Vaccine and Rotavirus Vaccine) with the presence of tropical enteropathy using Lactose/Mannitol ratio in urine. (time frame: Birth to one year). 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 NCT01571505, 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 31 Aug 2017.