ACTIVE_NOT_RECRUITING

Trial of an Inactivated Chikungunya Virus Vaccine

Conditions

Chikungunya Fever Chikungunya Virus Chikungunya HydroVax dose-ranging double blind placebo-controlled vaccine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This trial will be a randomized, placebo controlled, double-blind (within dosing group), dose escalation Phase 1 trial, evaluating dosages of 2.5 mcg and 8 mcg of HydroVax-005 CHIKV vaccine given intramuscularly on Day 1 and Day 29 in up to 48 healthy adults healthy adults ≥ 18 and \< 50 years of age. The primary objective is to assess the safety and reactogenicity of the HydroVax-005 CHIKV vaccine administered intramuscularly in a two-dose series on Days 1 and 29 at a dose of 2.5 mcg or a dose of 8 mcg.

Official Title

A Double Blind, Randomized, Placebo-Controlled, Phase 1 Dose Escalation Trial to Evaluate the Safety and Immunogenicity of an Inactivated Chikungunya Virus Vaccine, HydroVax-005 CHIKV, in Healthy Adults

Quick Facts

Study Start:2024-11-04

Study Completion:2026-02-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06669208

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 49 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Provide written informed consent prior to initiation of any study procedures. 2. Are able to understand and comply with planned study procedures and be available for all study visits. 3. Must agree to the collection of venous blood per protocol. 4. Are males or non-pregnant females, ≥18 and \<50 years of age, inclusive at time of enrollment. 5. Are in good health. As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical or psychiatric diagnoses or conditions, defined as those that have been present for at least 90 days, which would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations. Chronic medical diagnoses or conditions should be stable for the last 60 days (no hospitalizations, emergency room or urgent care for condition, or invasive medical procedure and no adverse symptoms that need medical intervention such as medication change/supplemental oxygen). This includes no change in chronic prescription medication, dose or in the 60 days prior to enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, as long as in the same class of medication, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site PI or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening or treatment of continued symptoms of medical diagnosis or condition. Note: Low dose topical, corticosteroids as outlined in the Subject Exclusion Criteria as well as herbals, vitamins and supplements are permitted. 6. Oral temperature is less than 100.0℉. 7. Pulse is 40 to 100 beats per minute, inclusive. 8. Systolic blood pressure is 90 to 140 mmHg, inclusive. 9. Diastolic blood pressure is 60 to 90 mmHg, inclusive. 10. Screening laboratories (White Blood Cell Count (WBC), Hemoglobin (Hgb), Platelet Count (PLTs), Sodium, Potassium, Bicarbonate, Calcium, Creatinine (Cr), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Total Bilirubin (TBIL) and urine protein and glucose) are within acceptable parameters. Hematology, blood chemistry and liver enzymes must be Grade 1 or less at screening; urine glucose negative and urine protein no greater than trace at screening for subjects to qualify for randomization and vaccination. 11. Negative test result at screening blood draw for hepatitis B virus (HBV) surface antigen (HBsAg), hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) types 1 or 2 antibodies. 12. Women of childbearing potential must use an acceptable contraception method from at least 30 days before the first study vaccination until 30 days after the second study vaccination. Not sterilized via, bilateral oophorectomy, salpingectomy, hysterectomy, or successful Essure® placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or \<1 year has passed since the last menses if menopausal. Includes non-male sexual relationships, full abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more and shown to be azoospermic prior to the subject receiving the study vaccination, effective intrauterine devices, NuvaRing®, tubal ligation, and licensed hormonal methods such as implants, injectables or oral contraceptives (i.e. "the pill"). 13. Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours prior to each study vaccination. 14. Sexually active males must agree to use a medically acceptable form of contraception in order to be in this study and must agree to continue such use until day 90 after the last vaccination. Medically acceptable contraceptives include: (1) surgical sterilization (such as a vasectomy), or (2) a condom used with a spermicide. Contraceptive measures such as Plan B™, sold for emergency use after unprotected sex, are not acceptable methods for routine use.	1. Have an acute illness or acute febrile illness (oral temperature ≥ 38℃ \[100.4℉\]), as determined by the site PI or appropriate sub-investigator, within 72 hours prior to study vaccination. An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol. 2. Have any medical disease or condition that, in the opinion of the site PI or appropriate sub-investigator, is a contraindication to study participation. Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial. 3. Have immunosuppression as a result of an underlying illness or treatment, a recent history or current use of immunosuppressive or immunomodulating disease therapy. 4. Use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination. 5. Have known active or recently active (12 months) neoplastic disease or a history of any hematologic malignancy. Non-melanoma, treated, skin cancers are permitted. 6. Known allergy to components of the study product. Including the following: aluminum hydroxide, sorbitol, potassium chloride, sodium chloride and polysorbate80 (Tween80) 7. Unstable seizure disorder (defined as requiring medication for seizure control or with seizure activity within the past 3 years). 8. Have a history of alcohol or drug abuse within 5 years prior to study vaccination. 9. Have any diagnosis, current or past, of schizophrenia, bipolar disease or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations. As determined by the site PI or appropriate sub-investigator. 10. Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 5 years prior to study vaccination. 11. Have a history of asthma, other than mild, well-controlled asthma. Cold or exercise induced asthma controlled with inhaled medications other than inhaled corticosteroids is permissible. Participants should be excluded if they require daily bronchodilator use, or have had an asthma exacerbation requiring oral/parenteral steroid use or have used theophylline or inhaled corticosteroids in the past year. 12. Have a history of diabetes mellitus. 13. Have taken oral or parenteral (including intra-articular) or chronic topical corticosteroids of any dose within 30 days prior to study vaccination. Corticosteroid nasal sprays for allergic rhinitis are permissible. Persons using a topical corticosteroid for a limited duration for mild uncomplicated dermatitis such as poison ivy or contact dermatitis may be enrolled the day after their therapy is completed. 14. Have taken high-dose inhaled corticosteroids within 30 days prior to study vaccination. High-dose 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. 15. Received or plan to receive a licensed, authorized or unlicensed, live vaccine within 30 days before or after each study vaccination. 16. Received or plan to receive a licensed, authorized or unlicensed, inactivated vaccine or allergy desensitization shot within 14 days before or after each study vaccination. 17. Received an experimental agent within 30 days prior to the study vaccination or expect to receive another experimental agent during the trial-reporting period. Including, drug, biologic, device, blood product, or medication. 18. Are participating or plan to participate in another clinical trial with an interventional agent that will be received during the trial-reporting period. Including licensed or unlicensed, drug, biologic, device, blood product, or medication. 19. Female subjects who are breastfeeding or plan to breastfeed from the time of the first study vaccination through 30 days after the last study vaccination. 20. Receipt of blood products or immunoglobulin within six months prior to enrollment. 21. Donation of a unit of blood within 60 days prior to enrollment or intends to donate blood during the study period. 22. Body mass index (BMI) ≥ 35. 23. History of a visit to, or prior residence in, South America, sub-Saharan Africa or Southeast Asia lasting one month or more. 24. Planned travel to areas known to be endemic with chikungunya virus during the study period. 25. History of vaccination against chikungunya virus. 26. History of vaccination with other alphavirus candidate vaccines. 27. History of chikungunya virus infection. 28. Plan to have a major change in exercise routine or perform strenuous exercise from 72 hours before any dose of study vaccine/placebo and for 72 hours before any safety laboratories. Safety laboratories are obtained on Days 4 and 15 following each dose of study product. 29. Contraindication to intramuscular vaccination of either upper arm (for example, due to lymphadenectomy or obscuring tattoos). 30. History of chronic arthralgia or arthritis

Inclusion Criteria

Exclusion Criteria

1. Provide written informed consent prior to initiation of any study procedures.
2. Are able to understand and comply with planned study procedures and be available for all study visits.
3. Must agree to the collection of venous blood per protocol.
4. Are males or non-pregnant females, ≥18 and \<50 years of age, inclusive at time of enrollment.
5. Are in good health. As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical or psychiatric diagnoses or conditions, defined as those that have been present for at least 90 days, which would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations. Chronic medical diagnoses or conditions should be stable for the last 60 days (no hospitalizations, emergency room or urgent care for condition, or invasive medical procedure and no adverse symptoms that need medical intervention such as medication change/supplemental oxygen). This includes no change in chronic prescription medication, dose or in the 60 days prior to enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, as long as in the same class of medication, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site PI or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening or treatment of continued symptoms of medical diagnosis or condition. Note: Low dose topical, corticosteroids as outlined in the Subject Exclusion Criteria as well as herbals, vitamins and supplements are permitted.
6. Oral temperature is less than 100.0℉.
7. Pulse is 40 to 100 beats per minute, inclusive.
8. Systolic blood pressure is 90 to 140 mmHg, inclusive.
9. Diastolic blood pressure is 60 to 90 mmHg, inclusive.
10. Screening laboratories (White Blood Cell Count (WBC), Hemoglobin (Hgb), Platelet Count (PLTs), Sodium, Potassium, Bicarbonate, Calcium, Creatinine (Cr), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Total Bilirubin (TBIL) and urine protein and glucose) are within acceptable parameters. Hematology, blood chemistry and liver enzymes must be Grade 1 or less at screening; urine glucose negative and urine protein no greater than trace at screening for subjects to qualify for randomization and vaccination.
11. Negative test result at screening blood draw for hepatitis B virus (HBV) surface antigen (HBsAg), hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) types 1 or 2 antibodies.
12. Women of childbearing potential must use an acceptable contraception method from at least 30 days before the first study vaccination until 30 days after the second study vaccination. Not sterilized via, bilateral oophorectomy, salpingectomy, hysterectomy, or successful Essure® placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or \<1 year has passed since the last menses if menopausal. Includes non-male sexual relationships, full abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more and shown to be azoospermic prior to the subject receiving the study vaccination, effective intrauterine devices, NuvaRing®, tubal ligation, and licensed hormonal methods such as implants, injectables or oral contraceptives (i.e. "the pill").
13. Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours prior to each study vaccination.
14. Sexually active males must agree to use a medically acceptable form of contraception in order to be in this study and must agree to continue such use until day 90 after the last vaccination. Medically acceptable contraceptives include: (1) surgical sterilization (such as a vasectomy), or (2) a condom used with a spermicide. Contraceptive measures such as Plan B™, sold for emergency use after unprotected sex, are not acceptable methods for routine use.

1. Have an acute illness or acute febrile illness (oral temperature ≥ 38℃ \[100.4℉\]), as determined by the site PI or appropriate sub-investigator, within 72 hours prior to study vaccination. An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.
2. Have any medical disease or condition that, in the opinion of the site PI or appropriate sub-investigator, is a contraindication to study participation. Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial.
3. Have immunosuppression as a result of an underlying illness or treatment, a recent history or current use of immunosuppressive or immunomodulating disease therapy.
4. Use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination.
5. Have known active or recently active (12 months) neoplastic disease or a history of any hematologic malignancy. Non-melanoma, treated, skin cancers are permitted.
6. Known allergy to components of the study product. Including the following: aluminum hydroxide, sorbitol, potassium chloride, sodium chloride and polysorbate80 (Tween80)
7. Unstable seizure disorder (defined as requiring medication for seizure control or with seizure activity within the past 3 years).
8. Have a history of alcohol or drug abuse within 5 years prior to study vaccination.
9. Have any diagnosis, current or past, of schizophrenia, bipolar disease or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations. As determined by the site PI or appropriate sub-investigator.
10. Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 5 years prior to study vaccination.
11. Have a history of asthma, other than mild, well-controlled asthma. Cold or exercise induced asthma controlled with inhaled medications other than inhaled corticosteroids is permissible. Participants should be excluded if they require daily bronchodilator use, or have had an asthma exacerbation requiring oral/parenteral steroid use or have used theophylline or inhaled corticosteroids in the past year.
12. Have a history of diabetes mellitus.
13. Have taken oral or parenteral (including intra-articular) or chronic topical corticosteroids of any dose within 30 days prior to study vaccination. Corticosteroid nasal sprays for allergic rhinitis are permissible. Persons using a topical corticosteroid for a limited duration for mild uncomplicated dermatitis such as poison ivy or contact dermatitis may be enrolled the day after their therapy is completed.
14. Have taken high-dose inhaled corticosteroids within 30 days prior to study vaccination. High-dose 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.
15. Received or plan to receive a licensed, authorized or unlicensed, live vaccine within 30 days before or after each study vaccination.
16. Received or plan to receive a licensed, authorized or unlicensed, inactivated vaccine or allergy desensitization shot within 14 days before or after each study vaccination.
17. Received an experimental agent within 30 days prior to the study vaccination or expect to receive another experimental agent during the trial-reporting period. Including, drug, biologic, device, blood product, or medication.
18. Are participating or plan to participate in another clinical trial with an interventional agent that will be received during the trial-reporting period. Including licensed or unlicensed, drug, biologic, device, blood product, or medication.
19. Female subjects who are breastfeeding or plan to breastfeed from the time of the first study vaccination through 30 days after the last study vaccination.
20. Receipt of blood products or immunoglobulin within six months prior to enrollment.
21. Donation of a unit of blood within 60 days prior to enrollment or intends to donate blood during the study period.
22. Body mass index (BMI) ≥ 35.
23. History of a visit to, or prior residence in, South America, sub-Saharan Africa or Southeast Asia lasting one month or more.
24. Planned travel to areas known to be endemic with chikungunya virus during the study period.
25. History of vaccination against chikungunya virus.
26. History of vaccination with other alphavirus candidate vaccines.
27. History of chikungunya virus infection.
28. Plan to have a major change in exercise routine or perform strenuous exercise from 72 hours before any dose of study vaccine/placebo and for 72 hours before any safety laboratories. Safety laboratories are obtained on Days 4 and 15 following each dose of study product.
29. Contraindication to intramuscular vaccination of either upper arm (for example, due to lymphadenectomy or obscuring tattoos).
30. History of chronic arthralgia or arthritis

Contacts and Locations

Study Locations (Sites)

Duke University Health System

Durham, North Carolina, 27705

United States

Collaborators and Investigators

Sponsor: Najit Technologies, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-04

Study Completion Date2026-02-20

Study Record Updates

Study Start Date2024-11-04

Study Completion Date2026-02-20

Terms related to this study

Keywords Provided by Researchers

Chikungunya virus
HydroVax
dose-ranging
double blind
placebo-controlled
vaccine

Additional Relevant MeSH Terms

Chikungunya Fever
Chikungunya Virus
Chikungunya