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PoliomyelitisPhase 4mOPV1NCT03722004

Monovalent Oral Poliovirus Vaccine Type 1 Intestinal and Humoral Immunity Study

A Phase 4 study testing mOPV1, bOPV and fIPV in people with Poliomyelitis, run by Centers for Disease Control and Prevention at 1 site in Bangladesh.

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

This is an open-label phase IV randomized clinical trial that will assess intestinal and humoral immunity among infants who receive a combination of monovalent oral poliovirus vaccine type 1 and fractional dose of inactivated poliovirus vaccine, monovalent oral poliovirus vaccine type 1 only, and bivalent oral… Read more about this study

Who is it for?
Ages 35 to 41 daysHealthy volunteers can take part
Conditions the study is for
Poliomyelitis
What is being tested?
mOPV1, bOPV and fIPV
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,256 participants
Where
1 siteBangladesh
Study dates
18 Dec 2018to 19 Dec 2019
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 35 to 41 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Healthy infants 5 weeks of age (range: 35-41 days).
  • Parents that consent for participation in the full length of the study.
  • Parents that are able to understand and comply with planned study procedures.

Who cannot join

  • Parents and infants who are unable to participate in the full length of the study.
  • A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member.
  • A diagnosis or suspicion of bleeding disorder that would contraindicate parenteral administration of fIPV or collection of blood by venipuncture.
  • Evidence of a chronic medical condition identified by a study medical officer during physical exam.
  • Infection or illness at the enrolment visit (i.e., 5 weeks of age) that a study medical officer judges would prevent the start of study activities at 6 weeks of age (i.e., blood collection and vaccination).
  • Receipt of any polio vaccine (OPV or IPV/fIPV) before enrolment based upon documentation or parental recall.
Show all 9Show fewer
  • Known allergy/sensitivity or reaction to polio vaccine, or its contents.
  • Infants from multiple births. Infants from multiple births will be excluded because the infant(s) who is/are not enrolled would likely receive OPV through routine immunization and transmit vaccine poliovirus to the enrolled infant.
  • Infants from premature births (<37 weeks of gestation).

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site

  • icddr,b study clinics (Mirpur and CTU Dhaka)

    Dhaka

Other trials in Bangladesh

About this study

Official title: Intestinal and Humoral Immunity of Monovalent Oral Poliovirus Vaccine Type 1 When Administered With and Without Fractional Inactivated Poliovirus Vaccine

This is an open-label phase IV randomized clinical trial that will assess intestinal and humoral immunity among infants who receive a combination of monovalent oral poliovirus vaccine type 1 and fractional dose of inactivated poliovirus vaccine, monovalent oral poliovirus vaccine type 1 only, and bivalent oral poliovirus vaccine only.

Read the detailed description

The risk for circulating vaccine-derived poliovirus (cVDPV) will increase in the years immediately after the cessation of oral poliovirus vaccine (OPV) use in routine immunization programs. Judicious use of type-specific monovalent OPV (mOPV) will be necessary for outbreak response to prevent further paralytic infections and transmission; however, data on the intestinal and humoral immunity induced by mOPV1 are very limited. Furthermore, the additional benefit of fractional dose inactivated poliovirus vaccine (fIPV) on type 1 immunity when given with mOPV1 is unclear. Data on intestinal and humoral immunity of mOPV type 1 (mOPV1) and combination use of mOPV1 and fractional dose of IPV (fIPV) are urgently needed and would be used to inform guidelines for type 1 outbreak response in a post-OPV world. In the immediate future, a strategy of shifting from bivalent OPV (bOPV) to mOPV1 as part of supplemental immunization activities in endemic countries is under consideration but data on intestinal and humoral immunity to support this change does not exist. This trial is designed to address both areas in which data are lacking.

Healthy infants 5 weeks of age will be enrolled at two study clinics in Dhaka, Bangladesh, and randomized to one of four study arms: mOPV1 + fIPV at 6 weeks, mOPV1 + fIPV at 14 weeks, mOPV1 only, and bOPV only. Infants will be followed-up until 18 weeks of age by clinic and household visits. Blood and stool specimens will be collected to test for vaccine response (humoral immunity) and vaccine virus shedding (intestinal immunity).

Conditions
Poliomyelitis
Being tested
mOPV1, bOPV, fIPV
Keywords
monovalent oral poliovirus vaccine type 1, bivalent oral poliovirus vaccine, inactivated poliovirus vaccine, fractional inactivated poliovirus vaccine, humoral immunity, intestinal immunity, Bangladesh
Medical subject headings
Poliomyelitis

What participants receive

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

  • mOPV1Biological

    Monovalent oral poliovirus vaccine type 1 is a type-specific, live, attenuated oral poliovirus vaccine that protects against poliovirus type 1.

  • bOPVBiological

    Bivalent oral poliovirus vaccine is a live, attenuated oral poliovirus vaccine that protects against poliovirus types 1 and 3.

  • fIPVBiological

    Fractional dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.1 milliliter (mL) dose (fractional) by intradermal injection in lieu of the full 0.5mL dose that is given intramuscularly.

Study groups in NCT03722004
Study groupRoleWhat they receive
mOPV1 + fIPV 6 weeksActive comparatormOPV1 administered at 6, 10, and 14 weeks and fIPV at 6 weeks.
Receives: Biological: mOPV1; Biological: fIPV
mOPV1 + fIPV 10 weeksActive comparatormOPV1 administered at 6, 10, and 14 weeks and fIPV at10 weeks.
Receives: Biological: mOPV1; Biological: fIPV
mOPV1 onlyActive comparatormOPV1 administered at 6, 10, and 14 weeks.
Receives: Biological: mOPV1
bOPV onlyActive comparatorbOPV administered at 6, 10, and 14 weeks.
Receives: Biological: bOPV

What is being measured

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

  1. Vaccine response

    Dichotomous (yes/no) variable defined as participants who are either seronegative (<1:8 titers) at baseline who become seropositive (≥1:8) after vaccination (seroconversion) or participants who demonstrate a four-fold rise in titers after vaccination between two specimens, e.g. a change from 1:8 to 1:32, after adjusting for expected decay in maternal antibodies. Antibody titers at 6 weeks of age will be the starting point for the expected decline in maternal antibodies, assuming at half-life of 28 days.

    Measured: Measured four weeks after administration of study vaccine(s). Vaccine response will be measured at 10 weeks, 14 weeks, and 18 weeks of age after 1, 2, and 3 doses of OPV, respectively.

  2. Vaccine virus particles

    Presence or absence of vaccine virus particles in stool specimens.

    Measured: Measured 7 and 14 days after administration of the study vaccine. For Arms B, C, and D, this will be after administration of the first mOPV1 or bOPV dose. For Arms A, B, and C, this will be after the mOPV1 challenge dose at 14 weeks of age.

Secondary outcomes (1)

  1. Reciprocal antibody titers

    Variable of the observed reciprocal antibody titer results.

    Measured: Measured four weeks after administration of study vaccine(s). Vaccine response will be measured at 10 weeks, 14 weeks, and 18 weeks of age after 1, 2, and 3 doses of OPV, respectively.

Timeline

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

  1. First posted26 Oct 2018
  2. Study start18 Dec 2018
  3. Primary completion19 Dec 2019
  4. Study completion19 Dec 2019

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,256 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03722004
Sponsor's protocol ID
PR-18045
Acronym
mOPV1
Status last verified
Jan 2020
First submitted
25 Oct 2018
Last updated
21 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Snider CJ, Zaman K, Wilkinson AL, Binte Aziz A, Yunus M, Haque W, Jones KAV, Wei L, Estivariz CF, Konopka-Anstadt JL, Mainou BA, Patel JC, Lickness JS, Pallansch MA, Wassilak SGF, Steven Oberste M, Anand A. Poliovirus type 1 systemic humoral and intestinal mucosal immunity induced by monovalent oral poliovirus vaccine, fractional inactivated poliovirus vaccine, and bivalent oral poliovirus vaccine: A randomized controlled trial. Vaccine. 2023 Sep 22;41(41):6083-6092. doi: 10.1016/j.vaccine.2023.08.055. Epub 2023 Aug 29.

    PubMed 37652822

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing mOPV1, bOPV and fIPV in people with Poliomyelitis, run by Centers for Disease Control and Prevention at 1 site in Bangladesh.

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 9 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 21 Feb 2021. 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 Bangladesh. 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?

Vaccine response (time frame: Measured four weeks after administration of study vaccine(s). Vaccine response will be measured at 10 weeks, 14 weeks, and 18 weeks of age after 1, 2, and 3 doses of OPV, respectively.). 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 NCT03722004, 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 21 Feb 2021.

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