Chikungunya Vaccine for Chikungunya

Phase 1

Recruiting

Research Sponsored by Najit Technologies, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women of childbearing potential must have negative pregnancy tests

Be males or non-pregnant females, aged 18 to less than 50 years at time of enrollment

Must not have

Have known active or recently active neoplastic disease or hematologic malignancy

Have immunosuppression or recent use of immunosuppressive therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at days 15 and 29 after first vaccination and at days 15, 29, 57, and 180 following second vaccination

Summary

"This trial will test a new vaccine for Chikungunya virus on healthy adults aged 18 to 50. Participants will receive two doses of the vaccine, either a low dose or a high dose

Who is the study for?

This trial is for healthy adults aged 18 to 49 who are interested in participating in a study for a Chikungunya virus vaccine. Participants must be in good health without any medical conditions that could affect their safety or the study results.

What is being tested?

The trial is testing two different doses of the HydroVax-005 CHIKV vaccine against a placebo. It's randomized and double-blind, meaning neither the participants nor the researchers know who gets the real vaccine or placebo until after the results are collected.

What are the potential side effects?

Potential side effects include reactions at the injection site, like pain or swelling, as well as general symptoms such as fever, headache, fatigue, muscle pains which are common with vaccines but usually mild and temporary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman who can have children and my pregnancy test is negative.

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I am between 18 and 49 years old and not pregnant.

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I use birth control methods if I am sexually active.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active cancer or blood disease.

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I am currently immunosuppressed or have recently used immunosuppressive therapy.

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My BMI is 35 or higher.

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I have seizures that are not well-controlled.

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I have not been sick or had a fever in the last 3 days.

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I am currently breastfeeding or plan to breastfeed.

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I cannot receive vaccines by injection into my muscles.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at days 15 and 29 after first vaccination and at days 15, 29, 57, and 180 following second vaccination

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at days 15 and 29 after first vaccination and at days 15, 29, 57, and 180 following second vaccination

This trial's timeline: 3 weeks for screening, Varies for treatment, and at days 15 and 29 after first vaccination and at days 15, 29, 57, and 180 following second vaccination for reporting.