A Phase 1/2 interventional study of Novel oral poliomyelitis vaccine type 1 (nOPV1) and Novel oral poliomyelitis vaccine type 2 (nOPV2) in Poliomyelitis, sponsored by PATH. Recruiting at 2 sites in Bangladesh. Open to participants aged 0 Days to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-03.
Sponsored by PATH · Phase 1/2, Interventional, and Prevention
The main objectives of this study are to :
This trial will use co-administered novel monovalent types 1, 2, and 3 vaccines to simulate administration of a potential trivalent vaccine and compare to the active control bOPV (bivalent Sabin types 1 and 3) and will be conducted at a single clinical center.
The study population will include healthy adults (≥18 to ≤45 years old) who have previously completed their full routine polio immunization series, healthy young children (≥1 to \<5 years old) who have completed their full routine polio immunization series and healthy neonates (day of birth+3 days), who have not received any polio vaccination.
Enrollment in this study will be staggered into two stages and three age-descending cohorts.
Stage 1 will consist of an age-descension/dose escalation approach from adults to young children (Cohorts 1 and 2). Enrollment will begin with Cohort 1, in which 100 adults will be randomly allocated in a 1:1 ratio to Groups 1 and 2. Following a Protocol Safety Review Team (PSRT) review of the study Day 8 safety data (i.e. safety data reported up to 7 days post-vaccination #1, collected at Visit 2) of the adults in Cohort 1, and the absence of any safety concerns, 200 young children in Cohort 2 will be randomly allocated in a 1:1:1:1 ratio to Groups 3, 4, 5, and 6, respectively.
After the completion of enrollment of Cohort 2, the study will move into Stage 2. In addition to a PSRT review of Day 8 safety data of the young children in Cohort 2, there are two triggers of data from other studies to initiate the enrollment into Cohort 3:
Stage 2 will consist of dose exploration in neonates (Cohort 3). In Cohort 3, Groups 7-14, 2100 neonates will be randomly allocated in a 3:3:3:3:3:3:2:1 ratio, respectively.
274 studies on the registry are indexed under Poliomyelitis; 18 are open to participants now.
This study's planned enrollment of 2,400 is above the median of 476 across 249 interventional studies indexed under Poliomyelitis.
Browse Poliomyelitis studies →PATH is the lead sponsor of 113 studies on the registry; 7 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria
Inclusion Criteria for all participants:
Resides and plans to remain in study area and participants and parent, when applicable, understands and is able and willing to adhere to all study visits and procedures (as evidenced by a signed informed consent form [ICF] and assessment by the investigator).
Inclusion Criteria for Cohort 1 participants only:
Born and raised in Bangladesh in 1990 or later; if born before 1990 or not born and raised in Bangladesh, has documentation of a complete poliomyelitis immunization series containing OPV or IPV.
Inclusion Criteria for Cohort 2 participants only:
Based on documentation, previously received a 3 or 4 dose primary poliomyelitis immunization series containing bOPV ± IPV, with last dose received more than 3 months prior to initial study vaccination.
Inclusion Criteria for Cohort 3 participants only:
Exclusion Criteria
Exclusion Criteria for all participants (unless otherwise specified):
Participant or parent, when applicable, has any condition that in the opinion of the investigator would increase the participant's health risks in study participation or would increase the risk of not achieving the study's objectives (e.g., would compromise adherence to protocol requirements or interfere with planned safety and immunogenicity assessments).
Exclusion Criteria for Cohort 1 participants:
Will have professional handling of food, catering, or food production activities during the study.
Exclusion Criteria for Cohort 2 participants:
Presence of severe malnutrition [weight-for-length/height z-score \<-3SD median (per WHO published child growth standards)]-temporary exclusion if marginal and subsequently gains weight.
Exclusion Criteria for Cohort 3 participants:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults will receive nOPV1 (10\^6.5 Cell Culture Infectious Dose 50% \[CCID₅₀\]) plus nOPV2 (10\^5.6 CCID₅₀) plus nOPV3 (10\^6.5 CCID₅₀) on Day 1 and Day 29.
Biological: Novel oral poliomyelitis vaccine type 1 (nOPV1) · Biological: Novel oral poliomyelitis vaccine type 2 (nOPV2) · Biological: Novel oral poliomyelitis vaccine type 3 (nOPV3)
Adults will receive bivalent OPV (types 1 and 3) on Day 1 and Day 29. Each dose (2 drops = 0.1 mL) contains \>10\^6.0 infective units of type 1 and \>10\^5.8 of type 3.
Biological: Bivalent Oral Poliomyelitis Vaccine (bOPV)
Children aged ≥ 1 to \< 5 years old will receive nOPV1 (10\^6.0 CCID₅₀) plus nOPV2 (10\^5.3 CCID₅₀) plus nOPV3 (10\^6.0 CCID₅₀) on Day 1 and Day 29.
Biological: Novel oral poliomyelitis vaccine type 1 (nOPV1) · Biological: Novel oral poliomyelitis vaccine type 2 (nOPV2) · Biological: Novel oral poliomyelitis vaccine type 3 (nOPV3)
Children aged ≥ 1 to \< 5 years old will receive nOPV1 (10\^6.5 CCID₅₀) plus nOPV2 (10\^5.6 CCID₅₀) plus nOPV3 (10\^6.5 CCID₅₀) on Day 1 and Day 29.
Biological: Novel oral poliomyelitis vaccine type 1 (nOPV1) · Biological: Novel oral poliomyelitis vaccine type 2 (nOPV2) · Biological: Novel oral poliomyelitis vaccine type 3 (nOPV3)
Children aged ≥ 1 to \< 5 years old will receive nOPV2 (10\^5.3 CCID₅₀) on Day 1 and Day 29.
Biological: Novel oral poliomyelitis vaccine type 2 (nOPV2)
Children aged ≥ 1 to \< 5 years old will receive bivalent OPV (types 1 and 3) on Day 1 and Day 29. Each dose (2 drops = 0.1 mL) contains \> 10\^6.0 infective units of type 1 and \> 10\^5.8 of type 3.
Biological: Bivalent Oral Poliomyelitis Vaccine (bOPV)
Newborns will receive nOPV1 (10\^6.0 CCID₅₀) plus nOPV2 (10\^5.3 CCID₅₀) plus nOPV3 (10\^6.0 CCID₅₀) at birth, week 6, week 10 and week 14 of life.
Biological: Novel oral poliomyelitis vaccine type 1 (nOPV1) · Biological: Novel oral poliomyelitis vaccine type 2 (nOPV2) · Biological: Novel oral poliomyelitis vaccine type 3 (nOPV3)
Newborns will receive nOPV1 (10\^6.5 CCID₅₀) plus nOPV2 (10\^5.3 CCID₅₀) plus nOPV3 (10\^6.5 CCID₅₀) at birth, week 6, week 10 and week 14 of life.
Biological: Novel oral poliomyelitis vaccine type 1 (nOPV1) · Biological: Novel oral poliomyelitis vaccine type 2 (nOPV2) · Biological: Novel oral poliomyelitis vaccine type 3 (nOPV3)
Newborns will receive nOPV1 (10\^6.0 CCID₅₀) plus nOPV2 (10\^5.3 CCID₅₀) plus nOPV3 (10\^6.5 CCID₅₀) at birth, week 6, week 10 and week 14 of life.
Biological: Novel oral poliomyelitis vaccine type 1 (nOPV1) · Biological: Novel oral poliomyelitis vaccine type 2 (nOPV2) · Biological: Novel oral poliomyelitis vaccine type 3 (nOPV3)
Newborns will receive nOPV1 (10\^6.5 CCID₅₀) plus nOPV2 (10\^5.3 CCID₅₀) plus nOPV3 (10\^6.0 CCID₅₀) at birth, week 6, week 10 and week 14 of life.
Biological: Novel oral poliomyelitis vaccine type 1 (nOPV1) · Biological: Novel oral poliomyelitis vaccine type 2 (nOPV2) · Biological: Novel oral poliomyelitis vaccine type 3 (nOPV3)
Newborns will receive nOPV1 (10\^6.5 CCID₅₀) plus nOPV2 (10\^5.6 CCID₅₀) plus nOPV3 (10\^6.5 CCID₅₀) at birth, week 6, week 10 and week 14 of life.
Biological: Novel oral poliomyelitis vaccine type 1 (nOPV1) · Biological: Novel oral poliomyelitis vaccine type 2 (nOPV2) · Biological: Novel oral poliomyelitis vaccine type 3 (nOPV3)
Newborns will receive bivalent OPV (types 1 and 3) at birth, week 6, week 10 and week 14 of life. Each dose (2 drops = 0.1 mL) contains \>10\^6.0 infective units of type 1 and \>10\^5.8 of type 3.
Biological: Bivalent Oral Poliomyelitis Vaccine (bOPV)
Newborns will receive nOPV1 (10\^6.0 CCID₅₀) plus nOPV2 (10\^5.3 CCID₅₀) at birth, week 6, week 10 and week 14 of life.
Biological: Novel oral poliomyelitis vaccine type 1 (nOPV1) · Biological: Novel oral poliomyelitis vaccine type 2 (nOPV2)
Newborns will receive nOPV2 (10\^5.3 CCID₅₀) at birth, week 6, week 10 and week 14 of life.
Biological: Novel oral poliomyelitis vaccine type 2 (nOPV2)
Live attenuated novel poliomyelitis virus type 1 at two different dosages, containing middle-dose (MD) 10\^6.0, or high-dose (HD) 10\^6.5 CCID₅₀/dose
Live attenuated novel poliomyelitis virus type 2 administered at low-dose (LD) 10\^5.3 and HD 10\^5.6 CCID₅₀/dose.
Live attenuated novel poliomyelitis virus type 3 at two different dosages, containing MD 10\^6.0, or HD 10\^6.5 CCID₅₀/dose.
Live attenuated poliomyelitis viruses types 1 and 3 (Sabin strains). Each dose (2 drops = 0.1 mL) contains not less than 10\^6.0 infective units of type 1 and 10\^5.8 of type 3.
Number of Participants with Serious Adverse Events (SAEs)
A serious adverse event is any adverse event that results in any of the following outcomes: 1. Death. 2. Is life-threatening. 3. Requires inpatient hospitalization or prolongation of existing hospitalization. 4. Results in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. 5. Congenital abnormality or birth defect. 6. Important medical event that may not result in one of the above outcomes but may jeopardize the health of the study participant and require medical or surgical intervention to prevent one of the outcomes listed in the above definition of serious adverse event.
Time frame: From the time of first study vaccination through the end of the study (197 days)
Number of Participants with Solicited Adverse Events (AEs) for 7 Days After Each Vaccination
Solicited AEs are pre-specified AEs that are common or known to be associated with vaccination that are actively monitored as potential indicators of vaccine reactogenicity.
Time frame: 7 days (day of vaccination and 6 following days) after each vaccination
Number of Participants with Unsolicited AEs for 28 Days After Each Vaccination.
Unsolicited AEs are any AEs reported spontaneously by the participant or parent, observed by the study personnel during study visits or identified during review of medical records or source documents.
Time frame: 28 days (day of vaccination and 27 following days) after each vaccination
Neonates: Seroconversion Rate of Types 1, 2, and 3 Anti-polio Serum Neutralizing Antibodies 28 Days After Last Vaccination
For vaccine-naive neonates, seroconversion is defined as seropositive (titer ≥1:8) in those initially seronegative, or among those initially seropositive, as a minimum 4-fold higher (and seropositivity) than that which is expected due to maternal antibodies. This endpoint will be analyzed in neonates who receive nOPV types 1, 2, and 3.
Time frame: Baseline and 28 days following the last vaccination (week 18)
Neonates: Seroconversion Rate of Types 1, 2, and 1 & 2 Combined Anti-polio Serum Neutralizing Antibodies 28 Days After Last Vaccination
For vaccine-naive neonates, seroconversion is defined as seropositive (titer ≥1:8) in those initially seronegative, or among those initially seropositive, as a minimum 4-fold higher (and seropositivity) than that which is expected due to maternal antibodies. This endpoint will be analyzed in neonates who receive nOPV types 1 and 2 only.
Time frame: Baseline and 28 days following the last vaccination (week 18)
Neonates: Type-specific and Multitypic Seroconversion Rate of Anti-polio Serum Neutralizing Antibodies
For vaccine-naive neonates, seroconversion is defined as seropositive (titer ≥1:8) in those initially seronegative, or among those initially seropositive, as a minimum 4-fold higher (and seropositivity) than that which is expected due to maternal antibodies. Multitypic seroconversion refers to seroconversion to multiple types simultaneously, including types 1 \& 2, types 1 \& 3, types 2 \& 3, and types 1 \& 2 \& 3.
Time frame: Baseline and weeks 6, 10, 14, and 18
Adults and Young Children: Type-specific and Multitypic Seroconversion Rate of Anti-polio Serum Neutralizing Antibodies 4 Weeks After Each Vaccination
For previously vaccinated cohorts, seroconversion will be defined as either a minimum 4-fold rise in titer relative to the baseline value among those initially seropositive, or post-vaccination seropositivity among those seronegative at baseline. This endpoint will be analyzed in groups who receive nOPV types 1, 2, and 3.
Time frame: Baseline and Weeks 4 and 8
All Cohorts: Types 1, 2 and 3 Anti-polio Serum Neutralizing Antibody Titers Following Last Dose
This endpoint will be analyzed in groups who receive nOPV types 1, 2, and 3.
Time frame: Baseline and 4 weeks following the last vaccination (week 8 in adults and young children and week 18 in neonates)
Adults and Young Children: Types 1, 2 and 3 Anti-polio Serum Neutralizing Antibody Titers Following First Dose
This endpoint will be analyzed in groups who receive nOPV types 1, 2, and 3.
Time frame: Baseline and week 4
All Cohorts: Geometric Mean Titer (GMT) of Types 1, 2 and 3 Anti-polio Serum Neutralizing Antibodies Following Last Dose
This endpoint will be analyzed in groups who receive nOPV types 1, 2, and 3.
Time frame: Baseline and 4 weeks following the last vaccination (week 8 in adults and young children and week 18 in neonates)
Adults and Young Children: Geometric Mean Titer (GMT) of Types 1, 2 and 3 Anti-polio Serum Neutralizing Antibodies Following First Dose
This endpoint will be analyzed in groups who receive nOPV types 1, 2, and 3.
Time frame: Baseline and Week 4
All Cohorts: Type-specific and Multitypic Seroprotection Rate Following Last Dose
Seroprotection is defined as types 1, 2 and 3 anti-polio serum neutralizing antibody reciprocal titer ≥ 8. This endpoint will be analyzed in groups who receive nOPV types 1, 2, and 3.
Time frame: Baseline and 4 weeks following the last vaccination (week 8 in adults and young children and week 18 in neonates)
Adults and Young Children: Type-specific and Multitypic Seroprotection Rate Following First Dose
Seroprotection is defined as types 1, 2 and 3 anti-polio serum neutralizing antibody reciprocal titer ≥ 8. This endpoint will be analyzed in groups who receive nOPV types 1, 2, and 3.
Time frame: Baseline and week 4
Adults and Young Children: Geometric Mean Fold Rise (GMFR) in Neutralizing Antibody Titer Relative to Previous Dose
This endpoint will be analyzed in groups who receive nOPV types 1, 2, and 3.
Time frame: Baseline and weeks 4 and 8
Neonates: Geometric Mean Fold Rise (GMFR) in Neutralizing Antibody Titer Relative to the Expected Level of Maternal Antibody and Each Pre-dose Value
This endpoint will be analyzed in groups who receive nOPV types 1, 2, and 3.
Time frame: Baseline and weeks 6, 10, 14, and 18
Neonates: Percentage of Participants Shedding Types 1, 2 and/or 3 Poliovirus Post-vaccination
Stool samples will be analyzed using polymerase chain reaction (PCR) to detect poliovirus types 1, 2, and 3.
Time frame: From birth through 18 weeks
Plan to share: No
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