IPV Clinical Trial - The Gambia

NCT01847872 | Completed Phase 4 DMC

• 1 other identifier: SCC 1327
• Study Type: interventional
• Target: 1,504
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Poliomyelitis

Keywords

Inactivated Poliovirus Vaccine; Randomised Control Phase IV Study; Gambia; IPV; Safety and Immunogenicity; Non-interference study; IM Jet injector; ID Jet Injector

Outcome Measures

Primary Outcomes (2)

• 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

  4 - 6 weeks after vaccination

• 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

  up to 10 weeks after first vaccination

Secondary Outcomes (4)

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

  up to 4 - 6 weeks post vaccination

• stool tOPV quantification

  Day 14 - 21 after tOPV administration

• time motion study

  4- 6 weeks

• Perception of devices

  4 to 6 weeks

Study Arms (8)

IPV IM (Visit 1)

EXPERIMENTAL

IM 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

Drug: IPV IM Needle

IPV IM (Visit 2)

EXPERIMENTAL

MR vaccine at visit 1 followed by IM IPV vaccine using syringe and needle pair at visit 2, then YF vaccine at visit 3

Drug: IPV IM Needle

IPV IM (Device - Visit 2)

EXPERIMENTAL

YF vaccine at visit 1 followed by IPV given IM using a Jet injector device at visit 2 and MR vaccine at visit 3

Drug: IPV IM Device

IPV IM and MR (Visit1)

EXPERIMENTAL

IM IPV using syringe and needle pair is given alongside MR at visit 1 followed by YF vaccine at visit 2

Drug: IPV IM Needle

IPV IM and YF (Visit 1)

EXPERIMENTAL

IM IPV using syringe and needle pair is given alongside YF vaccine at visit 1 followed by MR at visit 2

Drug: IPV IM Needle

IPV ID (Visit 2)

EXPERIMENTAL

MR and YF vaccines are co-administered at visit 1 followed by ID IPV using syringe and needle pair is given at visit 2

Drug: IPV ID Needle

IPV IM and MR and YF (Visit 1)

EXPERIMENTAL

IM IPV using syringe and needle pair is given alongside YF vaccine and MR vaccine at visit 1

Drug: IPV IM Needle

IPV (ID Device Visit 2)

EXPERIMENTAL

MR vaccine is given at visit 1 followed by IPV vaccine by ID Jet injector device at visit 2 and YF vaccine at visit 3

Drug: IPV ID Device

Interventions

IPV IM Needle DRUG

Also known as: Inactivated Poliovirus Vaccine Intramuscular using syringe and needle pair

IPV IM (Visit 1); IPV IM (Visit 2); IPV IM and MR (Visit1); IPV IM and MR and YF (Visit 1); IPV IM and YF (Visit 1)

IPV ID Needle DRUG

Also known as: Inactivated Poliovirus Vaccine Intradermal using syringe and needle pair

IPV ID (Visit 2)

IPV IM Device DRUG

Also known as: Intramuscular Inactivated Poliovirus Vaccine using intramuscular Jet injector device

IPV IM (Device - Visit 2)

IPV ID Device DRUG

Also known as: Intradermal Inactivated Poliovirus Vaccine using intradermal device

IPV (ID Device Visit 2)

Eligibility Criteria

• Age: 9 Months - 10 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead

Study Sites (1)

Medical Research Council Unit

Fajara, The Gambia

Location

Related Publications (2)

• 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.

  PMID: 28444156 DERIVED

• 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.

  PMID: 27364568 DERIVED

MeSH Terms

Conditions

Poliomyelitis

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Study Officials

• Ed Clarke, MD

  Medical Research Council Unit, The Gambia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2013
• First Posted: May 7, 2013
• Study Start: July 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 22, 2018

Record last verified: 2018-03

Locations

TH (1)