A Phase 2 interventional study of VEE C-84 in Venezuelan Equine Encephalomyelitis, sponsored by U.S. Army Medical Research and Development Command. Status unknown at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-11.
Sponsored by U.S. Army Medical Research and Development Command · Phase 2, Interventional, and Prevention
The study is designed to assess the safety and immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination.
Study Objectives:
Primary:
To assess safety of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination as a single dose or a three-dose series, and To assess immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination as a single dose or a three-dose series
Secondary:
To assess incidence of VEE infection in C-84 boosted personnel.
125 studies on the registry are indexed under Encephalitis; 33 are open to participants now.
This study's planned enrollment of 500 is above the median of 55 across 62 interventional studies indexed under Encephalitis.
Browse Encephalitis studies →U.S. Army Medical Research and Development Command is the lead sponsor of 153 studies on the registry; 8 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) 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.
Exclusion Criteria:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
VEE C-84 - Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI-GSD 205
Biological: VEE C-84
Subjects will receive a 0.5 mL subcutaneous injection in the upper outer aspect of arm; maximum of four boosters in 1 year if titer \<1:20.
Frequency of Adverse Events (ITT)
Frequency of the following adverse events will be evaluated for all intent-to-treat subjects: headache, myalgia, fever, fatigue, sore throat, erythema, tenderness, and warmth.
Time frame: Day 28 after each booster dose
Immunogenicity: TC-83 with PRNT80 ≥ 1:20
Number of initial responders to TC-83 with PRNT80 ≥ 1:20 after C-84 booster dose.
Time frame: Between Days 28 and 35 after each booster dose
Immunogenicity: TC-83 with PRNT80 ≥ 1:20
Number of initial responders to TC-83 with PRNT80 ≥ 1:20 after C-84 booster dose.
Time frame: 12-15 months after booster dose
Immunogenicity: TC-83 with PRNT80 < 1:20
Number of initial responders to TC-83 who are non-responders (PRNT80 \< 1:20) to C-84 booster dose.
Time frame: Between Days 28 and 35 after each booster dose
Immunogenicity: TC-83 with PRNT80 < 1:20
Number of initial responders to TC-83 who are non-responders (PRNT80 \< 1:20) to C-84 booster dose.
Time frame: 12-15 months after vaccination
Immunogenicity: TC-83 with PRNT80 ≥ 1:20 after three booster doses
Time frame: After three booster doses
Immunogenicity: TC-83 with PRNT80 ≥ 1:20 12- 15 months after first booster dose
Time frame: 12- 15 months after first booster dose
Immunogenicity: PRNT80 ≥ 1:20 after 1 dose
Number of rollovers from past C-84 booster study with PRNT80 ≥ 1:20 after 1 dose.
Time frame: After 1 dose
Immunogenicity: PRNT80 ≥ 1:20 12-15 months post dose for new C-84 Protocol.
Time frame: 12-15 months post dose for new C-84 Protocol
VEE disease among vaccinated subjects who achieved a PRNT80 ≥ 1:20.
The number of confirmed cases of VEE disease among vaccinated subjects who achieved a PRNT80 ≥ 1:20.
Time frame: Length of the study
This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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