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PoliomyelitisPhase 4IPVNCT01847872

IPV Clinical Trial - The Gambia

A Phase 4 study testing IPV IM Needle, IPV ID Needle and IPV IM Device in people with Poliomyelitis, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The overall goal of this study is to identify interference between intramuscular Inactivated Polio Vaccine (IPV) and other vaccines (Measles Rubella and Yellow Fever) co-administered at nine months of age and to confirm the safety of co-administration. Read more about this study

Who is it for?
Ages 9 to 10 monthsHealthy volunteers can take part
Conditions the study is for
Poliomyelitis
What is being tested?
IPV IM Needle, IPV ID Needle and IPV IM Device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,504 participants
Where
1 siteThe Gambia
Study dates
Jul 2013to Jul 2015
Phase
Phase 4
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 9 to 10 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Nine to ten months of age inclusive
  • Receipt of at least three doses of tOPV (excluding a dose given at birth) a minimum of four weeks prior to recruitment date
  • Informed consent for trial participation obtained from a parent/guardian (see section 19.1.2 for definition of guardian and section 19.1.3 for details regarding consent procedure)
  • Resident in the study area and with no plans to travel outside the study area during the period of subject participation
  • Willingness and capacity to comply with the study protocol as judged by a member of the clinical trial team

Who cannot join

  • Use of any Investigational Medicinal Product(IMP) within the 28 days preceding enrolment
  • Planned administration of any vaccine outside those defined in the study protocol at anytime during trial participation (for procedure in the event of a national OPV campaign see section 12.5.1.1)
  • Previous receipt of a measles, rubella, yellow fever or IPV vaccine
  • Bacillus Calmette-Guérin(BCG) vaccination in the month prior to recruitment
  • Any suspected or confirmed congenital or acquired state of immune deficiency including but not limited to primary immunodeficiencies including thymus disorders, HIV/AIDS, hematological or lymphoid malignancies (blood tests will not be routinely undertaken with this regard as part of the study)
  • Any current immunosuppressive/immunomodulatory medication or treatment including, but not limited to corticosteroids, cyclosporin, azathioprine, cyclophosphamide, methotrexate, radiotherapy, bone marrow transplantation
Show all 15Show fewer
  • Receipt of any immunosuppressive or immunomodulatory medication or treatment within the six months preceding trial enrolment (for corticosteroids this is defined as a dose of prednisolone (or equivalent) of greater than 2mg/kg/day for one week or 1mg/kg/day for one month. The use of inhaled or topical corticosteroids is not an exclusion criteria
  • Receipt of pooled human immunoglobulin, other blood product or any monoclonal antibody therapy at any point prior to recruitment or plans to receive such therapy at any point during the trial-
  • Any significant congenital defect or significant chronic health problem (e.g. chronic hematological (including severe anemia), renal, gastrointestinal, respiratory, neurological and cardiovascular disorders).
  • A history of anaphylactic or anaphylactoid reaction to egg, chicken proteins, neomycin, streptomycin polymyxin B, any previous vaccination or any individual component of one of the vaccines
  • Confirmed fructose intolerance
  • Severe protein-energy malnutrition (weight-for-age Z-score of less than -3)
  • Any clinically suspected or confirmed congenital or acquired clotting or bleeding disorder or any mediation known to significantly interfere with clotting (e.g. hemophilia or current anti-coagulant therapy) (blood tests will not be routinely undertaken with this regard as part of the study)
  • Any other condition which, in the opinion of the research clinician or ultimately the PI, is likely to interfere with the assessment of the primary and secondary objectives
  • Any significant signs or symptoms of an acute illness or infection including a tympanic temperature >38.0°C or documented fever >38°C in the preceding 48 hours

Trial locations and contacts

1 site in 1 country.

The Gambia1 site

  • Medical Research Council Unit

    Fajara

Other trials in The Gambia

About this study

Official title: A Phase 4, Randomized Trial to Assess the Safety and Immunogenicity of Inactivated Poliovirus Vaccine When Given Concomitantly With Measles and Rubella Combined Vaccine and Yellow Fever Vaccine at Nine Months and When Administered Via Different Vaccination Routes

The overall goal of this study is to identify interference between intramuscular Inactivated Polio Vaccine (IPV) and other vaccines (Measles Rubella and Yellow Fever) co-administered at nine months of age and to confirm the safety of co-administration. In addition, the study will compare the immunogenicity and safety of IPV when administered via different routes.

A total of 1504 healthy infants between the ages of nine to ten months, who have completed their primary immunizations, including at least three doses of trivalent Oral Polio Vaccine (tOPV) will be recruited for this study.

Read the detailed description

In studies conducted to date, Inactivated Polio Vaccine (IPV) appears to boost the systemic immunity generated by Oral Polio Vaccine (OPV) priming significantly more effectively than the use of additional doses of OPV. The use of IPV to both enhance the immunity generated by OPV and also to provide protection against circulating Vaccine Derived Polio Virus type 2 outbreaks and Vaccine Associated Paralytic Poliomyelitis has the potential to address concerns regarding a switch to bivalent OPV.

Concomitant administration with Expanded Program of Immunisations(EPI) vaccines given at about nine months would be a feasible programmatic approach. Maternal antibodies will have largely waned by this point negating any inhibitory effect which they may have within the priming schedule. Significant interference between IPV, Measles and Rubella (MR) and Yellow Fever (YF) vaccines must be excluded to ensure that IPV introduction does not negatively impact on the immunogenicity or safety of the other vaccines in the program at the same point.

Restricted manufacturing capacity in the context of a higher manufacturing cost than OPV would currently limit the rate at which IPV could be rolled out within a modified EPI schedule. The administration of a fractional dose of the vaccine by the Intradermal route would facilitate vaccine role out through limiting the cost and the manufacturing scale-up required. The proposed study is phase 4, eight-arm, open label, randomized controlled clinical vaccine trial. A total of 1504 randomized healthy infants between nine and ten months will receive IPV, MR and YF vaccines either alone, in combinations of two vaccines, or all three vaccines will be given together. Different routes (IM and fractional dose ID) and needle free jet injections devices for administration of IPV will be compared in the different groups. The participants will be assigned to one of eight groups using blocked randomization scheme in a 1:1:1:1:1:1:1:1:1 ratio.

Non- inferiority of serological responses and median antibody titers will be the primary immunogenicity end points. The incidence of serious adverse events and other important medical events at any point during the study will be the primary safety end point in all groups. Following device of reference needle/syringe administration, any local adverse event (reactogenicity), which will be collected on day 0(day of vaccination), day 1, day 2 and day 3 will be a second primary safety endpoint.

Conditions
Poliomyelitis
Being tested
IPV IM Needle, IPV ID Needle, IPV IM Device, IPV ID Device
Keywords
Inactivated Poliovirus Vaccine, Randomised Control Phase IV Study, Gambia, IPV, Safety and Immunogenicity, Non-interference study, IM Jet injector, ID Jet Injector
Medical subject headings
Poliomyelitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IPV IM NeedleDrug

    Also called Inactivated Poliovirus Vaccine Intramuscular using syringe and needle pair

  • IPV ID NeedleDrug

    Also called Inactivated Poliovirus Vaccine Intradermal using syringe and needle pair

  • IPV IM DeviceDrug

    Also called Intramuscular Inactivated Poliovirus Vaccine using intramuscular Jet injector device

  • IPV ID DeviceDrug

    Also called Intradermal Inactivated Poliovirus Vaccine using intradermal device

Study groups in NCT01847872
Study groupRoleWhat they receive
IPV IM (Visit 1)ExperimentalIM IPV vaccine using syringe and needle pair is given at visit 1 followed by MR vaccine at visit 2 and YF vaccine at visit 3
Receives: Drug: IPV IM Needle
IPV IM (Visit 2)ExperimentalMR vaccine at visit 1 followed by IM IPV vaccine using syringe and needle pair at visit 2, then YF vaccine at visit 3
Receives: Drug: IPV IM Needle
IPV IM (Device - Visit 2)ExperimentalYF vaccine at visit 1 followed by IPV given IM using a Jet injector device at visit 2 and MR vaccine at visit 3
Receives: Drug: IPV IM Device
IPV IM and MR (Visit1)ExperimentalIM IPV using syringe and needle pair is given alongside MR at visit 1 followed by YF vaccine at visit 2
Receives: Drug: IPV IM Needle
IPV IM and YF (Visit 1)ExperimentalIM IPV using syringe and needle pair is given alongside YF vaccine at visit 1 followed by MR at visit 2
Receives: Drug: IPV IM Needle
IPV ID (Visit 2)ExperimentalMR and YF vaccines are co-administered at visit 1 followed by ID IPV using syringe and needle pair is given at visit 2
Receives: Drug: IPV ID Needle
IPV IM and MR and YF (Visit 1)ExperimentalIM IPV using syringe and needle pair is given alongside YF vaccine and MR vaccine at visit 1
Receives: Drug: IPV IM Needle
IPV (ID Device Visit 2)ExperimentalMR vaccine is given at visit 1 followed by IPV vaccine by ID Jet injector device at visit 2 and YF vaccine at visit 3
Receives: Drug: IPV ID Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. interference and immunugenicity

    Serological responses (seropositivity for polioviruses 1, 2 and 3 and seroconversion for measles, rubella and yellow fever) will be measured four weeks following vaccination.

    Median antibody titers will be measured four weeks following vaccine administration

    Measured: 4 - 6 weeks after vaccination

  2. Safety

    Severe Adverse Event or Important Medical Event at any point during the study Any local AE (reactogenicity) on days 0, 1, 2 or 3 following vaccination using the IM or ID needle-free jet-injector devices or in the reference needle/syringe groups Any local or systemic Adverse Event on days 0 or 3 following all other vaccinations

    Measured: up to 10 weeks after first vaccination

Secondary outcomes (4)

  1. Cellular immune responses (B and T cells) to IPV vaccination

    The poliovirus specific B-cell and T-cell responses following IPV vaccination using the IM or ID needle-free jet-injector or in the reference needle/syringe groups

    Measured: up to 4 - 6 weeks post vaccination

  2. stool tOPV quantification

    The level of poliovirus in the stool 14-21 days after a dose of tOPV in the context of previous IPV boosting using the IM or ID jet injector or in the reference needle/syringe routes.

    Measured: Day 14 - 21 after tOPV administration

  3. time motion study

    The time taken to administer IPV when the IM and ID needle/syringe routes are compared with the same routes of administration using a jet injector device

    Measured: 4- 6 weeks

  4. Perception of devices

    The perceptions of the vaccinators and parents/guardians regarding the needle-free jet-injector devices.

    For the parent/guardian a questionnaire with 4 questions will be administered following vaccination to assess parental/guardian perception of the device compared to standard needle and syringe base use.

    For the vaccinators will a questionnaire will be administered to assess their perception of the device in terms of ease of use and speed compared to standard needle and syringe base pair

    Measured: 4 to 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionApr 2015
  4. Study completionJul 2015

Resources

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,504 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01847872
Sponsor's protocol ID
SCC 1327
Acronym
IPV
Status last verified
Mar 2018
First submitted
19 Apr 2013
Last updated
22 Mar 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Bibby J, Saidu Y, Umesi A, Moneke-Anyanwoke N, Bashorun AO, Hydara MB, Adigweme I, Adetifa JU, Okoye M, Roberts E, Clemens R, Bandyopadhyay AS, Muhammad AK, Mulwa S, Royals M, Jarrahian C, Jeffries D, Kampmann B, Clarke E. The Immunogenicity of Fractional Intradermal Doses of the Inactivated Poliovirus Vaccine Is Associated With the Size of the Intradermal Fluid Bleb. Clin Infect Dis. 2017 Sep 1;65(5):851-854. doi: 10.1093/cid/cix381.

    PubMed 28444156

  • Clarke E, Saidu Y, Adetifa JU, Adigweme I, Hydara MB, Bashorun AO, Moneke-Anyanwoke N, Umesi A, Roberts E, Cham PM, Okoye ME, Brown KE, Niedrig M, Chowdhury PR, Clemens R, Bandyopadhyay AS, Mueller J, Jeffries DJ, Kampmann B. Safety and immunogenicity of inactivated poliovirus vaccine when given with measles-rubella combined vaccine and yellow fever vaccine and when given via different administration routes: a phase 4, randomised, non-inferiority trial in The Gambia. Lancet Glob Health. 2016 Aug;4(8):e534-47. doi: 10.1016/S2214-109X(16)30075-4. Epub 2016 Jun 27.

    PubMed 27364568

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing IPV IM Needle, IPV ID Needle and IPV IM Device in people with Poliomyelitis, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.

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 5 inclusion and 15 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 22 Mar 2018. 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 The Gambia. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

interference and immunugenicity (time frame: 4 - 6 weeks after vaccination). The study lists 2 primary outcomes in all. 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 NCT01847872, which also lists 2 linked publications.

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 22 Mar 2018.

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