IPVID-ADAPNCT02769923
ID Administration of fIPV Using Intradermal Adapters vs. BCG Syringe
A study testing Westpharma ID adapter, Star ID syringe and BCG NS in people with IPV, run by Aga Khan University.
Trial summary
The investigators will assess the usability and immune response following fractional dose inactivated polio virus vaccine (fIPV) administration with two novel intradermal adapters (ID adapter by West Pharmaceutical services Inc. Read more about this study
- Who is it for?
- Ages 6 to 12 months
- Conditions the study is for
- IPV
- What is being tested?
- Westpharma ID adapter, Star ID syringe and BCG NS
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Nov 2016
- Phase
- Interventional
- 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 6 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6-12 months living in four peri-urban slums of Bin Qasim Town, Karachi (Rehri Goth, Bhains Colony, Ali Akber Shah, Ibrahim Hydri).
Who cannot join
- Child found acutely ill at the time of enrolment and requiring emergent medical care/hospitalization.
- Refusal of blood testing.
- Any contraindication for ID injection.
- A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family.
- e.g. several early infant deaths, household member on chemotherapy) will render the newborn ineligible for the study.
About this study
Official title: Intradermal Administration of Fractional Dose of Inactivated Poliovirus Vaccine Using Intradermal Adapters vs. BCG Syringe: Community Based Randomized Control Trial in Pakistan
The investigators will assess the usability and immune response following fractional dose inactivated polio virus vaccine (fIPV) administration with two novel intradermal adapters (ID adapter by West Pharmaceutical services Inc. and Star Intradermal syringe by Star Syringe Ltd.) and compare the response with the one achieved with fIPV administered with traditional BCG needle syringe.
Read the detailed description
The study will be conducted in following two phases.
- Phase I: Ergonometric evaluation and serology: Phase I is based on community based randomized controlled trial with three arms. List of households with child aged 6-12 months will be retrieved from demographic surveillance system. Train CHWs will visit the household and provide relevant information regarding the study to the parents. The children of the parents who provide written informed consent will be screened for eligibility and enrolled into the study. The children accompanied with parents/guardians will be carried to the primary health center of the Dept. of pediatrics and child health, AKU. Baseline 3ml of blood will be collected by trained study phlebotomist in EDT tubes and will be transported to infectious disease research laboratory (IDRL) at AKU. A sample of 450 children will be randomized using sealed envelopes into one of the three study arms. Arm 1, will receive fIPV using WestPharma device, arm 2 will receive fIPV using Star ID syringe and arm 3 will receive fIPV using BCG syringe. The child will be observed for 30 minutes for any adverse event. The research Assistants will interview the parents to fill the socio-demographic questionnaire and vaccinators will fill ergonometric and injection quality questionnaires. The child will be followed after 28 days (4 weeks) of enrollment and another 3ml of blood will be collected by trained phlebotomist. Details of the visit will be recorded in follow-up questionnaire. Both baseline and endline blood samples will be tested for immune response against polio virus 1,2 and 3.
- Phase II: Pilot campaign demonstration: In this phase, investigators will conduct a door to door campaign in the high risk community to provide fIPV using either WestPharma device or Star ID syringe or BCG needle syringe. In this campaign, any child less than 5 years of age, living in the study area and whose parents provide verbal consent will receive intradermal injection of fIPV using any of the three devices by the trained research assistants. This will be a one day campaign in coordination with provincial polio emergency operation center (EOC). About 300 children will receive fIPV using any of the three devices.
- Conditions
- IPV
- Being tested
- Westpharma ID adapter, Star ID syringe, BCG NS
- Keywords
- WestPharma ID-adapter, Star ID syringe, BCG needle syringe, fractional dose IPV, fIPV, polio, Polio Endgame, IPV
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Westpharma ID adapterDevice
device used for administering intradermal injection
Star ID syringeDevice
device used for administering intradermal injection
BCG NSDevice
syringe used for administering intradermal injection
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Westpharma ID Adapter Receives: Device: Westpharma ID adapter |
| Arm B | Active comparator | Star ID syringe Receives: Device: Star ID syringe |
| Arm C | Active comparator | BCG NS Receives: Device: BCG NS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in immune response against poliovirus type 1, 2 and 3 after 28 days of administration of fractional dose IPV
Seropositivity is defined as reciprocal titers of poliovirus neutralizing antibodies >8; seroconversion is defined as the change from seronegative to seropositive (from reciprocal titer of <8 to >8); and boosting is defined as >4-fold increase in titers. In this study, "immune response" combines both boosting and seroconversion.
Measured: up to day 28.
Secondary outcomes (3)
Difference in bleb size after the intradermal injection among three arms
The bleb size will measured immediately after the administration of injection using the millimeter scale.
Measured: immediately after injection
Difference in vaccine loss after the intradermal injection among three arms
The measurement is performed by blotting the skin with filter paper to collect liquid that was not delivered into the skin or leaked out after injection. The wet spot on the filter paper will be circled and the diameter of the circle compared to a reference template to quantify the amount of liquid present into the following categories: 0 μl, 0 to 5 μl, 5 to 10 μl, 10 to 20 μl, 20 to 40 μl, more than 40 μl.
Measured: immediately after injection
Difference in local adverse events
local adverse events include redness, itching, etc.
Measured: within 30 minutes after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startSep 2015
- Primary completionJun 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IPVStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization
- Responsible party
- Principal investigator, Ali Faisal Saleem, Aga Khan University
- Investigators
- Ali F Saleem, FCPS,MSc, Principal investigator, The Aga Khan University, KarachiMohammad T Yousafzai, MPH, MSc, Principal investigator, The Aga Khan University, Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769923
- Sponsor's protocol ID
- 3519-Ped-ERC-15
- Acronym
- ID-ADAP
- Status last verified
- Sep 2017
- First submitted
- 2 May 2016
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: in process
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intradermal Administration of Fractional Dose of Inactivated Poliovirus Vaccine Using Intradermal Adapters vs. BCG Syringe: Community Based Randomized Control Trial in Pakistan
- ClinicalTrials.gov ID
- NCT02769923
- Acronym / sponsor ID
- ID-ADAP / 3519-Ped-ERC-15
- Conditions
- IPV
- Keywords
- WestPharma ID-adapter, Star ID syringe, BCG needle syringe, fractional dose IPV, fIPV, polio, Polio Endgame, IPV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- World Health Organization
- Study start
- Sep 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 12 May 2016 (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.
The investigators will assess the usability and immune response following fractional dose inactivated polio virus vaccine (fIPV) administration with two novel intradermal adapters (ID adapter by West Pharmaceutical services Inc. and Star Intradermal syringe by Star Syringe Ltd.) and compare the response with the one achieved with fIPV administered with traditional BCG needle syringe.
Detailed description
The study will be conducted in following two phases.
- Phase I: Ergonometric evaluation and serology: Phase I is based on community based randomized controlled trial with three arms. List of households with child aged 6-12 months will be retrieved from demographic surveillance system. Train CHWs will visit the household and provide relevant information regarding the study to the parents. The children of the parents who provide written informed consent will be screened for eligibility and enrolled into the study. The children accompanied with parents/guardians will be carried to the primary health center of the Dept. of pediatrics and child health, AKU. Baseline 3ml of blood will be collected by trained study phlebotomist in EDT tubes and will be transported to infectious disease research laboratory (IDRL) at AKU. A sample of 450 children will be randomized using sealed envelopes into one of the three study arms. Arm 1, will receive fIPV using WestPharma device, arm 2 will receive fIPV using Star ID syringe and arm 3 will receive fIPV using BCG syringe. The child will be observed for 30 minutes for any adverse event. The research Assistants will interview the parents to fill the socio-demographic questionnaire and vaccinators will fill ergonometric and injection quality questionnaires. The child will be followed after 28 days (4 weeks) of enrollment and another 3ml of blood will be collected by trained phlebotomist. Details of the visit will be recorded in follow-up questionnaire. Both baseline and endline blood samples will be tested for immune response against polio virus 1,2 and 3.
- Phase II: Pilot campaign demonstration: In this phase, investigators will conduct a door to door campaign in the high risk community to provide fIPV using either WestPharma device or Star ID syringe or BCG needle syringe. In this campaign, any child less than 5 years of age, living in the study area and whose parents provide verbal consent will receive intradermal injection of fIPV using any of the three devices by the trained research assistants. This will be a one day campaign in coordination with provincial polio emergency operation center (EOC). About 300 children will receive fIPV using any of the three devices.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Device: Westpharma ID adapterWestpharma ID Adapter |
| Arm B | Active comparator | Device: Star ID syringeStar ID syringe |
| Arm C | Active comparator | Device: BCG NSBCG NS |
Who may qualify
- Ages
- 6 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 6-12 months living in four peri-urban slums of Bin Qasim Town, Karachi (Rehri Goth, Bhains Colony, Ali Akber Shah, Ibrahim Hydri).
Key exclusion criteria (5 listed)
- Child found acutely ill at the time of enrolment and requiring emergent medical care/hospitalization.
- Refusal of blood testing.
- Any contraindication for ID injection.
- A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family.
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 |
|---|---|---|
| Westpharma ID adapterdevice used for administering intradermal injection | Device | Arm A |
| Star ID syringedevice used for administering intradermal injection | Device | Arm B |
| BCG NSsyringe used for administering intradermal injection | Device | Arm C |
Primary outcome
Difference in immune response against poliovirus type 1, 2 and 3 after 28 days of administration of fractional dose IPV
Time frame: up to day 28.
Seropositivity is defined as reciprocal titers of poliovirus neutralizing antibodies >8; seroconversion is defined as the change from seronegative to seropositive (from reciprocal titer of <8 to >8); and boosting is defined as >4-fold increase in titers. In this study, "immune response" combines both boosting and seroconversion.
3 secondary outcomes
Difference in bleb size after the intradermal injection among three arms
Time frame: immediately after injection
Difference in vaccine loss after the intradermal injection among three arms
Time frame: immediately after injection
Difference in local adverse events
Time frame: within 30 minutes after injection
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 13 Sep 2017.
- Individual participant dataSharing planned: Yes. in process
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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.
Ali F Saleem, FCPS,MSc principal investigator
The Aga Khan University, Karachi
Mohammad T Yousafzai, MPH, MSc principal investigator
The Aga Khan University, Karachi
Questions about this trial
What is this clinical trial studying?
A study testing Westpharma ID adapter, Star ID syringe and BCG NS in people with IPV, run by Aga Khan University.
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 1 inclusion and 5 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 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Difference in immune response against poliovirus type 1, 2 and 3 after 28 days of administration of fractional dose IPV (time frame: up to day 28.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2017.