A Phase 1 interventional study of HEV 239 and Placebo in Hepatitis E and Immunisation, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-24.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Prevention
This is a Phase I double-blind, randomized, placebo controlled trial (1:4 ratio of placebo to vaccine) of Hepatitis E virus vaccine containing a 239 amino acid subfragment of Hecolin(R) (HEV-239) in 25 US males and non-pregnant females ages 18 - 45 (inclusive) to assess the safety, reactogenicity, and immunogenicity of HEV-239. Subjects will receive 3 doses of study product on Days 1, 29, and 180. Subjects will remain in the study for up to 13 months (including screening). The study duration will be approximately 15 months. Subjects will be observed for 30 minutes after vaccination. The occurrence of solicited injection site and systemic reactogenicity events will be measured from the time of study vaccination through Day 8 after each vaccination. These will be ascertained through use of an electronic memory (e-memory) aid, a telephone call on day 4 after each dose of vaccine, a Day 8 clinic visit, and potentially at the Day 15 clinic visit after each dose of vaccine. Unsolicited adverse events will be collected from vaccination through Day 29 after each vaccination. Serious adverse events will be collected from the time of the first study vaccination through the last study visit (Day 360). The study includes multiple phlebotomy time points for immunogenicity and blood collection for future use at visit 1 and Days 8, 15, and 29 after each vaccination. The durability of the immune response and future use collection will be assessed at 5 months after the first boost (Day 180) and at 6 months after the second boost (Day 360). The primary objectives of the study are to; 1) assess the safety and reactogenicity of HEV-239 following delivery of each vaccine dose; and 2) assess the number of subjects with > / = 4 fold rise in Hepatitis E virus (HEV) immunoglobulin G (IgG) at any time after vaccination.
This is a Phase I double-blind, randomized, placebo controlled trial (1:4 ratio of placebo to vaccine) of Hepatitis E virus vaccine containing a 239 amino acid subfragment of Hecolin(R) (HEV-239) in 25 US males and non-pregnant females ages 18 - 45 (inclusive) to assess the safety, reactogenicity, and immunogenicity of HEV-239. Subjects will receive 3 doses of study product on Days 1, 29, and 180. Subjects will remain in the study for up to 13 months (including screening). The study duration will be approximately 15 months. Subjects will be observed for 30 minutes after vaccination. The occurrence of solicited injection site and systemic reactogenicity events will be measured from the time of study vaccination through Day 8 after each vaccination. These will be ascertained through use of an electronic memory (e-memory) aid, a telephone call on day 4 after each dose of vaccine, a Day 8 clinic visit, and potentially at the Day 15 clinic visit after each dose of vaccine. Unsolicited adverse events will be collected from vaccination through Day 29 after each vaccination. Serious adverse events will be collected from the time of the first study vaccination through the last study visit (Day 360). The study includes multiple phlebotomy time points for immunogenicity and blood collection for future use at visit 1 and Days 8, 15, and 29 after each vaccination. The durability of the immune response and future use collection will be assessed at 5 months after the first boost (Day 180) and at 6 months after the second boost (Day 360). The primary objectives of the study are to; 1) Assess the safety and reactogenicity of HEV-239 following delivery of each vaccine dose; and 2) Assess the number of subjects with > / = 4 fold rise in Hepatitis E virus (HEV) immunoglobulin G (IgG) at any time after vaccination. The secondary objectives are to; 1) Assess the number of subjects with HEV immunoglobulin M (IgM) seroconversion at any time after vaccination; 2) Assess the number of subjects with HEV IgG seroconversion at any time after vaccination; and 3) Assess the HEV IgG geometric mean concentrations (GMCs) at any time after vaccination.
37 studies on the registry are indexed under Hepatitis E; 9 are open to participants now.
This study's enrollment of 25 is below the median of 330 across 26 interventional studies indexed under Hepatitis E.
Browse Hepatitis E studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subject must be a man or a non-pregnant woman* aged 18-45 years (inclusive).
*Females of must have a negative serum human chorionic gonadotropin (beta-HCG) pregnancy test at screening and negative urine beta-HCG pregnancy test within 24 hours prior to (each) vaccination.
Subject must be in good general health as determined by medical history, vital signs*, (BMI)**, physical examination, and clinical judgment of the investigator.
*Oral temp \< 38.0 Degrees Celsius /100.4 Degrees Fahrenheit; pulse 51 to 100 bpm; systolic blood pressure 90 to 140 mm Hg, and diastolic blood pressure 55 to 90 mm Hg.
**BMI > / = 18.5 and \< 35 kg/m\^2.
Subject's screening laboratory values*,** must be within site normal limits*** within 28 days of enrollment.
*Screening labs will include: White blood cell (WBC) count; (HgB); ; (ANC); Absolute eosinophil count (AEC); Creatinine; Glucose (random, must be \< 140); (ALT); 1/2 antibody/antigen test, surface antigen (HBsAg), and virus (HCV) antibody.
**Minor abnormalities are considered acceptable if not (e.g., Mean Corpuscular Volume (MCV)). Repeating the screening tests once is permitted for out-of-range values provided there is an alternative explanation for the out-of-range value. The alternative explanation for the out-of-range value should be documented in the subject's source documents.
***Creatinine, glucose, and ALT values lower than the normal range may be acceptable if the PI or a designated licensed clinician determines that these laboratory findings are not clinically significant. The HIV 1/2 antibody/antigen test, Hepatitis B surface antigen (HBsAg), and Hepatitis C virus (HCV) antibody must be non-reactive.
Female subjects must be of non-childbearing potential* OR must use an acceptable method of ** from 28 days before prime vaccination until at least 3 months after the last vaccination.
*Surgically sterile via tubal ligation, bilateral oophorectomy, hysterectomy or for > / = 1 year.
**Abstinence (defined as refraining from heterosexual intercourse), monogamous relationship with vasectomized partner, barrier methods such as male or female condoms with spermicide or diaphragms with spermicide, intrauterine devices, and licensed hormonal methods (such as birth control pills, skin patches, Implanon(R), Nexplanon(R), DepoProvera(R), or NuvaRing(R)).
Male subjects must be surgically sterile via vasectomy OR must use an acceptable method of contraception* from prime vaccination until at least 3 months after the last boost vaccination.
Exclusion Criteria:
Has received any experimental agent* within 30 days prior to first vaccination, or the expected recipient of any experimental agent during this trial-reporting period.
*Including vaccines, drugs, biologics, devices, and/or blood products.
Has a positive urine drug screen for amphetamines*, cocaine, opiates, or phencyclidine.
*Prescription amphetamines are not exclusionary.
Chronic, medical or psychiatric conditions* that, in the opinion of the investigator, may pose additional risk to the subject if she/he participates in the study.
*Permissible conditions include but are not limited to mild, well-controlled asthma, well-controlled depression, well-controlled anxiety, seasonal allergies, and well-controlled hypertension.
Receipt of drugs*,**,*** or biologic agents within the 30 days prior to enrollment.
*This includes use of oral or parental prednisone. This also includes allergy desensitization injections from 14 days prior to each vaccination through 14 days after each vaccination. The use of topical for mild uncomplicated dermatitis permissible after therapy is completed. Over-the-counter (OTC) corticosteroid nasal sprays for allergic rhinitis are permissible. The use of low or moderate dose inhaled steroids is permissible. Doses are defined as per age as using inhaled high-dose per reference chart in the National Heart, Lung and Blood Institute Guidelines for the Diagnosis and Management of Asthma (EPR-3) or other lists published in UPTODATE.
**Receipt of systemic, prescription medications for the treatment of chronic medical conditions or variations of normal physiologic functions may be permissible if, in the opinion of the investigator, they are used for conditions that are not clinically significant and would not impact the safety of the subject or the safety and immunogenicity outcomes of the protocol.
***Use of systemic, over-the-counter medications and PRN systemic, prescription medication may be allowed if, in the opinion of the investigator, they pose no additional risk to subject safety or assessment of immunogenicity/reactogenicity.
Has known neoplastic disease* anticancer therapy, or radiation therapy within 3 years prior to first study vaccination.
*Excluding non-melanoma skin cancer, such as squamous cell skin cancer or basal cell skin cancer, cured by surgical excision.
Travel to Asia, the Middle East, Africa, or Central America or to an area with an active Hepatitis E outbreak* within the last 90 days or intention to travel to such areas during the study.
*Outbreaks within the last 3 years.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
0.5 mL of HEV-239 administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180. N=20
Biological: HEV 239
0.5 mL of HEV-239 placebo administered intramuscularly into the deltoid muscle as a single injection on Days 1, 29, and 180. N=5
Other: Placebo
Hepatitis E vaccine against HEV genotypes 1 and 4. The HEV 239 vaccine is a 26 kDa recombinant polypeptide corresponding to amino acid residues 368-606 of the capsid protein of a genotype 1 HEV strain. The vaccine is expressed in Escherichia coli (E. coli) and vaccine doses contain 30 µg of the purified antigen in 0.5 mL buffered saline adsorbed to 0.8 mg aluminium hydroxide.
0.9% Sodium Chloride Injection, USP (Normal Saline) is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection (WFI). Each mL contains sodium chloride 9 mg and may contain HCl or NaOH for pH adjustment (pH 5.3 \[4.5 - 7.0\]).
Number of Participants With Solicited Local Reactogenicity Events
Injection site Adverse Events (AEs) solicited on an e-memory aid available to participants included: pain, tenderness, pruritis/itching, ecchymosis/bruising, induration/swelling (functional grade based on interference with daily activities). Ecchymosis/bruising (any measured value \>/= 25mm), induration/swelling (any measured value \>/= 25mm), and erythema/redness (any measured value \>/= 25mm). Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days at or following vaccination.
Time frame: Post Dose 1 (Day 1 through Day 8), Post Dose 2 (Day 29 through Day 36), Post Dose 3 (Day 180 through Day 187)
Number of Participants With Solicited Systemic Reactogenicity Events
Systemic AEs solicited on an e-memory aid provided to participants included: feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, and elevated oral temperature (38.0 degrees Celsius/100.4 degrees Fahrenheit or greater). Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days at or following vaccination.
Time frame: Post Dose 1 (Day 1 through Day 8), Post Dose 2 (Day 29 through Day 36), Post Dose 3 (Day 180 through Day 187)
Number of Participants With Vaccine-related Unsolicited Adverse Events (AEs)
Unsolicited adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Unsolicited AEs that were deemed vaccine-related were collected from participants from the time of vaccination through Day 29 after each study vaccination.
Time frame: Post Dose 1 (Day 1 through Day 29), Post Dose 2 (Day 29 through Day 57), Post Dose 3 (Day 180 through Day 208)
Number of Participants With Clinical Safety Laboratory Adverse Events (AEs) - Chemistry
Chemistry parameters included: alanine aminotransferase (ALT) and creatinine. Thresholds for adverse events were considered as ALT 30 U/L or greater (female) or 47 U/L or greater (male); creatinine 1.11 mg/dL or greater (female) or 1.36 mg/dL or greater (male).
Time frame: Baseline, Post Dose 1 (Day 8), Post Dose 2 (Day 36), Post Dose 3 (Day 187)
Number of Participants With Clinical Safety Laboratory Adverse Events (AEs) - Hematology
Hematology parameters included: hemoglobin, platelets, absolute neutrophil count (ANC), absolute eosinophil count (AEC), and white blood cells (WBC). Thresholds for adverse events were considered as hemoglobin 11.0 g/dL or greater (female) or 12.0 g/dL or greater (male); WBC increase 10.9 thousand/uL or greater; WBC decrease 3.7 thousand/uL or less; ANC decrease 1499 cells/uL or less; AEC increase 501 cells/uL or greater; platelet decrease 139 thousand/uL or less.
Time frame: Baseline, Post Dose 1 (Day 8), Post Dose 2 (Day 36), Post Dose 3 (Day 187)
Number of Participants With Vaccine-related Serious Adverse Events (SAEs)
SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; a congenital anomaly/birth defect; or any important medical event that may not result in death, be life-threatening, or require hospitalizations, that may be considered serious when, based on appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Time frame: Day 1 through Day 360
Percentage of Participants Showing >/=4-fold Rise in Serum Hepatitis E Virus Immunoglobulin G (IgG) Concentration
Blood was collected for IgG assay which was conducted with HEV as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean fold rise was calculated for each study arm from the available results at Day 8 and Day 15 post first study vaccination, Day 29 prior to second study vaccination, Day 36, Day 43, Day 57, Day 180 prior to third study vaccination, Day 187, Day 194, Day 208 and Day 360. A 4-fold rise was defined as a HEV IgG \>/=0.154 Wu/mL in a participant that was HEV seronegative at Day 1.
Time frame: Day 8, Day 15, Day 29 (Dose 2), Day 36, Day 43, Day 57, Day 180 (Dose 3), Day 187, Day 194, Day 208, Day 360
Percentage of Participants With Hepatitis E Virus Immunoglobulin M (IgM) Seroconversion
Blood was collected for the IgM assay conducted with HEV as the antigen. Each sample was tested in duplicate per the laboratory's standard operating procedure and retested in duplicate if a result was borderline (A / C.O. = 0.9-1.1). If any replicate was seropositive \[A/C.O. \>1.1 as defined by the Wantai HEV-IgM enzyme-linked immunosorbent assay (ELISA) package insert\] the sample's result was positive. If no replicates were positive the sample's result was negative. Seroconversion was defined as a change from a seronegative result to a seropositive result.
Time frame: Day 8, Day 15, Day 29 (Dose 2), Day 36, Day 43, Day 57, Day 180 (Dose 3), Day 187, Day 194, Day 208, Day 360
Percentage of Participants With Hepatitis E Virus IgG Seroconversion
Blood was collected for the IgG assay conducted with HEV as the antigen. Each sample was tested in duplicate per the laboratory's standard operating procedure and retested in duplicate if a result was borderline (A / C.O. = 0.9-1.1). If any replicate was seropositive (A/C.O. \>1.1 as defined by the Wantai HEV-IgG ELISA package insert) the sample's result was positive. If no replicates were positive the sample's result was negative. Seroconversion was defined as a change from a seronegative result to a seropositive result.
Time frame: Day 8, Day 15, Day 29 (Dose 2), Day 36, Day 43, Day 57, Day 180 (Dose 3), Day 187, Day 194, Day 208, Day 360
Geometric Mean Concentrations (GMC) of Hepatitis E Virus IgG
Blood was collected for IgG assay which was conducted with HEV as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean concentration (Wu/mL) was calculated for each study arm from the available results at each timepoint.
Time frame: Day 1 (Dose 1), Day 8, Day 15, Day 29 (Dose 2), Day 36, Day 43, Day 57, Day 180 (Dose 3), Day 187, Day 194, Day 208, Day 360
Participants were healthy males and non-pregnant females between 18 and 45 years old, inclusively. They were recruited from the community at large around the clinical site. Participants were enrolled between 12APR2019 and 24JUL2019.
| Milestone | HEV-239 | Placebo |
|---|---|---|
| Started | 20 | 5 |
| Completed | 17 | 3 |
| Not completed | 3 | 2 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Became ineligible after enrollment | 1 | 2 |
Injection site Adverse Events (AEs) solicited on an e-memory aid available to participants included: pain, tenderness, pruritis/itching, ecchymosis/bruising, induration/swelling (functional grade based on interference with daily activities). Ecchymosis/bruising (any measured value \>/= 25mm), induration/swelling (any measured value \>/= 25mm), and erythema/redness (any measured value \>/= 25mm). Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days at or following vaccination.
| Participants | HEV-239 | Placebo |
|---|---|---|
| Post Dose 1 | 11 | 3 |
| Post Dose 2 | 17 | 1 |
| Post Dose 3 | 9 | 1 |
| Post Any Dose | 19 | 3 |
Systemic AEs solicited on an e-memory aid provided to participants included: feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, and elevated oral temperature (38.0 degrees Celsius/100.4 degrees Fahrenheit or greater). Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days at or following vaccination.
| Participants | HEV-239 | Placebo |
|---|---|---|
| Post Dose 1 | 11 | 3 |
| Post Dose 2 | 12 | 1 |
| Post Dose 3 | 7 | 1 |
| Post Any Dose | 17 | 4 |
Unsolicited adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Unsolicited AEs that were deemed vaccine-related were collected from participants from the time of vaccination through Day 29 after each study vaccination.
| Participants | HEV-239 | Placebo |
|---|---|---|
| Number of Participants With Vaccine-related Unsolicited Adverse Events (AEs) | 0 | 0 |
Chemistry parameters included: alanine aminotransferase (ALT) and creatinine. Thresholds for adverse events were considered as ALT 30 U/L or greater (female) or 47 U/L or greater (male); creatinine 1.11 mg/dL or greater (female) or 1.36 mg/dL or greater (male).
| Participants | HEV-239 | Placebo |
|---|---|---|
| Number of Participants With Clinical Safety Laboratory Adverse Events (AEs) - Chemistry | 0 | 0 |
Hematology parameters included: hemoglobin, platelets, absolute neutrophil count (ANC), absolute eosinophil count (AEC), and white blood cells (WBC). Thresholds for adverse events were considered as hemoglobin 11.0 g/dL or greater (female) or 12.0 g/dL or greater (male); WBC increase 10.9 thousand/uL or greater; WBC decrease 3.7 thousand/uL or less; ANC decrease 1499 cells/uL or less; AEC increase 501 cells/uL or greater; platelet decrease 139 thousand/uL or less.
| Participants | HEV-239 | Placebo |
|---|---|---|
| Baseline — None | 20 | 5 |
| Baseline — Mild/Grade 1 | 0 | 0 |
| Baseline — Moderate/Grade 2 | 0 | 0 |
| Baseline — Severe/Grade 3 | 0 | 0 |
| Baseline — Missing | 0 | 0 |
| Post Dose 1 — None | 20 | 5 |
| Post Dose 1 — Mild/Grade 1 | 0 | 0 |
| Post Dose 1 — Moderate/Grade 2 | 0 | 0 |
| Post Dose 1 — Severe/Grade 3 | 0 | 0 |
| Post Dose 1 — Missing | 0 | 0 |
| Post Dose 2 — None | 19 | 3 |
| Post Dose 2 — Mild/Grade 1 | 0 | 0 |
| Post Dose 2 — Moderate/Grade 2 | 1 | 0 |
| Post Dose 2 — Severe/Grade 3 | 0 | 0 |
| Post Dose 2 — Missing | 0 | 2 |
| Post Dose 3 — None | 17 | 3 |
| Post Dose 3 — Mild/Grade 1 | 0 | 0 |
| Post Dose 3 — Moderate/Grade 2 | 1 | 0 |
| Post Dose 3 — Severe/Grade 3 | 0 | 0 |
| Post Dose 3 — Missing | 1 | 0 |
SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; a congenital anomaly/birth defect; or any important medical event that may not result in death, be life-threatening, or require hospitalizations, that may be considered serious when, based on appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
| Participants | HEV-239 | Placebo |
|---|---|---|
| Number of Participants With Vaccine-related Serious Adverse Events (SAEs) | 0 | 0 |
Blood was collected for IgG assay which was conducted with HEV as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean fold rise was calculated for each study arm from the available results at Day 8 and Day 15 post first study vaccination, Day 29 prior to second study vaccination, Day 36, Day 43, Day 57, Day 180 prior to third study vaccination, Day 187, Day 194, Day 208 and Day 360. A 4-fold rise was defined as a HEV IgG \>/=0.154 Wu/mL in a participant that was HEV seronegative at Day 1.
| percentage of participants | HEV-239 | Placebo |
|---|---|---|
| Day 8 | 0 (0 to 17) | 0 (0 to 52) |
| Day 15 | 65 (41 to 85) | 0 (0 to 52) |
| Day 29 (Dose 2) | 100 (83 to 100) | 0 (0 to 52) |
| Day 36 | 100 (83 to 100) | 0 (0 to 71) |
| Day 43 | 100 (82 to 100) | 0 (0 to 71) |
| Day 57 | 100 (83 to 100) | 0 (0 to 52) |
| Day 180 (Dose 3) | 100 (82 to 100) | 0 (0 to 52) |
| Day 187 | 100 (81 to 100) | 0 (0 to 71) |
| Day 194 | 100 (81 to 100) | 0 (0 to 71) |
| Day 208 | 100 (82 to 100) | 0 (0 to 71) |
| Day 360 | 100 (80 to 100) | 0 (0 to 71) |
Blood was collected for the IgM assay conducted with HEV as the antigen. Each sample was tested in duplicate per the laboratory's standard operating procedure and retested in duplicate if a result was borderline (A / C.O. = 0.9-1.1). If any replicate was seropositive \[A/C.O. \>1.1 as defined by the Wantai HEV-IgM enzyme-linked immunosorbent assay (ELISA) package insert\] the sample's result was positive. If no replicates were positive the sample's result was negative. Seroconversion was defined as a change from a seronegative result to a seropositive result.
| percentage of participants | HEV-239 | Placebo |
|---|---|---|
| Day 8 | 0 (0 to 17) | 0 (0 to 52) |
| Day 15 | 0 (0 to 17) | 0 (0 to 52) |
| Day 29 (Dose 2) | 15 (3 to 38) | 0 (0 to 52) |
| Day 36 | 15 (3 to 38) | 0 (0 to 71) |
| Day 43 | 16 (3 to 40) | 0 (0 to 71) |
| Day 57 | 10 (1 to 32) | 0 (0 to 52) |
| Day 180 (Dose 3) | 0 (0 to 18) | 0 (0 to 52) |
| Day 187 | 0 (0 to 19) | 0 (0 to 71) |
| Day 194 | 0 (0 to 19) | 0 (0 to 71) |
| Day 208 | 0 (0 to 18) | 0 (0 to 71) |
| Day 360 | 0 (0 to 20) | 0 (0 to 71) |
Blood was collected for the IgG assay conducted with HEV as the antigen. Each sample was tested in duplicate per the laboratory's standard operating procedure and retested in duplicate if a result was borderline (A / C.O. = 0.9-1.1). If any replicate was seropositive (A/C.O. \>1.1 as defined by the Wantai HEV-IgG ELISA package insert) the sample's result was positive. If no replicates were positive the sample's result was negative. Seroconversion was defined as a change from a seronegative result to a seropositive result.
| percentage of participants | HEV-239 | Placebo |
|---|---|---|
| Day 8 | 0 (0 to 17) | 0 (0 to 52) |
| Day 15 | 60 (36 to 81) | 0 (0 to 52) |
| Day 29 (Dose 2) | 100 (83 to 100) | 0 (0 to 52) |
| Day 36 | 100 (83 to 100) | 0 (0 to 71) |
| Day 43 | 100 (82 to 100) | 0 (0 to 71) |
| Day 57 | 100 (83 to 100) | 0 (0 to 52) |
| Day 180 (Dose 3) | 100 (82 to 100) | 0 (0 to 52) |
| Day 187 | 100 (81 to 100) | 0 (0 to 71) |
| Day 194 | 100 (81 to 100) | 0 (0 to 71) |
| Day 208 | 100 (82 to 100) | 0 (0 to 71) |
| Day 360 | 100 (80 to 100) | 0 (0 to 71) |
Blood was collected for IgG assay which was conducted with HEV as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean concentration (Wu/mL) was calculated for each study arm from the available results at each timepoint.
| Wu/mL | HEV-239 | Placebo |
|---|---|---|
| Day 1 (Dose 1) | 0.0385 (0.0385 to 0.0385) | 0.0385 (0.0385 to 0.0385) |
| Day 8 | 0.0385 (0.0385 to 0.0385) | 0.0385 (0.0385 to 0.0385) |
| Day 15 | 0.24999 (0.0385 to 1.4405) | 0.0385 (0.0385 to 0.0385) |
| Day 29 (Dose 2) | 1.44483 (0.2175 to 8.9019) | 0.0385 (0.0385 to 0.0385) |
| Day 36 | 3.3466 (0.9397 to 13.1263) | 0.0385 (0.0385 to 0.0385) |
| Day 43 | 5.8947 (1.2107 to 20.2568) | 0.0385 (0.0385 to 0.0385) |
| Day 57 | 6.15722 (1.6774 to 18.7678) | 0.0385 (0.0385 to 0.0385) |
| Day 180 (Dose 3) | 3.79298 (1.0944 to 13.2313) | 0.0385 (0.0385 to 0.0385) |
| Day 187 | 5.52867 (1.8484 to 23.2002) | 0.0385 (0.0385 to 0.0385) |
| Day 194 | 9.62189 (2.7346 to 47.4511) | 0.0385 (0.0385 to 0.0385) |
| Day 208 | 11.50262 (2.7182 to 33.0241) | 0.0385 (0.0385 to 0.0385) |
| Day 360 | 2.92278 (0.6188 to 11.0412) | 0.05396 (0.0385 to 0.1060) |
Collected over Solicited injection site and systemic reactogenicity events were reported from the time of each study vaccination through Day 8 after each study vaccination. Unsolicited non-serious AEs were documented and reported at all visits from signing of the ICF until Day 57, then from Day 180 through Day 208. Serious Adverse Events (SAEs) were collected from the time of the first study vaccination through the last study visit on Day 360.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HEV-239 | 0/20 (0%) | 0/20 (0%) | 19/20 (95%) |
| Placebo | 0/5 (0%) | 1/5 (20%) | 5/5 (100%) |
| Event | HEV-239 | Placebo |
|---|---|---|
| DysmenorrhoeaReproductive system and breast disorders | 0/20 | 1/5 |
| Event | HEV-239 | Placebo |
|---|---|---|
| Injection Site PainGeneral disorders | 17/20 | 3/5 |
| HeadacheNervous system disorders | 11/20 | 3/5 |
| Injection Site IndurationGeneral disorders | 10/20 | 1/5 |
| MyalgiaMusculoskeletal and connective tissue disorders | 6/20 | 2/5 |
| FatigueGeneral disorders | 7/20 | 1/5 |
| NauseaGastrointestinal disorders | 5/20 | 0/5 |
| MalaiseGeneral disorders | 5/20 | 0/5 |
| VomitingGastrointestinal disorders | 1/20 | 1/5 |
| Injection Site HaemorrhageGeneral disorders | 2/20 | 1/5 |
| NasopharyngitisInfections and infestations | 4/20 | 0/5 |
The baseline analysis population includes all participants who were enrolled in the study
| Age, Categorical(Participants) | HEV-239 | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 20 | 5 | 25 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | HEV-239 | Placebo | Total |
|---|---|---|---|
| Mean | 29.9 ± 6.7 | 32.8 ± 7.9 | 30.4 ± 6.9 |
| Sex: Female, Male(Participants) | HEV-239 | Placebo | Total |
|---|---|---|---|
| Female | 15 | 4 | 19 |
| Male | 5 | 1 | 6 |
| Ethnicity (NIH/OMB)(Participants) | HEV-239 | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 19 | 4 | 23 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | HEV-239 | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 2 | 5 |
| White | 15 | 3 | 18 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | HEV-239 | Placebo | Total |
|---|---|---|---|
| United States | 20 | 5 | 25 |
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