Chikungunya Vaccine for Chikungunya

Overseen By Mark K Slifka, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Najit Technologies, Inc.

Must not be taking: Immunosuppressants, Chemotherapy, Corticosteroids, others

Disqualifiers: Immunosuppression, Neoplastic disease, Diabetes, others

Compensation: Varies

Number of Visits: 17

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and side effects of a new vaccine, HydroVax-005 CHIKV, designed to protect against chikungunya, a virus that causes fever and joint pain. Participants will receive either a low dose, a high dose, or a placebo (a substance with no active ingredient) to determine the best dosage. The trial seeks healthy adults without major health conditions who have never been infected by chikungunya. Participants should not have traveled to regions where chikungunya is common, such as South America or Southeast Asia, for extended periods. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new vaccine.

Do I need to stop my current medications to join the trial?

The trial does not require you to stop taking your current medications as long as they are stable and do not pose additional risks. However, certain medications like high-dose inhaled corticosteroids or recent use of oral corticosteroids may exclude you from participation.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that the HydroVax-005 CHIKV vaccine has been tested for its ability to create an immune response against different strains of the chikungunya virus. In earlier trials, more than 10% of participants experienced common side effects, such as soreness at the injection site and headaches. These reactions are typical for many vaccines and are usually mild.

Reports of serious side effects, including hospitalizations and a few deaths, have been associated with another chikungunya vaccine, but not with HydroVax-005 CHIKV. Awareness of potential risks is important, though the HydroVax-005 CHIKV vaccine remains in the early stages of testing. It is primarily being tested for safety and tolerability, with any severe reactions being closely monitored. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about HydroVax-005 CHIKV because it represents a new approach to fighting chikungunya, a mosquito-borne virus with no specific antiviral treatment currently available. Unlike typical supportive care that focuses on alleviating symptoms, HydroVax-005 CHIKV is a vaccine designed to prevent the infection altogether. The vaccine uses a novel inactivated virus platform, which is different from traditional live-attenuated vaccines, potentially offering a safer alternative for individuals with weakened immune systems. This innovation could significantly change how we manage and protect against chikungunya outbreaks.

What evidence suggests that the HydroVax-005 CHIKV vaccine might be an effective treatment for Chikungunya?

Research has shown that the HydroVax-005 CHIKV vaccine produced promising results in early tests. In past studies, this vaccine generated strong immune responses, crucial for fighting infections. Animal studies demonstrated that vaccinated animals were protected against key symptoms of chikungunya, such as the virus in the blood and joint pain. This suggests the vaccine could prevent chikungunya symptoms in people. In this trial, participants will receive either a high dose, a low dose of HydroVax-005 CHIKV, or a placebo. These findings are encouraging, but further testing in humans is needed to confirm its effectiveness. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Provide written informed consent prior to initiation of any study procedures

Agree to the collection of venous blood per protocol

Exclusion Criteria

I haven't had cancer treatment or radiation in the last 3 years.

I have an active cancer or blood disease.

I am currently immunosuppressed or have recently used immunosuppressive therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two doses of HydroVax-005 CHIKV vaccine or placebo on Days 1 and 29

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Multiple visits (in-person and virtual) at days 15, 29, 57, and 180 following second vaccination

What Are the Treatments Tested in This Trial?

Interventions

• HydroVax-005 CHIKV

Trial Overview 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.

How Is the Trial Designed?

Group I: Low Dose Experimental Treatment 1 Intervention

20 subjects will receive 2.5 mcg intramuscularly (IM) of HydroVax-005 CHIKV on Days 1 and 29

Group II: High Dose Experimental Treatment 1 Intervention

20 subjects will receive 8 mcg intramuscularly (IM) of HydroVax-005 CHIKV on Days 1 and 29

Group III: Placebo Placebo Group 1 Intervention

8 subjects will receive normal saline placebo intramuscularly (IM) on Days 1 and 29

Who Is Running the Clinical Trial?

Najit Technologies, Inc.

Lead Sponsor

Trials

2

Recruited

70+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Published Research Related to This Trial

The oral live recombinant bivaccine (Revax-BT) showed a good safety profile, with only slight reactogenicity observed after the initial small dose, and no clinical manifestations after subsequent larger doses.

The bivaccine effectively induced a protective level of virus-neutralizing antibodies to the vaccinia virus in 90-100% of volunteers one month after double immunization, although it did not significantly enhance immune responses to hepatitis B markers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical trials of oral recombinant bivaccine against variola and hepatitis B during double vaccination]. Pliasunov, IV., Sergeev, AN., Sergeev, AA., et al.[2016]

In a study of 376 Nigerian participants, the Shanvac-B rDNA hepatitis B vaccine demonstrated high immunogenicity, with 100% protective sero-conversion after the third dose, highlighting the importance of completing the three-dose vaccination schedule.

The study found that while only 6.3% of participants developed protective antibodies after the first dose, this increased to 89.3% after the second dose, indicating that the second dose significantly enhances immune response, especially in males.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a recombinant DNA hepatitis B vaccine in a vaccinated Nigerian population. Adoga, MP., Pennap, G., Akande, BO., et al.[2019]

In a study of 102 participants, including 42 haemodialysis patients and 60 staff members, 89.5% of patients and 93.3% of staff developed protective antibody levels after receiving the Euvax-B hepatitis B vaccine, indicating strong immunogenicity.

The geometric mean of antibody levels was significantly higher in staff members (2,209 IU/L) compared to haemodialysis patients (322.8 IU/L), suggesting that while both groups responded well to the vaccine, staff had a notably stronger immune response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity of a recombinant hepatitis B vaccine (Euvax-B) in haemodialysis patients and staff. Tele, SA., Martins, RM., Lopes, CL., et al.[2019]

The new Hepacare vaccine, which uses three surface antigens of the Hepatitis B virus, demonstrated significantly higher seroprotection rates compared to the existing Engerix-B vaccine, especially with a 1 month/two dose regimen.

In a study of 400 adult subjects, Hepacare achieved a seroprotection rate of 61% after two doses, compared to only 38% for Engerix-B, indicating that Hepacare could offer a more effective and faster vaccination option against Hepatitis B.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multi-center controlled study of rapid hepatitis B vaccination using a novel triple antigen recombinant vaccine. Young, MD., Rosenthal, MH., Dickson, B., et al.[2019]

The new yeast-derived hepatitis B vaccine TGP-943 demonstrated strong protective efficacy in chimpanzees, with all vaccinated animals remaining free of infection after being challenged with the virus, indicating its potential effectiveness in preventing hepatitis B.

The vaccine was well-tolerated, with no significant side effects observed in the chimpanzees, and it induced a robust immune response, particularly with the higher dose of 40 micrograms, which led to earlier and higher levels of protective antibodies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protective efficacy of a novel hepatitis B vaccine consisting of M (pre-S2 + S) protein particles (a third generation vaccine). Fujisawa, Y., Kuroda, S., Van Eerd, PM., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9286250/

Development of a next-generation chikungunya virus vaccine ... Our immunogenicity results indicated that the HydroVax-CHIKV vaccine provided robust neutralizing antibody responses after immunization ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06669208

Trial of an Inactivated Chikungunya Virus Vaccine 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 ...

3. cdn.who.int cdn.who.int/media/docs/default-source/immunization/pdvac/pdvac-2023/09_chikungunya_vaccine_sessions_121223-merged.pdf?sfvrsn=ee311945_1

Chikungunya: Epidemiology and Risk Groups effectiveness of CHIKV vaccines, including: – Effectiveness endpoints, such as viremia, arthritis-related endpoints or other essential ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35788221/

Development of a next-generation chikungunya virus vaccine ... Following heterologous infection with CHIKV-SL15649, HydroVax-CHIKV-immunized mice were protected against viremia, CHIKV-associated arthritic ...

5. insight.jci.org insight.jci.org/articles/view/160173

Effectiveness of CHIKV vaccine VLA1553 demonstrated by ... In this study, we demonstrated that NHPs were protected from WT CHIKV-induced viremia, fever, and further clinical signs of CHIK disease upon ...

6. fda.gov fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-update-safety-ixchiq-chikungunya-vaccine-live

FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, ... Reported serious adverse events have included 21 hospitalizations and 3 deaths. Furthermore, the clinical benefit of the vaccine has not yet ...

7. cdc.gov cdc.gov/chikungunya/hcp/vaccines/index.html

Chikungunya Vaccine Information for Healthcare Providers Common adverse reactions following vaccination that occurred in more than 10% of vaccinated participants in clinical trials included tenderness, headache, ...

8. mayoclinic.org mayoclinic.org/drugs-supplements/chikungunya-vaccine-live-intramuscular-route/description/drg-20559698

Chikungunya vaccine, live (intramuscular route) This vaccine may cause severe or prolonged chikungunya-like reactions. Check with your doctor right away if you have blurred vision, confusion, ...