Chikungunya Vaccine for Chikungunya
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Najit Technologies, Inc.
Must not be taking: Immunosuppressants, Chemotherapy, Corticosteroids, others
Disqualifiers: Immunosuppression, Neoplastic disease, Diabetes, others
Trial Summary
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.
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.
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
+11 more
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.
+18 more
Trial 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
Participant Groups
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.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low DoseExperimental Treatment1 Intervention
20 subjects will receive 2.5 mcg intramuscularly (IM) of HydroVax-005 CHIKV on Days 1 and 29
Group II: High DoseExperimental Treatment1 Intervention
20 subjects will receive 8 mcg intramuscularly (IM) of HydroVax-005 CHIKV on Days 1 and 29
Group III: PlaceboPlacebo Group1 Intervention
8 subjects will receive normal saline placebo intramuscularly (IM) on Days 1 and 29
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Duke University Health SystemDurham, NC
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Who Is Running the Clinical Trial?
Najit Technologies, Inc.Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)Collaborator
References
Evaluation of a recombinant DNA hepatitis B vaccine in a vaccinated Nigerian population. [2019]Recombinant hepatitis B vaccine was introduced in 1986 and has gradually replaced the plasma-derived hepatitis B vaccine. No published data are available on the immunogenicity of hepatitis B vaccines in Nigerians. The current study aimed to evaluate protective sero-conversion rates after vaccination with Shanvac-B rDNA hepatitis B vaccine in Nigerian subjects between January and September 2009.
Immunogenicity of a recombinant hepatitis B vaccine (Euvax-B) in haemodialysis patients and staff. [2019]Hepatitis B vaccine is the most effective strategy for preventing the transmission of hepatitis B virus (HBV) in haemodialysis centers. Nevertheless, lower vaccine responses have been reported in haemodialysis patients as compared with healthy subjects. This study examines the response to Euvax-B in Brazilian haemodialysis patients and staff. A total of 102 eligible patients (n = 42) and staff members (n = 60) consented to be studied. Patients were immunized intramuscularly with four doses of 40 microg of Euvax-B vaccine at 0, 1, 2 and 6 months. In staff members, the vaccine was administered in three doses of 20 microg at 0, 1, and 6 months. Post-vaccine samples were taken from all subjects I month after each dose. The vaccine response was determined by measuring antibody to the hepatitis B surface antigen (anti-HBs) levels using ELISA. Subjects with anti-HBs titres equal to or higher than 10 UI/L were considered immune protected. Of the haemodialysis patients who received four doses of hepatitis B vaccine, 89.5% responded to Euvax-B vaccine. The geometric mean of anti-HBs titres was 322.8 IU/L (95% CI: 317.7-328). Among staff members, 93.3% reached anti-HBs protective titres after the third vaccine dose. The geometric mean of anti-HBs titres was 2,209 IU/L (Cl: 2,198-2,219). Age, male gender and body mass index were not associated with vaccine response in either group. This study showed a good immunogenicity response to Euvax-B in haemodialysis patients and staff.
A multi-center controlled study of rapid hepatitis B vaccination using a novel triple antigen recombinant vaccine. [2019]Hepatitis B vaccines have been available for 20 years, however, the disease still remains a global problem. Clearly, the protection of at-risk groups could be improved if a more potent vaccine with a shorter vaccination regimen were available. Hepacare is new recombinant vaccine, which contains three of the surface antigens of the HB virus and has higher immunogenicity than present single antigen (HBsAg only) vaccines. This study evaluates the potential for developing seroprotection rapidly and the viability of a 1 month/two dose regimen. A total of 400 adult subjects were vaccinated using either the present accelerated 2 month/three dose regimen of Engerix-B or a 1 month/two dose regimen of a novel triple antigen vaccine (Hepacare). Both vaccines were well tolerated. Four weeks after a single dose, the seroprotective rates for Engerix-B and the triple antigen vaccine were 5 and 17%, respectively. By month 2, 4 weeks after two doses of vaccine, it was 38 and 61%. Finally by month 3, 4 weeks after a third dose of Engerix-B or placebo, respectively, the seroprotection rates were 71 and 82%. The geometric mean titres (GMTs), of these responders was then 119 and 120 IU/l, respectively. Both vaccines were well tolerated. At all points up to and including 3 months after beginning vaccination, the novel 1 month/two dose regimen of Hepacare was significantly more effective in producing seroporotective titres than the 2 month/three dose regimen of Engerix-B (P = 0.001).
Protective efficacy of a novel hepatitis B vaccine consisting of M (pre-S2 + S) protein particles (a third generation vaccine). [2019]The protective efficacy of a new type of yeast-derived hepatitis B (HB) vaccine (TGP-943, subtype adr), which was formulated from modified M (pre-S2 + S; P31) protein (M-P31c) particles, was investigated in chimpanzees. Animals were injected intramuscularly three times at 4-week intervals with doses of 10 or 40 micrograms (as a protein) of TGP-943. There were no significant differences in the immunogenicity of 10 micrograms compared to that of 40 micrograms of TGP-943 in terms of anti-S antibody response, while the induction and persistence of anti-pre-S2 antibodies seemed dose-related. Chimpanzees, vaccinated with 40 micrograms of TGP-943, produced anti-pre-S2 antibodies 2 weeks after the first injection, which appeared earlier than anti-HBs (S) antibodies. A maximum level of the anti-pre-S2 antibodies was reached 2 weeks after the second injection. Apart from immunization with TGP-943, chimpanzees injected with denatured TGP-943, consisting of 10 micrograms (as a protein) of non-particulate M-P31c antigen, produced anti-pre-S2 antibodies with a non-protecting level of anti-S antibodies (less than 10 mIU ml-1). Five weeks after the third injection, all animals were challenged intravenously with 1000 chimpanzee infectious units of HBV subtype (ayw) and were protected as confirmed by normal serological markers, no signs of infection in the sera and liver biopsies, and no detection of HBV-DNA by PCR method. No side effects from inoculation with TGP-943 or denatured TGP-943 were also encountered in any animals.
[Clinical trials of oral recombinant bivaccine against variola and hepatitis B during double vaccination]. [2016]Clinical trials of oral live recombinant embryonic variola and hepatitis B bivaccine as tablets (Revax-BT) were performed. When volunteers were prevaccinated with oral variola vaccine first in a small dose and, 7, 14, 30, 90, and 180 days later, in a larger dose, a slight reactoginicity was sometimes observed after the first vaccination (with a small dose) whereas revaccination with a larger dose did not give rise to any clinical manifestations. A month after vaccination, a protective level of virus-neutralizing antibodies to vaccinia virus (VV) was observed in 90-100% of the volunteers twice immunized with the bivaccine (in a small dose and in a larger one at an administration intervals of 1-2 weeks under remote revaccination while 6-9 months following vaccination, this level was recorded in 80% of the volunteers. A month following vaccination, 50-55% seroconversion to VV was observed in the volunteers twice immunized with the bivaccine (at an interval of 1 or 3-6 months). Cellular immunity to VV was low (0-20%). Double immunization of volunteers with the oral bivaccine under remote vaccination failed to produce the significant levels of humoral and cellular immune responses to hepatitis B markers. Recombinant VV was not recorded in any blood, saliva, and urine samples taken in the volunteers twice immunized with the bivaccine.