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

48 Participants Needed

Trial Summary

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.

What makes the HydroVax-005 CHIKV treatment unique for Chikungunya?

There is no relevant information available in the provided research articles about the HydroVax-005 CHIKV treatment for Chikungunya. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Evaluation of a recombinant DNA hepatitis B vaccine in a vaccinated Nigerian population. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Immunogenicity of a recombinant hepatitis B vaccine (Euvax-B) in haemodialysis patients and staff. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

A multi-center controlled study of rapid hepatitis B vaccination using a novel triple antigen recombinant vaccine. [2019]

4. Netherlands 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). [2019]

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Clinical trials of oral recombinant bivaccine against variola and hepatitis B during double vaccination]. [2016]