AzTrials
AzTrials

PoliomyelitisPhase 2NCT04579510

Immunogenicity nOPV2 With and Without bOPV

A Phase 2 study testing Novel monovalent oral poliovirus vaccine type 2 (nOPV2) and Bivalent oral poliovirus vaccine (bOPV) 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 randomized clinical trial that will compare immune responses among infants who receive either novel monovalent oral poliovirus vaccine type 2 (nOPV2) alone, bivalent oral poliovirus vaccine (bOPV) alone, or co-administered nOPV2 and bOPV. Read more about this study

Who is it for?
Ages 42 to 48 daysHealthy volunteers can take part
Conditions the study is for
Poliomyelitis
What is being tested?
Novel monovalent oral poliovirus vaccine type 2 (nOPV2) and Bivalent oral poliovirus vaccine (bOPV)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
795 participants
Where
1 siteBangladesh
Study dates
8 Feb 2021to 23 Dec 2021
Phase
Phase 2
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 48 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Healthy infants 6 weeks of age (range: 42-48 days).
  • Parents that consent for participation in the full length of the study.
  • Parents that can understand and comply with planned study procedures.
  • Infant has at least one sibling aged <10 years living in the same household that is eligible for participation in the study.

Who cannot join

  • Parents and infants who are unable to participate in the full length of the study (e.g., plan to move away from the study area during the study period).
  • 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 administration of bOPV or nOPV2 or collection of blood by venipuncture.
  • Acute diarrhoea, infection or illness at the time of enrolment (6 weeks of age) that would require infant's admission to a hospital.
  • Acute vomiting and intolerance to liquids within 24 hours before the enrolment visit (6 weeks of age).
  • Evidence of a chronic medical condition identified by a study medical officer during physical exam.
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  • Receipt of any polio vaccine (OPV or IPV) before enrolment based upon documentation or parental recall.
  • 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. Even if all births from a multiple birth could be enrolled in the study, we will exclude multiple births as discontinuation of one may lead to discontinuation of multiple participants.
  • Infants from premature births (<37 weeks of gestation).

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site

  • Icddr,B Study Clinics

    Dhaka

Other trials in Bangladesh

About this study

Official title: Immunogenicity of Novel Monovalent Oral Poliovirus Vaccine Type 2 (nOPV2) With and Without Bivalent OPV

This is an open-label randomized clinical trial that will compare immune responses among infants who receive either novel monovalent oral poliovirus vaccine type 2 (nOPV2) alone, bivalent oral poliovirus vaccine (bOPV) alone, or co-administered nOPV2 and bOPV.

Read the detailed description

It is expected that nOPV2 would replace mOPV2 for responding to type 2 outbreaks. Outbreak response for cVDPV2 also offers the opportunity to close immunity gaps to polioviruses types 1 and 3. Furthermore, GPEI might have to respond to two poliovirus outbreaks in the same geography. For either scenario, it would be important to get data on the immunogenicity of co-administered nOPV2 and bOPV, compared to either vaccine given alone.

This clinical trial assesses and compares the immunogenicity of nOPV2 given with or without bOPV. Healthy infants 6 weeks of age will be enrolled in Dhaka, Bangladesh, and randomized to one of three study arms â " Arm A: nOPV2 only, Arm B: nOPV2 and bOPV, or Arm C: bOPV only. Infants will be followed-up until 18 weeks of age through clinic and household visits. Blood specimens will be collected to test for immunological response. Stool specimens will be collected from infant vaccine recipients and one sibling household contact each to assess viral recombinants and nOPV2 household transmission.

Conditions
Poliomyelitis
Being tested
Novel monovalent oral poliovirus vaccine type 2 (nOPV2), Bivalent oral poliovirus vaccine (bOPV)
Keywords
oral poliovirus vaccine, immunization, antibodies, poliovirus vaccines
Medical subject headings
Poliomyelitis

What participants receive

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

  • Novel monovalent oral poliovirus vaccine type 2 (nOPV2)Biological

    nOPV2 candidate 1 (S2/cre5/S15domV/rec1/hifi3) is a live-attenuated serotype-2 poliovirus that was derived from a modified Sabin type-2 infectious cDNA clone and propagated in Vero cells. To improve genetic stability, nucleotide sequence modifications were made in the major determinant for attenuation in the Sabin 5'-untranslated region. Additionally, two modifications in the polymerase 3D were made to further improve stability of the attenuation, and a key replication element from the 2C coding region was relocated to the 5'-untranslated region to inhibit recombination.

  • Bivalent oral poliovirus vaccine (bOPV)Biological

    The live types 1 \& 3 oral polio vaccine (bOPV) is a bivalent vaccine containing suspension of types 1 \& 3 attenuated Polio viruses (Sabin strains).

Study groups in NCT04579510
Study groupRoleWhat they receive
nOPV2 onlyActive comparatorParticipants in this arm will receive nOPV2 at 6, 10, and 14 weeks of age
Receives: Biological: Novel monovalent oral poliovirus vaccine type 2 (nOPV2)
nOPV2 and bOPVActive comparatorParticipants in this arm will receive both nOPV2 and bOPV at 6, 10, and 14 weeks of age
Receives: Biological: Novel monovalent oral poliovirus vaccine type 2 (nOPV2); Biological: Bivalent oral poliovirus vaccine (bOPV)
bOPV onlyActive comparatorParticipants in this arm will receive bOPV at 6, 10, and 14 weeks of age
Receives: Biological: Bivalent oral poliovirus vaccine (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).

Secondary outcomes (3)

  1. Reciprocal antibody titers

    Variable of the observed reciprocal antibody titer results.

    Measured: Measured four weeks after administration of study vaccine(s).

  2. Household transmission of nOPV2

    Detection of type 2 OPV in stool of household contact

    Measured: 1, 2, and 4 weeks after first vaccination with nOPV2

  3. Viral recombinants

    Detection and characterization of viral recombinants

    Measured: 2 and 4 weeks after first vaccination with study vaccine(s)

Timeline

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

  1. First posted8 Oct 2020
  2. Study start8 Feb 2021
  3. Primary completion23 Dec 2021
  4. Study completion23 Dec 2021

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 2
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
795 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04579510
Sponsor's protocol ID
20060
Status last verified
Oct 2024
First submitted
22 Sep 2020
Last updated
4 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Aggregated data will be added to the registration with publication. In accordance with the protocol, icddr,b investigators will have access to participant data with identifiers. External investigators will have access to deidentified participant data. Deidentified data may be shared with national and international vaccine manufacturers and regulatory authorities upon request.

Publications

  • Wilkinson AL, Zaman K, Hoque M, Estivariz CF, Burns CC, Konopka-Anstadt JL, Mainou BA, Kovacs SD, An Q, Lickness JS, Yunus M, Snider CJ, Zhang Y, Coffee E, Abid T, Wassilak SGF, Pallansch MA, Oberste MS, Vertefeuille JF, Anand A. Immunogenicity of novel oral poliovirus vaccine type 2 administered concomitantly with bivalent oral poliovirus vaccine: an open-label, non-inferiority, randomised, controlled trial. Lancet Infect Dis. 2023 Sep;23(9):1062-1071. doi: 10.1016/S1473-3099(23)00139-1. Epub 2023 May 10.

    PubMed 37178706

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Novel monovalent oral poliovirus vaccine type 2 (nOPV2) and Bivalent oral poliovirus vaccine (bOPV) 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 4 inclusion and 10 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 4 Oct 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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).). 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 NCT04579510, 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 4 Oct 2024; AzTrials last refreshed its copy on 27 Oct 2026.

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