PoliomyelitisPhase 1NCT04529538
Study of Novel Types 1 and 3 Oral Poliomyelitis Vaccines
A Phase 1 study testing Novel Oral Polio Vaccine Type 1 (nOPV1), Novel Oral Polio Vaccine Type 3 (nOPV3) and Sabin Monovalent Oral Polio Vaccine Type 1 (mOPV1) in people with Poliomyelitis, run by PATH at 4 sites in United States.
Trial summary
The purpose of this study is to assess the safety (primary objective), the ability to trigger the production of antibodies (immunogenicity; a secondary objective) and presence of vaccine virus in the stool (fecal shedding; a secondary objective) of two novel oral polio vaccines (nOPV), novel oral poliomyelitis vaccine… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- Novel Oral Polio Vaccine Type 1 (nOPV1), Novel Oral Polio Vaccine Type 3 (nOPV3) and Sabin Monovalent Oral Polio Vaccine Type 1 (mOPV1)
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 4 sitesUnited States
- Study dates
- 26 Mar 2021to 17 Feb 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females, from 18 to 45 years of age (inclusive) at the time of enrollment
- Healthy, as defined by the absence of any clinically significant medical conditions, either acute or chronic, as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator
- Willing and able to provide written informed consent prior to performance of any study-specific procedure
- If female and of childbearing potential*, be not breastfeeding and not pregnant (based on a negative serum pregnancy test at screening and a negative urine pregnancy test during the 24 hours prior to any study vaccination), agreeing to have repeated pregnancy tests prior to any study vaccination, and having practiced adequate contraception** for 30 days prior to first study vaccination and willing to continue using adequate contraception consistently for at least 90 days after the last study vaccination and until cessation of vaccine virus shedding is confirmed
- Females can be considered not of childbearing potential if they are with current bilateral tubal ligation, occlusion or removal, or post-total hysterectomy, or post-bilateral ovariectomy
- Adequate contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly and when applicable, in accordance with the product label, for example:
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- Abstinence from penile-vaginal intercourse
- Combined estrogen and progesterone oral contraceptives
- Hormonal (e.g., progestogen) injections
- Hormonal (e.g., etonogestrel or levonorgestrel) implants
- Contraceptive vaginal ring
- Percutaneous contraceptive patches
- Intrauterine device
- Intrauterine hormonal system
- Male condom combined with a vaginal spermicide (foam, gel, film, cream, or suppository), and/or progesterone alone oral contraceptive
- Monogamous relationship with vasectomized (≥ 180 days prior to enrollment) partner
- Resides in study area and is able and willing to adhere to all study restrictions and to all study visits and procedures (as evidenced by a signed informed consent form [ICF] and assessment by the investigator)
- Agrees not to and has no plans to travel outside the United States (US) until confirmation of cessation of vaccine virus shedding in stool at or after the study Day 57 stool collection
- Able and willing to be contacted by telephone or text, and willing for study staff to leave telephone voice or electronic messages as needed
- Neutralizing antibody titer ≥ 1:8 for poliovirus type 1 (for participants in cohorts 1 and 2) and ≥ 1:8 for poliovirus type 3 (for participants in cohorts 3 and 4)
- For Cohorts 1 and 3 only: previously received at least 3 doses of IPV and with no history of receipt of OPV. For Cohorts 2 and 4 only: previously received a primary polio immunization series containing OPV
Who cannot join
- Have any condition (medical, psychiatric or behavioral) 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)
- Receipt of polio vaccine within 12 months before the start of the study
- Having Crohn's disease or ulcerative colitis or having had major surgery of the gastrointestinal tract involving significant loss or resection of the bowel
- A known allergy, hypersensitivity, or intolerance to any components of the study vaccines, including all macrolide and aminoglycoside antibiotics (e.g., erythromycin and kanamycin)
- Any confirmed or suspected immunosuppressive or immunodeficiency condition (human immunodeficiency virus [HIV] infection, or total serum immunoglobulin A (IgA) or immunoglobulin G (IgG) level below the testing laboratory's lower limit of normal [LLN])
- Administration of any long-acting immune-modifying drugs (e.g., infliximab or rituximab) or the chronic administration (i.e., longer than 14 days) of immunosuppressant drugs (e.g., oral or systemic steroids) or other immune-modifying drugs within 6 months prior to the first vaccine dose or planned use during the study (inhaled and topical steroids are allowed whereas intraarticular and epidural injection/administration of steroids are not allowed)
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- Will have household direct or close professional contact during the study with individuals expected to be immunosuppressed (due to underlying condition or treatments) or individuals who have not yet completed their primary infant polio immunization series (i.e., three doses)
- Will have household direct or close professional contact during the study with pregnant women
- Will have household direct or close professional (e.g., neonatal nurses) contact during the study with children less than 2 years of age or with individuals who are encopretic (i.e., infants/toddlers who are not yet toilet trained or other individuals, including adults, with fecal incontinence)
- Will have professional handling of food, catering, or food production activities during the study
- Reside in homes with septic tanks
- Acute illness or fever (body temperature measured orally ≥ 38°C or 100.4°F) at the time of study vaccine administration (once acute illness/fever is resolved, if appropriate, as per investigator assessment, participant may complete screening)
- Indications of drug abuse or excessive use of alcohol as deemed by the investigator to confound safety assessments or render the participant unable or unlikely to adhere to protocol requirements or provide accurate safety reports
- Participation in another investigational product (drug or vaccine) clinical trial within 30 days prior to entry in this study or receipt of any such investigational product other than the study vaccine within 30 days prior to the first administration of study vaccine, or planned use during the study period
- Administration of any vaccine (except seasonal inactivated influenza and COVID-19 vaccines which are prohibited for only 14 days prior to or following each study vaccination) other than the study vaccine or any intramuscular injection within 30 days prior to the first dose of study vaccine or planned administration within 30 days prior to or after any study vaccination.
- Receipt of transfusion of any blood product or application of immunoglobulins within the 12 weeks prior to the first administration of study vaccine or planned use during the study period
- Hepatitis B or C virus infection
- Any hematological# or chemistry** parameter that is out of range of normal†† and is considered clinically significant by the investigator
- #Complete blood count (CBC), includes hemoglobin, hematocrit, white blood cell (WBC) count, neutrophil count, lymphocyte count, eosinophil count, and platelet count
- Creatinine, alanine transaminase (ALT), total bilirubin
- ††Per the site clinical laboratory's reference ranges. All tests with out of range results that are regarded as clinically significant by the clinician must be repeated and determined to be not clinically significant before any participant can be enrolled.
- The following hematological or chemistry laboratory results will be considered exclusionary, irrespective of assessment of clinical significance:
- Hemoglobin (Male) < 12.5 g/dL
- Hemoglobin (Female) < 11.0 g/dL
- Neutrophil count < 1,000 cells/mm^3
- Eosinophil count > 650 cells/mm^3
- Platelet count < 125,000 cells/mm^3
- Creatinine > 1.4 mg/dL
- ALT > 1.1 X upper limit of normal (ULN) (per the site clinical laboratory's reference ranges)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Pharmaron CPC, Inc.
Baltimore, Maryland, 21201
University of Vermont Vaccine Testing Center
Burlington, Vermont, 05405
University of North Carolina Institute for Global Health and Infectious Diseases (IGHID)
Chapel Hill, North Carolina, 27599-7215
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: A First-in-human, Phase 1, Randomized, Observer-blind, Controlled Study to Assess the Safety and Immunogenicity of Novel Live Attenuated Type 1 and Type 3 Oral Poliomyelitis Vaccines in Healthy Adults
The purpose of this study is to assess the safety (primary objective), the ability to trigger the production of antibodies (immunogenicity; a secondary objective) and presence of vaccine virus in the stool (fecal shedding; a secondary objective) of two novel oral polio vaccines (nOPV), novel oral poliomyelitis vaccine type 1 (nOPV1) and novel oral poliomyelitis vaccine type 3 (nOPV3), as compared to Sabin strain monovalent oral poliomyelitis vaccine (mOPV) controls, in healthy adults.
Read the detailed description
This multicenter trial is the first-in-human assessment of two novel oral polio vaccines for poliovirus type 1 and type 3. It will be a 4-cohort, 8-arm, randomized, observer-blind, controlled trial, with Sabin monovalent vaccines serving as the control for each type:
Cohort 1: Healthy adults with an exclusive inactivated poliovirus vaccine (IPV) prior vaccination history will be randomized in a 1:1 ratio and allocated to receive nOPV1 (Group 1) or mOPV1 (Group 2).
Cohort 2: Healthy adults with an OPV-containing prior vaccination history will be randomized in a 2:1 ratio and allocated to receive two doses of nOPV1 (Group 3) or mOPV1 (Group 4), respectively;
Cohort 3: Healthy adults with an exclusive IPV prior vaccination history will be randomized in a 1:1 ratio and allocated to receive nOPV3 (Group 5) or mOPV3 (Group 6);
Cohort 4: Healthy adults with an OPV-containing prior vaccination history will be randomized in a 2:1 ratio to study groups 3 and 4 and allocated to receive two doses of nOPV3 (Group 7) or mOPV3 (Group 8), respectively.
- Conditions
- Poliomyelitis
- Being tested
- Novel Oral Polio Vaccine Type 1 (nOPV1), Novel Oral Polio Vaccine Type 3 (nOPV3), Sabin Monovalent Oral Polio Vaccine Type 1 (mOPV1), Sabin Monovalent Oral Polio Vaccine Type 3 (mOPV3)
- Keywords
- Vaccine tolerability, Vaccine reactogenicity, Vaccine viral shedding, Vaccine immunogenicity
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel Oral Polio Vaccine Type 1 (nOPV1)Biological
Each 0.1 mL (2 drops) dose of vaccine contains approximately 10^6.5 CCID50.
Novel Oral Polio Vaccine Type 3 (nOPV3)Biological
Each 0.1 mL (2 drops) dose of vaccine contains approximately 10^6.5 CCID50.
Sabin Monovalent Oral Polio Vaccine Type 1 (mOPV1)Biological
The Sabin mOPV1 control vaccine contains ≥ 10^6.0 CCID50 per 0.1 mL (2 drops) dose.
Sabin Monovalent Oral Polio Vaccine Type 3 (mOPV3)Biological
Also called Sabin monovalent oral polio vaccine type 3
the Sabin mOPV3 control vaccine contains ≥ 10^5.8 CCID50 per 0.1 mL (2 drops) dose.
| Study group | Role | What they receive |
|---|---|---|
| Group1: nOPV1 (IPV History) | Experimental | Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of novel OPV type 1 (nOPV1) containing 10^6.5 cell culture infectious dose 50% (CCID50) on Day 1. Receives: Biological: Novel Oral Polio Vaccine Type 1 (nOPV1) |
| Group 2: mOPV1 (IPV History) | Active comparator | Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of mOPV1 containing 10^6.0 CCID50 on Day 1. Receives: Biological: Sabin Monovalent Oral Polio Vaccine Type 1 (mOPV1) |
| Group 3: nOPV1 (OPV History) | Experimental | Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10^6.5 CCID50/dose, given 28 days apart. Receives: Biological: Novel Oral Polio Vaccine Type 1 (nOPV1) |
| Group 4: mOPV1 (OPV History) | Active comparator | Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of mOPV1 containing ≥ 10^6.0 CCID50/dose, given 28 days apart. Receives: Biological: Sabin Monovalent Oral Polio Vaccine Type 1 (mOPV1) |
| Group 5: nOPV3 (IPV History) | Experimental | Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10^6.5 CCID50 on Day 1. Receives: Biological: Novel Oral Polio Vaccine Type 3 (nOPV3) |
| Group 6: mOPV3 (IPV History) | Active comparator | Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of mOPV3 containing ≥ 10^5.8 CCID50 on Day 1. Receives: Biological: Sabin Monovalent Oral Polio Vaccine Type 3 (mOPV3) |
| Group 7: nOPV3 (OPV History) | Experimental | Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 in a dose of 10^6.5 CCID50/dose, given 28 days apart. Receives: Biological: Novel Oral Polio Vaccine Type 3 (nOPV3) |
| Group 8: mOPV3 (OPV History) | Active comparator | Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10^5.8 CCID50/dose, given 28 days apart. Receives: Biological: Sabin Monovalent Oral Polio Vaccine Type 3 (mOPV3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Serious Adverse Events (SAEs)
A serious adverse event is any adverse event that resulted in any of the following outcomes:
- Death
- Was life-threatening
- Required inpatient hospitalization or prolongation of existing hospitalization
- Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
- Congenital anomaly or birth defect
- Important medical event that may not result in one of the above outcomes but may jeopardize the health of the study participant and/or require medical or surgical intervention to prevent one of the outcomes listed above
Measured: From Day 1 to end of study, up to 169 days
Number of Participants With Solicited Adverse Events (AEs) 7 Days After First Dose of Study Vaccine
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. Solicited AEs for this study included:
- Fever (oral temperature ≥ 38.0°C or 100.4°F)
- Chills
- Fatigue
- Headache
- Muscle aches/myalgias
- Joint aches/arthralgias
- Nausea
- Vomiting
- Abdominal pain
- Diarrhea
Measured: From vaccination to 7 days post vaccination (Days 1-7)
Number of Participants With Solicited Adverse Events 7 Days After Second Dose of Study Vaccine
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. Solicited AEs for this study included:
- Fever (oral temperature ≥ 38.0°C or 100.4°F)
- Chills
- Fatigue
- Headache
- Muscle aches/myalgias
- Joint aches/arthralgias
- Nausea
- Vomiting
- Abdominal pain
- Diarrhea
Measured: From Day 29 to Day 35
Number of Participants With Unsolicited Adverse Events (AEs) up to 28 Days Post Vaccination
Unsolicited AEs are any AEs reported spontaneously by the participant, observed by the study personnel during study visits or those identified during review of medical records or source documents.
In the absence of a diagnosis, abnormal physical examination findings or abnormal clinical safety laboratory test results that are assessed by the investigator to be clinically significant were reported as an AE.
Measured: From vaccination to 28 days post vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination)
Secondary outcomes (20)
Median Anti-poliovirus Type 1 Serum Neutralizing Antibody Titers at Baseline and Post-vaccination Among Participants With a Vaccine History of IPV
Blood samples collected from participants for type-specific poliovirus neutralizing antibodies were analyzed at the Polio and Picornavirus Laboratory Branch at the United States Centers for Disease Control and Prevention (CDC).
For all immunogenicity endpoints, data are presented separately by:
- Prior vaccination history (exclusively IPV vs OPV), and
- Type-specific poliovirus vaccine received (type 1 vs type 3).
Measured: Baseline and Day 29 (28 days post-vaccination)
Median Anti-poliovirus Type 1 Serum Neutralizing Antibody Titers at Baseline and Post-vaccination Among Participants With a Vaccine History of OPV
Measured: Baseline, Day 29 (28 days post-vaccination) and Day 57 (28 days after 2nd vaccination)
Median Anti-poliovirus Type 3 Serum Neutralizing Antibody Titers at Baseline and Post-vaccination Among Participants With a Vaccine History of IPV
Measured: Baseline and Day 29 (28 days post-vaccination)
Median Anti-poliovirus Type 3 Serum Neutralizing Antibody Titers at Baseline and Post-vaccination Among Participants With a Vaccine History of OPV
Measured: Baseline, Day 29 (28 days after the 1st vaccination) and Day 57 (28 days after 2nd vaccination)
Geometric Mean Titer (GMT) of Anti-poliovirus Type 1 Serum Neutralizing Antibodies at Baseline and Post-vaccination Among Participants With a Vaccine History of IPV
GMT and 95% confidence intervals are maximum likelihood estimates incorporating left and right censoring at the lower limit of quantitation (LLOQ) and ULOQ, respectively.
Measured: Baseline and Day 29 (28 days post-vaccination)
Geometric Mean Titer of Anti-poliovirus Type 1 Serum Neutralizing Antibodies at Baseline and Post-vaccination Among Participants With a Vaccine History of OPV
Measured: Baseline, Day 29 (28 days after 1st vaccination) and Day 57 (28 days after 2nd vaccination)
Geometric Mean Titer of Anti-poliovirus Type 3 Serum Neutralizing Antibodies at Baseline and Post-vaccination Among Participants With a Vaccine History of IPV
Measured: Baseline and Day 29 (28 days post-vaccination)
Geometric Mean Titer of Anti-poliovirus Type 3 Serum Neutralizing Antibodies at Baseline and Post-vaccination Among Participants With a Vaccine History of OPV
Measured: Baseline, Day 29 (28 days after 1st vaccination) and Day 57 (28 days after 2nd vaccination)
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 1 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Vaccination Among Participants With a Vaccine History of IPV
- Seroconversion (SCR) is defined as a minimum 4-fold increase in titer from Baseline (pre-vaccination) to 28 days post-vaccination among those participants with a 4-fold increase possible to observe, i.e., with a Baseline titer not greater than 8.5 log₂.
- Minimum 2-fold-rise from Baseline to 28 days post-vaccination among those participants with a 2-fold increase possible to observe, i.e., with a Baseline titer not greater than 9.5 log₂.
- Any fold-rise is defined as any increase in titer from Baseline to 28 days post-vaccination (log₂ neutralizing antibody titer post-dose minus Baseline > 0), among those with an increase possible to observe, i.e., with a Baseline titer less than 10.5 log₂.
Measured: Baseline (pre-vaccination) and Day 29 (28 days post-vaccination)
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 1 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Each Vaccination Among Participants With a Vaccine History of OPV
- Seroconversion (SCR) is defined as a minimum 4-fold increase in titer from Baseline (pre-vaccination) to 28 days post-vaccination among those participants with a 4-fold increase possible to observe, i.e., with a Baseline titer not greater than 8.5 log₂.
- Minimum 2-fold-rise from Baseline to 28 days post-vaccination among those participants with a 2-fold increase possible to observe, i.e., with a Baseline titer not greater than 9.5 log₂.
- Any fold-rise is defined as any increase in titer from Baseline to 28 days post-vaccination (log₂ neutralizing antibody titer post-dose minus Baseline > 0), among those with an increase possible to observe, i.e., with a Baseline titer less than 10.5 log₂.
Measured: Baseline, Day 29 (28 days post-vaccination) and Day 57 (28 days after 2nd vaccination)
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 3 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Vaccination Among Participants With a Vaccine History of IPV
- Seroconversion (SCR) is defined as a minimum 4-fold increase in titer from Baseline (pre-vaccination) to 28 days post-vaccination among those participants with a 4-fold increase possible to observe, i.e., with a Baseline titer not greater than 8.5 log₂.
- Minimum 2-fold-rise from Baseline to 28 days post-vaccination among those participants with a 2-fold increase possible to observe, i.e., with a Baseline titer not greater than 9.5 log₂.
- Any fold-rise is defined as any increase in titer from Baseline to 28 days post-vaccination (log₂ neutralizing antibody titer post-dose minus Baseline > 0), among those with an increase possible to observe, i.e., with a Baseline titer less than 10.5 log₂.
Measured: Baseline and Day 29 (28 days post-vaccination)
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 3 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Each Vaccination Among Participants With a Vaccine History of OPV
- Seroconversion (SCR) is defined as a minimum 4-fold increase in titer from Baseline (pre-vaccination) to 28 days post-vaccination among those participants with a 4-fold increase possible to observe, i.e., with a Baseline titer not greater than 8.5 log₂.
- Minimum 2-fold-rise from Baseline to 28 days post-vaccination among those participants with a 2-fold increase possible to observe, i.e., with a Baseline titer not greater than 9.5 log₂.
- Any fold-rise is defined as any increase in titer from Baseline to 28 days post-vaccination (log₂ neutralizing antibody titer post-dose minus Baseline > 0), among those with an increase possible to observe, i.e., with a Baseline titer less than 10.5 log₂.
Measured: Baseline, Day 29 (28 days after 1st vaccination) and Day 57 (28 days after 2nd vaccination)
Time to Cessation of Fecal Shedding of Vaccine Virus in Participants With IPV Vaccination History
The presence of the vaccine virus in stool samples was assessed using polymerase chain reaction (PCR). Time to cessation of shedding is defined as the time between vaccination and the last PCR-positive stool prior to 2 consecutive PCR-negative stools (with a minimum 24-hour interval between the 2 negative stools). The time to cessation of fecal shedding of nOPV1 and nOPV3 in prior IPV recipients was estimated using Kaplan-Meier methodology with interval-censoring.
Measured: Up to Day 57
Time to Cessation of Fecal Shedding of Vaccine Virus in Participants With OPV Vaccination History
The presence of the vaccine virus in stool samples was assessed using polymerase chain reaction (PCR). Time to cessation of shedding is defined as the time between vaccination and the last PCR-positive stool prior to 2 consecutive PCR-negative stools (with a minimum 24-hour interval between the 2 negative stools). The time to cessation of fecal shedding of nOPV1 and nOPV3 in prior OPV recipients was evaluated separately after each dose, estimated using Kaplan-Meier methodology with interval-censoring.
Measured: From vaccination through 28 days after each vaccination
Percentage of Participants Shedding Type 1 Vaccine Virus at Each Post-vaccination Stool Collection in Participants With IPV Vaccination History
Presence of the vaccine virus in stool samples was assessed by polymerase chain reaction (PCR).
This endpoint was pre-specified to be analyzed in participants with IPV vaccination history.
Measured: Days 3, 5, 8, 10, 15, 22, 29, 36, 43, 50, and 57
Percentage of Participants Shedding Type 3 Vaccine Virus at Each Post-vaccination Stool Collection in Participants With IPV Vaccination History
Presence of the vaccine virus in stool samples was assessed by polymerase chain reaction (PCR).
This endpoint was pre-specified to be analyzed in participants with IPV vaccination history.
Measured: Days 3, 5, 8, 10, 15, 22, 29, 36, 43, 50, and 57
Amount of Type 1 Vaccine Virus in Each Stool Sample Positive for Virus in Participants With IPV Vaccination History
Samples positive for vaccine virus in stool as detected by PCR were quantified using a cell culture infectious dose assay. Participants who were PCR-positive for type 1 viral shedding but with log₁₀ CCID50 per gram ≤ LLOQ contributed a value equal to the LLOQ.
This endpoint was pre-specified to be analyzed in participants with IPV vaccination history.
Measured: Days 3, 5, 8, 10, 15, 22, 29, 36, 43, 50, and 57
Amount of Type 3 Vaccine Virus in Each Stool Sample Positive for Virus in Participants With IPV Vaccination History
Samples positive for vaccine virus in stool as detected by PCR were quantified using a cell culture infectious dose assay. Participants who were PCR-positive for type 3 viral shedding but with log₁₀ CCID50 per gram ≤ LLOQ contributed a value equal to the LLOQ.
This endpoint was pre-specified to be analyzed in participants with IPV vaccination history.
Measured: Days 3, 5, 8, 10, 15, 22, 29, 36, 43, 50, and 57
Shedding Index of Vaccine Virus Shedding in Stool in Participants With IPV Vaccination History
The Shedding Index Endpoint (SIE) was computed as the mean of the log₁₀ cell culture infectious dose 50% (CCID50) per gram from nominal collection days 7, 14, 21, and 28 post-dose (i.e., study days 8, 15, 22, and 29). Participants who were PCR-positive for type-specific viral shedding but with log₁₀ CCID50 per gram ≤ LLOQ contributed a value equal to the LLOQ.
This endpoint was pre-specified to be analyzed in participants with IPV vaccination history.
Measured: Days 8, 15, 22, and 29
Area Under the Curve From Vaccination to 28 Days After Vaccination (AUC₀-₂₈) of Vaccine Virus Shed in Stool in Participants With an IPV Vaccination History
Area under the curve (AUC) was computed for each participant using CCID50 per gram data collected through Day 29 using the linear trapezoidal rule. Participants were assumed to be not shedding at time of vaccination (i.e. there was no stool collection on Day 1). Participants who were PCR-positive for type-specific viral shedding but with log₁₀ CCID50 per gram ≤ LLOQ contributed a value equal to the LLOQ.
This endpoint was pre-specified to be analyzed in participants with IPV vaccination history.
Measured: Days 3, 5, 8, 10, 15, 22, and 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start26 Mar 2021
- Primary completion17 Feb 2023
- Study completion17 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PoliomyelitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It will be an 8-arm, randomized, observer-blind, controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Centers for Disease Control and Prevention, Viroclinics Biosciences B.V., The Emmes Company, LLC
- Responsible party
- Sponsor
- Investigators
- Jessica Crothers, MD, Principal investigator, University of VermontArlene Sena, MD, Principal investigator, University of North CarolinaPeter Wright, MD, Principal investigator, Dartmouth-Hitchcock Medical CenterMohamed Al-Ibrahim, MB CHB, FACP, Principal investigator, Pharmaron CPC, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529538
- Sponsor's protocol ID
- CVIA 076
- Status last verified
- Oct 2024
- First submitted
- 24 Aug 2020
- Last updated
- 20 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mercer LD, Sena AC, Colgate ER, Crothers JW, Wright PF, Al-Ibrahim M, Tritama E, Vincent A, Mainou BA, Zhang Y, Konopka-Anstadt J, Bandyopadhyay AS, Fix A, Konz JO, Gast C. Safety and immunogenicity of novel live attenuated type 1 and type 3 oral poliomyelitis vaccines in healthy adults in the USA: a first-in-human, observer-masked, multicentre, phase 1 randomised controlled trial. Lancet Infect Dis. 2025 Dec;25(12):1363-1376. doi: 10.1016/S1473-3099(25)00285-3. Epub 2025 Aug 13.
PubMed 40818478Thompson KM, Kalkowska DA, Kidd SE, Burns CC, Badizadegan K. Trade-offs of different poliovirus vaccine options for outbreak response in the United States and other countries that only use inactivated poliovirus vaccine (IPV) in routine immunization. Vaccine. 2024 Feb 6;42(4):819-827. doi: 10.1016/j.vaccine.2023.12.081. Epub 2024 Jan 12.
PubMed 38218668
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Phase 1, Randomized, Observer-blind, Controlled Study to Assess the Safety and Immunogenicity of Novel Live Attenuated Type 1 and Type 3 Oral Poliomyelitis Vaccines in Healthy Adults
- ClinicalTrials.gov ID
- NCT04529538
- Acronym / sponsor ID
- CVIA 076
- Conditions
- Poliomyelitis
- Keywords
- Vaccine tolerability, Vaccine reactogenicity, Vaccine viral shedding, Vaccine immunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Centers for Disease Control and Prevention, Viroclinics Biosciences B.V., The Emmes Company, LLC
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 17 Feb 2023 (actual)
- Study completion
- 17 Feb 2023 (actual)
- First posted
- 27 Aug 2020 (actual)
- Results
- Posted 25 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety (primary objective), the ability to trigger the production of antibodies (immunogenicity; a secondary objective) and presence of vaccine virus in the stool (fecal shedding; a secondary objective) of two novel oral polio vaccines (nOPV), novel oral poliomyelitis vaccine type 1 (nOPV1) and novel oral poliomyelitis vaccine type 3 (nOPV3), as compared to Sabin strain monovalent oral poliomyelitis vaccine (mOPV) controls, in healthy adults.
Detailed description
This multicenter trial is the first-in-human assessment of two novel oral polio vaccines for poliovirus type 1 and type 3. It will be a 4-cohort, 8-arm, randomized, observer-blind, controlled trial, with Sabin monovalent vaccines serving as the control for each type:
Cohort 1: Healthy adults with an exclusive inactivated poliovirus vaccine (IPV) prior vaccination history will be randomized in a 1:1 ratio and allocated to receive nOPV1 (Group 1) or mOPV1 (Group 2).
Cohort 2: Healthy adults with an OPV-containing prior vaccination history will be randomized in a 2:1 ratio and allocated to receive two doses of nOPV1 (Group 3) or mOPV1 (Group 4), respectively;
Cohort 3: Healthy adults with an exclusive IPV prior vaccination history will be randomized in a 1:1 ratio and allocated to receive nOPV3 (Group 5) or mOPV3 (Group 6);
Cohort 4: Healthy adults with an OPV-containing prior vaccination history will be randomized in a 2:1 ratio to study groups 3 and 4 and allocated to receive two doses of nOPV3 (Group 7) or mOPV3 (Group 8), respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 8
- Model description
- It will be an 8-arm, randomized, observer-blind, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group1: nOPV1 (IPV History) | Experimental | Biological: Novel Oral Polio Vaccine Type 1 (nOPV1)Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of novel OPV type 1 (nOPV1) containing 10^6.5 cell culture infectious dose 50% (CCID50) on Day 1. |
| Group 2: mOPV1 (IPV History) | Active comparator | Biological: Sabin Monovalent Oral Polio Vaccine Type 1 (mOPV1)Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of mOPV1 containing 10^6.0 CCID50 on Day 1. |
| Group 3: nOPV1 (OPV History) | Experimental | Biological: Novel Oral Polio Vaccine Type 1 (nOPV1)Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10^6.5 CCID50/dose, given 28 days apart. |
| Group 4: mOPV1 (OPV History) | Active comparator | Biological: Sabin Monovalent Oral Polio Vaccine Type 1 (mOPV1)Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of mOPV1 containing ≥ 10^6.0 CCID50/dose, given 28 days apart. |
| Group 5: nOPV3 (IPV History) | Experimental | Biological: Novel Oral Polio Vaccine Type 3 (nOPV3)Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10^6.5 CCID50 on Day 1. |
| Group 6: mOPV3 (IPV History) | Active comparator | Biological: Sabin Monovalent Oral Polio Vaccine Type 3 (mOPV3)Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of mOPV3 containing ≥ 10^5.8 CCID50 on Day 1. |
| Group 7: nOPV3 (OPV History) | Experimental | Biological: Novel Oral Polio Vaccine Type 3 (nOPV3)Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 in a dose of 10^6.5 CCID50/dose, given 28 days apart. |
| Group 8: mOPV3 (OPV History) | Active comparator | Biological: Sabin Monovalent Oral Polio Vaccine Type 3 (mOPV3)Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10^5.8 CCID50/dose, given 28 days apart. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- Males or females, from 18 to 45 years of age (inclusive) at the time of enrollment
- Healthy, as defined by the absence of any clinically significant medical conditions, either acute or chronic, as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator
- Willing and able to provide written informed consent prior to performance of any study-specific procedure
- If female and of childbearing potential*, be not breastfeeding and not pregnant (based on a negative serum pregnancy test at screening and a negative urine pregnancy test during the 24 hours prior to any study vaccination), agreeing to have repeated pregnancy tests prior to any study vaccination, and having practiced adequate contraception** for 30 days prior to first study vaccination and willing to continue using adequate contraception consistently for at least 90 days after the last study vaccination and until cessation of vaccine virus shedding is confirmed
- Adequate contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly and when applicable, in accordance with the product label, for example:
Key exclusion criteria (29 listed)
- Have any condition (medical, psychiatric or behavioral) 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)
- Receipt of polio vaccine within 12 months before the start of the study
- Having Crohn's disease or ulcerative colitis or having had major surgery of the gastrointestinal tract involving significant loss or resection of the bowel
- A known allergy, hypersensitivity, or intolerance to any components of the study vaccines, including all macrolide and aminoglycoside antibiotics (e.g., erythromycin and kanamycin)
- Any confirmed or suspected immunosuppressive or immunodeficiency condition (human immunodeficiency virus [HIV] infection, or total serum immunoglobulin A (IgA) or immunoglobulin G (IgG) level below the testing laboratory's lower limit of normal [LLN])
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel Oral Polio Vaccine Type 1 (nOPV1)Each 0.1 mL (2 drops) dose of vaccine contains approximately 10^6.5 CCID50. | Biological | Group 3: nOPV1 (OPV History), Group1: nOPV1 (IPV History) |
| Novel Oral Polio Vaccine Type 3 (nOPV3)Each 0.1 mL (2 drops) dose of vaccine contains approximately 10^6.5 CCID50. | Biological | Group 5: nOPV3 (IPV History), Group 7: nOPV3 (OPV History) |
| Sabin Monovalent Oral Polio Vaccine Type 1 (mOPV1)The Sabin mOPV1 control vaccine contains ≥ 10^6.0 CCID50 per 0.1 mL (2 drops) dose. | Biological | Group 2: mOPV1 (IPV History), Group 4: mOPV1 (OPV History) |
| Sabin Monovalent Oral Polio Vaccine Type 3 (mOPV3)Also: Sabin monovalent oral polio vaccine type 3the Sabin mOPV3 control vaccine contains ≥ 10^5.8 CCID50 per 0.1 mL (2 drops) dose. | Biological | Group 6: mOPV3 (IPV History), Group 8: mOPV3 (OPV History) |
Primary outcome
Number of Participants With Serious Adverse Events (SAEs)
Time frame: From Day 1 to end of study, up to 169 days
A serious adverse event is any adverse event that resulted in any of the following outcomes: * Death * Was life-threatening * Required inpatient hospitalization or prolongation of existing hospitalization * Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * Congenital anomaly or birth defect * Important medical event that may not result in one of the above outcomes but may jeopardize the health of the study participant and/or require medical or surgical intervention to prevent one of the outcomes listed above
Number of Participants With Solicited Adverse Events (AEs) 7 Days After First Dose of Study Vaccine
Time frame: From vaccination to 7 days post vaccination (Days 1-7)
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. Solicited AEs for this study included: * Fever (oral temperature ≥ 38.0°C or 100.4°F) * Chills * Fatigue * Headache * Muscle aches/myalgias * Joint aches/arthralgias * Nausea * Vomiting * Abdominal pain * Diarrhea
Number of Participants With Solicited Adverse Events 7 Days After Second Dose of Study Vaccine
Time frame: From Day 29 to Day 35
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. Solicited AEs for this study included: * Fever (oral temperature ≥ 38.0°C or 100.4°F) * Chills * Fatigue * Headache * Muscle aches/myalgias * Joint aches/arthralgias * Nausea * Vomiting * Abdominal pain * Diarrhea
Number of Participants With Unsolicited Adverse Events (AEs) up to 28 Days Post Vaccination
Time frame: From vaccination to 28 days post vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination)
Unsolicited AEs are any AEs reported spontaneously by the participant, observed by the study personnel during study visits or those identified during review of medical records or source documents. In the absence of a diagnosis, abnormal physical examination findings or abnormal clinical safety laboratory test results that are assessed by the investigator to be clinically significant were reported as an AE.
20 secondary outcomes
Median Anti-poliovirus Type 1 Serum Neutralizing Antibody Titers at Baseline and Post-vaccination Among Participants With a Vaccine History of IPV
Time frame: Baseline and Day 29 (28 days post-vaccination)
Median Anti-poliovirus Type 1 Serum Neutralizing Antibody Titers at Baseline and Post-vaccination Among Participants With a Vaccine History of OPV
Time frame: Baseline, Day 29 (28 days post-vaccination) and Day 57 (28 days after 2nd vaccination)
Median Anti-poliovirus Type 3 Serum Neutralizing Antibody Titers at Baseline and Post-vaccination Among Participants With a Vaccine History of IPV
Time frame: Baseline and Day 29 (28 days post-vaccination)
Median Anti-poliovirus Type 3 Serum Neutralizing Antibody Titers at Baseline and Post-vaccination Among Participants With a Vaccine History of OPV
Time frame: Baseline, Day 29 (28 days after the 1st vaccination) and Day 57 (28 days after 2nd vaccination)
Geometric Mean Titer (GMT) of Anti-poliovirus Type 1 Serum Neutralizing Antibodies at Baseline and Post-vaccination Among Participants With a Vaccine History of IPV
Time frame: Baseline and Day 29 (28 days post-vaccination)
Geometric Mean Titer of Anti-poliovirus Type 1 Serum Neutralizing Antibodies at Baseline and Post-vaccination Among Participants With a Vaccine History of OPV
Time frame: Baseline, Day 29 (28 days after 1st vaccination) and Day 57 (28 days after 2nd vaccination)
Geometric Mean Titer of Anti-poliovirus Type 3 Serum Neutralizing Antibodies at Baseline and Post-vaccination Among Participants With a Vaccine History of IPV
Time frame: Baseline and Day 29 (28 days post-vaccination)
Geometric Mean Titer of Anti-poliovirus Type 3 Serum Neutralizing Antibodies at Baseline and Post-vaccination Among Participants With a Vaccine History of OPV
Time frame: Baseline, Day 29 (28 days after 1st vaccination) and Day 57 (28 days after 2nd vaccination)
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 1 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Vaccination Among Participants With a Vaccine History of IPV
Time frame: Baseline (pre-vaccination) and Day 29 (28 days post-vaccination)
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 1 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Each Vaccination Among Participants With a Vaccine History of OPV
Time frame: Baseline, Day 29 (28 days post-vaccination) and Day 57 (28 days after 2nd vaccination)
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 3 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Vaccination Among Participants With a Vaccine History of IPV
Time frame: Baseline and Day 29 (28 days post-vaccination)
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 3 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Each Vaccination Among Participants With a Vaccine History of OPV
Time frame: Baseline, Day 29 (28 days after 1st vaccination) and Day 57 (28 days after 2nd vaccination)
Time to Cessation of Fecal Shedding of Vaccine Virus in Participants With IPV Vaccination History
Time frame: Up to Day 57
Time to Cessation of Fecal Shedding of Vaccine Virus in Participants With OPV Vaccination History
Time frame: From vaccination through 28 days after each vaccination
Percentage of Participants Shedding Type 1 Vaccine Virus at Each Post-vaccination Stool Collection in Participants With IPV Vaccination History
Time frame: Days 3, 5, 8, 10, 15, 22, 29, 36, 43, 50, and 57
Percentage of Participants Shedding Type 3 Vaccine Virus at Each Post-vaccination Stool Collection in Participants With IPV Vaccination History
Time frame: Days 3, 5, 8, 10, 15, 22, 29, 36, 43, 50, and 57
Amount of Type 1 Vaccine Virus in Each Stool Sample Positive for Virus in Participants With IPV Vaccination History
Time frame: Days 3, 5, 8, 10, 15, 22, 29, 36, 43, 50, and 57
Amount of Type 3 Vaccine Virus in Each Stool Sample Positive for Virus in Participants With IPV Vaccination History
Time frame: Days 3, 5, 8, 10, 15, 22, 29, 36, 43, 50, and 57
Shedding Index of Vaccine Virus Shedding in Stool in Participants With IPV Vaccination History
Time frame: Days 8, 15, 22, and 29
Area Under the Curve From Vaccination to 28 Days After Vaccination (AUC₀-₂₈) of Vaccine Virus Shed in Stool in Participants With an IPV Vaccination History
Time frame: Days 3, 5, 8, 10, 15, 22, and 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40818478Mercer LD, Sena AC, Colgate ER, Crothers JW, Wright PF, Al-Ibrahim M, Tritama E, Vincent A, Mainou BA, Zhang Y, Konopka-Anstadt J, Bandyopadhyay AS, Fix A, Konz JO, Gast C. Safety and immunogenicity of novel live attenuated type 1 and type 3 oral poliomyelitis vaccines in healthy adults in the USA: a first-in-human, observer-masked, multicentre, phase 1 randomised controlled trial. Lancet Infect Dis. 2025 Dec;25(12):1363-1376. doi: 10.1016/S1473-3099(25)00285-3. Epub 2025 Aug 13.
- Derived from this study: PubMed 38218668Thompson KM, Kalkowska DA, Kidd SE, Burns CC, Badizadegan K. Trade-offs of different poliovirus vaccine options for outbreak response in the United States and other countries that only use inactivated poliovirus vaccine (IPV) in routine immunization. Vaccine. 2024 Feb 6;42(4):819-827. doi: 10.1016/j.vaccine.2023.12.081. Epub 2024 Jan 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Crothers, MD principal investigator
University of Vermont
Arlene Sena, MD principal investigator
University of North Carolina
Peter Wright, MD principal investigator
Dartmouth-Hitchcock Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Novel Oral Polio Vaccine Type 1 (nOPV1), Novel Oral Polio Vaccine Type 3 (nOPV3) and Sabin Monovalent Oral Polio Vaccine Type 1 (mOPV1) in people with Poliomyelitis, run by PATH at 4 sites in United States.
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 21 inclusion and 29 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 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Serious Adverse Events (SAEs) (time frame: From Day 1 to end of study, up to 169 days). The study lists 4 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 NCT04529538, which also lists 2 linked publications.
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 20 Nov 2024.