Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
PHASE1
Total Enrollment
48 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-11-04
Study Completion Date
2026-02-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Chikungunya Vaccine (V184) Study in Previously Exposed Adults (V184-006)
NCT03807843
Chikungunya Virus Infection
COMPLETED
PHASE2
Trial of an Inactivated Yellow Fever Virus Vaccine
NCT05172544
Yellow Fever
COMPLETED
PHASE1
Randomized, Placebo-controlled, Observer-blinded Phase 1 Safety and Immunogenicity Study of Inactivated Zika Virus Vaccine Candidate in Healthy Adults
NCT03425149
Zika Virus
Zika Virus Infection
COMPLETED
PHASE1
Phase 1 Trial of Inactivated West Nile Virus Vaccine
NCT02337868
West Nile Viral Infection
COMPLETED
PHASE1
Zika Virus Purified Inactivated Vaccine (ZPIV) Accelerated Vaccination Schedule Study
NCT02937233
Zika
COMPLETED
PHASE1
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 (the day of first vaccination is defined as Day 1) and Day 29 in healthy adults ≥ 18 and \< 50 years of age. The study will consist of two dosing groups of HydroVax-005 CHIKV vaccine to be enrolled sequentially. Each dose group will consist of 20 individuals who receive HydroVax-002 YFV, as well as 8 total subjects who receive placebo. Each dose-group will include a sentinel subgroup consisting of 5 vaccine and 1 placebo recipient. In each of the two (2.5 mcg and 8 mcg) dose phases, enrollment is halted after the dose 1 vaccination of the sentinel subgroup. Following assessment of safety and reactogenicity data of Group 1 by the Internal Safety Review Committee (ISRC), the vaccine dose will be increased to 8 mcg for Group 2.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Chikungunya Fever
Chikungunya Virus
Chikungunya
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
SEQUENTIAL
Primary Study Purpose
PREVENTION
Blinding Strategy
TRIPLE
Participants
Investigators
Outcome Assessors
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Low Dose
20 subjects will receive 2.5 mcg intramuscularly (IM) of HydroVax-005 CHIKV on Days 1 and 29
Group Type
EXPERIMENTAL
HydroVax-005 CHIKV
Intervention Type
BIOLOGICAL
HydroVax-005 CHIKV vaccine
High Dose
20 subjects will receive 8 mcg intramuscularly (IM) of HydroVax-005 CHIKV on Days 1 and 29
Group Type
EXPERIMENTAL
HydroVax-005 CHIKV
Intervention Type
BIOLOGICAL
HydroVax-005 CHIKV vaccine
Placebo
8 subjects will receive normal saline placebo intramuscularly (IM) on Days 1 and 29
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
OTHER
NaCl 0.9%, Normal Saline
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HydroVax-005 CHIKV
HydroVax-005 CHIKV vaccine
Intervention Type
BIOLOGICAL
Placebo
NaCl 0.9%, Normal Saline
Intervention Type
OTHER
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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.
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.
Exclusion Criteria
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
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
Minimum Eligible Age
18 Years
Maximum Eligible Age
49 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Sponsor Role
collaborator
Najit Technologies, Inc.
INDUSTRY
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Duke University Health System
Durham, North Carolina, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
24-0001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Dose-escalation Phase 1 to Evaluate the Safety and Efficacy of MG1111 in Healthy Adults
NCT02367638
COMPLETED
PHASE1
Safety and Immunogenicity of an Inactivated West Nile Virus Vaccine in Healthy Adults
NCT06745921
ACTIVE_NOT_RECRUITING
PHASE1
Trial of Yellow Fever Inactivated Vaccine
NCT00995865
COMPLETED
PHASE1
Immunogenicity and Safety of Booster Immunization of ZF2001 After Inoculation With Two Doses of CoronaVac
NCT05205096
COMPLETED
PHASE1/PHASE2
A Multicenter, Randomized, Placebo-Controlled, Double-Blinded, Phase I Trial to Evaluate the Safety and Immunogenicity of Live Recombinant Canarypox ALVAC-HIV vCP205 Combined With GM-CSF in Healthy, HIV-1 Uninfected Volunteers
NCT00001090
COMPLETED
PHASE1
Dose-ranging Study of an Investigational Yellow Fever Candidate Vaccine in Adults
NCT04142086
COMPLETED
PHASE1
Safety and Immunogenicity of Recombinant SARS-CoV-2 Spike Protein Vaccine (CHO Cell) for the Prevention of COVID-19
NCT05313022
UNKNOWN
PHASE1/PHASE2
VRC 705: A Zika Virus DNA Vaccine in Healthy Adults and Adolescents
NCT03110770
COMPLETED
PHASE2
A Study to Evaluate Immunogenicity and Safety After the First and Second Doses of MG1111 (BARYCELA Inj.) in Healthy Children Aged 12 Months to 12 Years
NCT07054099
NOT_YET_RECRUITING
PHASE3
Safety and Immunogenicity of a Candidate ZIKV Vaccine (ZIKA001)
NCT04015648
COMPLETED
PHASE1
Long-term Efficacy of Recombinant Zoster Vaccine (CHO Cell) Study
NCT07293065
NOT_YET_RECRUITING
PHASE3
A Study of V330 in Healthy Younger (18 to 49 Years Inclusive) and Healthy Older (60 to 79 Years Inclusive) Participants (V330-001)
NCT06630117
COMPLETED
PHASE1
A Clinical Trial to Evaluate the Recombinant SARS-CoV-2 Vaccine (CHO Cell) for COVID-19
NCT04869592
COMPLETED
PHASE1/PHASE2
Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cells) and Inactivated COVID-19 Vaccine (Vero Cells) in Population Aged 18 Years and Above
NCT05033847
UNKNOWN
PHASE2
Dose Escalation Study to Evaluate the Safety and Immunogenicity of the Cholera Conjugate Vaccine in Healthy Adults
NCT05559983
COMPLETED
PHASE1
A Clinical Trial of a Prophylactic Plasmid DNA Vaccine for COVID-19 [Covigenix VAX-001] in Adults
NCT04591184
COMPLETED
PHASE1/PHASE2
Study to Evaluate the Immunogenicity and Safety of an Ebola Virus (EBOV) Glycoprotein (GP) Vaccine in Healthy Subjects
NCT02370589
COMPLETED
PHASE1
Phase 1b Study Investigating Safety & Immunogenicity of TDV Given Intradermally by Needle or Needle-Free PharmaJet Injector
NCT01765426
COMPLETED
PHASE1
Study of the Immunogenicity, Safety and Tolerability of the Convacell Vaccine.
NCT05156723
COMPLETED
PHASE1/PHASE2
A Study of Purified Inactivated Zika Virus Vaccine (PIZV) in Healthy Adults
NCT05469802
WITHDRAWN
PHASE2
Phase I Study to Evaluate Basic Pharmacodynamic, Pharmacological and Toxicological Effects of the Newly Developed Crimean-Congo Hemorrhagic Fever Vaccine for Humans
NCT03020771
COMPLETED
PHASE1
VRC 320: A Phase I, Randomized Clinical Trial to Evaluate the Safety and Immunogenicity of a Zika Virus DNA Vaccine, VRC-ZKADNA090-00-VP, Administered Via Needle and Syringe or Needle-free Injector, PharmaJet, inHealthy Adults
NCT02996461
COMPLETED
PHASE1
A Study of an Investigational Zoster Vaccine in Subjects With a History of Varicella (Chickenpox) Given Concomitantly With Another Vaccine (V211-011)
NCT00231816
COMPLETED
PHASE3
Study to Evaluate the Safety and Effectiveness of Zostavax™ in Subjects 50 - 59 Years of Age (V211-022)
NCT00534248
COMPLETED
PHASE3