Trial Outcomes & Findings for Inactivated Poliovirus Vaccine (IPV) With or Without E.Coli Double Mutant Heat-Labile Toxin (dmLT) Challenge Study in Healthy Adults (NCT NCT04232943)

Last Updated: 2022-09-06

Results Overview

A serious adverse event (SAE) was any event that resulted in any of the following outcomes: 1. Death; 2. Was life-threatening; 3. Required inpatient hospitalization or prolongation of existing hospitalization; 4. Resulted 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 did not result in one of the above outcomes but jeopardized the health of the study participant or required medical or surgical intervention to prevent one of the outcomes listed in the above definition of SAE.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

87 participants

Primary outcome timeframe

Up to 6 months

Results posted on

2022-09-06

Participant Flow

This study was conducted at a single center at the University of Antwerp in Belgium.

Participants were randomized in a 3:3:2 ratio to receive either a single, intramuscular (IM) dose of inactivated poliovirus vaccine (iPV), a single, standard dose of IPV co-administered with a 0.5 μg dose of E.coli double mutant heat-labile toxin (dmLT) or a single oral dose of bivalent oral polio vaccine (bOPV). Twenty-eight (28) days after receiving study vaccine, participants in all groups received a standard oral dose of bOPV challenge.

Participant milestones

Participant milestones
Measure	Inactivated Poliomyelitis Vaccine Participants received a single intramuscular injection of 0.5 mL inactivated poliomyelitis vaccine (IPV) on Day 1 followed by a single dose (2 drops) of bivalent oral polio vaccine (bOPV) 28 days later.	Inactivated Poliomyelitis Vaccine + dmLT Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Bivalent Oral Polio Vaccine Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.
Overall Study STARTED	32	33	22
Overall Study Received Study Vaccination	30	30	20
Overall Study Received bOPV Challenge on Day 29	29	30	20
Overall Study COMPLETED	29	29	20
Overall Study NOT COMPLETED	3	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Inactivated Poliomyelitis Vaccine Participants received a single intramuscular injection of 0.5 mL inactivated poliomyelitis vaccine (IPV) on Day 1 followed by a single dose (2 drops) of bivalent oral polio vaccine (bOPV) 28 days later.	Inactivated Poliomyelitis Vaccine + dmLT Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Bivalent Oral Polio Vaccine Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.
Overall Study Enrolled but Treatment not Administered	2	3	2
Overall Study Withdrawal by Subject	1	1	0

Baseline Characteristics

Inactivated Poliovirus Vaccine (IPV) With or Without E.Coli Double Mutant Heat-Labile Toxin (dmLT) Challenge Study in Healthy Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Inactivated Poliomyelitis Vaccine n=30 Participants Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Inactivated Poliomyelitis Vaccine + dmLT n=30 Participants Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Bivalent Oral Polio Vaccine n=20 Participants Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.	Total n=80 Participants Total of all reporting groups
Age, Continuous	18.9 years STANDARD_DEVIATION 1.61 • n=5 Participants	18.8 years STANDARD_DEVIATION 1.35 • n=7 Participants	20.1 years STANDARD_DEVIATION 4.18 • n=5 Participants	19.2 years STANDARD_DEVIATION 2.48 • n=4 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	17 Participants n=7 Participants	13 Participants n=5 Participants	48 Participants n=4 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	13 Participants n=7 Participants	7 Participants n=5 Participants	32 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants	29 Participants n=7 Participants	19 Participants n=5 Participants	78 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants	30 Participants n=7 Participants	18 Participants n=5 Participants	76 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 6 months

Population: The total vaccinated population includes all participants in the enrolled population who were randomized and received a study vaccination.

Outcome measures

Outcome measures
Measure	Inactivated Poliomyelitis Vaccine n=30 Participants Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Inactivated Poliomyelitis Vaccine + dmLT n=30 Participants Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Bivalent Oral Polio Vaccine n=20 Participants Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.
Number of Participants With Serious Adverse Events Over the Course of the Study	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 28 days after study vaccination (prior to bOPV challenge)

Population: Total vaccinated population

Severe adverse events are events that interrupted a participant's usual daily activity and may have required systemic drug therapy or other treatment. Severe events are usually potentially life-threatening or incapacitating.

Outcome measures

Outcome measures
Measure	Inactivated Poliomyelitis Vaccine n=30 Participants Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Inactivated Poliomyelitis Vaccine + dmLT n=30 Participants Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Bivalent Oral Polio Vaccine n=20 Participants Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.
Number of Participants With Severe Adverse Events During the 28 Days Following Study Vaccination	2 Participants	2 Participants	0 Participants

PRIMARY outcome

Timeframe: 7 days following study vaccination

Population: Total vaccinated population - participants who received intramuscular injection

Solicited adverse events (AEs) are pre-specified local and systemic adverse events that are common or known to be associated with vaccination and that are actively monitored as indicators of vaccine reactogenicity. Local/injection site reactions included pain, erythema/redness, swelling, induration, and hyperpigmentation, applicable to participants in the IPV and IPV + dmLT arms who received study injections. Severity was graded according to the following: Mild: Transient or mild discomfort; does not interfere with activities, erythema or swelling 2.5 - 5 cm, hyperpigmentation 1- 4 cm. Moderate: Mild to moderate limitation in activity; no or minimal medical intervention/therapy required, erythema or swelling 5.1 - 10 cm, hyperpigmentation 4.1 - 8 cm, or repeated use of nonnarcotic pain reliever \> 24 hours. Severe: All normal activity is prevented for 24 hours or more, erythema or swelling \> 10 cm, hyperpigmentation \> 8 cm, or any use of narcotic pain reliever.

Outcome measures

Outcome measures
Measure	Inactivated Poliomyelitis Vaccine n=30 Participants Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Inactivated Poliomyelitis Vaccine + dmLT n=30 Participants Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Bivalent Oral Polio Vaccine Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.
Number of Participants With Solicited Local Adverse Events Mild	17 Participants	23 Participants	—
Number of Participants With Solicited Local Adverse Events Moderate	3 Participants	1 Participants	—
Number of Participants With Solicited Local Adverse Events Severe	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: 7 days following study vaccination

Population: Total vaccinated population

Systemic reactions included fever (oral temperature ≥ 38.0°C), chills, fatigue, headache, muscle aches/myalgia, joint ache/arthralgia, rash, nausea, vomiting, and diarrhea. Severity was graded according to the following: Mild: Transient or mild discomfort; does not interfere with activities, 2-3 vomiting episodes in 24 hours, 3-5 loose stools/day or diarrhea volume \<1000 mL/day, or temperature 38.0 - 38.9˚C. Moderate: Mild to moderate limitation in activity; no or minimal medical intervention/therapy required, 4-5 vomiting episodes in 24 hours, 6-9 loose stools/day or 1000-1999 mL output per 24 hours, or temperature 39.0 - 39.9˚C. Severe: All normal activity is prevented for 24 hours or more, \> 6 vomiting episodes in 24 hours, \> 10 loose stools/day or orthostatic hypotension, or temperature \> 40.0˚C.

Outcome measures

Outcome measures
Measure	Inactivated Poliomyelitis Vaccine n=30 Participants Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Inactivated Poliomyelitis Vaccine + dmLT n=30 Participants Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Bivalent Oral Polio Vaccine n=20 Participants Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.
Number of Participants With Solicited Systemic Adverse Events Mild	13 Participants	9 Participants	9 Participants
Number of Participants With Solicited Systemic Adverse Events Moderate	4 Participants	6 Participants	4 Participants
Number of Participants With Solicited Systemic Adverse Events Severe	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: 28 days following study vaccination

Population: Total vaccinated population

An adverse event is any untoward medical occurrence in a participant after administration of the investigational vaccine and that does not necessarily have a causal relationship with the investigational vaccine. AEs were graded for severity on the following scale: Grade 1 - Mild: Transient or mild discomfort; does not interfere with activities; Grade 2 - Moderate: Mild to moderate limitation in activity; no or minimal medical intervention/therapy required; Grade 3 - Severe: All normal activity is prevented for 24 hours or more.

Outcome measures

Outcome measures
Measure	Inactivated Poliomyelitis Vaccine n=30 Participants Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Inactivated Poliomyelitis Vaccine + dmLT n=30 Participants Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Bivalent Oral Polio Vaccine n=20 Participants Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.
Number of Participants With Unsolicited Adverse Events During the 28 Days Following Study Vaccination Any adverse event	14 Participants	15 Participants	10 Participants
Number of Participants With Unsolicited Adverse Events During the 28 Days Following Study Vaccination Severe adverse events	2 Participants	2 Participants	0 Participants
Number of Participants With Unsolicited Adverse Events During the 28 Days Following Study Vaccination Any adverse event ≥ Grade 2	7 Participants	9 Participants	4 Participants
Number of Participants With Unsolicited Adverse Events During the 28 Days Following Study Vaccination Any AE leading to withdrawal	0 Participants	0 Participants	0 Participants
Number of Participants With Unsolicited Adverse Events During the 28 Days Following Study Vaccination Any adverse event related to study treatment	5 Participants	4 Participants	5 Participants

PRIMARY outcome

Timeframe: Day 36 (7 days after bOPV challenge)

Population: Participants in the per protocol population who received the bOPV challenge and had available shedding data. The per protocol (PP) population includes all enrolled participants who were randomized, received a study vaccination, and who had no protocol violations determined to potentially interfere with the immunogenicity assessment up to each time point.

The presence of the bOPV virus (Sabin strains Type 1 and Type 3) in stool samples was determined using polymerase chain reaction (PCR).

Outcome measures

Outcome measures
Measure	Inactivated Poliomyelitis Vaccine n=28 Participants Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Inactivated Poliomyelitis Vaccine + dmLT n=24 Participants Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Bivalent Oral Polio Vaccine n=20 Participants Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.
Percentage of Participants Positive for bOPV Viral Shedding 7 Days Following bOPV Challenge Poliovirus Type 1	35.7 percentage of participants Interval 18.64 to 55.93	41.7 percentage of participants Interval 22.11 to 63.36	35.0 percentage of participants Interval 15.39 to 59.22
Percentage of Participants Positive for bOPV Viral Shedding 7 Days Following bOPV Challenge Poliovirus Type 3	64.3 percentage of participants Interval 44.07 to 81.36	62.5 percentage of participants Interval 40.59 to 81.2	40.0 percentage of participants Interval 19.12 to 63.95

SECONDARY outcome

Timeframe: Day 29 (28 days after study vaccination) and Day 43 (14 days after bOPV challenge)

Population: The per protocol (PP) population includes all enrolled participants who were randomized and received a study vaccination and who had no protocol violations determined to potentially interfere with the immunogenicity assessment up to each time point.

Positive response is defined as a minimum 4-fold increase from the pre-vaccination (Baseline) value in fecal anti-poliovirus neutralization antibodies. Serotype-specific poliovirus neutralizing antibody quantitation was conducted using standardized assays at the Wright Laboratory at Dartmouth University.

Outcome measures

Outcome measures
Measure	Inactivated Poliomyelitis Vaccine n=29 Participants Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Inactivated Poliomyelitis Vaccine + dmLT n=26 Participants Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Bivalent Oral Polio Vaccine n=20 Participants Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.
Percentage of Participants With a Positive Poliovirus Fecal Neutralization Response 28 Days After Vaccination and 14 Days After bOPV Challenge Serotype 1: Day 29	3.4 percentage of participants Interval 0.09 to 17.76	0 percentage of participants Interval 0.0 to 13.23	0 percentage of participants Interval 0.0 to 16.84
Percentage of Participants With a Positive Poliovirus Fecal Neutralization Response 28 Days After Vaccination and 14 Days After bOPV Challenge Serotype 1: Day 43	3.6 percentage of participants Interval 0.09 to 18.35	0 percentage of participants Interval 0.0 to 14.25	0 percentage of participants Interval 0.0 to 16.84
Percentage of Participants With a Positive Poliovirus Fecal Neutralization Response 28 Days After Vaccination and 14 Days After bOPV Challenge Serotype 2: Day 29	0 percentage of participants Interval 0.0 to 11.94	0 percentage of participants Interval 0.0 to 13.23	0 percentage of participants Interval 0.0 to 16.84
Percentage of Participants With a Positive Poliovirus Fecal Neutralization Response 28 Days After Vaccination and 14 Days After bOPV Challenge Serotype 2: Day 43	3.6 percentage of participants Interval 0.09 to 18.35	0 percentage of participants Interval 0.0 to 14.25	0 percentage of participants Interval 0.0 to 16.84
Percentage of Participants With a Positive Poliovirus Fecal Neutralization Response 28 Days After Vaccination and 14 Days After bOPV Challenge Serotype 3: Day 29	0 percentage of participants Interval 0.0 to 11.94	0 percentage of participants Interval 0.0 to 13.23	0 percentage of participants Interval 0.0 to 16.84
Percentage of Participants With a Positive Poliovirus Fecal Neutralization Response 28 Days After Vaccination and 14 Days After bOPV Challenge Serotype 3: Day 43	3.6 percentage of participants Interval 0.09 to 18.35	0 percentage of participants Interval 0.0 to 14.25	0 percentage of participants Interval 0.0 to 16.84

SECONDARY outcome

Timeframe: Baseline (before vaccination), Day 29 (28 days after study vaccination, prior to bOPV challenge) and Day 43 (14 days after bOPV challenge)

Population: Per protocol population with available data at each time point

Fecal IgA were quantified using a Luminex assay in which monovalent IPVs are covalently conjugated to fluorescently coated beads in order to quantify total and polio-type specific concentrations of IgA in stool specimens.

Outcome measures

Outcome measures
Measure	Inactivated Poliomyelitis Vaccine n=30 Participants Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Inactivated Poliomyelitis Vaccine + dmLT n=27 Participants Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Bivalent Oral Polio Vaccine n=20 Participants Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.
Level of Fecal Poliovirus Immunoglobulin A (IgA) Antibodies at Baseline, 28 Days After Vaccination and 14 Days After bOPV Challenge Serotype 1: Baseline	4.40 relative fluorescence units Interval 0.2 to 18.15	14.40 relative fluorescence units Interval 4.9 to 26.9	8.65 relative fluorescence units Interval 1.15 to 16.15
Level of Fecal Poliovirus Immunoglobulin A (IgA) Antibodies at Baseline, 28 Days After Vaccination and 14 Days After bOPV Challenge Serotype 1: Day 29	7.60 relative fluorescence units Interval 1.4 to 13.6	1.40 relative fluorescence units Interval 0.0 to 4.9	0.45 relative fluorescence units Interval 0.0 to 6.4
Level of Fecal Poliovirus Immunoglobulin A (IgA) Antibodies at Baseline, 28 Days After Vaccination and 14 Days After bOPV Challenge Serotype 1: Day 43	9.75 relative fluorescence units Interval 6.1 to 20.1	7.60 relative fluorescence units Interval 1.1 to 17.6	3.60 relative fluorescence units Interval 0.7 to 13.0
Level of Fecal Poliovirus Immunoglobulin A (IgA) Antibodies at Baseline, 28 Days After Vaccination and 14 Days After bOPV Challenge Serotype 2: Baseline	13.35 relative fluorescence units Interval 4.35 to 19.1	15.10 relative fluorescence units Interval 9.1 to 22.1	14.10 relative fluorescence units Interval 6.6 to 32.1
Level of Fecal Poliovirus Immunoglobulin A (IgA) Antibodies at Baseline, 28 Days After Vaccination and 14 Days After bOPV Challenge Serotype 2: Day 29	6.10 relative fluorescence units Interval 3.3 to 17.1	8.35 relative fluorescence units Interval 2.1 to 13.6	5.10 relative fluorescence units Interval 0.05 to 13.6
Level of Fecal Poliovirus Immunoglobulin A (IgA) Antibodies at Baseline, 28 Days After Vaccination and 14 Days After bOPV Challenge Serotype 2: Day 43	7.20 relative fluorescence units Interval 2.65 to 14.3	2.80 relative fluorescence units Interval 0.0 to 11.8	3.55 relative fluorescence units Interval 0.0 to 8.2
Level of Fecal Poliovirus Immunoglobulin A (IgA) Antibodies at Baseline, 28 Days After Vaccination and 14 Days After bOPV Challenge Serotype 3: Baseline	13.15 relative fluorescence units Interval 5.9 to 23.4	10.90 relative fluorescence units Interval 5.9 to 16.4	7.90 relative fluorescence units Interval 0.2 to 20.65
Level of Fecal Poliovirus Immunoglobulin A (IgA) Antibodies at Baseline, 28 Days After Vaccination and 14 Days After bOPV Challenge Serotype 3: Day 29	9.40 relative fluorescence units Interval 1.9 to 15.4	3.40 relative fluorescence units Interval 0.0 to 7.9	9.85 relative fluorescence units Interval 1.9 to 17.9
Level of Fecal Poliovirus Immunoglobulin A (IgA) Antibodies at Baseline, 28 Days After Vaccination and 14 Days After bOPV Challenge Serotype 3: Day 43	14.05 relative fluorescence units Interval 6.8 to 18.3	9.10 relative fluorescence units Interval 2.3 to 13.3	8.85 relative fluorescence units Interval 2.9 to 13.35

SECONDARY outcome

Timeframe: Baseline, Day 29 (28 days after study vaccination, prior to bOPV challenge) and Day 43 (14 days after bOPV challenge)

Population: Per protocol population with available data at each time point

Outcome measures

Outcome measures
Measure	Inactivated Poliomyelitis Vaccine n=29 Participants Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Inactivated Poliomyelitis Vaccine + dmLT n=26 Participants Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Bivalent Oral Polio Vaccine n=20 Participants Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.
Change From Baseline in Fecal Poliovirus IgA Antibodies 28 Days After Study Vaccination and 14 Days After bOPV Challenge Serotype 1: Day 29	0.00 relative fluorescence units Interval -5.0 to 7.6	-7.90 relative fluorescence units Interval -21.2 to -3.7	-2.95 relative fluorescence units Interval -10.2 to 1.45
Change From Baseline in Fecal Poliovirus IgA Antibodies 28 Days After Study Vaccination and 14 Days After bOPV Challenge Serotype 1: Day 43	3.05 relative fluorescence units Interval 0.0 to 9.5	-8.60 relative fluorescence units Interval -14.4 to 0.2	-1.65 relative fluorescence units Interval -9.9 to 0.1
Change From Baseline in Fecal Poliovirus IgA Antibodies 28 Days After Study Vaccination and 14 Days After bOPV Challenge Serotype 2: Day 29	0.00 relative fluorescence units Interval -8.3 to 3.5	-3.75 relative fluorescence units Interval -14.65 to 1.85	-11.75 relative fluorescence units Interval -23.05 to -0.55
Change From Baseline in Fecal Poliovirus IgA Antibodies 28 Days After Study Vaccination and 14 Days After bOPV Challenge Serotype 2: Day 43	0.00 relative fluorescence units Interval -9.55 to 1.0	-9.35 relative fluorescence units Interval -15.3 to 0.0	-14.10 relative fluorescence units Interval -28.1 to -2.95
Change From Baseline in Fecal Poliovirus IgA Antibodies 28 Days After Study Vaccination and 14 Days After bOPV Challenge Serotype 3: Day 29	-0.50 relative fluorescence units Interval -10.4 to 4.9	-4.00 relative fluorescence units Interval -11.0 to -0.95	-0.20 relative fluorescence units Interval -11.5 to 5.9
Change From Baseline in Fecal Poliovirus IgA Antibodies 28 Days After Study Vaccination and 14 Days After bOPV Challenge Serotype 3: Day 43	4.80 relative fluorescence units Interval -4.1 to 12.4	-3.25 relative fluorescence units Interval -6.9 to 5.4	-0.20 relative fluorescence units Interval -15.6 to 8.1

SECONDARY outcome

Timeframe: Day 29 (28 days after study vaccination, prior to bOPV challenge)

Population: Per protocol population

Serum neutralizing antibody seroconversion rate is defined as the percentage of participants demonstrating a minimum four-fold increase in type-specific poliovirus serum neutralizing antibody titers between baseline and 28 days post vaccination, or post-vaccination titer \> 1:8 if seronegative at baseline.

Outcome measures

Outcome measures
Measure	Inactivated Poliomyelitis Vaccine n=29 Participants Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Inactivated Poliomyelitis Vaccine + dmLT n=25 Participants Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Bivalent Oral Polio Vaccine n=20 Participants Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.
Serum Neutralizing Antibody Seroconversion Rate 28 Days After Study Vaccination Serotype 1	93.1 percentage of participants Interval 77.23 to 99.15	84.0 percentage of participants Interval 63.92 to 95.46	80.0 percentage of participants Interval 56.34 to 94.27
Serum Neutralizing Antibody Seroconversion Rate 28 Days After Study Vaccination Serotype 2	100 percentage of participants Interval 88.06 to 100.0	92.0 percentage of participants Interval 73.97 to 99.02	15.0 percentage of participants Interval 3.21 to 37.89
Serum Neutralizing Antibody Seroconversion Rate 28 Days After Study Vaccination Serotype 3	86.2 percentage of participants Interval 68.34 to 96.11	96.0 percentage of participants Interval 79.65 to 99.9	50.0 percentage of participants Interval 27.2 to 72.8

SECONDARY outcome

Timeframe: Baseline (pre-vaccination) and Day 29 (28 days after study vaccination, prior to bOPV challenge)

Population: Per protocol population with available data at each time point

Outcome measures

Outcome measures
Measure	Inactivated Poliomyelitis Vaccine n=30 Participants Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Inactivated Poliomyelitis Vaccine + dmLT n=27 Participants Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Bivalent Oral Polio Vaccine n=20 Participants Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.
Geometric Mean Titer of Serum Poliovirus Neutralizing Antibodies at Baseline and 28 Days After Study Vaccination Serotype 2: Day 29	45241 titer Interval 24760.0 to 82665.0	43251 titer Interval 23053.0 to 81147.0	241.3 titer Interval 119.95 to 485.51
Geometric Mean Titer of Serum Poliovirus Neutralizing Antibodies at Baseline and 28 Days After Study Vaccination Serotype 1: Baseline	190.5 titer Interval 110.19 to 329.43	422.7 titer Interval 238.89 to 747.83	248.7 titer Interval 128.91 to 479.7
Geometric Mean Titer of Serum Poliovirus Neutralizing Antibodies at Baseline and 28 Days After Study Vaccination Serotype 1: Day 29	18731 titer Interval 10502.0 to 33405.0	25048 titer Interval 13152.0 to 47705.0	15657 titer Interval 7770.3 to 31549.0
Geometric Mean Titer of Serum Poliovirus Neutralizing Antibodies at Baseline and 28 Days After Study Vaccination Serotype 2: Baseline	187.9 titer Interval 93.36 to 378.07	205.0 titer Interval 100.47 to 418.37	221.2 titer Interval 96.3 to 508.11
Geometric Mean Titer of Serum Poliovirus Neutralizing Antibodies at Baseline and 28 Days After Study Vaccination Serotype 3: Baseline	1021.6 titer Interval 554.63 to 1881.9	1266.4 titer Interval 666.45 to 2406.4	2041.3 titer Interval 956.82 to 4354.9
Geometric Mean Titer of Serum Poliovirus Neutralizing Antibodies at Baseline and 28 Days After Study Vaccination Serotype 3: Day 29	91419 titer Interval 55229.0 to 151324.0	52165 titer Interval 30175.0 to 90179.0	7874.5 titer Interval 4331.6 to 14315.0

SECONDARY outcome

Timeframe: Baseline (before vaccination) and Day 29 (28 days after vaccination, prior to bOPV challenge)

Population: Per protocol population with available data at each time point

Seroprotection rate of serum poliovirus neutralizing antibodies is defined as a type-specific poliovirus serum neutralizing antibody titer ≥ 1:8.

Outcome measures

Outcome measures
Measure	Inactivated Poliomyelitis Vaccine n=30 Participants Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Inactivated Poliomyelitis Vaccine + dmLT n=27 Participants Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Bivalent Oral Polio Vaccine n=20 Participants Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.
Seroprotection Rate of Serum Poliovirus Neutralizing Antibodies at Baseline and 28 Days Following Vaccination Serotype1: Day 29	100 percentage of participants Interval 88.06 to 100.0	100 percentage of participants Interval 86.28 to 100.0	100 percentage of participants Interval 83.16 to 100.0
Seroprotection Rate of Serum Poliovirus Neutralizing Antibodies at Baseline and 28 Days Following Vaccination Serotype 1: Baseline	93.3 percentage of participants Interval 77.93 to 99.18	100 percentage of participants Interval 87.23 to 100.0	100 percentage of participants Interval 83.16 to 100.0
Seroprotection Rate of Serum Poliovirus Neutralizing Antibodies at Baseline and 28 Days Following Vaccination Serotype 2: Baseline	93.3 percentage of participants Interval 77.93 to 99.18	96.3 percentage of participants Interval 81.03 to 99.91	90.0 percentage of participants Interval 68.3 to 98.77
Seroprotection Rate of Serum Poliovirus Neutralizing Antibodies at Baseline and 28 Days Following Vaccination Serotype 2: Day 29	100 percentage of participants Interval 88.06 to 100.0	100 percentage of participants Interval 86.28 to 100.0	95.0 percentage of participants Interval 75.13 to 99.87
Seroprotection Rate of Serum Poliovirus Neutralizing Antibodies at Baseline and 28 Days Following Vaccination Serotype 3: Baseline	100 percentage of participants Interval 88.43 to 100.0	100 percentage of participants Interval 87.23 to 100.0	90.0 percentage of participants Interval 68.3 to 98.77
Seroprotection Rate of Serum Poliovirus Neutralizing Antibodies at Baseline and 28 Days Following Vaccination Serotype 3: Day 29	100 percentage of participants Interval 88.06 to 100.0	100 percentage of participants Interval 86.28 to 100.0	100 percentage of participants Interval 83.16 to 100.0

SECONDARY outcome

Timeframe: Baseline (before vaccination) and Day 29 (28 days after vaccination, prior to bOPV challenge)

Population: Per protocol population

Outcome measures

Outcome measures
Measure	Inactivated Poliomyelitis Vaccine n=29 Participants Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Inactivated Poliomyelitis Vaccine + dmLT n=25 Participants Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Bivalent Oral Polio Vaccine n=20 Participants Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.
Geometric Mean Fold-Rise in Serum Poliovirus Neutralizing Antibodies Serotype 2	346.7 fold-rise Interval 121.99 to 985.3	151.9 fold-rise Interval 49.54 to 465.86	0.8 fold-rise Interval 0.22 to 2.66
Geometric Mean Fold-Rise in Serum Poliovirus Neutralizing Antibodies Serotype 1	134.3 fold-rise Interval 53.94 to 334.23	54.2 fold-rise Interval 20.27 to 144.98	40.8 fold-rise Interval 13.6 to 122.27
Geometric Mean Fold-Rise in Serum Poliovirus Neutralizing Antibodies Serotype 3	103.9 fold-rise Interval 40.67 to 265.47	41.5 fold-rise Interval 15.09 to 113.85	8.6 fold-rise Interval 2.77 to 26.47

SECONDARY outcome

Timeframe: Baseline (pre-vaccination), Day 8 (7 days after study vaccination), Day 29 (28 days after study vaccination prior to bOPV challenge), and Day 36 (7 days after bOPV challenge)

Population: Per protocol population with available data at each time point

Poliovirus antibody secreting cell (ASC) response is defined as ≥ 8 ASC/10⁶ peripheral blood mononuclear cells (PBMC) at any time point following both study vaccination and bOPV challenge.

Outcome measures

Outcome measures
Measure	Inactivated Poliomyelitis Vaccine n=30 Participants Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Inactivated Poliomyelitis Vaccine + dmLT n=27 Participants Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Bivalent Oral Polio Vaccine n=20 Participants Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.
Percentage of Participants With a Circulating Poliovirus IgA Antibody-Secreting Cell Response Serotype 1: Baseline	0.0 percentage of participants Interval 0.0 to 11.57	0.0 percentage of participants Interval 0.0 to 12.77	0.0 percentage of participants Interval 0.0 to 16.84
Percentage of Participants With a Circulating Poliovirus IgA Antibody-Secreting Cell Response Serotype 1: Day 8	10.0 percentage of participants Interval 2.11 to 26.53	7.4 percentage of participants Interval 0.91 to 24.29	25.0 percentage of participants Interval 8.66 to 49.1
Percentage of Participants With a Circulating Poliovirus IgA Antibody-Secreting Cell Response Serotype 1: Day 29	0.0 percentage of participants Interval 0.0 to 11.94	0.0 percentage of participants Interval 0.0 to 13.23	0.0 percentage of participants Interval 0.0 to 16.84
Percentage of Participants With a Circulating Poliovirus IgA Antibody-Secreting Cell Response Serotype 1: Day 36	6.9 percentage of participants Interval 0.85 to 22.77	15.4 percentage of participants Interval 4.36 to 34.87	0.0 percentage of participants Interval 0.0 to 16.84
Percentage of Participants With a Circulating Poliovirus IgA Antibody-Secreting Cell Response Serotype 2: Baseline	0.0 percentage of participants Interval 0.0 to 11.57	0.0 percentage of participants Interval 0.0 to 12.77	0.0 percentage of participants Interval 0.0 to 16.84
Percentage of Participants With a Circulating Poliovirus IgA Antibody-Secreting Cell Response Serotype 2: Day 8	6.7 percentage of participants Interval 0.82 to 22.07	3.7 percentage of participants Interval 0.09 to 18.97	10.0 percentage of participants Interval 1.23 to 31.7
Percentage of Participants With a Circulating Poliovirus IgA Antibody-Secreting Cell Response Serotype 2: Day 29	0.0 percentage of participants Interval 0.0 to 11.94	0.0 percentage of participants Interval 0.0 to 13.23	0.0 percentage of participants Interval 0.0 to 16.84
Percentage of Participants With a Circulating Poliovirus IgA Antibody-Secreting Cell Response Serotype 2: Day 36	3.4 percentage of participants Interval 0.09 to 17.76	7.7 percentage of participants Interval 0.95 to 25.13	0.0 percentage of participants Interval 0.0 to 16.84
Percentage of Participants With a Circulating Poliovirus IgA Antibody-Secreting Cell Response Serotype 3: Baseline	0.0 percentage of participants Interval 0.0 to 11.57	0.0 percentage of participants Interval 0.0 to 12.77	0.0 percentage of participants Interval 0.0 to 16.84
Percentage of Participants With a Circulating Poliovirus IgA Antibody-Secreting Cell Response Serotype 3: Day 8	3.3 percentage of participants Interval 0.08 to 17.22	3.7 percentage of participants Interval 0.09 to 18.97	15.0 percentage of participants Interval 3.21 to 37.89
Percentage of Participants With a Circulating Poliovirus IgA Antibody-Secreting Cell Response Serotype 3: Day 29	0.0 percentage of participants Interval 0.0 to 11.94	0.0 percentage of participants Interval 0.0 to 13.23	0.0 percentage of participants Interval 0.0 to 16.84
Percentage of Participants With a Circulating Poliovirus IgA Antibody-Secreting Cell Response Serotype 3: Day 36	3.4 percentage of participants Interval 0.09 to 17.76	7.7 percentage of participants Interval 0.95 to 25.13	0.0 percentage of participants Interval 0.0 to 16.84

SECONDARY outcome

Timeframe: Baseline (pre-vaccination), Day 8 (7 days after study vaccination), Day 29 (28 days after study vaccination prior to bOPV challenge), and Day 36 (7 days after bOPV challenge)

Population: Per protocol population with available data at each time point

Outcome measures

Outcome measures
Measure	Inactivated Poliomyelitis Vaccine n=30 Participants Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Inactivated Poliomyelitis Vaccine + dmLT n=27 Participants Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Bivalent Oral Polio Vaccine n=20 Participants Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.
Number of Circulating Poliovirus IgA Antibody Secreting Cells at Baseline and After Study Vaccination Serotype 1: Baseline	0.00 cells/10⁶ PBMC Interval 0.0 to 0.25	0.00 cells/10⁶ PBMC Interval 0.0 to 0.167	0.00 cells/10⁶ PBMC Interval 0.0 to 0.0
Number of Circulating Poliovirus IgA Antibody Secreting Cells at Baseline and After Study Vaccination Serotype 1: Day 8	0.17 cells/10⁶ PBMC Interval 0.0 to 0.292	0.50 cells/10⁶ PBMC Interval 0.0 to 1.25	0.63 cells/10⁶ PBMC Interval 0.0 to 4.917
Number of Circulating Poliovirus IgA Antibody Secreting Cells at Baseline and After Study Vaccination Serotype 1: Day 29	0.00 cells/10⁶ PBMC Interval 0.0 to 0.0	0.00 cells/10⁶ PBMC Interval 0.0 to 0.0	0.00 cells/10⁶ PBMC Interval 0.0 to 0.25
Number of Circulating Poliovirus IgA Antibody Secreting Cells at Baseline and After Study Vaccination Serotype 1: Day 36	0.92 cells/10⁶ PBMC Interval 0.25 to 2.75	0.38 cells/10⁶ PBMC Interval 0.0 to 2.5	0.17 cells/10⁶ PBMC Interval 0.0 to 0.708
Number of Circulating Poliovirus IgA Antibody Secreting Cells at Baseline and After Study Vaccination Serotype 2: Baseline	0.00 cells/10⁶ PBMC Interval 0.0 to 0.125	0.00 cells/10⁶ PBMC Interval 0.0 to 0.083	0.00 cells/10⁶ PBMC Interval 0.0 to 0.333
Number of Circulating Poliovirus IgA Antibody Secreting Cells at Baseline and After Study Vaccination Serotype 2: Day 8	0.17 cells/10⁶ PBMC Interval 0.0 to 0.313	0.00 cells/10⁶ PBMC Interval 0.0 to 0.75	0.00 cells/10⁶ PBMC Interval 0.0 to 0.167
Number of Circulating Poliovirus IgA Antibody Secreting Cells at Baseline and After Study Vaccination Serotype 2: Day 29	0.00 cells/10⁶ PBMC Interval 0.0 to 0.0	0.00 cells/10⁶ PBMC Interval 0.0 to 0.25	0.00 cells/10⁶ PBMC Interval 0.0 to 0.25
Number of Circulating Poliovirus IgA Antibody Secreting Cells at Baseline and After Study Vaccination Serotype 2: Day 36	0.33 cells/10⁶ PBMC Interval 0.0 to 1.25	0.08 cells/10⁶ PBMC Interval 0.0 to 0.25	0.00 cells/10⁶ PBMC Interval 0.0 to 0.5
Number of Circulating Poliovirus IgA Antibody Secreting Cells at Baseline and After Study Vaccination Serotype 3: Baseline	0.00 cells/10⁶ PBMC Interval 0.0 to 0.333	0.00 cells/10⁶ PBMC Interval 0.0 to 0.0	0.21 cells/10⁶ PBMC Interval 0.0 to 0.25
Number of Circulating Poliovirus IgA Antibody Secreting Cells at Baseline and After Study Vaccination Serotype 3: Day 8	0.00 cells/10⁶ PBMC Interval 0.0 to 0.083	0.00 cells/10⁶ PBMC Interval 0.0 to 0.25	0.00 cells/10⁶ PBMC Interval 0.0 to 0.375
Number of Circulating Poliovirus IgA Antibody Secreting Cells at Baseline and After Study Vaccination Serotype 3: Day 29	0.00 cells/10⁶ PBMC Interval 0.0 to 0.0	0.00 cells/10⁶ PBMC Interval 0.0 to 0.0	0.00 cells/10⁶ PBMC Interval 0.0 to 0.125
Number of Circulating Poliovirus IgA Antibody Secreting Cells at Baseline and After Study Vaccination Serotype 3: Day 36	0.25 cells/10⁶ PBMC Interval 0.0 to 0.667	0.00 cells/10⁶ PBMC Interval 0.0 to 0.5	0.00 cells/10⁶ PBMC Interval 0.0 to 0.375

SECONDARY outcome

Timeframe: Baseline (pre-vaccination), Day 8 (7 days after study vaccination), Day 29 (28 days after study vaccination prior to bOPV challenge), and Day 36 (7 days after bOPV challenge)

Population: Per protocol population with available data at each time point

Poliovirus antibody secreting cell (ASC) response is defined as ≥ 8 ASC/10⁶ peripheral blood mononuclear cells (PBMC) at any time point following both study vaccination and bOPV challenge.

Outcome measures

Outcome measures
Measure	Inactivated Poliomyelitis Vaccine n=30 Participants Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Inactivated Poliomyelitis Vaccine + dmLT n=27 Participants Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Bivalent Oral Polio Vaccine n=20 Participants Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.
Percentage of Participants With a Circulating Poliovirus Immunoglobulin G (IgG) Antibody-Secreting Cell Response Serotype 1: Day 8	90.0 percentage of participants Interval 73.47 to 97.89	74.1 percentage of participants Interval 53.72 to 88.89	50.0 percentage of participants Interval 27.2 to 72.8
Percentage of Participants With a Circulating Poliovirus Immunoglobulin G (IgG) Antibody-Secreting Cell Response Serotype 3: Day 8	40.0 percentage of participants Interval 22.66 to 59.4	40.7 percentage of participants Interval 22.39 to 61.2	20.0 percentage of participants Interval 5.73 to 43.66
Percentage of Participants With a Circulating Poliovirus Immunoglobulin G (IgG) Antibody-Secreting Cell Response Serotype 1: Baseline	0.0 percentage of participants Interval 0.0 to 11.57	0.0 percentage of participants Interval 0.0 to 12.77	0.0 percentage of participants Interval 0.0 to 16.84
Percentage of Participants With a Circulating Poliovirus Immunoglobulin G (IgG) Antibody-Secreting Cell Response Serotype 1: Day 29	0.0 percentage of participants Interval 0.0 to 11.94	0.0 percentage of participants Interval 0.0 to 13.23	0.0 percentage of participants Interval 0.0 to 16.84
Percentage of Participants With a Circulating Poliovirus Immunoglobulin G (IgG) Antibody-Secreting Cell Response Serotype 1: Day 36	27.6 percentage of participants Interval 12.73 to 47.24	23.1 percentage of participants Interval 8.97 to 43.65	10.0 percentage of participants Interval 1.23 to 31.7
Percentage of Participants With a Circulating Poliovirus Immunoglobulin G (IgG) Antibody-Secreting Cell Response Serotype 2: Baseline	0.0 percentage of participants Interval 0.0 to 11.57	0.0 percentage of participants Interval 0.0 to 12.77	0.0 percentage of participants Interval 0.0 to 16.84
Percentage of Participants With a Circulating Poliovirus Immunoglobulin G (IgG) Antibody-Secreting Cell Response Serotype 2: Day 8	56.7 percentage of participants Interval 37.43 to 74.54	51.9 percentage of participants Interval 31.95 to 71.33	10.0 percentage of participants Interval 1.23 to 31.7
Percentage of Participants With a Circulating Poliovirus Immunoglobulin G (IgG) Antibody-Secreting Cell Response Serotype 2: Day 29	0.0 percentage of participants Interval 0.0 to 11.94	0.0 percentage of participants Interval 0.0 to 13.23	0.0 percentage of participants Interval 0.0 to 16.84
Percentage of Participants With a Circulating Poliovirus Immunoglobulin G (IgG) Antibody-Secreting Cell Response Serotype 2: Day 36	3.4 percentage of participants Interval 0.09 to 17.76	3.8 percentage of participants Interval 0.1 to 19.64	0.0 percentage of participants Interval 0.0 to 16.84
Percentage of Participants With a Circulating Poliovirus Immunoglobulin G (IgG) Antibody-Secreting Cell Response Serotype 3: Baseline	0.0 percentage of participants Interval 0.0 to 11.57	0.0 percentage of participants Interval 0.0 to 12.77	0.0 percentage of participants Interval 0.0 to 16.84
Percentage of Participants With a Circulating Poliovirus Immunoglobulin G (IgG) Antibody-Secreting Cell Response Serotype 3: Day 29	0.0 percentage of participants Interval 0.0 to 11.94	0.0 percentage of participants Interval 0.0 to 13.23	0.0 percentage of participants Interval 0.0 to 16.84
Percentage of Participants With a Circulating Poliovirus Immunoglobulin G (IgG) Antibody-Secreting Cell Response Serotype 3: Day 36	13.8 percentage of participants Interval 3.89 to 31.66	3.8 percentage of participants Interval 0.1 to 19.64	5.0 percentage of participants Interval 0.13 to 24.87

SECONDARY outcome

Timeframe: Baseline (pre-vaccination), Day 8 (7 days after study vaccination), Day 29 (28 days after study vaccination prior to bOPV challenge), and Day 36 (7 days after bOPV challenge)

Population: Per protocol population with available data at each time point

Outcome measures

Outcome measures
Measure	Inactivated Poliomyelitis Vaccine n=30 Participants Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Inactivated Poliomyelitis Vaccine + dmLT n=27 Participants Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Bivalent Oral Polio Vaccine n=20 Participants Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.
Number of Circulating Poliovirus IgG Antibody Secreting Cells at Baseline and After Study Vaccination Serotype 2: Day 36	0.50 cells/10⁶ PBMC Interval 0.0 to 1.0	0.25 cells/10⁶ PBMC Interval 0.0 to 1.375	0.00 cells/10⁶ PBMC Interval 0.0 to 0.375
Number of Circulating Poliovirus IgG Antibody Secreting Cells at Baseline and After Study Vaccination Serotype 3: Baseline	0.00 cells/10⁶ PBMC Interval 0.0 to 0.125	0.00 cells/10⁶ PBMC Interval 0.0 to 0.25	0.00 cells/10⁶ PBMC Interval 0.0 to 0.25
Number of Circulating Poliovirus IgG Antibody Secreting Cells at Baseline and After Study Vaccination Serotype 3: Day 8	5.00 cells/10⁶ PBMC Interval 2.5 to 11.5	5.25 cells/10⁶ PBMC Interval 1.5 to 14.75	0.25 cells/10⁶ PBMC Interval 0.0 to 4.875
Number of Circulating Poliovirus IgG Antibody Secreting Cells at Baseline and After Study Vaccination Serotype 3: Day 29	0.00 cells/10⁶ PBMC Interval 0.0 to 0.0	0.00 cells/10⁶ PBMC Interval 0.0 to 0.25	0.00 cells/10⁶ PBMC Interval 0.0 to 0.0
Number of Circulating Poliovirus IgG Antibody Secreting Cells at Baseline and After Study Vaccination Serotype 1: Baseline	0.25 cells/10⁶ PBMC Interval 0.0 to 0.375	0.00 cells/10⁶ PBMC Interval 0.0 to 0.0	0.13 cells/10⁶ PBMC Interval 0.0 to 0.5
Number of Circulating Poliovirus IgG Antibody Secreting Cells at Baseline and After Study Vaccination Serotype 1: Day 8	29.75 cells/10⁶ PBMC Interval 23.0 to 45.75	18.00 cells/10⁶ PBMC Interval 9.75 to 49.5	7.00 cells/10⁶ PBMC Interval 1.0 to 19.375
Number of Circulating Poliovirus IgG Antibody Secreting Cells at Baseline and After Study Vaccination Serotype 1: Day 29	0.00 cells/10⁶ PBMC Interval 0.0 to 0.0	0.00 cells/10⁶ PBMC Interval 0.0 to 0.25	0.00 cells/10⁶ PBMC Interval 0.0 to 0.0
Number of Circulating Poliovirus IgG Antibody Secreting Cells at Baseline and After Study Vaccination Serotype 1: Day 36	3.00 cells/10⁶ PBMC Interval 0.75 to 5.0	2.00 cells/10⁶ PBMC Interval 0.0 to 5.125	0.38 cells/10⁶ PBMC Interval 0.0 to 1.0
Number of Circulating Poliovirus IgG Antibody Secreting Cells at Baseline and After Study Vaccination Serotype 2: Baseline	0.13 cells/10⁶ PBMC Interval 0.0 to 0.375	0.25 cells/10⁶ PBMC Interval 0.0 to 0.25	0.00 cells/10⁶ PBMC Interval 0.0 to 0.0
Number of Circulating Poliovirus IgG Antibody Secreting Cells at Baseline and After Study Vaccination Serotype 2: Day 8	11.13 cells/10⁶ PBMC Interval 5.875 to 20.5	9.50 cells/10⁶ PBMC Interval 2.25 to 19.0	0.13 cells/10⁶ PBMC Interval 0.0 to 0.25
Number of Circulating Poliovirus IgG Antibody Secreting Cells at Baseline and After Study Vaccination Serotype 2: Day 29	0.00 cells/10⁶ PBMC Interval 0.0 to 0.0	0.00 cells/10⁶ PBMC Interval 0.0 to 0.375	0.00 cells/10⁶ PBMC Interval 0.0 to 0.25
Number of Circulating Poliovirus IgG Antibody Secreting Cells at Baseline and After Study Vaccination Serotype 3: Day 36	0.00 cells/10⁶ PBMC Interval 0.0 to 1.0	0.50 cells/10⁶ PBMC Interval 0.0 to 1.75	0.00 cells/10⁶ PBMC Interval 0.0 to 0.25

SECONDARY outcome

Timeframe: Days 33, 36, 43, 50, and 57 (i.e., 4, 7, 14, 21, and 28 days, respectively, following bOPV challenge).

Population: Per protocol population

AUC was calculated using the linear trapezoidal rule with all samples collected from Day 33 to 57.

Outcome measures

Outcome measures
Measure	Inactivated Poliomyelitis Vaccine n=29 Participants Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Inactivated Poliomyelitis Vaccine + dmLT n=26 Participants Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Bivalent Oral Polio Vaccine n=20 Participants Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.
Area Under the Curve (AUC) of Viral Shedding in Stool for 28 Days After bOPV Challenge	43.578 log₁₀(CCID₅₀/g) * days Standard Deviation 25.381	46.867 log₁₀(CCID₅₀/g) * days Standard Deviation 33.673	13.138 log₁₀(CCID₅₀/g) * days Standard Deviation 27.627

SECONDARY outcome

Timeframe: Days 33, 36, 39, 43, 46, 50, and 57

Population: Per-protocol population participants who received the bOPV challenge and had post-challenge viral shedding results.

Time to cessation of viral shedding in stool is defined as the study day of the first instance of 3 consecutive samples PCR-negative for virus, with samples taken on separate days.

Outcome measures

Outcome measures
Measure	Inactivated Poliomyelitis Vaccine n=29 Participants Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Inactivated Poliomyelitis Vaccine + dmLT n=27 Participants Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Bivalent Oral Polio Vaccine n=20 Participants Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.
Time to Cessation of Viral Shedding in Stool After bOPV Challenge Poliovirus Type I	6 days Interval 5.0 to 9.0	7 days Interval 5.0 to 14.0	5 days Interval 4.0 to 9.0
Time to Cessation of Viral Shedding in Stool After bOPV Challenge Poliovirus Type 3	NA days Could not be estimated due to the low number of events	19 days Interval 10.0 to 27.0	5 days Interval 4.0 to 11.0

Adverse Events

Inactivated Poliomyelitis Vaccine

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Inactivated Poliomyelitis Vaccine + dmLT

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Bivalent Oral Polio Vaccine

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Rahsan Erdem, MD, Senior Medical Officer

PATH

Phone: +1 202 540 4546

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place